IFPMA Developing World Health Partnerships Directory 2010 by Irish Pharmaceutical Healthcare Association

The International Federation of Pharmaceutical Manufacturers & Associations is the global non-profit NGO representing the research-based pharmaceutical industry, including the biotech and vaccine sectors. Its members comprise 25 leading international companies and 45 national and regional industry associations covering developed and developing countries. The industry’s R&D pipeline contains hundreds of new medicines and vaccines being developed to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials Portal (www.ifpma.org/ClinicalTrials), the IFPMA’s Ethical Promotion online resource (www.ifpma.org/EthicalPromotion/) and its Developing World Health Partnerships Directory (www.ifpma.org/HealthPartnerships) help make the industry’s activities more transparent. The IFPMA supports a wide range of WHO technical activities, notably those relating to medicine efficacy, quality and safety, and coordinates industry participation in the WHO IMPACT initiative to combat counterfeit medicines. It also provides the secretariat for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The program information in this book is also available in searchable form in the IFPMA website, at www.ifpma.org/healthpartnerships, and on the Global Health Progress website www.globalhealthprogress.org.

Developing World Health Partnerships Directory

Chemin Louis-Dunant 15

Tel: +41 22 338 32 00

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E-mail: info@ifpma.org

Switzerland

Web: www.ifpma.org

2010

Developing World Health Partnerships Directory 2010

Cover photo: A few Children are waiting for medicine and hold a cup in their hands, Madagascar, Merck Praziquantel Donation Program.

Table of Contents 7

Introduction

HIV/AIDS

HIV/AIDS – ARV Access

AAI - Accelerating Access Initiative Abbott Program for Expanding Access to Treatment Boehringer Ingelheim Access Bristol-Myers Squibb Global Access Program Gilead Access Program Merck & Co., Inc. Access to ARVs Roche - Access to ARVs Single Tablet per Day: Atripla® Fixed-Dose Combination Technology Transfer & ARV Licensing in Developing Countries ViiV Healthcare Access to ARVs

10 10 11 11 12 12 13 13 14 15

HIV/AIDS – Mother & Child Programs

Abbott Fund Program for Supporting Children Affected by AIDS Bristol-Myers Squibb’s Secure The Future® Children’s Clinics & Pediatric AIDS Corps Elizabeth Glaser Pediatric AIDS Foundation Empowering Africa’s Young People Initiative End Violence against Women and Prevent HIV and AIDS Program Life Skills: Community Support for Children Affected by HIV/AIDS Mothers 2 Mothers Mentoring Program Nyumbani Children’s Home PMTCT: Abbott Rapid HIV Test Donation Program Regional Psychosocial Support Initiative Roche Children’s Walk Women and Families Initiative

16 16 17 17 18 18 19 19 20 20 21 21

HIV/AIDS – Capacity Building

Abbott Fund Program to Strengthen Tanzania’s Health Care System African Comprehensive HIV/AIDS Partnerships (ACHAP) Associação Saude Da Familia HIV/AIDS Awareness AstraZeneca & AMREF: An Integrated Approach to Managing HIV/AIDS, Malaria & TB in Uganda Bristol-Myers Squibb’s Secure The Future® Collaboration for Health in Papua New Guinea (CHPNG) GlaxoSmithKline- Other HIV/AIDS Capacity-Building Initiatives Health at Home/Kenya HIV South Africa Humana: Total Control of the Epidemic IMIFAP: HIV/AIDS Education J&J Health Care Training Fund J&J - UCLA Management Development Institute JPMA’s HIV/AIDS Training Program Medical Mission Sisters Merck & Co., Inc. HIV/AIDS Programs - Africa Merck & Co., Inc. HIV/AIDS Programs - Caribbean Merck & Co., Inc. HIV/AIDS Programs - China Merck & Co., Inc. HIV/AIDS Programs - Latin America Nawa Sport Program Pfizer Diflucan® Partnership Pfizer Global Health Fellows Pfizer - Infectious Diseases Institute Pfizer - PDA Positive Partnership Saber para Reagir Sikiliza Leo Project, Uganda Takeda Initiative with Global Fund Tibotec Cost Recovery Distribution Program ViiV Healthcare’s Positive Action on HIV/AIDS ‘Youth Speak-Up!’ HIV Peer Education

22 22 23 23 24 24 25 25 26 26 27 27 28 28 29 29 30 30 31 31 32 32 33 33 34 34 35 35 36 36

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R&D

Gilead Clinical Development Partnerships HIVACAT public-private partnership for HIV vaccine development International AIDS Vaccine Initiative (IAVI) International Partnership for Microbicides (IPM) Merck & Co., Inc. HIV Vaccine R&D Pediatric Formulations for ARVs PEPFAR Partnership for Pediatric AIDS Treatment ViiV Healthcare Collaborative Research Program for Resource-Poor Settings

37 37 38 39 39 40 41 41

TUBERCULOSIS

TUBERCULOSIS – Access & Capacity Building

AstraZeneca & Red Cross: Fight against TB in Africa AstraZeneca & Red Cross: Fight against TB in Central Asia Lilly MDR-TB Partnership Novartis TB DOTS Donation Sanofi-aventis: TB Free & Other Initiatives Stop TB Partnership

44 44 45 45 46 46

TUBERCULOSIS – R&D

Aeras Global TB Vaccine Foundation AstraZeneca Bangalore Research Institute GlaxoSmithKline - TB Alliance Drug Discovery Program Global Alliance for TB Drug Development (TB Alliance) Lilly TB Drug Discovery Initiative Moxifloxacin TB Clinical Trials (Bayer HealthCare) Novartis Institute for Tropical Diseases (NITD) Otsuka Pharmaceutical: MDR-Tuberculosis R&D Ranbaxy R&D for TB Sanofi-aventis: R&D for TB

47 47 48 48 49 49 50 50 51 51

MALARIA

MALARIA – Access & Capacity Building

ACCESS II - Improving Access to Effective Malaria Treatment GlaxoSmithKline & Access to Malaria Care Millennium Villages Project Novartis Coartem® Pfizer - Mobilize Against Malaria Roll Back Malaria Partnership Sanofi-aventis: Impact Malaria

54 54 55 55 56 56 57

MALARIA – R& D

Crucell’s Malaria Vaccine R&D Medicines for Malaria Venture (MMV) Eisai Exploratory Research for the Treatment of Malaria Eurartesim™ International Development Program GlaxoSmithKline & Malaria R&D Novartis R&D for Malaria PATH Malaria Vaccine Initiative (MVI) Pfizer - Azithromycin/chloroquine for Malaria Ranbaxy R&D for Malaria Sanofi-aventis - DNDi Malaria Medicine Sanofi-aventis - Semisynthetic Artemisinin Project TLR9 Inhibitor for Cerebral Malaria

58 58 59 59 60 60 61 61 62 62 63 63

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES

TROPICAL DISEASES – Access & Capacity Building

Bayer HealthCare & African Sleeping Sickness Bayer HealthCare: Fight Against Chagas Disease Children Without Worms Gilead - AmBisome for Leishmaniasis Global Alliance to Eliminate Lymphatic Filariasis (GAELF) Guinea Worm Eradication Program (GWEP) International Trachoma Initiative (ITI) Leprosy Elimination Merck Mectizan® Donation Program Merck Praziquantel Donation Program Sanofi-aventis Sleeping Sickness Program Sanofi-aventis ‘Most Neglected Diseases’ Program

66 66 67 67 68 68 69 69 70 70 71 71

TROPICAL DISEASES – R&D

Eisai - DNDi Chagas R&D Collaboration GlaxoSmithKline - DNDi Collaboration GlaxoSmithKline Proprietary Knowledge Pool GlaxoSmithKline’s Sitamaquine for Leishmaniasis GlaxoSmithKline’s Tres Cantos Open Lab for DDW R&D Merck & Co., Inc. – DNDi Master Agreement Merck Serono Collaboration with TDR Next-Generation Onchocerciasis Treatment R&D Nifurtimox-Eflornithine for Sleeping Sickness with TDR Pfizer Collaborative Programs for Parasitic & Worm Diseases Ranbaxy R&D for Dengue Singapore Dengue Consortium

72 72 73 73 74 74 75 75 76 76 77 77

PREVENTABLE DISEASES

PREVENTABLE DISEASES – Access & Capacity Building

Bristol-Myers Squibb Foundation: Delivering Hope GAVI Alliance Global Polio Eradication Initiative HPV Vaccine & Cervical Cancer Merck Vaccine Network - Africa (MVN-A) Pandemic Influenza & Developing Countries Pneumococcal Conjugate Vaccine Programs Rotavirus Vaccine Program Sanofi-aventis & EPIVAC Sigma-Tau & AMREF: ‘Uganda Project’

80 81 82 82 83 83 84 84 85 85

PREVENTABLE DISEASES – R& D

Crucell Vaccine Research Infectious Disease Research Institute (IDRI) MSD-Wellcome Trust Hilleman Laboratories Novartis Vaccines Institute for Global Health (NVGH) Pediatric Dengue Vaccine Initiative (PDVI)

86 86 87 87 88

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH CHILD & MATERNAL HEALTH – Access & Capacity Building Abbott Fund Program to Fight Malnutrition in Vietnam Abbott Fund Program to Improve Children’s Health in Cambodia Abbott Fund Program to Improve Children’s Health in the Democratic Republic of Congo Abbott Fund Program to Improve Maternal & Child Health in Afghanistan Arpana Research and Charitable Trust Bayer Schering Pharma & Family Planning Bidan Delima Midwife Training Program Computerized Training for Management of Childhood Diseases Freedom of Breath, Fountain of Life Fuyang AIDS Orphan Salvation Ghazipur Children’s Hospital GlaxoSmithKline & Integrated Management of Childhood Illness GlaxoSmithKline: Namibia Sanitation & Hygiene Program GlaxoSmithKline’s Midwife Training in Vietnam GlaxoSmithKline’s PHASE Program Global Campaign to End Fistula Global Fund for Women Home-Based Newborn Care (HBNC) Initiative Integrated Midwives Association of the Philippines International Rescue Committee It’s Worth Dreaming Project Pankararu Health & Culture Project Ranbaxy Community Health Care Society Renascer: Helping Poor Mothers in Brazil Safe Motherhood Initiative Sanofi-aventis Children’s Programs Save the Children Unamos al Mundo por la Vida

CHRONIC DISEASES

90 92 92 92 93 93 94 94 95 95 96 96 97 97 98 98 99 99 100 100 101 101 102 102 103 103 104 104 105 105

106

CHRONIC DISEASES – Access & Capacity Building

108

Abbott Fund Program to Improve Cardiac Care in Rwanda Abbott Program to Advance Diabetes Care in Bolivia AstraZeneca Breast Cancer Program in Ethiopia Bayer HealthCare Nexavar® Access Program Cancer Awareness Leadership Initiative (CALI) Changing Diabetes in Children China Diabetes Education Program Circle of Care: Mental Health in Malaysia Glivec® International Patient Assistance Program (GIPAP™) Hypertension Program in China IDF BRIDGES Program India Diabetes Educator Project Novo Nordisk: Differential Pricing on Insulin Novo Nordisk: Haemophilia Foundation Novo Nordisk: World Partner Project Piramal: HelpyourbodyTM Chronic Disease Campaign Pfizer Global Health Partnerships Sanofi-aventis: Diabetes Prevention Sanofi-aventis: Impact Epilepsy Program for Developing Countries Sanofi-aventis: Mental Health Disorders (Schizophrenia) Sanofi-aventis: My Child Matters Staying Away from Tobacco for a Healthy Life The World Diabetes Foundation

108 108 109 109 110 110 111 111 112 112 113 113 114 114 115 115 116 116 117 117 118 118 119

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

ADDITIONAL HEALTH INITIATIVES

120

ADDITIONAL HEALTH INITIATIVES – Access & Capacity Building

122

Arogya Parivar Program - A Rural Health Initiative AstraZeneca Product Donations Boehringer Ingelheim Cares Foundation Boehringer Ingelheim: Strengthening Healthcare Capacity Bristol-Myers Squibb Medical Product Donations Ghana Surgical Skills Training Center GlaxoSmithKline & Leonard Cheshire Disability in Sri Lanka GlaxoSmithKline: Nurse Training in Tamil Nadu GlaxoSmithKline: Reinvestment in LDC Communities GlaxoSmithKline: Saloum Islands Health Project, Senegal Global Pharma Health Fund Health Training at Egypt’s National Training Institute Healthy Communities, Healthy Ecosystems Initiative Accès: Access to Primary Health Care in Mali Johnson & Johnson Burn Treatment Center (JJBTC) in Soweto JPMA: Anti-Counterfeiting Program in Cambodia JPMA: Strengthening Quality Control in Asia LEEM Quality Control Program Medical Product Donations Fellowship Program Merck Medical Outreach Program Nurse Training in East Africa Nurse Training in Somalia Red Cross Children’s Hospital, Cape Town Regional Hospital Management Program Otsuka Welfare Clinic Phelophepa Healthcare Train Roche Employee Secondment Tanzanian Training Center for International Health

122 122 123 123 124 124 125 125 126 126 127 127 128 128 129 129 130 130 131 131 132 132 133 133 134 134 135 135

DDITIONAL HEALTH INITIATIVES EMERGENCY RELIEF EFFORTS

96 136

COMPLETED PROGRAMS

141

Note: “Merck & Co., Inc.” has its headquarters in Whitehouse Station, NJ, USA and operates in most countries outside the USA as Merck Sharp & Dohme. “Merck KGaA” has its headquarters in Darmstadt, Germany. “Bayer Schering Pharma AG”, with its headquarters in Berlin, Germany, is a division of “Bayer HealthCare AG”, which has its headquarters in Leverkusen, Germany. Merck & Co. Inc., Merck KGaA and Bayer HealthCare are all members of the IFPMA. Merck & Co., Inc. and Schering-Plough merged in 2009, while Pfizer acquired Wyeth. Merck & Co., Inc. and Pfizer remain members of the IFPMA. ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

INTRODUCTION The research-based pharmaceutical industry implements a wide and growing range of access and capacity building programs to help improve health in developing countries. It is also the third largest funder of R&D for diseases of the developing world. These programs are documented in this directory, which exists as an electronic book and as a searchable online database at www.ifpma.org/healthpartnerships. Many industry programs are focused on one or more of the health-related UN Millennium Development Goals: MDG 4) reduce child mortality, MDG 5) improve maternal health, MDG 6) combat HIV/AIDS, malaria and other diseases and MDG 8E) provide access to affordable, essential drugs in developing countries. However, there are also industry programs helping to address other developing world health issues, such as the growing burden of chronic diseases, or strengthening primary care. In the 2010 edition, we document a total of 213 programs, up from 202 last year. In fact, the total number of industry programs has continued to grow year on year since we started recording them in 2003. In that year, we listed 36 programs, in HIV/AIDS, tuberculosis, malaria and tropical diseases. Today, the number of programs for those 4 disease areas alone has grown to 119, but we have had to expand the directory to capture the growing number of programs to address other health needs, including preventable diseases, child and maternal health, chronic diseases and additional health initiatives. The latter do not address a single disease or disease area, but rather aim at strengthening overall health care. Japanese companies have contributed to this growth. Eisai has notified two new R&D partnerships for malaria and one for Chagas disease, while Takeda started a capacity building program with the Global Fund to fight AIDS, Tuberculosis and Malaria. Also contributing to the increased tropical disease R&D effort was Merck & Co., Inc. through a new master agreement with DNDi covering Chagas disease, leishmaniasis and other diseases. GlaxoSmithKline also played a part, through its new Proprietary Knowledge Pool and Tres Cantos Open Lab initiatives. Listed in the Directory for the first time this year is a Quality Control program run by the IFPMA’s member association in France, LEEM, which offers expert analytical resources to help poorly resourced African countries to fight counterfeit and substandard medicines. The contribution of the research-based pharmaceutical industry to R&D for diseases of the developing (DDW) world is substantial. The end of 2009 saw the publication of the second G-FINDER report on funding for DDW R&D, covering the year 2008. Once again, our industry was the third largest source of funding for R&D for these diseases, after the US Government and the Bill and Melinda Gates Foundation. Complementary IFPMA data shows that the number of DDW medicine R&D projects undertaken by our companies continues to increase, from 32 in 2005 to 75 in 2009. Our industry’s strong and sustained commitment to help improve health in developing countries is underlined by the further increase in the number of industry programs in 2009. In particular, our industry is playing an important and growing role in the development of new medicines and vaccines for diseases of the developing world, including ones focused primarily on addressing children’s health problems. Our companies are willing to enter into new partnerships to help improve global health and the IFPMA is pleased to help bring together potential partners in this area.

Eduardo Pisani Director General IFPMA

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS

Western and Central Europe 13,000

North America 25,000

Caribbean 12,000

Latin America 77,000

Estimated adult and child deaths from AIDS during 2008 (Source: UNAIDS/WHO AIDS Epidemic Update, 2009

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

An estimated 33.4 million people were living with HIV in 2008. There were 2.7 million new HIV infections and 2 million AIDS-related deaths. AIDS continues to be the leading cause of death in Africa which is home to 67% of all people living with HIV. In Africa, 60% of people living with HIV in the region are women and three out of four young people living with HIV are female. Nearly 2 million children live with HIV worldwide, two-thirds in sub-Saharan Africa. In addition, 12 million children in sub-Saharan Africa have lost one or two parents due to HIV/AIDS. Many more live with a parent or carer with HIV. As of December 2008, approximately 4 million people in low- and middle-income countries were receiving antiretroviral therapy - a 10-fold increase over five years. Antiretroviral therapy coverage rose from 7% in 2003 to 42% in 2008, with especially high coverage achieved in eastern and southern Africa (48%) While the rapid expansion of access to antiretroviral therapy is helping to lower AIDS-related death rates in multiple countries and regions, it is also contributing to increases in HIV prevalence.

the drop in new HIV infections among children in 2008 suggests that these efforts are saving lives. Although current estimates of coverage of antiretroviral therapy for children are close to those of adults, the provision of antiretroviral therapy to children has specific challenges, including the faster progression to AIDS and death, the difficulty of diagnosing HIV in children and the challenges in developing affordable and appropriate antiretroviral regimens for children. Despite substantial progress in 2008, most low- and middle-income countries are still far from achieving universal access goals. Obstacles include weak health care systems, a critical shortage of human resources and a lack of sustainable, long-term funding. Pharmaceutical research and biotechnology companies are continuing their efforts to develop more effective new therapies and vaccines to contain the disease and improve and lengthen the lives of patients. In 2009, they were testing 97 medicines and vaccines to treat and prevent HIV/AIDS and related conditions. A total of 31 medicines to treat HIV/AIDS have been approved since the virus was first identified in 1983.

Globally, coverage for services to prevent mother-to-child HIV transmission (PMTCT) rose from 10% in 2004 to 45% in 2008, and (Sources: UNAIDS/WHO AIDS Epidemic Update 2009; PhRMA 2009 Report: Medicines in Development for HIV/AIDS)

East Asia 59,000

Middle East and North Africa 20,000

Eastern Europe and Central Asia 87,000 South and South-East Asia 270,000

Sub-Saharan Africa 1.4 million Oceania 2,000

Total AIDS deaths in 2008: 2 million Developing World Health Partnerships Directory ÂŠ IFPMA 2010 â&#x20AC;&#x201C; www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

AAI - Accelerating Access Initiative

Abbott Program for Expanding Access to Treatment

HIV/AIDS Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co. Inc., Roche, Tibotec, ViiV Healthcare UNAIDS, UNFPA, UNICEF, WHO, World Bank Since 2000 Access - Pricing & Tech Transfer Developing countries www.who.int/hiv/AAI_fs_4Q2005.pdf

HIV/AIDS Abbott Various partners Since 2001 Access - Pricing Africa, LDCs, low & lower-middle income countries www.abbottglobalcare.org

The Accelerating Access Initiative (AAI), begun in 2000, is a partnership between UNAIDS, the World Health Organization (WHO), the UN Children’s Fund (UNICEF), the UN Population Fund (UNFPA), the World Bank and seven research-based pharmaceutical companies (Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co., Inc., Roche, Tibotec (an affiliate of Johnson & Johnson) and ViiV Healthcare, which combines the HIV medicine operations of GlaxoSmithKline, Pfizer. Participants in AAI are committed to working with governments, international organizations and other stakeholders to find ways to broaden access, whilst ensuring rational, safe and effective use of medicines for HIV/AIDS.

Abbott has a longstanding commitment to the fight against HIV/AIDS and has implemented five practical measures to ensure the company’s medicines are as broadly available as possible:

The strong commitment of the AAI companies to improve access to treatment has manifested itself in many innovative ways. All AAI companies have individual programs through which they provide their own antiretroviral medicines at more affordable prices in developing countries. Some AAI companies have also expanded manufacturing capacity to meet product demand in the developing world. Individual AAI companies are also taking other actions to increase the overall availability of ARVs, including the granting of voluntary licenses or non-assert declarations, contract manufacturing with generic manufacturers and technology transfer agreements. These efforts are delivering results. As of 30 September 2008, some 773,803 patients in developing countries were estimated to be taking one or more medicines supplied at preferential prices by an AAI company. In addition, the number of patients in developing countries treated with generic ARVs - including those through cooperative efforts with AAI companies - has increased significantly. AAI companies also recognize that expanded access to medications requires a collaborative approach with governments, NGOs, multilateral organizations, and other public and private bodies. Many AAI companies are involved in initiatives to strengthen healthcare systems, streamline product registrations, and conduct clinical studies in developing countries. AAI companies also continue to invest significantly in research and development of new medications - including pediatric formulations - and diagnostics, to help combat the global HIV/AIDS pandemic.

• Innovation with the Needs of the Developing World in Mind: Abbott developed the lopinavir/ritonavir tablet, the only co-formulated protease inhibitor tablet that does not require refrigeration and can be taken with or without food – two important advances in delivering HIV medicine, especially in developing countries. • Broad Registration: The heat-stable tablet formulation of lopinavir/ritonavir has been filed, is available or has been approved in 170 countries. The new, lower-strength tablet formulation of lopinavir/ritonavir, which is suitable for pediatric use, has been filed, is available or has been approved in 124 countries. Abbott intends to make the lower-strength tablet available or approved in every country where the adult tablet is available. • In January 2010, Abbott received approval for a new, heat-stable tablet formulation of its protease inhibitor ritonavir, and the company intends to register the new ritonavir tablet as broadly worldwide as the lopinavir/ritonavir tablet. • Commitment to the Treatment of Children with HIV: Abbott has a longstanding commitment to the treatment of children with HIV. The company has made the liquid formulation of lopinavir/ritonavir available in the developing world since 2001. The new, lowerstrength lopinavir/ritonavir tablet complements the liquid formulation and was first launched in Africa in 2007, even before it was available in developed countries. • Investment in Consistent Quality Manufacturing: Abbott has invested hundreds of millions of dollars in the development of the heat-stable tablet formulations and sufficient manufacturing capacity to ensure they can be supplied to all who need them at universally high quality standards. • Affordable Pricing: Since 2002, our HIV medicines have been available in all 69 African and least developed countries at prices that are among the lowest for branded or generic protease inhibitors. • Philanthropic Measures: As part of the company's broad efforts to expand access to health care, Abbott and the company's philanthropic foundation, the Abbott Fund, have invested more than USD 175 million to improve the lives of more than 1 million people affected by HIV/AIDS in Africa and elsewhere in the developing world.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

Boehringer Ingelheim Access

Bristol-Myers Squibb Global Access Program

HIV/AIDS Boehringer Ingelheim Governments in most recipient countries Since 2000 Access - Donation & Pricing 59 developing countries www.boehringer-ingelheim.com

HIV/AIDS Bristol-Myers Squibb Various partners, including Health Ministries Since 2001 Access - Pricing Africa & least developed countries www.bms.com

As part of its policy to extend access to Viramune®, since 2000 Boehringer Ingelheim offers its antiretroviral product Viramune® (nevirapine) for single-dose use in the prevention of mother-to-child transmission (PMTCT) for free through the Viramune® Donation Program. So far, around 1.9 million mother/child doses have been made available to 170 programs in 60 countries.

The goal of the Bristol-Myers Squibb Global Access program is to enable broad access to the company’s HIV medicines at no-profit prices in the regions most impacted by HIV and with limited ability to pay, notably sub-Saharan Africa. The Global Access program is based on three essential pillars of activity and policy: 1) no-profit pricing policy; 2) patent policy; and 3) efforts to enable generic manufacturing. Information on the latter two activities can be found below under the heading “ARV Licensing in Developing Countries”.

Viramune® should be administered with additional anti-retroviral medicine as recommended by actual WHO guidelines. Recent studies suggest that in women and infants previously treated with singledose nevirapine for prevention of mother-to-child-transmission of HIV-1, the efficacy of subsequent Viramune® combination therapy may be reduced. For chronic treatment, Boehringer Ingelheim charges a substantially reduced price for all countries classified by the World Bank as low income, all Least Developed Countries according to UN definition and for all countries in sub-Saharan Africa - a total of 74 countries. In addition, all middle income countries qualify for a lowered price (67 countries). For more information on the company’s other HIV/AIDS activities, see the HIV/AIDS - Mother & Child Programs section, ARV Licensing in Developing Countries (non-assert declarations) and Additional Health Initiatives.

In 2001, BMS announced that it would provide all of its HIV medicines at no-profit prices in sub-Saharan Africa, because of the extreme burden of disease there, combined with the region’s limited ability to pay for HIV medicines. In July 2005, the company announced a further reduction in the price of pediatric formulations from no-profit to significantly below cost in an attempt to reduce all barriers hampering accelerated, broad access to treatment for the millions of children in sub-Saharan Africa who need these medicines most. BMS has also implemented a differential pricing policy globally, to enable collaboration with and support for government activities in regions with high incidence and low ability to pay for HIV medicines.

Lamvelase Clinic in Swaziland is supported by EGPAF and provides various services for its community. (Keri Oberg, Boehringer Ingelheim)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

Gilead Access Program

Merck & Co., Inc. Access to ARVs

HIV/AIDS Gilead Various partners Since 2003 Access - Pricing Least-developed countries www.gilead.com

HIV/AIDS Merck & Co. Inc. Various governments & NGOs Since 2001 Access - Pricing Developing countries www.merck.com

Gilead Sciences, Inc. is committed to providing access to its HIV medicines to all patients who need them worldwide, regardless of income or geography. Gilead has developed a tiered pricing system for its HIV medicines, including Viread® (tenofovir disoproxil fumarate) and Truvada® (emtricitabine and tenofovir disoproxil fumarate), based on a country’s economic status and HIV prevalence. It offers substantial price reductions through its Access Program in 130 countries, representing two-thirds of the countries in the world, and the regions hardest hit by the AIDS epidemic.

Since 2001, Merck & Co., Inc. has had a tiered pricing policy whereby it provides its antiretroviral medicines (ARVs) at access prices in least developed countries and those hardest hit by the AIDS pandemic. The offer extends to the governments of these countries, as well as to international donor agencies, non-governmental organizations (NGOs), charitable organizations and private-sector employers.

Gilead has established an international network of distributors, whose local knowledge helps to accelerate country-level regulatory approval of its medicines. These distributors also provide local outreach and on-the-ground logistics, and help ensure secure distribution of Gilead’s HIV medicines in the developing world.

Merck’s ARV pricing policy applies to all of the company’s ARVs: Crixivan™, Stocrin™, Atripla™ and Isentress™. For each product, Merck offers its lowest price - a price at which Merck does not profit - to the world’s least developed countries and those countries hardest hit by the HIV/AIDS pandemic, as measured by adult HIV prevalence. Countries with a higher degree of economic development and/or lower prevalence rate receive a significantly discounted price, within a price band. The price at which patients and countries can obtain their ARVs are based on their relative level of economic development, relative burden of disease, the degree to which the governments are committed to treating its HIV-infected population and the value that the Merck ARV plays in the local marketplace and treatment regimen. For the most economically-developed countries, Merck applies competitive, market-based principles in pricing its ARV products. Merck believes that the most relevant measure of the success of its ARV access strategy is the number of patients treated, and where they are treated (developing versus developed countries). As of December 31, 2008, 653,867 patients in 131 countries and territories were being treated with regimens containing at least one of Merck’s ARVs. Three out of four (76 percent) – or an estimated 498,845 patients – obtained these ARVs in the more than 80 countries in which Merck sells them at a price at which the company does not profit. An additional 9% received Merck ARVs in countries where they are offered at significantly discounted prices. Nine out of 10 patients using Merck ARVs live in developing countries in Africa, Asia, Latin America and the Caribbean, where the pandemic is having its most devastating impact. Of those being treated with Merck ARVs, there are an estimated 111, 471 children using pediatric formulas, representing 17% of all patients on Merck ARVs.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

Roche - Access to ARVs

Single Tablet per Day: Atripla® Fixed-Dose Combination

HIV/AIDS Roche Various partners Since 2002 Access - Pricing All low & lower-middle income countries www.roche.com

HIV/AIDS Bristol-Myers Squibb, Gilead, Merck & Co. Inc. Ministries of Health Since 2003 Access - Pricing Developing countries www.bms.com, www.gilead.com, www.merck.com

In 2002, Roche recognized that, as efforts to scale up the number of people on first-line therapy in resource-limited countries became successful and greater numbers of people received treatment, the need for second-line treatment options would also become increasingly important. In response, Roche committed to innovative, transparent policies to remove barriers to its second-line HIV protease inhibitor medicines in countries where resources are fewest and the need for treatment is greatest.

Combinations of different ARVs are used to treat people living with HIV/AIDS to reduce the risk of them developing resistance. Atripla® - the first once-daily single tablet regimen for the treatment of HIV infection in adults - is a fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz, and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate. Efavirenz is marketed by Bristol-Myers Squibb as Sustiva® and by Merck & Co., Inc. as Stocrin®. Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences under the tradenames Emtriva® and Viread®.

Roche supplies its HIV protease inhibitors, Invirase® and Viracept® (including pediatric powder), at no profit prices for people living in Least Developed Countries (as defined by the United Nations) and in sub-Saharan Africa. These prices are the lowest at which these medicines can be provided in a sustained, long-term manner, and have been shown to be similar or less than that of generic versions of the medicine. In addition, Roche established significantly reduced pricing for Invirase® and Viracept® for low and lower middle income countries (as defined by the World Bank), where there is need for access to HIV/AIDS treatments, and where local governments are able to play a greater role and make a more significant contribution towards the provision of public healthcare. The reduced prices apply to 86% of all people living with HIV/AIDS worldwide.

Atripla® was developed by Bristol-Myers Squibb and Gilead and approved by the US FDA in July 2006, Health Canada in October 2007 and the European Commission in December 2007. On January 15, 2008, the WHO granted Atripla® prequalification status. In August 2006, Gilead and Merck announced an agreement for the distribution of Atripla® in 106 developing countries around the world where convenient treatment options are critical to patient compliance and adherence to therapy. Gilead is manufacturing Atripla® using efavirenz supplied by Merck, and Merck is distributing Atripla® in these markets. In all of these countries, Atripla® is being sold at significantly discounted prices. As of 1 April 2008, 55 countries - including most in sub-Saharan Africa - had either granted regulatory approval for Atripla® or allowed the product to be imported. Tens of thousands of patients are already benefitting from this first-of-its-kind fixed dose combination ARV.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

Technology Transfer & ARV Licensing in Developing Countries HIV/AIDS Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck & Co. Inc., Roche Various generic pharmaceutical manufacturers Since 2001 Access – Tech Transfer Kenya, India, South Africa www.boehringer-ingelheim.com, www.bms.com, www.gilead.com, www.gsk.com, www.merck.com, www.roche.com

Pharmaceutical companies’ preferential pricing of antiretrovirals make effective, safe, high quality HIV/AIDS treatments available to developing countries. In some cases, companies also issue voluntary licenses (VLs) which allow local manufacturers in developing countries to produce and sell generic versions of their products. VLs are not a universal solution to HIV/AIDS but a response to specific circumstances. Local factors encouraging VL use include a severe HIV/AIDS epidemic, adequate health care infrastructure, suitable economic conditions and sufficient manufacturing expertise. Local manufacturers must ensure a long-term supply of good-quality medicines and implement safeguards to prevent diversion of medicines to wealthier markets. Along with its policy to expand access to nevirapine in Least Developed Countries, low income countries and all countries in Africa, Boehringer Ingelheim offers a non-assert declaration to all WHO pre-qualified manufacturers, stating that it will not enforce its nevirapine patent rights in these countries, in order to ensure supply at lowest possible cost. To date, eleven generic producers benefit from the non-assert declaration. The policy reinforces the need to allow only high-quality products to be distributed in developing countries. Since 2001, Bristol-Myers Squibb has had a policy of not enforcing its patents for HIV products in sub-Saharan Africa and has immunity from suit agreements with eleven African generic companies for stavudine and didanosine and three for atazanavir. In February 2006, it concluded technology transfer agreements with generic companies Aspen PharmaCare (South Africa) and Emcure Pharmaceuticals (India), for its newest antiretroviral, atazanavir (sold as Reyataz® in the US). Bristol-Myers Squibb has transferred intellectual property and technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and finished dosage form. Gilead has partnered with Aspen Pharmacare, South Africa to manufacture and distribute branded and generic versions of Viread® and Truvada® in Africa. Gilead has entered into non-exclusive licensing agreements with 13 Indian generic companies, allowing them to distribute generic versions of tenofovir and tenofovir-based regimens in 95 developing countries, including India, South Africa and Thailand. The agreements include technology transfer to ensure high-quality products. The generic companies are free to establish their own pricing for their products, as Gilead believes this will ensure competitive pricing and the broadest access possible for patients. Gilead receives a five percent royalty on finished product sales. These Indian generic manufacturers have received a combined 10 tentative approvals through the U.S. Food and Drug Administration and two prequalifications by the World Health Organization. Most importantly, more than 700,000 patients are now receiving Gilead’s medicines and more than half of these patients are receiving high-quality, lowcost generic versions of Gilead’s medicines.

GlaxoSmithKline granted its first voluntary license in 2001. Now under the auspices of ViiV Healthcare, the number of licenses has been extended to eight royalty free licensing agreements for ViiV Healthcare’s ARVs to all of sub-Saharan Africa. Since August 2007 ViiV Healthcare has allowed Apotex, a Canadian company, to manufacture a generic fixed-dose combination ARV, containing two molecules over which ViiV Healthcare has patent rights, for the treatment of HIV/AIDS in Rwanda. This consent was granted under Canada’s Access to Medicines Regime which reflects the WTO ‘31f’ agreement. This enables governments to authorize the production of certain patented medicines for export. ViiV Healthcare agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a not-for-profit basis. ViiV Healthcare’s licensees supplied 439 million tablets of their versions of Epivir® and Combivir® to Africa in 2009. This represents more than 60% growth over 2008. This trend is welcome as it gives customers in subSaharan Africa greater choice and contributes to better security of supply. Merck & Co., Inc. is committed to seeking additional ways to reduce the cost of its ARVs and increase access for people living in the world’s poorest countries and those hardest hit by the pandemic, including through working with external manufacturers and suppliers to achieve incremental efficiencies. In addition, to date Merck has granted royalty-free licenses of its ARV efavirenz to five generic manufacturers, of which four are currently on the market. All but one licensee donates a percentage of efavirenz net sales to Msizi (Cares) Trust, a charitable trust established to further the fight against HIV/AIDS in South Africa through the provision of preventative and educational programs. Roche has committed not to file any new patents or enforce existing patents for any of its medicines in the UN-defined Least Developed Countries. Nor will it enforce existing patents for its antiretrovirals in sub-Saharan Africa. As a result, generic versions of ARVs can be produced in these countries, encompassing 88% of all people living with HIV. In 2006, Roche committed to an ‘AIDS Technology Transfer Initiative’, to help local firms in Least Developed Countries and subSaharan Africa to manufacture second-line HIV medicines. Thirteen agreements have now been signed with entities from eligible countries and expressions of interest have been received from 41 more in 17 eligible countries. Roche has conducted assessment visits with 39 companies to determine timing and delivery of technical expertise. Roche expanded its program in 2008 to include training seminars for local manufacturers across sub-Saharan Africa, focused on the development of good manufacturing practices to improve locally-produced essential medicines - not just ARVs. The first two training seminars were attended by 56 delegates from 21 organizations.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – ARV Access

ViiV Healthcare Access to ARVs

HIV/AIDS ViiV Healthcare Various partners Since 1997 Access - Pricing 37 developing countries www.viivhealthcare.com

In the Least Developed Countries and sub-Saharan Africa GlaxoSmithKline has offered its HIV/AIDS medicines at not-for-profit (nfp) prices since 2001. ViiV Healthcare will maintain this commitment, and will include the additional products in its portfolio. All of ViiV Healthcare’s ARVs are now available at not-for-profit prices to public sector customers and not-for-profit organizations in all Least Developed Countries and all of sub-Saharan Africa - 64 countries in total. In addition, all private employers in sub-Saharan Africa who provide care and treatment to their uninsured staff can purchase its ARVs at not-for-profit prices. All CCM projects fully funded by the Global Fund to Fight AIDS, TB and Malaria and projects funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR) are also eligible bringing the number of countries accessing ViiV Healthcare nfp price to over 80. ViiV Healthcare’s prices are sustainable - it does not make a profit on them, but it does cover its costs. This means that it can sustain supply of these high-quality products for as long as they are needed. ViiV Healthcare’s not-for profit prices are applicable to orders of any size and are not dependent on large order quantities. They also include insurance and freight costs. Combivir, ViiV Healthcare’s leading ARV, now sells at USD 197 per patient per year in the Least Developed Countries compared to USD 730 in 2001. During 2009, ViiV Healthcare supplied ARVs at not-for-profit prices to 21 countries, compared to 37 in 2008. ViiV Healthcare shipped 11.7 million tablets of not-for-profit Combivir® and 21.0 million tablets of not-for-profit Epivir® to the developing world in 2009 compared with 11.4 million and 58.6 million tablets respectively in 2008. This decrease was expected and is primarily due to more customers purchasing ARVs from generic manufacturers, including those licensed by ViiV Healthcare. In 2009, ViiV Healthcare licensees supplied more than 439 million tablets of their versions of Epivir® and Combivir® to Africa. These figures do not include syrup and capsule formulations. They are therefore conservative in giving an estimate of the ARV treatments shipped at preferential prices by ViiV Healthcare and ViiV Healthcare licensees. This a positive indication that ViiV Healthcare’s licensing policy is working (see section on ARV Licensing in Developing Countries).

Technology transfer involves an R&D-based company which has developed a particular medicine helping a generic manufacturer, usually in a low or middle income country, to make an identical copy of that medicine, with the same quality level as the original. This approach is not a “soft option”, as it requires significant investment in time and money by both parties to achieve the required standards. (Merck & Co., Inc.)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

Abbott Fund Program for Supporting Children Affected by AIDS

Bristol-Myers Squibb’s Secure The Future® Children’s Clinics & Pediatric AIDS Corps

HIV/AIDS Abbott Baylor College of Medicine, EGPAF & other partners Since 2000 Capacity Building - Support & Training Burkina Faso, India, Kenya, Malawi, Romania, Tanzania, Uganda www.abbottglobalcare.org

HIV/AIDS Bristol-Myers Squibb Baylor College of Medicine in USA Since 1999 Capacity Building - Support & Training 8 developing countries in Africa www.securethefuture.com

The Abbott Fund is partnering with several organizations to expand access to health care for mothers and children affected by HIV/AIDS in developing countries. Since 2001, more than 1 million children and adults have received services in Burkina Faso, India, Kenya, Malawi, Romania, Tanzania and Uganda.

Bristol-Myers Squibb’s Secure The Future® initiative (see HIV/AIDS Capacity Building), in partnership with Baylor College of Medicine, Houston, Texas, USA, funded the first clinical center in Africa for children and families with HIV/AIDS, located in Botswana. This center now has more than 1,500 children under treatment. Additional children’s clinical centers have now been opened in Lesotho, Swaziland and Uganda, and two more are being built in Tanzania and Kenya. These centers add capacity to fight HIV/AIDS by providing modern facilities for testing, treating and monitoring children and their families, as well as training of local health care professionals.

The Abbott Fund supported the Baylor College of Medicine in establishing a pediatric HIV/AIDS treatment program in Romania that reduced the death rate for children with HIV in the program by more than 90%. The Abbott Fund is now supporting Baylor’s efforts to replicate this model across Africa, including opening the first pediatric treatment center in Malawi and building Tanzania’s first pediatric treatment center. Baylor and the Abbott Fund also partnered to establish the Baylor Children’s Clinical Centers of Excellence Network to train health professionals who together treat 30,000 children - the largest number of children with HIV in any treatment program worldwide. The Abbott Fund is working with Catholic Medical Mission Board (CMMB) to help prevent mother-to-child HIV transmission in 100 health facilities in Kenya. Through the partnership, testing, care and treatment will be provided to pregnant women and exposed infants.

To increase the number of trained pediatric specialists, Secure The Future® and Baylor College of Medicine created the Pediatric AIDS Corps, which will send 50 doctors a year over five years to Africa to treat some 100,000 children and train local health care professionals. The first class of 50 doctors arrived in Africa in August 2006. Additional Secure The Future® projects provide education, psychosocial care and support for orphans and vulnerable children, training, food security and income-generating projects for caregivers; and works to reduce stigma and encourage testing.

The Abbott Fund-Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) partnership in Tanzania and Uganda is working to accelerate enrollment of HIV-infected children into care and treatment programs, and to train and support health care workers. The Abbott Fund and Family Health International (FHI) partnered in Tanzania and Malawi to reduce mother-to-child HIV transmission and expand access to HIV care and treatment for children. In Kenya, the Abbott Fund works with the Academic Model for Providing Access To Healthcare, or AMPATH (also known as the Indiana University-Moi University, Kenya Partnership) to prevent HIV infections through testing and counseling (primarily home-based), education and treatment. Abbott Fund is working with Partners In Health in Malawi to scale up and improve pediatric HIV services and support construction of a new 40-bed hospital.

The Abbott Fund is supporting efforts to provide testing, care and treatment to pregnant women and infants exposed to HIV in 100 health facilities in Kenya. (Craig Bender, Abbott Fund)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

Elizabeth Glaser Pediatric AIDS Foundation

Empowering Africa’s Young People Initiative

HIV/AIDS Abbott, Boehringer Ingelheim, Johnson & Johnson EGPAF Since 1988 Access - Donation, Capacity Building - Training, Education 17 developing countries www.pedaids.org

HIV/AIDS Johnson & Johnson International Youth Foundation Since 2006 Capacity Building – Support, Education Zambia www.jnj.com

The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is an international leader in the fight to eliminate pediatric HIV/AIDS, working in 17 countries around the world to halt the pandemic and help those already infected with HIV to lead healthier lives. Since its inception in 1988, EGPAF has remained deeply committed to preventing motherto-child transmission (PMTCT) of HIV, ensuring better overall medical treatments, and creating a healthier future for children and families worldwide. The Abbott Fund, Boehringer Ingelheim and Johnson & Johnson are major supporters of EGPAF and its work.

Johnson & Johnson partners with the International Youth Foundation on the HIV/AIDS prevention program Empowering Africa’s Young People Initiative in Zambia. Support from Johnson & Johnson enables the International Youth Foundation to expand its services and training, including increasing the number of peer educators who teach other youth in their communities about preventing the spread of HIV/AIDS. Since the partnership began in 2006, more than 1,900 peer educators have been trained.

EGPAF collaborates with host governments, international health care facilities, non-governmental organizations and community-based organizations to plan, implement and/or expand pediatric HIV/AIDS programs. It also provides technical assistance and support for community mobilization and training of health care workers, HIV counseling and testing, prevention of mother-to-child transmission regimes and infant feeding education. As of September 2009, EGPAF had provided more than 8.6 million women with services to prevent transmission of HIV from mothers to their babies, and tested more than 7.4 million women for HIV. More than 850,000 individuals have been enrolled into EGPAF care and support programs, including nearly 69,000 children under the age of 15. Of those ever enrolled, more than 442,000 individuals have begun antiretroviral treatment (ART), including more than 35,000 children. EGPAF’s comprehensive approach includes prevention, diagnosis, and treatment of opportunistic infections such as pneumonia, malaria and tuberculosis. EGPAF is working to increase identification and care and treatment of young HIV-positive or HIV-exposed children and their mothers, through reproductive and child health (RCH) clinics, general clinics, and inpatient wards. EGPAF is also implementing routine testing of children and/or mothers of unknown HIV status in well-child clinics and inpatient pediatric wards. The Abbott Fund-EGPAF partnership in Tanzania and Uganda is working to accelerate enrolment of HIV-infected children into care and treatment and develop the capacity of health care workers. J&J has supported EGPAF’s international programs since 2003, with support to six countries during 2009. As of June 2009, the EGPAFJ&J PMTCT Partnership has contributed to reaching more than 1.6 million women with counseling, providing over 1.4 million women with HIV testing, and administering ARV prophylaxis to over 124,000 HIV-positive mothers in over 1,300 sites.

Two-thirds of all people living with HIV/AIDS are in sub-Saharan Africa. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

End Violence against Women and Prevent HIV and AIDS Program

Life Skills: Community Support for Children Affected by HIV/AIDS

HIV/AIDS Johnson & Johnson UNIFEM, UNAIDS Since 2006 Capacity Building – Support, Education Botswana, Dominican Republic, India, Nigeria, Vietnam www.unifem.org, www.jnj.com

HIV/AIDS Johnson & Johnson Life Skills Development Foundation Since 2005 Capacity Building - Training, Education Thailand www.lifeskills-stl.org

Globally, violence against women is both a cause and a consequence of HIV/AIDS: women facing violence within intimate relationships often cannot negotiate safer sex practices, such as condom use. Rape and harmful practices such as female genital mutilation also spread the virus. In addition to untenable levels of stigma and discrimination from the community, women who test positive for HIV are often subjected to physical abuse from partners and can face eviction from their homes. Further, as a result of such stigma associated with HIV/AIDS, they are prevented from obtaining life-saving medical care and treatment.

There are some 150,000 AIDS orphans in the Upper Northern region of Thailand. From economic struggle and emotional hardship to social stigma and isolation, they face many problems. The Life Skills Development Foundation, a NGO that provides life skills education and training for children, youth, women and families, works in many districts to reach children affected by HIV/AIDS. With the help of Johnson & Johnson, the foundation provides assistance to these children and their caregivers through HIV/AIDS education, psychological and financial support, and community education. Using a holistic approach, the foundation extends its support to the people it serves, and to the communities and schools that have a stake in the well-being of their children.

Johnson & Johnson partners with the United Nations Development Fund for Women (UNIFEM) to award grants to community-based organizations. These organizations implement prevention programs addressing the link between gender-based violence and HIV/AIDS. They pursue innovative strategies to raise awareness, uphold laws, provide medical assistance, train service providers and reduce stigma and discrimination to empower women.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

Mothers 2 Mothers Mentoring Program

Nyumbani Children’s Home

HIV/AIDS Johnson & Johnson Mothers 2 Mothers Since 2005 Capacity Building - Training, Education Kenya, Lesotho, Malawi, Rwanda, South Africa, Swaziland, Zambia www.m2m.org

HIV/AIDS Johnson & Johnson Nyumbani Children’s Home Since ? Capacity Building – Support, Education Kenya www.jnj.com

Mothers 2 Mothers (M2M) provides education for South African HIVpositive pregnant women about how to prevent mother-to-child transmission of the disease and later mentor other HIV-positive pregnant women. Program participants learn about medications, nutrition, formula feeding, and how to combat stigma and societal pressures. After their infants are born, the women become mentors to new women entering the program. Mentors are paid, helping them to gain financial independence.

Johnson & Johnson supports the Nyumbani Children’s Home which covers communities throughout Nairobi. The Children’s Home serves as a home to nearly 100 abandoned or orphaned children with HIV/AIDS. The children receive holistic care antiretroviral therapy, psychological, academic and spiritual support.

Johnson & Johnson began its partnership with M2M in 2005 in East London, focusing on hospitals with high numbers of HIV-positive patients who needed better health care. Since the Company’s association with M2M, 50% more women in the area are now getting tested for HIV. J&J helped establish two M2M sites in 2005 and the company currently supports 15 sites across East London, Port Elizabeth and the Cape Town area. M2M has established itself in six provinces in South Africa, and other African countries such as Kenya, Lesotho, Malawi, Rwanda, Swaziland and Zambia. By 2008, the M2M program had grown to 400 program sites, reaching 130,000 women each month. More than 1,000 mothers have been trained as mentors. M2M served more than 6,000 HIV-positive mothers-to-be at these locations in 2008.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

PMTCT: Abbott Rapid HIV Test Donation Program

Regional Psychosocial Support Initiative

HIV/AIDS Abbott Various partners Since 2002 Access - Donation 39 countries, including all of Africa www.abbottglobalcare.org

HIV/AIDS Novartis REPSSI, Swiss & Swedish Development Agencies Since 2002 Capacity Building - Support 13 developing countries in Africa www.novartisfoundation.org, www.repssi.org

Each year, approximately 430,000 babies around the world become infected with HIV during their mothers’ pregnancy, during birth or through breastfeeding. Enabling pregnant women to know their HIV status before they give birth is the first step in preventing mother-tochild transmission (PMTCT) of HIV. However, for many pregnant women living in the developing world, testing is limited because of cost, time required to receive results, and lack of trained health care staff and testing facilities.

UNAIDS estimated that by the end of 2007 there were approximately 6.5 million children orphaned by AIDS in Southern Africa. Millions more children in the region feel the triple effects and impact of HIV/AIDS, poverty and conflict. While there is no doubt that all these children have to be provided with basic services like food, shelter, education and healthcare, they also need care and support to cope with the emotional side of these difficult life situations.

Rapid on-site testing can have a significant impact in the fight against HIV/AIDS. Using a small amount of whole blood, serum or plasma, any program in a remote setting can obtain results regardless of access to laboratory equipment or electricity. To facilitate access to rapid HIV testing, Abbott has made a commitment to donate a rapid (15 minute) HIV test to PMTCT programs in 69 countries, including all of Africa and the Least Developed Countries, as defined by the United Nations. Abbott also has extended its PMTCT donations to include testing of spouses and children of pregnant women who are found to be HIV positive through the program. To date, Abbott has donated 15 million rapid HIV tests in 40 countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Central African Republic, Chad, Côte d’Ivoire, Djibouti, Democratic Republic of Congo, Ethiopia, Gabon, Ghana, Guinea Bissau, Guinea, Haiti, Kenya, Laos, Lesotho, Liberia, Madagascar, Malawi, Mali, Mozambique, Namibia, Nepal, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

The Regional Psychosocial Support Initiative for Children affected by AIDS, Poverty and Conflict (REPSSI) was founded with the support of the Novartis Foundation for Sustainable Development and the official development aid agencies of Switzerland (SDC and Sweden (SIDA), with the aim of laying down benchmarks in psychosocial support (PSS) in Eastern and Southern Africa. REPSSI works with over 140 local NGOs to train course leaders and develop courses and manuals, and cooperates with the governments of the 13 countries in which it operates with the objective of securing recognition of PSS as a basic right and a fundamental element of social policy. REPSSI, along with its partners, has developed a range of tools and approaches in order to maximize both the quality of psychosocial care and support, as well as the numbers of children who are able to access various levels of PSS. The organization had reached over 3 million children orphaned by AIDS by the end of 2009.

The Abbott Fund is supporting efforts in Western Kenya to prevent HIV infections through Home-based Counseling and Testing (HCT), education and treatment services. (Craig Bender, Abbott Fund)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Mother & Child Programs

Roche Children’s Walk

Women and Families Initiative

HIV/AIDS Roche UNICEF & European Coalition of Positive People Since 2003 Capacity Building - Support, Education Malawi www.roche.com

HIV/AIDS Johnson & Johnson HIV Collaborative Fund Since ? Capacity Building – Support, Education Uganda www.jnj.com, www.hivcollaborativefund.org

The Roche Children’s Walk (formerly the Global Roche Employee AIDS Walk) extended its scope to all vulnerable children in 2008. In 2008, 14,000 employees from 100 sites walked around five kilometers each to raise an estimated CHF 1.2 million, including the amount contributed by the company. While 35% was contributed via company affiliates to local children’s charities, the balance was donated through Re&Act to Roche’s long-term partners, the European Coalition of Positive People and UNICEF Switzerland, for their work in Malawi.

The HIV Collaborative Fund, a community organization that raises funds to support treatment for people living with HIV/AIDS, and Johnson & Johnson are partnering in a Women and Families initiative, which focuses on HIV/AIDS treatment preparation services for women. These services include advocacy, treatment and adherence education, counseling on stigma and discrimination, skills-building workshops, and direct service delivery in each of the communities served. Thousands of women in communities throughout SubSaharan Africa have been reached over the past few years. In Uganda, the partnership supports The Mama’s Club and the Together Against AIDS Positive Association, two grassroots groups focused on treatment preparedness education of women.

In 2003, a pilot Roche Employee AIDS Walk was initiated across three sites in Switzerland and the USA to support children orphaned as a result of AIDS in Malawi, Africa. The event is now conducted each year, across Roche sites worldwide. To date, over 60,000 Roche employees from 100 sites worldwide have raised a total of over CHF 6 million. Funds raised via the Employee Walk supports 7 orphan day care centers in the Mulanje district of Southern Malawi where the children are given food, clothing, vocational training and the chance of a secondary school education. The centers are supported by the European Coalition of Positive People, a UK-Malawi NGO, led by and for people living with HIV and AIDS. The centers currently look after some 3,000 children. Local community leaders and villagers are being trained to manage the centers. A further partnership was announced in 2006 with the United Nations Children’s Fund (UNICEF), to strengthen the local primary schools these children attend. Seventy five percent of children are unable to access secondary school education in Malawi. Money raised by the Employee Walk has paid for the construction, repair and equipment of the orphan centers and school classrooms, the drilling of bore holes for water, as well as school fees and educational equipment. All efforts are designed to make a visible, long term and sustainable difference in the lives of these orphaned children.

Boehringer Ingelheim offers the antiretroviral medicine Viramune® free-of-charge to developing countries. (Keri Oberg, Boehringer Ingelheim)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Abbott Fund Program to Strengthen Tanzania’s Health Care System

African Comprehensive HIV/AIDS Partnerships (ACHAP)

HIV/AIDS Abbott Tanzania Ministry of Health Since 2003 Access - Donation, Capacity Building - Support & Training Tanzania www.abbottglobalcare.org

HIV/AIDS Merck & Co. Inc. Bill and Melinda Gates Foundation & other partners Since 2000 Access - Donation, Capacity Building - Support & Training, Education Botswana www.achap.org

The Abbott Fund and the Government of Tanzania have formed a unique public-private partnership to modernize the country’s health care system. The Abbott Fund has invested more than USD 60 million aimed at enhancing access to health care on a national scale. Today, one in three Tanzanians with HIV taking antiretroviral therapy receive services at a facility that has benefited from Abbott Fund support.

The African Comprehensive HIV/AIDS Partnerships (ACHAP) was established in 2000 by the Government of Botswana, The Merck Company Foundation/Merck & Co., Inc. and the Bill & Melinda Gates Foundation, to support and enhance Botswana’s response to the HIV/AIDS epidemic through a comprehensive approach to prevention, care, treatment and support and impact mitigation. The two foundations have committed USD 106.5 million to the partnership and Merck is donating its antiretroviral (ARV) medicines to Botswana’s national ARV treatment program, Masa (new dawn), for the partnership’s duration.

Work is being conducted across the country, including significant work at Muhimbili National Hospital, the country’s leading teaching and referral hospital. Key results include a new three-story outpatient center that serves hundreds of patients a day, and a renovated laboratory that provides accurate, automated diagnostic testing crucial for lifelong monitoring of HIV and other chronic diseases. Donated laboratory equipment is maintained by engineers supported by the Abbott Fund.

In 2007, ACHAP expanded its support to target co-infection of HIV and tuberculosis, as it is estimated that 65-85% of TB patients in Botswana are HIV positive, and HIV-related TB is the leading cause of death among adult AIDS patients.

In 2009, a new Emergency Medical Department was opened and training programs in emergency medicine were initiated at Muhimbili. Through Abbott Fund support, emergency room services meeting international standards are now available for the first time at Muhimbili.

The partnership’s strength lies in its full integration with government strategy and with private-sector expertise. ACHAP has made a significant contribution to key aspects of Botswana’s response to the HIV and AIDS epidemic and has served as a catalyst for the provision of urgently needed infrastructure, equipment, human resources, training and program support for the Botswana ARV program.

More than 15,000 health care worker trainings have been conducted to date in Tanzania. At Muhimbili, 200 physicians now serve as trainers for other health staff. More than 250 staff have been trained in lab equipment operation, while 600 senior doctors and hospital directors have received management training.

Today, Masa is one of the largest national HIV treatment programs on the African continent, with 35 infectious disease care clinics and satellite facilities in operation across the country. As of October 2009, more than 141,000 people were receiving ARV treatment with ART compliance rates of 90 percent – among the highest in the world.

One of the most extensive hospital IT systems in East Africa has been installed at Muhimbili to track health history, referrals, test results and drug prescriptions. Volunteer Abbott employees provide technical support in construction, engineering, infection control, IT, waste management, security and lab management.

The partnership has worked with Harvard Medical School and the Botswana Ministry of Health to provide training for more than 6,300 of Botswana’s health care workers, while more than 3,200 physicians, nurses and other health care professionals have received hands-on, clinic-based training through the partnership’s preceptorship program between 2002 and 2006. The preceptorship program has now been incorporated into the ongoing national clinical training program managed by the Government of Botswana.

Facilities, systems and training have been upgraded at 90 sites throughout the country to improve VCT services. Due to these improvements, more than 300,000 people have received VCT services. The Abbott Fund also donated 1 million HIV tests to President Kikwete’s National Testing campaign. In addition, the Abbott Fund is modernizing all 23 of the country’s regional-level hospital laboratories. The Abbott Fund is working with the Touch Foundation to support 105 lab technology students pursuing university degrees, and also is providing funds to upgrade the laboratory at Bugando Medical Centre, a referral hospital for a population of 13 million in the Lake Zone.

ACHAP has also made significant contributions in the area of HIV prevention, including the development of a national plan for scaling up prevention, improving condom availability and safe blood transfusion.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Associação Saude Da Familia HIV/AIDS Awareness

AstraZeneca & AMREF: An Integrated Approach to Managing HIV/AIDS, Malaria & TB in Uganda

HIV/AIDS Johnson & Johnson Associação Saude da Familia Since 2004 Capacity Building - Support, Education Brazil www.saudedafamilia.org

HIV/AIDS, malaria, tuberculosis AstraZeneca AMREF Since 2004 Capacity Building - Training, Education Uganda www.astrazeneca.com

The Associação Saude da Familia (ASF) mobilizes community support in poor favelas in Sao Paulo, Brazil, to protect young people from unwanted pregnancies and sexually transmitted diseases. This includes raising awareness and spreading information about HIV/AIDS. In these teeming slums, where drugs and violent crime are a constant reminder of the fragility of civil societies, ASF works with local community leaders, and municipal and state governments, to implement its programs to encourage safer and healthier behavior.

AstraZeneca and the African Medical and Research Foundation (AMREF) have been working together since 2004. The partnership initially focused on TB in the Eastern Cape province of South Africa. In 2006, AstraZeneca extended its commitment to support AMREF in strengthening healthcare systems and integrating management of TB, HIV and malaria programs in Uganda, where there is a high burden of all three diseases. AstraZeneca is one of a few organizations involved in this integrated approach.

In its program ‘Expanding Prevention and Assistance to HIV/AIDS/STD’, ASF trains lay persons in poor communities to become outreach workers. They make door-to-door visits providing HIV prevention education and offer voluntary testing and counseling services. With a grant from Johnson & Johnson, ASF was able to expand the scope of this program, and to help local health care units to provide diagnosis, prevention, treatment and care for people living with HIV/AIDS.

The program is focused on women of child-bearing age, people living with HIV/AIDS and children under the age of seven in the poor, remote Luwero and Kiboga districts of central Uganda, which have high disease incidence rates, influenced by lack of healthcare funding in and destruction of local healthcare infrastructure by conflict. AMREF works with district health teams in Luwero and Kiboga to encourage ownership and continued implementation. Training and support for health workers, coupled with public campaigns, is essential for effective implementation. The program is focused on: • Enhancing the capacity of health centers to prevent, diagnose and treat malaria, HIV/AIDS and TB, particularly through improved laboratory diagnostic capacity; • Improving community-based prevention, treatment and care; • Strengthening links between the formal health system and informal community-based capabilities; • Gathering data to support an integrated and community based strategy. • The program is aligned to Ugandan Ministry of Health targets and also to MDGs 4 and 5, which focus on the reduction of child and maternal mortality. Progress to date includes: • Three laboratories have been completed to Ministry of Health standards, management of which has been handed over to district management teams; • 144 Village Health Teams with 776 members have been established, trained in health promotion; • 161 health awareness outreach activities and 91 educational films screenings s at HIV Counselling and Testing clinics; • 183 local peer educators trained in reproductive health, life skills, counseling and MAT (Malaria HIV/AIDS TB) testing; The Ministry of Health has implemented a policy of integrated MAT testing and is working with AMREF on this program.

In Tanzania, the Abbott Fund is training health care workers and modernizing or building 23 regional-level laboratories nationwide, including this newly opened laboratory in Tanga. (Craig Bender, Abbott Fund)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Bristol-Myers Squibb’s Secure The Future®

Collaboration for Health in Papua New Guinea (CHPNG)

HIV/AIDS Bristol-Myers Squibb Various partners, including African NGOs Since 1999 Capacity Building - Support & Training 20 developing countries www.securethefuture.com

HIV/AIDS Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck & Co., Inc., Pfizer, Tibotec Papua New Guinea Ministry of Health & others Since 2003 Capacity Building - Support & Training Papua New Guinea www.apbca.com/files/_media/CHPNG_Case_Study.pdf

Secure The Future® is a comprehensive initiative to fight HIV/AIDS in sub-Saharan Africa, sponsored by Bristol-Myers Squibb and the Bristol-Myers Squibb Foundation. It combines medical treatment and care, access to antiretroviral medicines, with research, social support with community education, and training for health care professionals with new facilities and infrastructure investments in remote areas of sub-Saharan Africa where resources are extremely limited. The initiative now is reaching women, children, their families and communities in 20 nations: Benin, Botswana, Burkina Faso, Burundi, Democratic Republic of Congo, Côte d’Ivoire, Kenya, Lesotho, Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Senegal, South Africa, Swaziland, Tanzania, Uganda and Zambia.

Papua New Guinea has the highest incidence of HIV in the Pacific region. An estimated 2 per cent of the adult population is now HIV positive. Recent research predicts that unless interventions to address the spread and impact are stepped up, by 2025 adult prevalence will have escalated to 11 per cent. Left unchecked, Papua New Guinea will be in a similar position to that of parts of Africa, where the impact of HIV has been felt in every aspect of society and the economy.

Secure The Future® has evolved and remained agile over the years in order to play as relavant a role as possible in the global response to HIV/AIDS. From 1999 to 2002, the program was focused on broad-based grant-making to support medical research and community outreach and education. From 2003 to 2007, focused investments were made in community based HIV/AIDS care and treatment support, NGO training, and pediatric AIDS. In 2008 Secure The Future® entered its third phase as a Technical Assistance and skills transfer program. This phase will capitalize on Secure The Future’s funding, program management experience and expertise, and track record as a committed private-public partnership program. The aim is to replicate Secure the Future’s lessons, experiences and successful models, and address a strategic challenge of operational multi-sectoral collaborations in HIV by harnessing community resources and capacity. Program support is executed by an experienced and expert pool of faculty members who have played a critical role in supporting NGO’s and CBO’s to provide essential services in the Community Based Treatment Support and NGO Training Institute Programs. The aim of the faculty is to develop and strengthen organizational and technical capacity and leverage and harness the potential of civil society in improve health outcomes of health programs.

The quality and availability of HIV diagnosis, care and treatment in PNG is limited by severe resource shortages in the health system. Many health centers lack medical supplies and essential drugs to deliver basic health services. Misinformation and poor understanding about HIV has contributed to discriminatory attitudes toward people living with the virus, creating a hurdle to access health services. The shortage of skilled health workers mirrors the greater human resource challenge impacting on all service sectors in PNG. Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck & Co., Inc., Pfizer and Tibotec have helped to set up the Collaboration for Health in Papua New Guinea (CHPNG), which works with various departments of the Government of PNG, Government departments in PNG, the National Catholic AIDS Office (PNG), the Australasian Society for HIV Medicine (ASHM) and the National Association for People Living with HIV/AIDS (NAPWA) in projects to build the local capacity of PNG to fight the HIV epidemic. CHPNG activities include the provision of day care centres to provide a safe space for people living with HIV/AIDS and where their carers can meet and share experiences. It also undertakes the training of multidisciplinary teams of nearly 300 healthcare workers to manage HIV and provides an ongoing education and mentoring programme to maintain and improve the skills of those providing care.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

GlaxoSmithKline - Other HIV/AIDS Capacity-Building Initiatives

Health at Home/Kenya

HIV/AIDS GlaxoSmithKline AMREF & other partners Since 1998 Capacity Building - Support & Training, Education 17 African countries www.gsk.com, www.childrensaidsfund.org

HIV/AIDS, tuberculosis, malaria Abbott, Bristol-Myers Squibb, Pfizer Kenya MoH, USAID, PEPFAR & other partners Since 2009 Capacity Building - Support Kenya www.pfizer.com

The GlaxoSmithKline Foundation supports a range of HIV/AIDSrelated programs around the world. Since 1998, the GSK France Foundation has supported 86 programs to improve healthcare through prevention, education and training in 14 developing countries. The GSK Foundation Canada also supports community programs in Africa, including AIDS Orphans Uganda, working with the African Medical Research Foundation (AMREF).

Health at Home/Kenya is an initiative coordinated by Global Business Coalition on HIV/AIDS, Tuberculosis & Malaria (GBC) that is providing home-based HIV/AIDS testing, TB screening and malaria bed nets, and de-worming for children into the homes of millions of Kenyans in a remote region with difficult access to health care. This innovative door-to-door model includes community preparation by local volunteers.

GSK supports community programs in Botswana, Cote d’Ivoire, Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Malawi, Mozambique, Namibia, Nigeria, Senegal, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe. These provide treatment for HIV/AIDS patients, counseling and testing, home-based care, training for health care professionals and community volunteers, life skills training for orphans, hospice care, day care centers, feeding schemes, as well as support for basic primary healthcare and HIV/AIDS clinics.

To date, 97% of households in communities reached by the Health at Home/Kenya Impact Initiative have welcomed HIV counselors inside their homes. More than 3,000 people have been found to be HIV positive and directly connected to treatment programs.

For example, GSK has supported the AIDS Care Treatment and Support (ACTS) initiative in Masoyi, South Africa, since 1999. GSK’s initial support included building a dedicated HIV/AIDS primary health care clinic and training center, and supporting running costs for the first three years. Since the opening of the ACTS clinic in May 2001 more than 28,000 patients have been tested and/or treated. ACTS offer a comprehensive service caring for people at all stages of HIV/AIDS. Facilities and services include a specialist HIV outpatient clinic, complemented by a home-based care team (average of 120 visits per month) an eight-bed community hospice, on-site laboratory, cervical cancer prevention program and a newly established Mother & Child Clinic. There are currently 1,737 patients on ARVs, 152 of which are children under the age of 12 years. Nearly 2,000 patients are seen each month.

On-the-ground implementation of Health at Home/Kenya is being managed by the Academic Model Providing Access to Healthcare (AMPATH), based in Eldoret, Kenya, working closely with the Kenyan government and PEPFAR. This two-year initiative is supported by PEPFAR and GBC member companies. The initiative is being brought to scale by industry competitors working side-by-side in common cause – serving as a model to be replicated in other AIDS endemic regions of the world. Participants in the initiative include the Abbott Fund, Accenture, Bristol-Myers Squibb Foundation, Standard Bank Group, CocaCola, Deutsche Post DHL, Pfizer, Premier Medical Corporation, SAB Miller, Standard Chartered Bank.

In 2004, GSK’s US Business launched a project called ‘Hope after HIV: Africa’. Through the Children’s AIDS Fund, GSK has helped open 6 clinics in Uganda, Malawi, Zambia, and South Africa that have treated more than 9,000 HIV/AIDS patients. The sponsored clinics offer testing, medicines, education, mother-to-child transmission care, counseling and follow-up. Patients are also supported by more than 1,500 volunteers who provide adherence counseling, disease education and palliative care. GSK has also established the ‘Hope after HIV 501(c)(3) Fund’ that allows employees and others to donate funds to support life-enhancing, non-medical needs. The fund has been used to improve nutrition and generate income for patients and their families; provide bicycles, pumps and refrigerators; and education for promising young HIVpositive people.

Medical services are provided by the African Medical and Research Foundation (AMREF) in the Kiberia slum district in Nairobi, Kenya. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

HIV South Africa

Humana: Total Control of the Epidemic

HIV/AIDS Johnson & Johnson HIV South Africa Since 2003 Access - Donation, Capacity Building - Support & Training South Africa www.hivsa.com

HIV/AIDS Johnson & Johnson International Humana People to People Movement, Irish Aid Since 2000 Education Developing countries in Africa, China, India, www.humana.org

With the support of Johnson & Johnson, HIV South Africa (a program of the Baragwanath Hospital Perinatal HIV Research Unit) has provided a wide variety of Johnson & Johnson healthcare products to community-based organizations that provide care and support to HIV patients in their homes.

‘Only people can liberate themselves from the AIDS epidemic’. These are the motivating words behind the Total Control of the Epidemic (TCE) program, which was created by the International Humana People to People Movement. Driven by a grassroots doorto-door approach, TCE has been completed in 24 areas with 2,340,000 inhabitants and at present is operating in 62 areas with 6,170,000 inhabitants in Africa, 2 areas with 200,000 inhabitants in India and 3 areas with 300,000 inhabitants in China. Created by Humana People to People, TCE provides communities with HIV risk assessments and prevention education.

The project has both an urban and a rural component, which together serve approximately 3,500 households at any given time. The project involves 39 home-based care partner organizations in Soweto and distributes approximately 2,500 healthcare product packs monthly. The product donation is complemented by distribution support, caregiver training and program monitoring. Supplemental support also is provided to selected hospice organizations.

Johnson & Johnson currently supports the TCE areas of Main Reef and Sekhukhune in South Africa, reaching up to 400,000 people. In partnership with Irish Aid, it also supports the TCE in Narela, Baddi in India, covering an additional 200,000 people. The projects supported by the company provide one-on-one counseling sessions, briefings for pregnant women about preventing transmission of disease to their newborns and large-scale distribution of condoms.

A lab worker at Nyumbani Diagnostic Laboratory, Nairobi, Kenya, which provides specialized HIV tests and other general diagnostic lab services for abandoned and orphaned children. (Willie Davis, Johnson & Johnson)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

IMIFAP: HIV/AIDS Education

J&J Health Care Training Fund

HIV/AIDS Johnson & Johnson Instituto Mexicano de Investigación de Familia y Población Since 2005 Education Mexico www.imifap.org.mx

HIV/AIDS Johnson & Johnson AMREF, i+solutions Since 2004 Capacity Building - Training Kenya, South Africa www.jnj.com, www.iplussolutions.org/platform

“I Want to, I Can prevent HIV/AIDS’, is the slogan behind the Instituto Mexicano de Investigación de Familia y Población (IMIFAP) HIV prevention programs, which mobilize citizens to raise neighborhood HIV/AIDS awareness in Mexico.

The Johnson & Johnson Health Care Training fund was started in 2004. It is a collaboration between J&J and i+solutions in the Netherlands which specializes in pharmaceutical supply chain management training in developing countries.

Johnson & Johnson supports an educational program for youth that utilizes the existing national network of middle schools to teach students about HIV prevention before they become sexually active, increasing the likelihood that these adolescents will practice safe sex in the future. IMIFAP engages all levels of the community from the Ministries of Health and Education, to the school administrators and local politicians, to the teachers and students.

Activities include:

The program includes teacher training, a software program, and Web site support. The 10,400 schools in Mexico with Internet access bring this program to more than 300,000 students. For those schools without Internet access, IMIFAP trains teachers and students to run the program, and has partnered with UNETE, a member of The Resource Fund, to raise educational levels using technology to distribute the program in more rural and remote areas.

• Training in ‘Supply Chain Management of HIV/AIDS Medicines & Supplies’. A two-week pilot course for 12 managers was organized in 2005, and the course is now run several times a year in Pretoria, South Africa; • Development of a web-based Supply Chain Management Discussion Platform in 2006, which is open to all health professionals involved in supply chain management of healthcare commodities; • Translation of the ‘Supply Chain Management of HIV/AIDS Medicines & Supplies’ training curriculum in 2007 to reach Francophone African health professionals. A 2-week course in French is run once a year in the Netherlands; • Training in ‘Monitoring & Evaluation of Antiretroviral Treatment Procurement & Supply Management’. Monitoring and evaluation is essential for donor reporting purposes and to identify and improve weaknesses in the supply chain. The curriculum was developed in 2007 and the first course took place in 2008 in the Netherlands, and is now run once a year. Since 2008, this course is also run in French once a year in the Netherlands; • CD-ROM-based training course on ‘Supply & Warehouse Management for the First level Health Facility’, for staff who are unable to attend off-site training courses. This course was developed in Nairobi with the African Medical and Research Foundation (AMREF); • Training of trainers (TOT) course for the CD-DROM-based training on ‘Supply & Warehouse Management for the First level Health Facility’ in English and French. The first English version of this course was run in Sudan in 2009 and the first French version in the Democratic Republic of Congo in 2009. Roll out of this course in four countries will be undertaken in 2010.

HIV prevention program. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

J&J - UCLA Management Development Institute

JPMA’s HIV/AIDS Training Program

HIV/AIDS Johnson & Johnson AMREF, GIMPA, UCLA Management Development Institute Since 2006 Education Ghana, Kenya www.anderson.ucla.edu/x13888.xml

HIV/AIDS JPMA ASEAN Institute for Health Development AIHD Since 2004 Capacity Building - Training 10 developing countries in Asia www.jpma.or.jp/english

The Johnson & Johnson - UCLA Management Development Institute (MDI) was created in 2006 as an intensive one-week program designed to enhance the management skills of health care leaders of East and West African organizations devoted to the care, treatment and support of people and their families living with HIV/AIDS.

The Japan Pharmaceutical Manufacturers Association (JPMA) has, at its own expense, commissioned the ASEAN Institute for Health Development (AIHD) to train medical professionals in ASEAN member countries in the ‘Management of Community-based Prevention of HIV/AIDS and Care’. This two-week course is intended to contribute to the promotion of the physical and mental health care of patients and residents through the professional development of health workers in the AIDS-related divisions of public institutions. Based upon accumulated observations, findings, insights and personal experiences, the participants will design their own ‘action plans’ that can be used when they return to their home country.

Dr. Ernest O. Nyamato, director of services at Liverpool Voluntary Counseling & Testing (LVCT) care & treatment centers in Kenya, attended the program in 2006. ‘MDI changed the way I oversee operations at 15 voluntary counseling and testing sites across Kenya’, he said. ‘My involvement in the program has helped me to more effectively get our patients treated’. ‘Attending the MDI training pointed me in the right direction’, noted Dr. Nyamato. With a new mental picture of how his LVCT sites should operate, he began building better communication channels between the staff, creating new human resources and compensation policies, and focusing more on patients´ perspectives, expectations and feedback.

To date, 141 health professionals have been trained, distributed as follows: Bhutan (6), Cambodia (26), China (2), Indonesia (4), Laos (30), Myanmar (16), Nepal (2), Pakistan (2), Sri Lanka (2), Thailand (21), Vietnam (30).

Assessing community needs, aligning operations with a mission and strategy, budgeting and human resources management were just a few areas discussed in the 2007 MDI training sessions, held in April and September. Participants in such sessions are encouraged to pass along the management and leadership skills they learn to all levels of their organization. By doing so, the knowledge to prevent and treat HIV/AIDS is spread throughout Africa´s sub-Saharan region. More than 200 AIDS-service organizations leaders from 12 countries have graduated since 2006.

JPMA trains health workers in the AIDS-related divisions of public health institutions in ASEAN countries. (JPMA)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Medical Mission Sisters

Merck & Co., Inc. HIV/AIDS Programs - Africa

HIV/AIDS Johnson & Johnson Medical Mission Sisters Since 2005 Capacity Building - Support, Education Kenya www.medicalmissionsisters.org

HIV/AIDS Merck & Co. Inc. Various partners, including universities & NGOs Since 1998 Capacity Building - Training, Education 31 African countries www.merck.com

In 1989, Sister Gill Horsfield of Medical Mission Sisters (MMS) began training health workers in Nairobi, Kenya, to provide home-based care to individuals suffering from HIV/AIDS-related illnesses. Her program offered medical and pastoral counseling, and social services in the Korogocho slums, one of Nairobi’s poorest areas.

In 2009, with support from The Merck Company Foundation, the Earth Institute at Columbia University launched a community health worker training program to strengthen community health services for over 400,000 people in 10 African countries as part of the Millennium Villages project. The initiative aims to develop a professional cadre of 800 community health workers to fill a critical gap in primary healthcare provision for rural communities throughout Africa.

Johnson & Johnson supports Sister Gill’s continued involvement in caring for people with HIV/AIDS. Today, MMS has joined with the Comboni Missionary Sisters to provide more extensive holistic care for those affected by HIV/AIDS. The partnership includes programs in home-based care and tuberculosis treatment, programs for deaf and handicapped youth, and a voluntary HIV/AIDS counseling and testing program. It also includes distribution of antiretroviral therapy, other medicines, and prepared meals and dry goods to families with sick parents. More than 1,800 people affected by HIV/AIDS are benefiting from this work. School dropout rates among children receiving nutrition and social support have decreased significantly.

In 2008, Merck began supporting Mothers2Mothers (m2m), an organization that addresses prevention of mother-to-child transmission by employing mothers living with HIV (“Mentor Mothers”) as peer educators and professional members of the healthcare team, in public health facilities in Kenya, Lesotho, Malawi, Rwanda, South Africa, Swaziland and Zambia. By the end of 2008, m2m had almost 500 sites across Africa, employing 1,400 mentors and reaching more than one million people. Since 2006, Merck & Co., Inc. has supported the Health Economics and HIV/AIDS Research Division (HEARD) of the University of KwaZulu-Natal, South Africa in a study of factors influencing participation rates, voluntary counseling and testing services. The research will estimate the economic costs of low uptake on the voluntary counseling and testing services offered by one multinational corporation. Since 2002, Merck has supported the Regional AIDS Initiative of Southern Africa (RAISA), a Voluntary Services Overseas project, to strengthen partners’ capacity to develop coordinated programs to respond to the HIV and AIDS pandemic. In 2008, Merck helped RAISA launch the “Glove Campaign” raising awareness of the need for clean gloves to reduce the spread of HIV infection as well as other infections. Since 2005, Merck has supported the African Medical & Research Foundation (AMREF) in its efforts to improve health of young people living with HIV and AIDS in the Nakasangola District of Northern Uganda. In 2008, Merck provided support to AMREF to scale up the HIV and AIDS intervention in Uganda where HIV prevalence among young women in Kawempe Division is at 24%. Since 2004, Merck has supported UNCHR’s Strategic Plan for HIV, AIDS and Refugees, strengthening HIV/AIDS interventions in refugee operations in Angola, Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Zambia and Zimbabwe. In 2008, UNHCR and the Red Cross scaled up HIV prevention programs, developing an HIV plan for refugees within the established HIV program in Malawi. Merck and DHL announced an agreement in 2004 to team up to expand access to critically needed HIV/AIDS medicines in countries throughout sub-Saharan Africa. Under this agreement, DHL is currently delivering Merck’s HIV and AIDS medicines at cost by air express to designated treatment centers in 35 countries.

Mothers2Mothers is an organization that addresses prevention of mother-to-child transmission by employing mothers living with HIV as peer educators and professional members of the healthcare team in public health facilities. (Merck & Co., Inc.)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Merck & Co., Inc. HIV/AIDS Programs - Caribbean

Merck & Co., Inc. HIV/AIDS Programs - China

HIV/AIDS Merck & Co. Inc. USAID & other partners Since 2003 Capacity Building - Training, Education Jamaica, Mexico, Venezuela www.merck.com

HIV/AIDS Merck & Co. Inc. China Ministry of Health & other partners Since 2005 Capacity Building - Training, Education China www.merck.com

Merck has been working in the Caribbean to spur a broader private sector response to HIV and AIDS. Merck recently awarded a grant to the AIDS Responsibility Project, which, in conjunction with the Constella Futures Group, supports the creation of a national business council on HIV and AIDS in Jamaica. The project aims to reduce stigma and discrimination in the workplace and to mobilize companies to formulate specific workplace policies on HIV and AIDS, with the goal of increasing disease awareness and prevention efforts, care, counseling, testing and, if needed, treatment. The establishment of the business coalition builds upon similar efforts that Merck has supported with partners in Mexico and Venezuela. This initiative, which also receives funding from USAID, is already serving as a model for regional Caribbean efforts to mobilize the private sector to take a more active role in fighting HIV and AIDS.

In 2005, Merck & Co., Inc. and the Government of China established the first large-scale comprehensive public/private partnership known as the China-MSD HIV/AIDS Partnership (C-MAP), to address HIV and AIDS prevention, patient care, treatment and support, in support of “China’s Action Plan for Reducing & Preventing the spread of HIV/AIDS 2006-2010.” The partners introduced the program in Liangshan Prefecture, Sichuan Province, with the aim of developing a model that could be replicated in other provinces. The Merck Company Foundation has committed USD 30 million to support this partnership over five years. The Government of China, through the leadership of the Ministry of Health, is providing staff, facilities and equipment. C-MAP is led by two co-national directors and has project offices in Beijing, Sichuan Province and Liangshan Prefecture.

In 2007, Merck and The Merck Company Foundation granted USD 36,500 to the Caribbean Coalition of National AIDS Programme Coordinators (CCNAPC), a peer-based organization working to improve national AIDS Programs in 35 Caribbean countries, committed to and Commissions. The grant is to support efforts to increase prevention and awareness. Also in 2007, Merck sponsored an exchange between Caribbean and Botswana business leaders to promote understanding of the private sector role in fighting HIV/AIDS.

From 2007 through 2008, C-MAP launched 82 initiatives in support of the following six core strategies: • Raising awareness and reducing discrimination among target populations through training and education; • Deploying comprehensive, integrated risk-education approaches to reduce HIV transmission in high-risk populations; • Establishing a service network to provide consecutive treatment, care and support to HIV and AIDS patients; • Providing support to orphans and families affected by HIV to alleviate negative social and economic impact; • Building capacity of health care workers and organizations and developing new anti-HIV strategies and techniques; • Strengthening monitoring and evaluation systems, data usage and follow-up outcomes to put intervention strategies into practice and apply best practices in a timely manner. When the partnership launched in 2005, C-MAP covered three countries in Liangshan Prefecture of Sichuan Province. In 2008, C-MAP expanded to cover 62 countries/districts targeting 21 million out of 87.5 million total population in Sichuan Province. As C-MAP continues to reach its goals, an important task will be to disseminate lessons learned to other health officials in China and other countries combating the pandemic.

An ACHAP training program for doctors in Botswana. (Merck & Co., Inc.)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Merck & Co., Inc. HIV/AIDS Programs - Latin America

Nawa Sport Program

HIV/AIDS Merck & Co. Inc. PAHO & other partners Since 2003 Capacity Building - Training, Education Argentina, Brazil, Chile, Colombia, Mexico, Venezuela www.merck.com

HIV/AIDS Johnson & Johnson Academy for Educational Development AED, NawaLife Trust Since 2008 Education Namibia www.jnj.com

With some 720,000 people infected with the HIV virus, Brazil is estimated to have approximately one third of Latin America’s HIV-positive population. In response to the epidemic and in support of the Brazilian government’s well-recognized commitment to address HIV and AIDS, Merck’s Office of Contributions and MSD Brazil provided financial support to HIV programs developed by local nongovernmental organizations, focusing primarily on prevention, education and awareness. These organizations have included Grupo de Amparo ao Doente de AIDS, which supported the creation of a mobile unit for STD/AIDS prevention and assistance to offer pre- and post-test counseling for HIV and AIDS in São Jose do Rio Preto

The Nawa Sport Program is a collaboration between the Academy for Educational Development (AED) and Johnson & Johnson, in partnership with NawaLife Trust. The program uses the large-scale appeal of soccer to inspire young men ages 14 to 25 to get involved in a community activity, which could provide a way to teach them about HIV/AIDS prevention.

A number of projects also have focused on adolescents and young adults — an especially vulnerable group. In Brazil, Centro Corsini’s ‘Prevention Just in Time’ project is aimed at increasing screening, diagnosis and early treatment of HIV and AIDS and other sexually transmitted diseases among low-income teenagers and adults in the city of Campinas. Another project, ‘Prevention: The Sooner The Better’ with INMED Partnership for Children, supports sexual health education and information and HIV/STD prevention programs for young people in the town of Francisco Morato, São Paulo.

But the program does more than just teach about HIV/AIDS prevention. It gives all involved a greater sense of accomplishment and involvement within the community. The program operates in 20 sites across two regions in the north of Namibia, Ohangwnea and Omusati. In its first year, the Nawa Sport Program enrolled more than 3,000 young men in its soccer and HIV/AIDS prevention education program. In its second year, the program has expanded to include female players and coaches as well.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Pfizer Diflucan® Partnership

Pfizer Global Health Fellows

HIV/AIDS Pfizer Axios International, IMA World Health, International Dispensary Association Since 2000 Access - Donation, Capacity Building - Training 63 developing countries www.diflucanpartnership.org, www.pfizerglobalhealth.com

HIV/AIDS, malaria Pfizer Multiple partner organizations Since 2003 Capacity Building - Support & Training, Education 36 developing countries www.pfizer.com

Pfizer created the Diflucan® Partnership in 2000 to provide treatment for two AIDS-related fungal infections in developing countries. Since the program’s inception, Pfizer has over provided USD 1.1 billion of products and its program partners distribute millions of Diflucan® (fluconazole) treatments free of charge to governments and NGOs in 63 developing countries in Africa, Asia, the Caribbean and Latin America. Pfizer has also provided training and education materials to 20,000 healthcare professionals.

The Pfizer Global Health Fellows program utilizes the professional expertise of Pfizer employees through specialized volunteer assignments with nonprofit organizations to improve health care services for underserved communities around the world. Since 2003, more than 230 employees with a range of technical skills have served in 39 nations for 3-6 month assignments investing nearly 200,000 hours of skills-based service to help increase the capacity of nonprofits organizations providing health care to the underserved (in the reporting period, 54 Global Health Fellows were deployed). The program has been recognized by the U.S. Corporation for National and Community Service as a pro bono “best-in-class” model of international corporate volunteerism. Global Health Fellows has been replicated in different forms by leading corporations such as: IBM, Becton Dickinson, Ernst and Young, and most recently, GlaxoSmithKline.

Pfizer’s partners provide technical assistance, support program management and distribute Diflucan to participating governments and organizations. These partners include Axois International, IMA World Health and International Dispensary Association. The Diflucan® Partnership involves the following activities: • Donating Diflucan® to governments and organizations to treat patients; • Distributing materials to train healthcare workers in the diagnosis and treatment of AIDS-related infections; • Providing inventory management training tools for pharmacists to improve medicine handling and distribution; • Sharing best practices for effective medicine distribution and supporting industry collaboration on access to medicines.

Since inception, Pfizer has worked with Boston University’s Center for Global Health and Development to evaluate the efficacy of the program and guide its development to drive impact on the ground. The following data reflects findings from the 2009 Global Health Fellows Evaluation Study: • 85% of Fellows and 83% of partner organizations reported the contributions of the Fellowship resulted in greater efficiency. Many accomplishments related to efficiency included introducing standard operating procedures (SOPs), technological support including databases, and supply and financial tracking sheets, communications, and overall general systems strengthening; • 75% of Fellows and 62% of partner organizations reported the contributions of the Fellowship improved the quality of services. Accomplishments related to improved quality of services included the introduction of stronger data collection, monitoring, and evaluation tools and skills, the introduction of best practices in areas from laboratories to customer relations, a variety of trainings, and the introduction of SOPs; • 53% of Fellows and 42% of partner organizations reported the contributions of the Fellowship resulted in service expansion. One partner reflects that its medical program had discussed conducting clinical research for over four years, but had made no progress. “When the Fellow came, he helped us develop the clinical research division of our team and established policies and procedures and the mechanisms for making the division operational.”

At the Mulago Hospital in Uganda, Pfizer Global Health Fellow Ponni Subbiah discusses her findings with medical students. Fellowship assignments are designed by Pfizer’s partners according to their needs. Many involve teaching. (Richard Lord, Pfizer)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Pfizer - Infectious Diseases Institute

Pfizer - PDA Positive Partnership

HIV/AIDS Pfizer Various partners, including universities Since 2002 Capacity Building - Support & Training Uganda www.academicalliancefoundation.org, www.pfizerglobalhealth.com

HIV/AIDS Pfizer Population and Community Development Association Since 2004 Capacity Building - Support Thailand www.pfizerfoundation.or.th

The Infectious Diseases Institute (IDI) in Kampala, Uganda was established in 2004 as a Center of Excellence in Infectious Disease, combining a research program, innovative training program, and locally relevant strategies for prevention, treatment & care, to build regional capacity to address HIV/AIDS, malaria and tuberculosis. Partners in the IDI include Accordia Global Health Foundation, Makerere University and Mulago Hospital, the Ugandan Ministry of Health, and the Infectious Diseases Society of America.

Since 2004, Pfizer Foundation New York, Pfizer Thailand Foundation and the Population and Community Development Association (PDA) have collaborated to improve the quality of life of people living with HIV/AIDS. This micro-credit loan scheme provides economic security for people living with AIDS while reducing stigmatization and discrimination in their communities. Since 2007, the Pfizer Thailand Foundation has provided financial support for the program and has worked together with PDA to equip project members with technical skills. The effort results in improved overall quality of life and health of people living with HIV/AIDS and strengthened bonds within their communities. To date, the project has provided new opportunities to 1,278 project members nationwide and has recently been recognized by UNAIDS as ‘Best Practice’ subject for duplication on international stage.

IDI is internationally recognized for building the capacity of health systems in Africa to deliver sustainable, high quality care and prevention of HIV/AIDS and related infectious diseases through training, research and advanced clinical services: By enhancing the stature and recognition of the Faculty of Medicine at Makerere University, Pfizer’s support of the IDI is helping to reverse the trend of African healthcare professionals pursuing career opportunities abroad. African doctors, medical scientists, and other healthcare professionals can now pursue their clinical interests in a worldclass academic medical setting and serve their home countries and people. The IDI model, combining training, clinical care and prevention, and research in an African-based and African-led academic medical institution, has proven extraordinarily productive. Since 2004, more than 5,100 health care workers from 27 African countries have received training in various aspects of the prevention and care of HIV/AIDS and related infectious diseases, and indicate they train on average 20 additional health care workers per month. Also, IDI provides ongoing care and treatment to over 14,000 HIV/AIDS patients in Uganda, and conducts regular outreach to strengthen other providers in the region. More than forty projects are currently underway in IDI’s research department, which works closely with Uganda’s Ministry of Health to improve national policy and practice.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Saber para Reagir

Sikiliza Leo Project, Uganda

HIV/AIDS Johnson & Johnson ALIA Since 2005 Education Brazil www.jnj.com, www.alia.org.br

HIV/AIDS Johnson & Johnson Sikiliza Leo Since 2003 Access - Donation, Capacity Building - Support Uganda www.tibotec.com

According to a survey of 600 adolescents from the impoverished São Jorge community in the Brazilian city of Londrina, 60% do not use contraceptives and 30 percent have used illegal drugs. To protect these vulnerable teens from infectious diseases, ALIA began the Saber para Reagir (To Know Is to React) program.

Johnson & Johnson, its Tibotec subsidiary and the African Medical Research Foundation help the Ugandan NGO Sikiliza Leo to provide HIV testing, counseling, treatment and care in rural Uganda. Since March 2003, HIV testing and counseling have been offered to 3,586 community members, of whom 559 have tested positive for HIV. A total of 272 persons receive Home Based Care and a first group of 20 are now receiving ARV therapy. Basic drug kits containing a variety of essential medicines, including miconazole MAT and co-trimoxazole prophylaxis, are among the tools used by home care volunteers.

The program’s workshops educate 80 participants at a time about sexually transmitted diseases (including HIV/AIDS), early pregnancy, correct use of male and female contraceptives, and citizen rights. In addition, monthly meetings with families in the community spark dialogue and empower their involvement in the education process. “ Saber para Reagir is just one of 18 projects run by ALIA, which was established in 1989 by HIV-positive professionals working in several fields. Now the largest HIV/AIDS-related organization in Brazil, its mission is to protect the civil rights of people living with HIV/AIDS and to prevent the spread of HIV/AIDS through the creation and implementation of scientific and social programs. ALIA is considered an authority in combating HIV/AIDS and actively participates in formulating policies related to public health, social assistance and education.

The program has also established two day-care facilities that support some 250 orphans and vulnerable children in Mulanda and Lwala parishes. Psychosocial development, education, nutrition and care are offered to children from 3 to 8 years of age. The program has been recognized by the American Embassy, and a grant has been provided to improve facilities and food.

Since the partnership with Johnson & Johnson began in 2005, ALIA’s Saber para Reagir program has reached more than 240 teens at high risk for HIV/AIDS infection.

Rapid on-site testing can have a significant impact in the fight against HIV/AIDS. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

Takeda Initiative with Global Fund

Tibotec Cost Recovery Distribution Program

HIV/AIDS, Tuberculosis, Malaria Takeda Pharmaceutical Global Fund to Fight AIDS, Tuberculosis & Malaria Since 2010 Capacity Building - Support Nigeria, Senegal, Tanzania www.takeda.com

HIV/AIDS Johnson & Johnson CCBRT in Tanzania Since 2003 Access - Pricing, Capacity Building - Support Sub-Saharan Africa www.tibotec.com

The Takeda Initiative is an endowment made by Takeda Pharmaceutical, with an annual value of JPY 100,000,000 (approximately USD 1 million). It is designed to support the Global Fund to Fight AIDS, Tuberculosis and Malaria over the period 2010-2019, primarily for the training of health care workers and strengthening of health care systems in Africa.

Johnson & Johnson’s Tibotec subsidiary makes TibozoleTM Miconazole MAT, a muco-adhesive buccal tablet that can treat oral thrush in AIDS patients. To date, Tibotec has sold at cost or donated over two million patient treatments of Miconazole nitrate 10 mg MAT for use in sub-Saharan Africa. Of these, more than 1,300,000 treatment units have been sold to international procurement agencies for distribution in resource poor settings, through Tibotec’s Cost recovery distribution program. Tibotec collaborates with major notfor-profit suppliers to the developing world, such as IDA and MSF, to maximize access and ensure sustainable product supply. Pilot collaborations with voluntary organizations have led to an increase in donations of patient treatments in a number of sub-Saharan African countries.

Controlling the spread of the three major infectious diseases is one of the eight targets set by the United Nations Millennium Development Goals (MDGs). The lack of trained health care workers is particularly severe in Africa, and poses a major obstacle to providing the health care services required to combat infectious diseases. The Takeda Initiative is contributing to Global Fund-supported programs in Africa, to enhance health care systems mainly through training and strengthening the competence of individuals involved in providing health care. During the first phase, the initiative will focus on: • Nigeria (target disease: HIV/AIDS): Scale-up of comprehensive HIV/AIDS treatment, care and support, training staff members of not-for-profit and grass-roots organizations engaged in providing community-based care for HIV/AIDS patients and orphans, and advocacy and awareness increasing activities; • Senegal (target disease: tuberculosis): Reinforce tuberculosis control by training health workers engaged in tuberculosis diagnosis and treatment;

One community-based program benefiting from at-cost miconazole is the Comprehensive Community Based Rehabilitation center in Dar es Salaam, Tanzania (CCBRT). Dr. Geert Vanneste, Medical Director of the holistic HIV program at CCBRT, said ‘the product has really provided us with a convenient, fast acting topical product, which can be used at the lowest level of care, and represents a real advance in the armamentarium for our home based care workers’. The home based care providers working in the program have also spoken out regarding the product benefits: its efficacy, minimal side effects and good compliance.

• Tanzania (target disease: malaria): Support the National Insecticide Treated Nets Implementation Plan (NATNETS) by strengthening the system to distribute insecticide treated nets and by developing the human resources engaged in promoting the use of nets.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – Capacity Building

ViiV Healthcare’s Positive Action on HIV/AIDS

‘Youth Speak-Up!’ HIV Peer Education

HIV/AIDS GlaxoSmithKline AMREF, CRS, EGPAF, IHAA, NEPHAK Since 1992 Capacity Building - Support & Training, Education 21 developing countries www.positiveaction.com

HIV/AIDS Johnson & Johnson Indonesian Youth Partnership Since 2006 Education Indonesia www.jnj.com

Set up in 1992, Positive Action is ViiV Healthcare’s international HIV/AIDS education, care and community support program. It works with community organizations to build capacity to counter the ignorance and stigma surrounding HIV and AIDS through outreach, education and advocacy. In 2009, ViiV Healthcare provided more than GBP 1 million, funding projects in 46 countries across Africa, Asia, Latin America and Eastern Europe. Positive Action has pioneered support for vulnerable communities, including men who have sex with men, intravenous drug users, sex workers, migrants, young people, orphans and vulnerable children and marginalized poor rural women. In July 2009, ViiV Healthcare launched a new Positive Action for Children Fund which will make GBP 50 million (USD 80 million) available over ten years to help prevent mother-to-child transmission of HIV and to support orphans and vulnerable children. During 2009, ViiV Healthcare supported 17 Positive Action programs in 46 countries, examples of which are given below.

Young people in Indonesia account for 46% of all HIV/AIDS infections. ‘Youth Speak-Up!’ was initiated by the Indonesian Youth Partnership (IYP), a nationwide network of youth leaders fighting for Adolescent Reproductive Health and Rights. ‘Youth Speak-Up!’ uses a network of peer educators to raise awareness about HIV/AIDS transmission and prevention. Johnson & Johnson supports ‘Youth Speak-Up!’ programs in which adolescents from 12 provinces are trained to educate others in their communities, reaching more than 3,000 young people. In 2007, 240 peer educators were recruited and an additional 21 peer education trainers were trained in the program. With the support of the IYP, the program is growing into a sustainable network of peer educators with the capacity to ensure education in the provinces. The IYP collaborates with the national media to spread the importance of their message.

Reach India aims to make HIV/AIDS prevention, financial and business education available to millions of poor women in rural India. ViiV is giving USD 595,000 over four years to develop the capacity of community organizations and self-help groups to reach 500,000 women and 2.5 million family members in rural areas. Reach India is supported by Catholic Relief Services (CRS). In Kenya, ViiV is giving USD 2.2 million over four years to integrate HIV/AIDS treatment and support services into 38 general healthcare clinics, to enable people to avoid the stigma of visiting an HIV clinic. Positive Action also helps to train healthcare professionals and create patient self-help groups. Other partners include the African Medical and Research Foundation (AMREF), Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) and the National Empowerment Network of People Living with HIV and AIDS in Kenya (NEPHAK). In Mexico, ViiV is working on a four-year project with the International HIV/AIDS Alliance (IHAA) and its Mexican partner, Colectivo Sol, to improve quality of life for people with HIV/AIDS, reduce stigma and discrimination, and educate people about HIV/AIDS. The TREAT Asia program is run by the Foundation for AIDS Research (amfAR) with support from Positive Action and seeks to teach proper, safe and effective use of HIV therapies, working with clinicians and other health care workers in 25 clinics across a number of Asian countries, including Cambodia, China, Thailand and Vietnam. In 2009 ViiV Healthcare announced support for the Staying Alive Foundation in its efforts to raise awareness about HIV/AIDS and its prevention among young people worldwide.

Many programs supported by industry involve training to strengthen local health care capacity. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R &D

Gilead Clinical Development Partnerships

HIVACAT public-private partnership for HIV vaccine development

HIV/AIDS Gilead US CDC, US NIH Since ? R&D Uganda, Zimbabwe www.gilead.com

HIV/AIDS Esteve IrsiCaixa, Obra Social La Caixa, Hospital Clínic de Barcelona, Catalan Government Since 2008 R&D R&D work in Spain www.esteve.com, www.irsicaixa.org

Gilead is investing in clinical research to develop new medical interventions that address the health needs of developing countries. At the end of 2008, Gilead was involved in 36 ongoing studies that had enrolled more than 13,500 patients in Asia, Africa and Latin America. The largest of these studies is the Development of Antiretroviral Therapy (DART) study with two sites in Uganda and one site in Zimbabwe

The development of an effective vaccine is the only affordable and sustainable way to halt the HIV pandemic. In response to this challenge, the “HIVACAT” program was launched in 1995to design, develop and test potential HIV vaccine candidates in clinical trials for further development and regulatory approval. HIVACAT is a joint effort by two leading European HIV research institutions - the Hospital Clinic de Barcelona and Irsicaixa - and brings together the expertise and projects of more than 60 investigators from both centers.

Clinical studies supported by the US Centers for Disease Control and Prevention, the National Institutes of Health and other public health leaders also are underway to evaluate the potential of Viread® and Truvada® to prevent HIV infection in high-risk individuals. For these studies, Gilead provides Viread®, Truvada® and/or placebo at no cost. Preliminary results from these studies may be available in 2010.

Esteve’s involvement started in 2008 and consists of financing part of the research phase and helping with regulatory and intellectual property issues. Once proof-of-concept in humans is reached, Esteve will take care of submission for regulatory approval and commercialization. The program tackles some of the current roadblocks in HIV vaccine design, including the incomplete knowledge of host immune control of HIV, viral sequence diversity and adequate vaccine vector design. Through extensive national and international collaboration and the stature of its members, the program is well integrated in the global effort to develop an HIV vaccine. The program is structured in 8 highly interactive lines of investigation that address cellular and humoral immunity to HIV and their relationship with viral control, assess the impact of viral sequence diversity and host genetics on vaccine immunogen design and study the function of dendritic cells as vaccine carriers. It contains a straightforward path to design preventive vaccine approaches and select the most promising candidates for clinical trials. The work is strongly supported by a unique access to patients and the proven ability of the two centers to conduct extensive clinical trials and cohort-based studies. The project is advancing at good pace. In the last months several important papers on the research have published, the latest in “Nature Medicine” (Feb 2010) about how innate immune mechanisms can control disease progression in HIV-positive patients.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R &D

International AIDS Vaccine Initiative (IAVI) HIV/AIDS Bristol-Myers Squibb, Crucell, GlaxoSmithKline, Merck & Co. Inc., Pfizer IAVI, BD, Gates, Rockefeller, USAID, World Bank Since 1996 R&D Worldwide www.iavi.org

The International AIDS Vaccine Initiative (IAVI) was created in 1996 out of the recognition that the best long-term solution to the growing AIDS epidemic is a vaccine. As a global organization operating across borders to meet the challenges posed by the epidemic, IAVI is working to ensure the development of safe, effective, accessible and preventive HIV vaccines for use throughout the world. IAVI’s work focuses on four areas: • Support through advocacy and education (by identifying and filling other scientific gaps); • Scientific progress (by supporting promising vaccine development partnerships); • Industrial participation in AIDS vaccine development (by expanding public-private collaboration and creating incentives for private sector investment and participation in HIV vaccine development); and • Global access (by creating the policies necessary for getting the vaccines to all those who need it). IAVI collaborates with developing countries, governments and international agencies that are dedicated to accelerating the development of a vaccine to halt the AIDS epidemic. IAVI is working on HIV/AIDS vaccine projects with Crucell and GlaxoSmithKline, while BristolMyers Squibb, Merck & Co., Inc. and Pfizer are IAVI funding partners, as are the Rockefeller Foundation, World Bank, USAID, the Bill and Melinda Gates Foundation and other donors. In 2005, GlaxoSmithKline launched the first formal public-private partnership with IAVI to research vaccines against HIV strains that circulate predominantly in Africa. IAVI contributes technical expertise and funding, and GSK and IAVI researchers form a joint research team. The partnership is doing preclinical research for a vaccine using a vector derived from an adenovirus common in non-human primates carrying pieces of the HIV genome. Disabled adenoviruses are innocuous and produce a very strong immune response. Previous exposure to naturally occurring adenoviruses may limit the potency of such vaccines, which is why GSK and IAVI are concentrating on adenoviruses that do not occur in humans. IAVI entered into an agreement with Crucell to develop an HIV vaccine based on Crucell’s AdVac adenovirus vector technology and obtained the rights from Crucell to use a cell line for these vectors. A Phase I clinical trial evaluating safety and immunogenicity of a candidate vaccine based on this technology started in 2009.

The virus that causes AIDS can become resistant to current treatments, so it is important to continue R&D to develop new medicines and vaccines. (Merck & Co., Inc.)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R &D

International Partnership for Microbicides (IPM)

Merck & Co., Inc. HIV Vaccine R&D

HIV/AIDS Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. Inc., ViiV Healthcare International Partnership for Microbicides Since 2004 R&D Rwanda, South Africa, Tanzania www.ipm-microbicides.org

HIV/AIDS Merck & Co. Inc. HIV Vaccine Trials Network & other partners Since 2003 R&D R&D around the world www.merck.com

Johnson & Johnson’s Tibotec affiliate established a first-of-its-kind public-private partnership with the non-profit International Partnership for Microbicides (IPM) in 2004, providing a royalty-free license and technology transfer to develop, manufacture and distribute TMC120 as a topical vaginal microbicide to reduce sexual transmission of HIV in developing countries. IPM is conducting safety trials of TMC120 as a vaginal gel in Belgium, South Africa, Rwanda and Tanzania. Following two successful safety studies, IPM is now researching dapivirine’s use in an innovative vaginal ring delivery system which could offer women extended HIV protection.

Merck & Co., Inc.’s HIV vaccine research program began in 1986 and continues to make progress in bringing forward new innovative vaccines, working with others in public/private partnership to make them accessible to those who need them around the world, and helping to build capacity in developing countries.

In October 2005, Bristol-Myers Squibb announced that it had granted a royalty-free license to IPM to develop, manufacture and distribute their new antiretroviral compound as a microbicide to protect women from HIV in resource poor countries. The compound was an ‘entry inhibitor’, some of which bind directly to the HIV itself, others to the CCR5 receptor. The compound is designed to prevent HIV from entering host cells efficiently, thus preventing infection. In December 2006, Gilead granted royalty-free rights to the IPM and Conrad to develop, manufacture, and distribute tenofovir gel as a microbicide. The gel is currently being evaluated in Phase II/III clinical studies conducted by the HIV Prevention Trials Network (HPTN), Microbicide Trials Network (MTN), and the Centre for the AIDS Programme of Research in South Africa (CAPRISA). In 2005, Merck granted a no-cost license to IPM for development, manufacture and distribution as a microbicide for use in developing countries. Most recently, in March 2008, Merck granted a non-royalty-bearing, non-exclusive license to IPM to develop, manufacture and distribute a novel antiretroviral compound for use as a potential vaginal microbicide. The compound is the fourth Merck has granted to IPM since 2005. In January 2008, Pfizer agreed to give IPM a royalty-free license to maraviroc, its newly-approved HIV treatment, as a microbicide for the prevention of HIV infection. Maraviroc is one of a new class of antiretroviral drugs known as CCR5 blockers. Under this agreement, IPM will work to develop maraviroc as a vaginal microbicide with the right to develop, manufacture and distribute it in developing countries. Pfizer granted these rights to IPM without a royalty. Pfizer’s contribution now falls under ViiV Healthcare.

Given the high-risk nature of pharmaceutical research and development, setbacks are common. Phase II ‘test of concept’ clinical trial of Merck’s lead HIV vaccine candidate, a trivalent adenovirus based vaccine, was conducted in partnership with the HIV Vaccine Trials Network (HVTN) and the National Institutes of Health (NIH). The study began in 2004 in Australia, the Caribbean, and North and South America. Another Phase II study of this vaccine candidate - called Phambili - was initiated in South Africa by the HVTN and NIH in February 2007. In 2007, Merck, the HVTN and NIH announced that vaccination and enrollment were discontinued in both STEP and Phambili trials because in interim analyses of STEP the vaccine was found to be ineffective. In scientific meetings, results from STEP were presented which showed that the vaccine neither prevented infection in uninfected volunteers nor reduced viral loads in those who became infected with HIV during the course of the study. In certain STEP subgroups, there were more infections in volunteers who received the vaccine than in those who received placebo. Merck, HVTN and NIH are conducting extensive analyses to better understand the STEP data and the reason for this result. While the STEP study results were disappointing to Merck and the external HIV community, the partners are committed to gaining scientific insights from STEP to inform the ongoing search for an HIV vaccine. The partnership between Merck, HVTN and NIH in this endeavor has been hailed by many as a model for collaboration between industry, government and academia in the advancement of science. Merck is also collaborating with NIH and HVTN to implement a fair and rigorous scientific evaluation of STEP results and to enable external investigators to gain access to specimens and data from this study in an effort to advance the search for an effective HIV vaccine. The HIV Vaccine Trials Network is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is funded and supported by the US National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH).

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R &D

Pediatric Formulations for ARVs HIV/AIDS Abbott, Bristol-Myers Squibb, Gilead, Ranbaxy, ViiV Healthcare Various partners Since ? R&D - Pediatric R&D Clinical programs include developing countries www.abbott.com, www.bms.com, www.gilead.com, www.gsk.com

Of the 2.5 million HIV-positive children in the world in 2007, nearly 90% were in sub-Saharan Africa, according to UNAIDS. Antiretrovirals (ARVs) are developed for adults, most clinical trials are in adults, with doses and dosage forms designed for adults. But children cannot be dosed like small adults, as their metabolic capacity to absorb ARVs is not simply proportional to their weight. Safety, efficacy and dosage need to be determined via specific pediatric trials. Most ARVs were developed in tablet form, yet these are impractical for children under five, who require special liquid formulations. While older children can take tablets, those intended for adults often contain too large a dose. Abbott has had a longstanding commitment to the treatment of children with HIV. In 2007, as an industry first, Abbott launched the lower-strength tablet formulation of lopinavir/ritonavir in the developing world (Uganda) before the product was available in the developed world. The lopinavir/ritonavir tablet is the only co-formulated protease inhibitor tablet that can be used in children, the tablets do not require refrigeration and can be taken with or without a meal – important advances in delivering HIV medicine in developing countries. The tablet is easier for children to take than its liquid formulation, which has been used in Africa since 2001. The lower-strength tablet is sold at half the price of the original formulation in 69 countries, including all of Africa.

Ranbaxy, which is majority owned by Daiichi Sankyo, is active in pediatric HIV R&D, with 2 fixed dose combinations and 9 single ingredient products in development, in line with WHO pediatric guidelines. Ranbaxy has developed a triple fixed dose combination of Lamivudine, Stavudine and Nevirapine but, as WHO subsequently changed its dosing recommendations for this combination, the company is now seeking a partner to help fund a new bio-equivalence study. In 2007, ViiV gained European Commission and FDA approval for new scored tablets for Epivir, Combivir and Ziagen. This will enable children above 14kg of weight to benefit from a solid dosage form. Scored tablets enable ARVs to be broken into two smaller doses which simplifies treatment for children. Tablets are often easier to store and distribute, and also less complicated to administer than the liquid formulations currently available - particularly when two or three medicines are combined in one pill. For example, a child weighing 20kg can now take half a tablet of Combivir in the morning and the second half in the evening in combination with another ARV, instead of requiring 8ml of Epivir solution twice a day plus 12ml of Retrovir solution three times daily.

Bristol-Myers Squibb currently produces pediatric formulations of Videx® (didanosine), Zerit® (stavudine) and Sustiva® (efavirenz), and is working with the Pediatric AIDS Clinical Trials Group to develop Reyataz® (atazanavir) for infants from 3 months old to 18 years. It is also developing Sustiva® oral solution for children from 3 months to 16 years. Sustiva capsules are currently approved for use in children 3 years and older. Gilead Sciences is working to advance development of a pediatric formulation of tenofovir. To address issues with the initial formulation, Gilead has developed a new heat-stable encapsulated sprinkle formulation for future studies. Two Phase III studies in pediatrics are fully enrolled and ongoing. GlaxoSmithKline’s ARV interests are now managed by ViiV Healthcare. It has developed a number of ARV liquid formulations for children, all available at not-for-profit prices in the world’s poorest countries. ViiV has also committed to support five pediatric clinical trials in resource-poor countries to determine the best ways to expand access to HIV/AIDS treatment. The development of oral solutions for its combination therapies, Combivir® and Trizivir®, is complicated because two key components (zidovudine and lamivudine) require different pH ranges to maintain stability, and daily dosing issues associated with abacavir have hampered a Kivexa® pediatric formulation.

An estimated 2.5 million children were living with HIV/AIDS in 2007. (Abbott)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

HIV/AIDS – R &D

PEPFAR Partnership for Pediatric AIDS Treatment

ViiV Healthcare Collaborative Research Program for Resource-Poor Settings

HIV/AIDS Abbott, Bristol-Myers Squibb, Gilead, Merck & Co. Inc., ViiV Healthcare PEPFAR, UNAIDS, UNICEF, WHO Since 2006 Access - Pricing, R&D - Pediatric R&D 15 developing countries www.pepfar.gov

HIV/AIDS ViiV Healthcare WHO & other partners Since 2000 R&D - Pediatric R&D 14 developing countries www.gsk.com

The US President’s Emergency Plan for AIDS Relief (PEPFAR) Partnership for Pediatric AIDS Treatment was launched in 2006. This public-private partnership includes innovator and generic pharmaceutical companies and multilateral organizations such as UNAIDS, WHO and UNICEF. The initiative will identify scientific obstacles to treatment for children, take practical steps to address key barriers, share best practices and develop systems for clinical and technical support.

ViiV Healthcare is committed to the development of new molecules that target unmet medical needs in HIV. The treatment of children with HIV/AIDS remains a significant unmet medical need and there is a pressing need for new medicines to tackle problems such as drug resistance, complex treatment regimens, and side effects associated with current treatments. Through its HIV-collaborative research program for resource-poor settings, ViiV Healthcare is supporting clinical trials that are sponsored by external organizations - such as the World Health Organization (WHO), the UK Medical Research Council and the US National Institutes of Health (NIH).

In addition to making medicines available at preferential prices to PEPFAR, Abbott is also working with PEPFAR to advance treatment for children with HIV in developing countries by actively participating in the PEPFAR Partnership for Pediatric AIDS Treatment. Bristol-Myers Squibb is an active partner in the PEPFAR Partnership for Pediatric AIDS Treatment, working to find solutions to issues concerning pediatric HIV treatment, formulations and access. In 2004, Bristol-Myers Squibb agreed to allow the FDA to make right of reference to its confidential dossiers and product registration files to facilitate approval of generic combination products under the PEPFAR program. Gilead is an active member of the PEPFAR Partnership for Pediatric AIDS Treatment. Merck & Co., Inc. is working in partnership with the PEPFAR Partnership for Pediatric AIDS Treatment, working to identify scientific and technical solutions to improving access to antiretroviral treatment for children living with HIV/AIDS in resource-limited settings.

At the end of 2009, 22 trials, involving approximately 23,300, patients, were either underway or committed to, with 19 of these trials being in Africa. These CRTs focus predominantly on public health-related issues such as prevention of mother-to-child HIV transmission, pediatric treatments strategies and HIV-TB co-infection. Five of these are pediatric studies, one of which will provide the first significant clinical data in the resource-poor setting on the efficacy, safety and pharmacokinetics of ViiV Healthcare’s NRTI scored tablets. ViiV Healthcare donates study antiretrovirals and/or financial support, and also provides scientific input. Countries in which HIV clinical trials are being conducted under the aegis of this program include: Botswana, Brazil, Cambodia, Haiti, India, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, Zambia and Zimbabwe.

ViiV Healthcare is a major supplier of ARVs to PEPFAR at access prices and has also participated in the State Department’s program to expand the number of pediatric formulations for HIV medicines that are appropriate for PEPFAR and other child access programs in the developing world.

The treatment of children with HIV/AIDS remains a significant unmet medical need. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS

Estimated TB incidence rates, 2008 > _ 300 100 – 299 50 – 99 25 – 49 0 – 24 No estimate (Source: WHO Global Tuberculosis Control 2009, A short update to the 2009 report)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

About one third of the world’s population is infected with Mycobacterium tuberculosis. While only 1 in 10 infected people with healthy immune systems will develop tuberculosis (TB) symptoms, those with weakened immune systems, such as those with HIV, are much more likely to contract TB. More than 90 % of TB cases and deaths occur in the developing world, primarily among young adults. In 2008, there were an estimated 9.4 million cases of TB globally, up from 9.3 million in 2007, as slow reductions in incidence continue to be outweighed by increases in population. Most of the cases in 2008 were in Asia (55 %) and Africa (30 %). In 2008, some 1.4 million (15 %) of all TB cases were HIV-positive, most of them in Africa and South-East Asia. Directly Observed Treatment Short-Course (DOTS) is the WHOrecommended TB therapy and uses a combination of antibiotics over a 6-8 month period. Patients are observed taking their medication, to ensure the continued compliance needed for complete eradication of the bacteria. Nearly 32 million TB patients have been treated under DOTS since 1995. Although a

vaccine exists to prevent childhood tuberculous meningitis, a 100% effective, affordable and practical vaccine has yet to be developed against adult pulmonary TB. Multidrug-resistant TB (MDR TB) affected some 440,000 people worldwide in 2008 and a third of them died. It does not respond to the standard first-line treatment and it can take up to two years or more to treat with medicines that are less potent, more toxic and more expensive. Extensively drug-resistant TB (XDR TB) occurs when resistance develops to the second-line drugs used to treat MDR-TB. It is virtually untreatable and cases have been confirmed in more than 57 countries, notably China and India. The pharmaceutical industry is developing new TB medicine and vaccine candidates and supports a range of programs to increase access to TB medicines and to strengthen healthcare capacity in affected countries.

(Source: WHO Global Tuberculosis Control 2009, Epidemiology, Strategy, Financing; WHO Global Tuberculosis Control, A short update to the 2009 report; WHO Multidrug and extensively drug-resistant TB (M/XDR TB), 2010 Global Report on Surveillance and Response)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – Access & Capacity Building

AstraZeneca & Red Cross: Fight against TB in Africa

AstraZeneca & Red Cross: Fight against TB in Central Asia

Tuberculosis AstraZeneca Red Cross Since 2006 Capacity Building - Training, Education Lesotho, Liberia, South Africa www.astrazeneca.com

Tuberculosis, HIV/AIDS AstraZeneca British Red Cross Since 2002 Capacity Building - Training, Education Kazakhstan, Kyrgyzstan, Turkmenistan www.astrazeneca.com

Since 2006, AstraZeneca has supported the Red Cross in its community-based work to help reduce TB incidence and improve the quality of life of people affected by TB and TB/HIV in sub-Saharan Africa.

AstraZeneca’s long-standing partnership with the British Red Cross Society is focused on helping the international Red Cross and Red Crescent movement to deliver community-based programs in Central Asia which encourage people to seek early diagnosis, Improve patient compliance, provide care in the home, promote TB and TB/HIV awareness/education and address the stigma associated with the diseases.

With AstraZeneca’s support, the South African Red Cross is delivering improved care and support to people living with TB or TB/HIV in 10 provinces, including the KwaZulu Natal, Western Cape, Eastern Cape, Limpopo, Gauteng and Free State. To date, some 2,500 people affected by TB or TB/HIV have successfully completed their treatment and over 6,000 suspected cases of TB identified and sent for screening. This has been achieved mainly through patient follow-up by trained volunteers. Volunteers also distribute TB prevention information and have reached over 60,000 people. In Lesotho, the company’s support has enabled the Lesotho Red Cross to deliver improved TB and TB/HIV care to people living in the isolated, rural communities of Mapholaneng, Leribe, Mafeteng, Kena and Maseru, who have little access to formal health facilities. More than 160 Red Cross volunteers have been trained in TB management and prevention, including how to recognize TB symptoms, how it is transmitted, infection control and care, and referral of people suffering from the disease. These trained volunteers then work within the local communities to share their knowledge with local volunteers and village committees. During 2008, AstraZeneca expanded its support to include a new project in Liberia, where treatment completion rates are estimated to be below 75%. Working with the Liberian Ministry of Health, the Liberian Red Cross has developed a new program to increase TB awareness through community based education and provide support to people living with TB. Implementation began in December 2008 in the Montserrado region, building on the existing communitybased health work of the Liberian Red Cross. To date, the Liberian Red Cross trained 27 community volunteers in TB care and prevention and 9 ‘focal’ volunteers, who coordinate activity within their communities. A further 67 volunteers are currently receiving training.

AstraZeneca’s support has helped the Red Cross to expand its coverage and form strong relationships with ministries of health and partner organizations and is playing a significant role in helping national TB programs in Kyrgyzstan, Turkmenistan and Kazakhstan to stabilize and reduce TB incidence in these countries. In 2002, AstraZeneca started helping the Red Cross to address TB in Kyrgyzstan and Turkmenistan, poor countries with a high incidence of TB. Since 2006, the company has also supported a program in Kazakhstan, aimed at mitigating the consequences of TB/HIV co-infection. All programs are managed by the national Red Crescent Societies. The Kyrgyz and Turkmen programs focus on improving patient compliance, raising awareness of TB and fighting the stigma associated with the disease. Progress to date includes: • Over 10,000 people living with TB or TB/HIV successfully completed their TB treatment; • TB treatment completion rates up to 89% and 92% in Turkmenistan and Kyrgyzstan, respectively; • Increased awareness following media campaigns and health education sessions in schools and public places that reached more than 2 million people. The Kazakh program is providing community-based social support for people living with TB and HIV, and their families, bringing together social workers, psychologists and employment lawyers, with volunteers – many of them former patients - to support those on treatment and those who have recently completed treatment. Consultations encourage treatment compliance and help patients deal with social and emotional difficulties. Between January and September 2009, over 800 consultations, 68 group discussion and 73 home visits took place and some 1,800 food parcels were distributed. Treatment completion rates increased from 54% to 73% in 2008.

Kyrgyz Red Crescent nurses and volunteers hand out leaflets in Bishkek’s Ortsai market. The leaflets explain the symptoms of TB and how to prevent infection. (Claudia Janke, British Red Cross)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – Access & Capacity Building

Lilly MDR-TB Partnership

Novartis TB DOTS Donation

Tuberculosis Lilly WHO & other partners Since 2003 Access - Pricing & Tech Transfer, Capacity Building - Support & Training, Education Partnership activities in over 80 countries www.lillymdr-tb.com

Tuberculosis Novartis WHO Since 2003 Access - Donation Tanzania www.novartisfoundation.org

The Lilly MDR-TB Partnership was launched by Eli Lilly and Company in response to the growing threat of multidrug-resistant tuberculosis. Operating in over 80 countries, and with a specific focus on those countries hardest hit by MDR-TB (China, India, Russia and South Africa), the partnership is based on a multi-pronged approach that includes the following components: technology transfer to increase the MDR-TB drug supply; training to improve disease management and surveillance; and support for communities, including patient advocacy and workplace awareness and prevention programs.

The WHO’s TB control strategy consists of Directly Observed Therapy Short-Course (DOTS) and combines political commitment to sustained TB control activities: early detection, a standardized treatment regimen, effective drug supply, as well as monitoring and evaluation.

In close collaboration with the WHO Green Light Committee, Lilly works to increase access to second-line TB medicines. Initially, it provided medicines at discounted prices; however, as demand began to exceed supply, Lilly began transferring the product and manufacturing know-how to produce its two second-line medicines to companies in China, India, Russia and South Africa. Lilly also partnered with Purdue University to provide assistance in safety, quality and business management to its manufacturing partners. The Lilly MDR-TB Partnership also supports a variety of activities aimed at increasing health-care provider knowledge and disease surveillance. Partner projects include: • The International Council of Nurses’ online “Global TB/MDR-TB Resource Center” for 13 million nurses worldwide. Launched in South Africa and the Philippines in 2005, this “train the trainers” has expanded to more than 20 countries; • Harvard Medical School and Partners in Health run an MDR-TB training Center of Excellence in Tomsk, Russia. PIH works with 5 Russian TB research centers to standardize MDR-TB training nationwide; • The International Hospital Federation has developed comprehensive TB and MDR-TB-control training manuals and distributed them to 65,000 hospitals and clinics in some 100 countries; • The World Medical Association has edited clinical MDR-TB guidelines targeted on physicians and has been training physicians worldwide.

From 2005 to 2008, Novartis donated nearly 250,000 rifampicinbased fixed-dose combination tablets for the treatment of TB in Tanzania. Another 250,000 treatments will be delivered from 2009 to 2012 which ensures a country-wide coverage. The medicines are given to the Global Drug Facility (GDF) of the Stop TB Partnership which is part of the WHO. Novartis also provides the necessary funds for logistics and independent quality control, to be carried out in addition to the quality control performed by the Novartis Group. The fixed-dose combination therapy reduces the treatment duration from 8 to 6 months. The medicines are provided in blister packs which facilitate the intake of several different pills, reduce the risk of resistance, simplify logistics and minimize prescription errors. In collaboration with the Tanzanian National Tuberculosis and Leprosy Control Program (NTLP), the Novartis Foundation for Sustainable Development developed the Patient-Centered Treatment (PCT) approach allowing people to choose where they wish to be treated and supervised – in a health center or at home with support of a family or community member. PCT also adheres to the DOTS strategy but avoids daily traveling for physically weak patients and those living far from the health facility. Moreover, PCT promotes patients’ empowerment and responsibility for their treatment. The Novartis Foundation and the NTLP complemented the PCT approach with a social marketing campaign to inform people about TB, its causes, symptoms and new therapies. The aim was to destigmatize the illness, since many patients are co-infected with HIV/AIDS. Results show that 88% of TB patients opt for home-based treatment and that the rate of treatment compliance (completed treatments) could be increased from 72% to 77.5%.

The partnership also supports various community, advocacy and workplace initiatives. These include: • A World Economic Forum toolkit to increase TB and MDR-TB workplace awareness in India, China and South Africa; • The International Federation of Red Cross and Red Crescent Societies is implementing patient-support programs in over 15 countries, including public-awareness, psychological support, and food supplements for vulnerable populations; • The Advocacy Partnership and Global Health Advocates have been raising awareness on TB and advocating on behalf of patients. These women are performing street theatre to educate the population on TB prevention and treatment in New Delhi, India. (Lilly)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – Access & Capacity Building

Sanofi-aventis: TB Free & Other Initiatives

Stop TB Partnership

Tuberculosis sanofi-aventis Nelson Mandela Foundation & other partners Since 2002 Capacity Building - Support & Training, Education India, Kenya, South Africa www.sanofi-aventis.com

Tuberculosis AstraZeneca, GlaxoSmithKline, Lilly, Novartis Stop TB, MSF, Red Cross & other partners Since 2000 Access - Donation & Pricing, R&D Endemic countries & vulnerable populations www.stoptb.org

In March 2002, sanofi-aventis and the Nelson Mandela Foundation established the TB Free program, a EUR 15 million effort to increase detection and treatment rates for tuberculosis in South Africa. Initially planned to finish in 2007, it has now been extended to 2010. The partnership trains volunteers to encourage patient compliance during the 6-month treatment, using the WHO-recommended DOTS (Directly Observed Therapy Short-Course) strategy.

The Stop TB Partnership was established in 2000 to realize the goal of eliminating tuberculosis (TB) as a public health problem. It comprises a network of more than 500 international, governmental, nongovernmental and private sector organizations and individuals with an interest in working together to achieve this goal. The Partnership is a global movement to accelerate social and political action to stop the spread of TB around the world. A number of IFPMA members, including AstraZeneca, GlaxoSmithKline, Lilly, Novartis, Pfizer and IFPMA are currently partners of the Stop TB Partnership, and actively contribute to its aims and programs.

The agreement mandated TB Free to provide infrastructure for training and conduct training and also develop and implement education and awareness programs. The actions would help to increase the TB cure rate by as much as 80% through improved compliance to TB treatment. In each of the country’s nine provinces, a TB Free Center has been established, which works closely with the Ministry of Health. By 2009, nine training centers had been opened, in which 33 000 ‘DOTS supporters’ have been trained. TB Free provides a fully accredited training program which equips the DOT supporters with skills to provide care and support to TB patients and their families. The training program is integrated with the South Africa Community Workers Program, designed to qualify Community Workers in the fields of health, social welfare and other disciplines. A comprehensive TB advocacy, communication and social mobilization program is being implemented, to increase testing, compliance and cure rates. The program harnesses television and radio adverts and information programs, billboard campaigns, print media, taxis advertisements and door-to-door information visits by DOTS supporters. Such activities are helping to change community attitudes to TB and put it high on decision makers’ agendas. In Kenya, sanofi-aventis works with the Kenya Association for the Prevention of Tuberculosis and Lung Diseases to train health-care workers in 200 targeted treatment centers. Sanofi-aventis also supports the Kenya’s World TB day awareness activities. In India, sanofi-aventis formed a partnership with the Association Père Ceyrac in 2007 to fight tuberculosis and support TB-affected families living in the slums of Mumbai, Navi-Mumbai and Pune. Sanofi-aventis supports the Inter-Aide NGO through local partners by means of 51 DOTS (Directly Observed Treatment short-course) centers, 11 centers for collecting samples, and 4 testing laboratories located in the heart of the slums, which manage to treat almost 4,000 patients a year.

The targets set by the Stop Partnership are: • By 2005: 70% of people with infectious TB will be diagnosed and 85% of them cured; • By 2015: the global burden of TB disease will be reduced by 50% relative to 1990 levels (Millennium Development Goal); • By 2050: The global incidence of TB disease will be less than 1 per million population (Elimination of TB as a global public health problem). The partnership develops advocacy and resource mobilization strategies in support of these priorities, and coordinates and ‘brokers’ resource flows. In addition, there are six Working Groups that contribute significantly to the achievement of partnership aims: DOTS Expansion Working Group; TB-HIV Working Group; Stop TB Working Group on MDR-TB; Working Group on New TB Drugs, Working Group on New TB Diagnostics and Working Group on New TB Vaccines. The Stop TB Partnership Private Sector Constituency is the community of businesses with a recognized role or interest in TB control. The Private Sector has been represented on the Coordinating Board of the Global Stop TB Partnership since 2004, following a proposal by the World Economic Forum. The current Board Members are AstraZeneca and Mérieux Alliance. The Global Drug Facility, run by the Stop TB Partnership, is expanding access to medicines for DOTS scale up; in just 5 years it has committed over 7 million TB treatments. Projects managing MDR-TB can apply through the Green Light Committee (GLC) for access to quality MDR-TB medicines at reduced prices - in some cases by as much as 99%. The Committee is operated by WHO and the Stop TB Partnership. Lilly has a program to make two critical medicines for treatment of drug-resistant strains available in developing countries and will supply 1.4 million vials of capreomycin at concessionary prices to the GLC in 2009. Novartis is donating 500,000 fixed dose combinations to the Global Drug Facility during 2005-2012.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – R & D

Aeras Global TB Vaccine Foundation

AstraZeneca Bangalore Research Institute

Tuberculosis Crucell, GlaxoSmithKline Aeras & other partners Since 2004 R&D Kenya, Philippines, South Africa www.aeras.org, www.crucell.com, www.gsk.com

Tuberculosis AstraZeneca European Union Framework Program VI Since 2003 R&D India www.astrazeneca.com

The Aeras Global TB Vaccine Foundation was founded in 1997 to develop new concepts and tools to control the global TB epidemic. It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years.

Backed by its skills and experience in infection research, AstraZeneca joined the global effort to find new TB therapies in 2003, with the opening of a USD 20 million dedicated TB research centre in Bangalore, India.

In partnership with the Aeras Global TB Vaccine Foundation, Crucell is developing a recombinant vaccine against tuberculosis. The Crucell-Aeras TB vaccine program focuses on improvement of the only currently available TB vaccine, the Bacillus Calmette-Guérin (BCG) vaccine. Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004. Data from completed AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of this candidate at all dose levels evaluated.

More than 80 scientists work there, with full access to all AstraZeneca’s platform technologies, such as high throughput screening and compound libraries. They also work closely with the company’s infection research centre in Boston, USA, as well as with external academic leaders, to capture and share best practice. The company continues to invest more than USD 5 million each year in this research effort, which is focused on finding new therapies that will act on drug-resistant strains, shorten the duration of treatment, eradicate disease (including the latent form) to reduce the chances of relapse, and be compatible with HIV/AIDS therapies (TB and HIV/AIDS form a lethal combination, each speeding the other’s progress).

Completed Phase I trials: • USA: safety; • South Africa: high CD8-cell immune response; • St. Louis, USA: immunogenic response for boost doses; • Kenya: no safety issues for AERAS-402 in BCG-vaccinated adults. Ongoing Phase I trials: • South Africa: vaccine safety in infants previously vaccinated with BCG vaccine. Ongoing Phase II trials: • South Africa: safety in adults who have had active TB. GSK Biologicals is developing a prophylactic vaccine to prevent mycobacterium tuberculosis disease in infants, adolescents and adults. The company’s candidate vaccine is composed of the M72 antigen and GSK’s proprietary AS01 adjuvant system. In a BCG prime-boost regimen, the candidate vaccine has been shown to improve the protection conferred by BCG and confer a long-term protection in monkeys primed with BCG and challenged with a high dose of virulent mycobacterium tuberculosis. Completed Phase I/II clinical trials: • Belgium and South Africa: PPD-negative adults; • South Africa and the Philippines: PPD-positive adults; • Switzerland: HIV positive individuals under HAART. Clinical trials are ongoing to evaluate the safety and immunogenicity of the candidate vaccine in adolescents, infants and HIV treatment naive adults, som in partnership with Aeras global TB foundation and TBVAC. The ultimate aim of these partnerships is to accelerate the vaccine development to ensure rapid access to the populations who need it most.

2009 was a year of considerable progress: • In December 2009, AstraZeneca’s first candidate TB drug, AZD5847, started phase I clinical trials, having showed potential in pre-clinical studies to treat MDR-TB. If phase I testing is successful, the company will conduct further clinical development with external partners; • In collaboration with the European Framework 6 consortium, AstraZeneca researchers in Bangalore have identified a new class of compounds with potential as novel TB treatments. The findings were published in Science, a leading academic journal, and the company continues to explore their potential; • Researchers at the National Institute of Health (NIH) in the USA discovered that meropenem, AstraZeneca’s marketed antibiotic for hospital-acquired infection, is also active against MDR-TB. The company donated supplies of meropenem for an NIH-sponsored research project in South Korea, combining meropenem and clavulanic acid (a component of another marketed antibiotic) to assess the combination’s potential as a treatment for MDR-TB. AstraZeneca is also part of the European Union Framework Program VI collaboration (NM4TB - New Medicines for Tuberculosis) that will enable it to work with academic leaders in TB research. AstraZeneca is the only major pharmaceutical company involved in this project, which began in 2006. Funded by a grant from the EU Framework VI program and consisting of around fifteen groups of prominent EU researchers, this consortium seeks to combine academic and pharmaceutical skills to further the discovery of new therapies for TB.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – R& D

GlaxoSmithKline - TB Alliance Drug Discovery Program

Global Alliance for TB Drug Development (TB Alliance)

Tuberculosis GlaxoSmithKline Global Alliance for TB Drug Development Since 2005 R&D R&D in Spain www.gsk.com

Tuberculosis Bayer HealthCare, Cumbre, GlaxoSmithKline, KRICT, Novartis DFID, NIAD, USAID & other partners Since 2000 R&D China, India, South Africa, Zambia www.tballiance.org

In March 2005, GlaxoSmithKline and the Global Alliance for TB Drug Development (TB Alliance) announced a joint discovery partnership to improve the treatment of tuberculosis (TB).

The Global Alliance for TB Drug Development (TB Alliance), established in 2000, brings together industry, NGOs, governments and foundations to work together with more than 30 partners around the world to accelerate the discovery and development of cost-effective new medicines. The TB Alliance draws on the best practices and resources of the public and private sectors. Its mission is to accelerate the discovery and development of cost-effective new anti-TB medicines, which should shorten or simplify treatment, provide a more effective treatment of multidrug-resistant TB and improve treatment of latent TB infection.

All compounds will be screened to ensure they can be taken with HIV treatments, since people living with AIDS are often susceptible to TB infection. The TB Alliance supports 25 full-time scientists working exclusively on the TB drug program at the GSK R&D facility in Tres Cantos, Spain. GSK will contribute a matching number of staff and all remaining overhead costs. Around 1.5 million compounds have been tested for anti-TB activity and any medicines discovered will be made as affordable and accessible as possible to those most in need. The program broadens the worldwide TB medicine pipeline by adding several novel classes of compounds that use new mechanisms of action. The joint research program consists of four projects intended to yield new compounds that attack Mycobacterium tuberculosis (M.tb) on multiple levels. Drug candidates arising from these projects could shorten the standard duration of treatment and treat patients who are resistant to conventional therapies. The program includes a novel class of antibiotics targeting a Mycobacterium gyrase and two target-based projects, malate synthase (MS) and InhA. The fourth project screened GSK’s antimicrobial libraries for novel compounds that could kill M.tb. A shorter TB regimen is expected to improve patient compliance, increase cure rates and lower toxic side effects, thereby limiting the rise of new resistant strains. A novel TB regimen that is compatible with HIV treatments would improve TB control and help in the fight against AIDS. In January 2008, GSK announced a 3-year extension of its program with the TB Alliance. Dr. Mel Spigelman, Director of R&D, TB Alliance, said ‘We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline. This collaboration is advancing the TB Alliance’s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease.

Company partners include: Bayer HealthCare, Cumbre, GlaxoSmithKline, the Korea Research Institute of Chemical Technology (KRICT) and Novartis. Other partners include the Beijing Institute of Materia Medica, the Beijing Tuberculosis and Thoracic Tumor Research Institute, the US National Institute of Allergy and Infectious Disease (NIAID), University of Auckland, University of Illinois, Yonsei University. Funders include the Bill and Melinda Gates Foundation, the Rockefeller Foundation, the US Agency for International Development (USAID), Irish Aid, the Netherlands’ Ministry of Foreign Affairs and the UK Department of International Development (DFID). The partnership functions as a virtual R&D organization. By outsourcing medicine research and development projects, medicine compounds are moved along the development line to achieve regulatory approval and bring them to market at affordable prices for those countries experiencing the highest burden from TB. The TB Alliance activities in developing countries include clinical trials in Kenya, South Africa and Zambia and non-clinical or preclinical work in China and India.

GSK’s lead TB project on Mycobacterium Gyrase Inhibitors expects to select a candidate for development in the first half of 2010.

GlaxoSmithKline and TB Alliance are working together to improve the treatment of tuberculosis. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – R & D

Lilly TB Drug Discovery Initiative

Moxifloxacin TB Clinical Trials (Bayer HealthCare)

Tuberculosis Lilly, Academia Sinica, Jubilant Biosystems, Summit plc IDRI, NIH NIAID & other partners Since 2007 R&D India www.TBDrugDiscovery.org, www.lillymdr-tb.com

Tuberculosis Bayer HealthCare Global Alliance for TB Drug Development Since 2005 R&D South Africa, Zambia www.bayerscheringpharma.de

Although a large percentage of tuberculosis cases worldwide remain susceptible to current TB antibiotics, drug-resistant TB is a major and growing threat. Created in June 2007, the Lilly TB Drug Discovery Initiative’s major goal is to fill the early stage pipeline. The primary members are Eli Lilly and Company, the Infectious Disease Research Institute (IDRI), and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the U.S. National Institutes of Health (NIH).

In 2005, Bayer HealthCare announced a partnership with the Global Alliance for TB Drug Development (TB Alliance) for a global clinical trial program to study the potential of an existing antibiotic, moxifloxacin, to shorten the standard 6-month treatment of pulmonary tuberculosis. If the trials are successful, the partnership is committed to register moxifloxacin for a pulmonary tuberculosis indication and to making it accessible in developing countries where patients need it most.

Lilly has given USD 15 million to establish the Initiative, including USD 9 million in-kind, including fully equipped high throughput screening and chemistry laboratories, research tools, databases, and scientific and technical expertise, plus USD 6 million in cash over five years to seed the organization. Lilly is also providing access to its library of 500,000 compounds and is making available its expertise in drug discovery and chemistry. IDRI, a Seattle-based not-for-profit organization committed to research and development of products for infectious diseases of poverty, is providing expertise in TB and chemistry, as well as managing the Initiative’s laboratories, and serving as its principal coordinator. Organizations co-developing compounds with the Initiative or contributing research tools can request access to NIH-sponsored resources and receive valuable data to assist in compound development. Others collaborating with the Initiative include Jubilant Biosystems (India), the Seattle Biomedical Research Institute, Summit plc (UK), the University of Washington’s Department of Global Health and YourEncore. The Microbial Chemistry Research Foundation in Japan brings strong expertise in natural product chemistry, as well as CPZEN-45, a compound with a novel mechanism of action which has shown promising in vitro and in vivo activity against multidrug resistant TB strains. Most recently, Academia Sinica joined the Lilly TB Drug Discovery Initiative as a Contributing member. Academia Sinica’s proprietary library of more than two million compounds adds critical chemical diversity, and their provision of some of the world’s most advanced technologies in high-throughput screening and genomic sequencing greatly enhances chances for success.

Moxifloxacin is being studied in a large, pivotal Phase III clinical trial (REMoxTB), which will enroll over 2,400 pulmonary tuberculosis patients. The REMoXTB study is currently being conducted in South Africa, Tanzania and Zambia. It is anticipated that the trial will also be performed in other countries, including China, India and some Latin American countries, if clinical trial approvals can be obtained in these countries. Two drug regimens are being tested. The first substitutes moxifloxacin for ethambutol, and the second substitutes moxifloxacin for isoniazid. Both moxifloxacin treatment arms comprise a shortened treatment duration of 4 months, while the control arm is current standard treament of 6 months duration. The aim is to prove that one or both shortened moxifloxacin treatment regimens are as good as the current 6-month treatment. If successful, the REMoxTB study results will be submitted to regulatory agencies to support approval of a shortened TB treatment indication with moxifloxacin. Bayer donates moxifloxacin for each trial site, provides ongoing operational support, and will cover the costs of regulatory filings. Current standard TB therapy is based on four medicines discovered forty or more years ago that must be administered for six to eight months, often under the direct observation of a healthcare professional (DOTS). A shorter TB treatment regimen should help to increase patient compliance, reduce failure rates and lower TB-related healthcare expenditure in endemic countries. Preclinical studies showed moxifloxacin could reduce treatment time by two months when substituted for isoniazid, a cornerstone of current TB treatment. The results of Phase II clinical studies support the treatment-shortening potential of moxifloxacin. Currently, moxifloxacin is approved in 104 countries to treat bacterial respiratory and skin infections.

Collectively, the Initiative mobilizes extensive resources to address the challenge of TB drug discovery. However, the magnitude of the task is so large and so urgent that the help of all qualified players is needed. Success will come about as the result of the combined efforts of all sectors.

The Lilly MDR-TB Partnership is about transfer of technology, know-how – and hope. (Lilly)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – R& D

Novartis Institute for Tropical Diseases (NITD)

Otsuka Pharmaceutical: MDR-Tuberculosis R&D

Tuberculosis Novartis Global Alliance for TB Drug Development & other partners Since 2003 R&D Indonesia www.nitd.novartis.com

Tuberculosis Otsuka Pharmaceutical Various partners Since 2004 R&D China, Egypt, Peru, Philippines www.otsuka-global.com

The Novartis Institute for Tropical Diseases (NITD) research center in Singapore is a public-private partnership between Novartis and the Singapore Economic Development Board (SEDB) and focuses exclusively on the discovery of innovative medicines for the treatment of diseases that are endemic to developing countries. With more than 110 scientists from 25 countries employed and activities that range from target discovery, screen development and compound optimization to preparation for clinical testing, NITD also offers teaching and training opportunities in the field of tropical diseases.

At a preclinical level, Otsuka Pharmaceutical’s OPC-67683 has shown particularly strong bactericidal activity on Mycobacterium tuberculosis. The compound has also been confirmed to have no cross resistance with any of the currently used anti-tuberculosis agents and its strong bactericidal effect is seen even on clinically isolated strains of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).

The goal of NITD’s Tuberculosis Unit is to apply new genomic and bioinformatic technologies to develop novel treatments for multidrugresistant TB. NITD researchers are using the tuberculosis mycobacterium genome sequence to identify vulnerable parts that could be targeted by small molecules. Those molecules can then be further refined to produce resulting medicines that will be made available at no profit in developing countries where the disease is endemic.

Phase II-a studies to evaluate the early bactericidal effects in TB patients have been completed and a Phase II-b study for MDR-TB is currently underway in China, Egypt, Peru and the Philippines, as well as five developed countries (Estonia, Japan, Korea, Latvia, and the USA).

In 2006, NITD and ten other collaborators led by the Imperial College received a grant from the Grand Challenges for Global Health Initiative to discover new targets for latent tuberculosis. A recent Collaboration and License Option Agreement between NITD and the Global Alliance for TB Drug Development aims at accelerating development of potential cost-effective new drugs towards clinical use. To secure direct access to hospitals and patients in a real-life context, in 2007 NITD also teamed up with the Hasanuddin University and Eijkman Institute for Molecular Biology in Indonesia to form NEHCRI - a clinical research initiative that aims to strengthen translational research in tuberculosis, but also malaria and dengue fever, two other diseases NITD is working on.

The Novartis Institute for Tropical Diseases research center in Singapore focuses exclusively on the discovery of innovative medicines for the treatment of diseases that are endemic to developing countries. (Novartis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TUBERCULOSIS – R &D

Ranbaxy R&D for TB

Sanofi-aventis: R&D for TB

Tuberculosis Ranbaxy Indian Ministry of Science and Technology Since 2008 R&D India www.ranbaxy.com

Tuberculosis sanofi-aventis Global Alliance for TB Drug Development & other partners Since 2007 R&D International R&D www.sanofi-aventis.com

In collaboration with the Department of Biotechnology of the Indian Ministry of Science and Technology, Ranbaxy has dedicated resources to explore its compound library to find molecules that may show activity against tuberculosis. Studies are also being conducted to determine the mode of action for identified compounds. Once a hit is identified, it can be optimized to develop a clinical candidate. All studies are conducted in a BSL3 facility funded by the Indian Government.

Sanofi-aventis helps various international organizations such as the US Centers for Disease Control and Prevention (CDC) and US National Institutes of Health (US NIH), the US CDC Foundation, the Global Alliance for TB Drug Development (TB Alliance), the Consortium to Respond Effectively to the TB/AIDS epidemic (CREATE) and the International Consortium for trials of chemotherapeutic agents in tuberculosis (INTER-TB) at St. George’s Medical School, in their clinical research into new therapeutic regimens for both latent and active tuberculosis, using Rifapentine and other TB drugs. The aim is to reduce treatment duration and the number of tablets, without compromising efficacy.

Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy in 2008.

Sanofi-aventis is also researching new treatment mechanisms, using two parallel approaches: • Systematic screening of sanofi-aventis’ product portfolio to identify new drugs which are active against M. tuberculosis, especially drug-resistant strains; • Evaluation of new compounds proposed by external partners. The objectives of this new sanofi-aventis research and development program coincide with those of the global Stop TB program backed by the WHO and the United Nations’ Millennium Summit, namely to arrest the spread of tuberculosis and begin reducing its incidence by 2015. In addition, Sanofi Pasteur, the vaccines division of sanofi-aventis, is actively engaged in TB vaccine development through a collaboration with the Statens Serum Institut of Denmark. The lead candidate of this collaboration is currently being evaluated in Phase I clinical studies being conducted in collaboration with the Aeras Global TB Foundation at sites in Europe and Africa. The outcome of these studies will guide the further development and continued clinical evaluation of Sanofi Pasteur’s candidate vaccine.

GSK is working on various new candidate therapies for TB. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA

Estimated incidence of malaria per 1000 population, 2006 >200 50-200 5-49 0-4 (Source: WHO World Malaria Report 2008)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

Malaria is now recognized as a major disease of poverty, alongside HIV/AIDS and tuberculosis, but it has become harder to combat, as drug-resistant forms have developed and health infrastructures in malaria-endemic areas have deteriorated. Malaria is caused by a unicellular parasite transmitted to humans through the bites of infected female anopheles mosquitoes. In the absence of immunity or medicines, the most virulent species of the parasite, plasmodium falciparum, can cause death within 24 hours of the appearance of noticeable symptoms. Malaria symptoms include anemia, chills, coma, exhaustion, fevers, partial paralysis, seizures and speech disorders. There were an estimated 243 million episodes of malaria in 2008, resulting in 863,000 malaria deaths in 2008, of which 89% were in Africa and 85% were of children under 5 years of age. Pregnant women are also particularly vulnerable, being three times more likely to develop serious malaria than other adults during a malaria epidemic.

very much underutilized, primarily due to inadequate funding and poor health infrastructure in endemic countries. The WHO also recommends sleeping under insecticide treated mosquito nets, spraying the interior of dwellings with approved insecticides, preventive antimalarial treatment for pregnant woman, diagnostic testing of anyone suspected of having malaria, followed by treatment with appropriate antimalarials for confirmed cases. The pharmaceutical industry is at the forefront of the growing number of R&D projects, looking for new medicines, vaccines, diagnostics and other health products to fight malaria. They are important actors in access programs to make current malaria treatments more widely available to those worst affected by the disease. In Cambodia and Thailand, artemisinin may be losing its potency, which underlines the need for continued R&D to find new malaria medicines.

Because of resistance, WHO recommends artemisinin combination therapies as the first line treatment for malaria, but these remain

(Sources : Roll Back Malaria, What Exactly Is Malaria ? ; WHO, World Malaria Report 2005 ; WHO World Malaria Report 2009)

Developing World Health Partnerships Directory ÂŠ IFPMA 2010 â&#x20AC;&#x201C; www.ifpma.org/healthpartnerships

MALARIA – Access & Capacity Building

ACCESS II – Improving Access to Effective Malaria Treatment

GlaxoSmithKline & Access to Malaria Care

Malaria Novartis Swiss Tropical and Public Health Institute & other partners Since 2003 Access - Pricing, Capacity Building - Support, Education Tanzania www.novartisfoundation.org

Malaria GlaxoSmithKline Various partners Since 2003 Access - Pricing, Capacity Building - Support, Education 13 developing countries www.gsk.com/malaria

Since 2003, the ACCESS Project has been devoted to analyzing and improving access to effective malaria treatment in Tanzania. Main interventions have included social marketing campaigns to inform the population on causes, symptoms and appropriate treatment of malaria, training and supportive supervision of health personnel and the establishment of licensed private drug stores.

GlaxoSmithKline offers its antimalarials at not-for-profit prices to publGlaxoSmithKline offers its antimalarials at not-for-profit prices to public sector customers and not-for-profit organizations in 64 countries - all the Least Developed Countries and all of sub-Saharan Africa. All CCM projects fully funded by the Global Fund to Fight AIDS TB and Malaria are also eligible. GSK does not make a profit at these prices, but it does cover its costs, so it can sustain supply of these high-quality products for as long as they are needed. These prices apply to orders of any size and include insurance and freight costs.

One of the initiative’s achievements has been the development of a general analytical and planning framework on the issue of access, which can also be applied to other diseases and contexts. The second phase of the project – ACCESS II – began in 2008 by building on this model as well as on the results and experiences gathered so far. The purpose of the project is to increase the demand for adequate malaria services to induce more people with the relevant symptoms to come for treatment in a health center or a licensed drug store. Despite the initial success, ACCESS II faces further challenges. An increasing number of people with fever go to health centers and drug stores, but may fail to receive adequate treatment in all of them. In addition, the results from the first phase show that beyond information on malaria and its treatment, the financial resources available to potential patients must be increased. People who are affected by malaria ultimately need enough money to be able to finance insurance coverage and treatment. Thus, access to insurance coverage through community health funds is being promoted. In addition, ACCESS II supports micro-credits and new measures to generate income, particularly for women. More participatory information campaigns on malaria and healthcare services with community involvement are also pursued. By simultaneously strengthening healthcare services and patient resources, access should sustainably improve.

GSK’s African Malaria Partnership was set up in 2003 to support education programs in eight African countries, through partnerships with Freedom from Hunger, AMREF and Plan International. These focused on prevention and prompt treatment, particularly among children and pregnant women. GSK funding for these initiatives has now ended, but the investment will have a long-term positive impact. The scale of the malaria problem requires a significantly bigger response, so in 2005, GSK gave a USD 1.5 million three-year grant to a new partner, the Malaria Consortium, to launch the Mobilizing for Malaria initiative. In 2009, GSK extended its support for the initiative for an additional year. The aim is to increase awareness, generate political commitment and sustained funding to combat the disease. It will increase the number of NGOs engaged in tackling malaria, and give more African communities the knowledge and tools they need to prevent transmission of malaria. National Coalitions Against Malaria were launched in Belgium, Cameroon, Mozambique, Ethiopia, France and the UK, bringing together advocates from the public sector, NGOs, the media, the private sector and the political, academic and scientific communities. Over the last two years Innovation Grants were awarded to NGOs in Africa to boost advocacy efforts. Grants were awarded to civil organizations in Nigeria, Tanzania, Ghana, Mozambique, Democratic Republic of Congo and Burkina Faso. The GSK African Malaria Partnership awarded four new grants in 2009, with a total commitment of GBP1.5 million over three years, to Kenya, (via Save the Children UK), Ghana (via Family Health International), Tanzania (via AMREF) and Nigeria (via the Planned Parenthood Foundation of Nigeria).

Girl receiving malaria treatment at a health facility near Ifakara, Tanzania. (Novartis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – Access & Capacity Building

Millennium Villages Project

Novartis Coartem®

Malaria Novartis Millenium Village Project Since 2007 Access - Donation, Capacity Building - Support Tanzania www.novartisfoundation.org

Malaria Novartis WHO, MMV Since 2001 Access - Pricing, Capacity Building - Training, Education 34 developing countries www.novartis.com

As three out of eight Millennium Development Goals (MDGs) are health-related, the Novartis Foundation for Sustainable Development agreed in 2007 to support the Millennium Villages Project (MVP) in health-related research interventions. The MVP was founded with the goal of helping impoverished communities in rural Africa achieve the MDGs formulated and agreed to by all member countries of the United Nations. The MVP is active at 12 sites in ten African countries.

Coartem® is the first World Health Organization-prequalified fixeddose, artemisinin-based combination therapy (ACT) antimalarial, approved by stringent regulatory authorities and on the WHO Model List of Essential Medicines. Coartem® is fast-acting and cures over 97% of patients after a 3-day treatment course. Coartem® combines artemether, a derivative of artemisinin (from the Chinese medicinal plant Artemisia annua), with a synthetic substance, lumefantrine, which has not been used as a monotherapy.

In 2007, the Novartis Foundation started financing one of the six Millennium Villages in Tanzania, the Ilolangulu Village. For a five-yearperiod, the Novartis Foundation invests in the village´s transition from mainly subsistence farming to more self-sustaining commercial activity. Challenges facing Ilolangulu Village included inadequate water supply, extreme hunger, failed crops and a high prevalence of malaria. The Novartis Foundation also donated the artemisinin-based combination therapy of Novartis (Coartem®) for the treatment of malaria in MVP sites all over sub-Saharan Africa where Coartem is registered on the national essential drugs list. After two years, positive results have been seen. Crop diversification and the use of fertilizers and hybrid seeds have increased the yields for maize from 1.5 tons/hectare in 2007 to close to 5 tons/hectare in 2009. A new clinic constructed by MVP in the Mbola cluster improved the overall health of the population with better health services and the distribution of more than 20,000 treated bed nets. Education and nutrition have improved for more than 7,000 children in the cluster with training of teachers, supply of new textbooks as well as meals in school. Finally, new infrastructures were developed – such as water and sanitation systems, as well as mobile phone towers.

Since 2001, Novartis has provided more than 300 million treatment courses of Coartem® - without profit - for public sector use in Africa. These treatments have helped save an estimated 750,000 lives in more than 60 malaria-endemic countries. In early 2009, Novartis and Medicines for Malaria Venture introduced Coartem® Dispersible, the first artemisinin-based combination therapy (ACT) developed especially for children with malaria, to address specific treatment needs of millions of children with malaria. Coartem® Dispersible contains the same amounts of artemether and lumefantrine as Coartem® tablets (20mg/120mg) and delivers the same high cure rates. Prior to this innovative pediatric medicine, health workers and parents had to crush bitter-tasting antimalarial tablets for children to swallow. New, sweet-tasting Coartem® Dispersible tablets dissolve quickly in small amounts of water, easing administration and ensuring effective dosing for children. Six million treatments of Coartem® Dispersible were delivered in 2009. To date, Coartem® Dispersible has been approved in 26 African countries as well as Brazil and Switzerland. Coartem® Dispersible received the Medicines for Malaria Venture (MMV) Project of the Year Award in 2008. Further, the Coartem® Dispersible packaging won the 2009 Healthcare Compliance Packaging Council Award. The pack was recognized for aiding patient compliance, thanks to clear separation per body weight, the availability of one full treatment course on the same blister and clear pictorial instructions. Education being a key factor in malaria control, the Coartem® program includes training materials and courses for healthcare workers and mothers/caregivers – translated into several African languages and distributed free of charge. Twice a year, Novartis also brings together the managers of national malaria control program across Africa to share best practice in community awareness, healthcare worker training, stock management and distribution, and health impact measurement.

Family in Millennium Village, Ilolangulu, Mbola, Tanzania. (Novartis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – Access & Capacity Building

Pfizer – Mobilize Against Malaria

Roll Back Malaria Partnership

Malaria Pfizer London School of Hygiene & Tropical Medicine & other partners Since 2006 Capacity Building - Support & Training Ghana, Kenya, Senegal www.pfizerglobalhealth.com

Malaria GlaxoSmithKline, Novartis, sanofi-aventis Roll Back Malaria & other partners Since 1998 Access - Pricing, Capacity Building - Support 35 developing countries www.rollbackmalaria.org

Unveiled at the Clinton Global Initiative in 2006, Mobilize Against Malaria is Pfizer’s signature social investment in malaria, supporting programs to reduce the malaria burden in three hard-hit African countries, Ghana, Kenya and Senegal, over a five year period (20072011). Under this USD 15 million program, Pfizer helps four leading NGOs to close critical gaps in malaria treatment, training, and public demand for quality services.

To provide a coordinated global approach to fighting malaria, the Roll Back Malaria (RBM) Partnership was launched in 1998 by the World Health Organization (WHO), the United Nations Children´s Fund (UNICEF), the United Nations Development Program (UNDP) and the World Bank.

In Ghana, Pfizer is helping to bring the public and private sectors together to find new solutions to the malaria challenge. The program specifically supports Family Health International and Ghana Social Marketing Foundation which have demonstrated that investments in Ghana’s licensed chemical sellers, small retail outlets which act as a major source of basic medicines, can dramatically improve malaria treatment, diagnosis and prevention. Through Pfizer’s partners, thousands of LCSs are receiving training and job support and are developing closer ties to the communities they serve. In Kenya, Pfizer is helping Population Services International to reduce malaria in pregnant women and children under five, two groups most at-risk for malaria-related mortality and morbidity. While Kenya is one of the most progressive African countries in terms of malaria programming, resources are still needed to reach women and healthcare providers, especially in hard-to-reach rural communities. Recognizing that more than 70% of women attend antenatal clinics at least once during their pregnancy, Pfizer’s partners are providing a boost to healthcare providers and patients at these clinics by supplying improved training, health education and new information packets designed especially for new mothers. In Senegal, Pfizer is working with IntraHealth International to strengthen the country’s system of health huts, rudimentary clinics which are often the only healthcare facility accessible to rural communities. During the rainy season, when populations become even more isolated, these clinics frequently function without running water, electricity, adequate supplies or medicines. Recognizing the critically important role these health huts play in the country’s healthcare system, Pfizer and its partners are investing in improving their infrastructure, malaria training, supply chain, provider skills, and community demand for services.

The RBM Partnership has expanded exponentially since its launch and is now made up of a wide range of partners, including malaria endemic countries, their bilateral and multilateral development partners, the private sector, nongovernmental and community-based organizations, foundations, and research and academic institutions. These bring a formidable array of expertise, infrastructure and funds to the fight against the disease. The partners are working together to scale up malaria-control efforts at country level, coordinating their activities to avoid duplication and fragmentation and to ensure optimal use of resources. A key role of the RBM Partnership is to lead continuing advocacy campaigns to raise awareness of malaria at the global, regional, national and community levels, thus keeping malaria high on the development agenda, mobilizing resources for malaria control and for research into new and more effective tools, including a vaccine, and ensuring that vulnerable individuals are key participants in rolling back malaria. In 2009, sanofi-aventis represented the private sector on the Partnership Board; GlaxoSmithKline is an alternate member. IFPMA member companies also take part in the private sector delegation to the Board and in various working groups. In 2009, Novartis initiated the SMS for Life pilot, a new public-private partnership involving RBM, IBM, Vodafone and the Ministry of Health in Tanzania. The program uses mobile phones, SMS messages and electronic mapping technology to monitor stock levels of artemisininbased combination therapies (ACTs) and quinine injectables at health facilities on a weekly basis. This helps eliminate stockouts, even in the most remote areas. In a five-month pilot covering 226 villages and over one million people in Tanzania, SMS for Life showed dramatic results. For example, during the first eight weeks, in one district alone, the number of health facilities with stock-outs was reduced by over 75%.

Pfizer is working with the London School of Hygiene and Tropical Medicine, along with KEMRI-Wellcome Trust and Health Partners Ghana, to evaluate the impact of this program.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – Access & Capacity Building

Sanofi-aventis: Impact Malaria Malaria sanofi-aventis Various national & international partners, including universities Since 2001 Access - Pricing, Capacity Building - Training, Education, R&D - Pediatric R&D Benin, Burkina Faso, Côte d’Ivoire, Ghana, Republic of Congo www.impact-malaria.com

The Impact Malaria program embodies sanofi-aventis´ longstanding commitment to fight malaria. Sanofi-aventis is researching new treatments that are affordable, adapted to patients´ needs, especially children, and can help circumvent growing resistance to existing medicines. The most advanced projects are ferroquine for uncomplicated malaria, developed with Lille University and ‘bicationic compounds’ for severe malaria with Montpellier University, both in Phase II clinical trials. Upstream projects include development of ‘trioxaquins’ with Palumed in Toulouse. Sanofi-aventis seeks to improve access to its antimalarials, by making them available at a ‘no profit, no loss’ prices to needy populations. Sanofi-aventis and Drugs for Neglected Diseases intitiative (DNDi) launched a new artesunate-amodiaquine combination treatment in early 2007. The company has relinquished its patents and committed to supply it at prices scaled to income. In the poorest countries, this is less than USD 1 for an adult treatment and a less than USD 0.5 for a pediatric one. Tablets are soluble, facilitating their use with children. This combination was pre-qualified by the WHO in October 2008 and, in 2009, 23 million treatments were sold at preferential prices to over 20 malaria-endemic countries. Sanofi-aventis, Medicines for Malaria Venture, DNDi, and Medicines for Malaria Venture have set up an innovative ‘ASAQ field monitoring program’ with clinical trials in sub-Saharan Africa to generate good efficacy and safety data on the new artemisinin-amodiaquine antimalarial in ‘real life’ conditions, and help build clinical trial and pharmacovigilance expertise. This program that aims at including over 20,000 patients was formalized as a “Risk Management Plan”, the first to be submitted to the World Health Organization. In 2009, sanofi-aventis provided over 20 African health professionals with high-level malaria training. In addition, information, education and communication tools and training sessions have been developed with national malaria control programs and NGOs. In 2009, over 40,000 children were informed about malaria in Côte d’Ivoire, Ghana and Burkina Faso, through an initiative entitled “Schoolchildren against malaria”. The www.impact-malaria.com website provides disease, prevention and treatment information, plus educational tools and an online library. In 2009, sanofi-aventis continued to support malaria prevention and treatment by Actions de Solidarité Internationales in Makoua, Republic of Congo and new initiatives were launched with the NGOs Jeremi in Burkina Faso and Caritas in several African countries. In Benin, the company works with PlanetFinance to help local NGOs to train health workers to educate communities about malaria.

Malaria is the leading cause of death in children under the age of five in Ghana. Mobilize Against Malaria works on local, national, and global levels to raise awareness and fight th disease. (Mark Tuschman, Pfizer)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – R &D

Crucell’s Malaria Vaccine R&D

Medicines for Malaria Venture (MMV)

Malaria Crucell, GlaxoSmithKline NIAID & other partners Since 2003 R&D R&D in USA (Phase I) www.crucell.com

Malaria Bayer HealthCare, Chong Qing Holley, Genzyme, GlaxoSmithKline, Merck & Co. Inc., Novartis, Pfizer, sanofi-aventis, Shin Poong, Sigma-Tau MMV & other partners Since 1999 R&D - Pediatric R&D 8 developing countries www.mmv.org

Many of the vaccines Crucell develops combat diseases severely affecting developing countries, including vaccines against tuberculosis and malaria. Crucell is currently developing a malaria vaccine in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). The vaccine candidate is based on Crucell´s AdVac adenovirus technology.

Medicines for Malaria Venture (MMV), was established as a not-forprofit public-private partnership in Switzerland in 1999, after talks between the World Health Organization (WHO) and the IFPMA. MMV brings public, private and philanthropic partners together to fund and manage the discovery, development and delivery of new medicines for the treatment and prevention of malaria.

The vaccine specifically targets Plasmodium falciparum, the most deadly of the malaria parasites and is being developed under a cooperative research and development agreement with the Walter Reed Army Institute of Research (WRAIR) and GlaxoSmithKline Biologicals (GSK). Under the CRADA, Crucell´s malaria vaccine candidate was tested in preclinical studies as a stand-alone vaccine and in combination with GSK´s RTS,S malaria vaccine candidate. Pre-clinical data generated from the CRADA indicated significantly enhanced immune responses against the malaria parasite (circumsporozoite stage of the Plasmodium falciparum) when Crucell’s AdVac® technology and GSK’s RTS,S technology are used in combination, versus either component alone. A Phase I study of a Crucell´s AdVac stand-alone vaccine candidate is currently underway in the USA. Initial findings of the Phase I trial are expected to be available in 2009.

MMV is funded by foundations, governments and corporations. Regarded by WHO and the Roll Back Malaria partnership as an important partner, it now manages the largest portfolio of malaria medicine research in history, with nearly 40 projects underway at the end of 2008. MMV has mini-portfolio agreements with Genzyme, GlaxoSmithKline, Novartis and sanofi-aventis. Other partners include Bayer HealthCare, Chong Qing Holley, Merck & Co., Inc., Pifzer, Shin Poong and Sigma-Tau. MMV subsidizes 30 scientists at GSK´s dedicated DDW research facility in Tres Cantos. As compounds move into clinical development, GSK provides clinical, regulatory and manufacturing expertise and resources via its global R&D and supply network. In 2008, GSK announced a new collaboration with MMV to identify novel drugs for the treatment of malaria. Research will focus on macrolide antibiotics, which may help treat drug-resistant malaria. GSK and MMV are currently developing tafenoquine, a potential new treatment for the radical cure of P vivax malaria). The Novartis Institute for Tropical Diseases is working with MMV to develop a one-dose cure for P. falciparum, and a curative modality for P. vivax. In 2009, Novartis and MMV introduced Coartem® Dispersible, the first artemisinin-based combination (ACT) developed for children with malaria. It delivers the same 97%+ cure rate as Coartem® and the sweet-tasting tablets dissolve quickly in water, easing administration and dosing for children. In 2008, MMV signed an MoU with sanofi-aventis for discovery work, including early-stage molecule testing, and screening, plus clinical development of ferroquine, SAR97276 and trioxaquine. In 2009, MMV contributed to the DNDi and sanofi-aventis ‘ASAQ field monitoring program’ in Côte d’Ivoire. With approximately 15,000 patients, this is the largest study ever done on an antimalarial and should help African experts and government bodies to develop innovative pharmacovigilance methods in ‘real life’ conditions. In 2009, Merck & Co., Inc. granted MMV an exclusive, royalty-free license to pursue development of an investigational drug candidate for the treatment of malaria in the developing world. The antimalarial candidate is an orally available compound, which could potentially provide a daily or twice-daily curative dosing regimen. In preclinical studies, it has shown to be effective against P. falciparum, the organism that causes acute malaria, including multi-drug resistant strains.

Many of the vaccines Crucell develops combat diseases severly affecting developing countries, including vaccines against tuberculosis and malaria. (Crucell)

In 2009, Pfizer and MMV signed an agreement which will allow Griffith University in Brisbane, Australia to screen approximately 200,000 compounds in the Pfizer compound library against P. falciparum malaria. Sigma-Tau is developing a new artemisinin combination with MMV.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – R & D

Eisai Exploratory Research for the Treatment of Malaria

Eurartesim™ International Development Program

Malaria Eisai University of Osaka in Japan Since 2006 R&D R&D in Japan www.eisai.co.jp

Malaria Sigma-Tau MMV Since 2004 R&D 8 developing countries www.mmv.org, www.sigma-tau.it

A potential new malaria target, GWT1, has been identified and a patent entitled “Methods of screening for compounds that inhibit the biosynthesis of GPI in malaria” was filed in 2003, based on the results from the collaborative research undertaken by Eisai & Co., Ltd. and the University of Osaka. Exploratory research targeting GWT1 is now underway, with a view to identifying suitable lead compounds.

Sigma-Tau S.p.A. and Medicines for Malaria Venture (MMV) have completed development of Eurartesim™ a fixed-dose Artemisininbased Combination Therapy (ACT) which contains dihydroartemisinin (a derivative of artemisinin) and piperaquine. Eurartesim™ is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. The registration dossier has been submitted to EMA on July 2009. The registration is expected during Q4 2010. After that, dossiers will be submitted to the endemic countries. The new Sigma-Tau ACT corresponds to WHO´s recommended firstline treatment for malaria, as it combines in a single tablet a shortlived but potent artemisinin-based active ingredient (dihydroartemisinin) with a second antimalarial (piperaquine) which remains longer in the body. The ACT strategy is based on the concept that the combination reduces the chances of resistance developing and improves its efficacy. The second edition of the WHO Guidelines for the treatment of malaria (March 2010) report. “DHA/PPQ is an option for the first line treatment of uncomplicated p. falciparum malaria worldwide. Strong recommendation, high quality evidence” During the last four years, several published trials, not sponsored by the company, showed that the cure rate of Eurartesim™ is not inferior to other ACTs (artemether-lumefantrine, artesunate-amodiaquine, artesunate-mefloquine). In addition, it has been documented that with Eurartesim™ in comparison with the other ACTs, there was a significantly lower percentage of new infections during the followup period which lasted up to two months. The treatment schedule is very simple: one daily administration for a total of 3 days. The new medicine is very well tolerated with no significant side effects. The Sigma-Tau / MMV clinical development included two large Phase III comparative clinical trials carried out in Africa and Asia, with a total of about 2,700 patients treated, all with uncomplicated P. falciparum malaria. The trial in Africa included about 1,600 children aged six months to 5 years, and the comparator was artemetherlumefantrine. The second Phase III trial was carried out in Asia in about 1,200 patients (aged six months to 63 years), and the comparator was artesunate-mefloquine. Eurartesim™ tablets used in the clinical development program were produced under Good Manufacturing Practice in Sigma-Tau´s industrial facilities in Italy. The Phase III trial results confirmed the efficacy and safety of Eurartesim™ as well as the prophylactic effect in lowering, in comparison with the other ACTs utilized, the incidence of new infections. The development of a water-dispersible Eurartesim™ tablet formulation is ongoing and clinical tests are expected to start between Q4 2010 and Q1 2011.

Investigational site in Uganda (Hospital of Mbrara). (Sigma-Tau)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – R &D

GlaxoSmithKline & Malaria R&D

Novartis R&D for Malaria

Malaria GlaxoSmithKline MMV, WRAIR Since 2001 R&D R&D in UK and Spain (Pre-clinical) www.gsk.com/malaria

Malaria Novartis TDR & other partners Since 2006 R&D - Pediatric R&D 8 developing countries www.novartis.com

GlaxoSmithKline has created a dedicated R&D group to focus on diseases of the developing world (DDW), specifically malaria and TB, with a DDW drug discovery centre at its Tres Cantos R&D site in Spain and clinical development experts in the UK and US. DDW projects are prioritized by their social and public health benefits rather than commercial return. GSK works closely with the Medicines for Malaria Venture (MMV), which subsidizes 30 scientists at Tres Cantos. GSK provides the clinical, regulatory and manufacturing expertise to advance compounds in clinical development.

Novartis is working with the UNICEF-UNDP-World Bank-WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Government of Zambia to study the use of Artemisinin Combination Therapy to treat uncomplicated P. falciparum malaria in pregnant women, for which there is currently little reliable data available.

GSK´s malaria treatment projects include: • Tafenoquine, which is a potential new treatment for the radical cure of P. vivax malaria being developed in partnership with MMV and the US Walter Reed Army Institute of Research (WRAIR). An initial clinical study is focusing on further understanding the safety of tafenoquine in subjects with G6PD deficiency. The study began in 2009 and interim results are expected in 2010;

Novartis has worked with the Medicines for Malaria Venture (MMV) to develop a pediatric formulation for Coartem®; an important need, given the disproportionate vulnerability of children under 5 year to malaria. Clinical development took place in several African countries and the new product, Coartem® Dispersible, was formally launched in January 2009. Since 2007, the Novartis Institute for Tropical Diseases (NITD) in Singapore has been working with MMV, the Singapore Economic Development Board and the Wellcome Trust to discover new malaria medicines.

• Pyridone GSK932121 is being developed in partnership with MMV. It entered ‘first time in human’ clinical trials early in 2009. In addition, a back-up effort is ongoing to identify a alternative pyridone compound in case issues with the lead GSK932121 prevent further development. These are a new class of compounds with the potential to be highly effective against drug-sensitive and drugresistant strains of both P. falciparum and P. vivax malaria.

The partnership is focusing on the development of a once daily-dose cure for P. falciparum, the most dangerous form of malaria, and a curative modality for P. vivax, the most frequently-occurring and widely distributed type of malaria. NITD will manage the program and conduct research jointly with several institutes including the Genomics Institute of the Novartis Research Foundation, the Swiss Tropical and Public Health Institute and the Biomedical Primate Research Center.

GlaxoSmithKline has an R&D center focused on diseases of the developing world in Tres Cantos, Spain. (GlaxoSmithKline)

Novartis is working on medicines to treat malaria in pregnant women and on pediatric formulations. (Novartis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – R &D

PATH Malaria Vaccine Initiative (MVI)

Pfizer - Azithromycin/chloroquine for Malaria

Malaria GlaxoSmithKline MVI & other partners Since 1999 Capacity Building - Support & Training, R&D - Pediatric R&D Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Tanzania www.malariavaccine.org

Malaria Pfizer London School of Hygiene & Tropical, MMV Since 2006 R&D - Pediatric R&D 9 developing countries www.pfizer.com/responsibility

The PATH Malaria Vaccine Initiative (MVI) was launched in 1999 to accelerate development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI was funded by a USD 50 million grant from the Bill & Melinda Gates Foundation and the Initiative is administered by the US not-for-profit Program for Appropriate Technology in Health (PATH). MVI is guided by Technical Advisory Groups, a Strategic Advisory Council and PATH´s board. Partners include malaria experts around the world, government agencies, academia, public and private research institutions, and vaccine producers.

Pfizer, in partnership with Medicines for Malaria Venture (MMV) and London School of Hygiene and Tropical Medicine, is developing a fixed dose combination of azithromycin and chloroquine (AZCQ) for intermittent treatment of malaria in pregnant women (IPTp) in subSaharan Africa. IPTp is aimed at lowering the incidence of adverse pregnancy outcomes associated with malaria in pregnancy. Sulfadoxine/pyrimethamine (SP) is the current standard of care for IPTp in high transmission areas in Africa. However, recent emergence of resistance to SP, especially in East and Southern Africa has made the search for SP replacement IPTp regimens an urgent priority.

GSK´s candidate RTS,S/AS is the most clinically advanced malaria vaccine in the world. In 2008, two separate Phase II trials confirmed of earlier studies´ findings that the vaccine provides infants and young children, the most vulnerable groups, with significant protection against malaria. In children aged five to 17 months, the RTS,S/ASO1 vaccine reduced the risk of clinical episodes of malaria by 53% over an eight-month period. In the other trial, amongst infants under 12 months who received three doses of a modified RTS,S/AS02 vaccine, the risk of first infection from malaria was reduced by 65% over a six month period. Importantly, trials also showed that the RTS,S/AS02 vaccine does not interfere with the efficacy of vaccines for other diseases, such as diphtheria, tetanus and polio, administered to infants through existing African national immunization programs. This means that in malaria-prevalent countries, the vaccine could be delivered through the current immunization schedule for infants, called the WHO Expanded Program on Immunization (EPI).

The AZCQ development program is in Phase III of clinical development. In two multi-country clinical trials in sub-Saharan Africa, AZCQ recently demonstrated 98% and 100% efficacy in treatment of symptomatic, uncomplicated falciparum malaria in non-pregnant adults. The trials were conducted in Burkina Faso, Ghana, Mali, Kenya, Senegal and Uganda. A phase III multi-country pediatric treatment trial is currently ongoing in Burkina Faso, Ghana, Mali, Cote d’Ivoire and Kenya. The pivotal IPTp trial is planned to start in the third quarter of 2010 in Kenya, Uganda, Tanzania and Malawi.

In 2009, GSK and its partners launched a large-scale phase III efficacy trial of RTS,S in seven countries in Africa. The trial, which is expected to involve up to 16,000 children, is on schedule, with almost 7,500 children enrolled by the end of January 2010. Christian Loucq, MVI Director, commented on the significance of the trial results by saying, “we are closer than ever before to developing a malaria vaccine for children in Africa”. Under current plans, the RTS.S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 517 months of age. Depending on the final clinical profile of the vaccine and timetable of the regulatory process, the first vaccine introduction could take place over the next three to five years.

Maintaining treatment records can be a challenge in developing countries. (GllaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

MALARIA – R &D

Ranbaxy R&D for Malaria

Sanofi-aventis - DNDi Malaria Medicine

Malaria Ranbaxy Clinical trial partners Since 2003 R&D India, Thailand www.ranbaxy.com

Malaria sanofi-aventis DNDi & other partners Since 2005 Access - Pricing, Capacity Building - Support & Training, R&D - Pediatric R&D 10 developing countries www.sanofi-aventis.com, www.dndi.org

Arterolane maleate, or RBx-11160, is a synthetic version of artemisinin discovered by the University of Nebraska Medical Center, Omaha, under a Medicines for Malaria Venture (MMV) program. Being synthetic, arterolane is not dependent on the artemisia annua plant-based supply chain which has presented some challenges to increasing the availability of artemisinin combination treatments (ACTs), and may also offer cost advantages.

In April 2005, sanofi-aventis signed an agreement with Drugs for Neglected Diseases initiative (DNDi) to develop a new medicine against malaria, in response to a call from the World Health Organization (WHO) for malaria be treated by drug combinations to combat resistance.

A partnership between Ranbaxy and MMV was initiated in May 2003 to develop the compound into a new anti-malarial medicine. A Phase IIa trial evaluating single doses of arterolane maleate demonstrated that the drug has parasiticidal properties similar to the short-acting artemisinin derivatives. In early 2007, MMV discontinued support for the program. However, Ranbaxy´s desire to develop a product for India and other malaria-endemic developing countries has encouraged it to continue development work. A Phase IIb clinical trial in India and Thailand has evaluated 3 daily doses of arterolane maleate with piperaquine phosphate, an established antimalarial drug in China and South East Asia. It has proven antimalarial activity against both P. vivax and P. falciparum, including strains of chloroquine-resistant P. falciparum. The arterolane maleate-piperaquine phosphate combination was found to be as effective and safe as the standard artemether-lumefantrine ACT. Ranbaxy has obtained approval from the Drug Controller General of India to initiate Phase III human clinical trials for this drug in India. Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy in 2008.

DNDi and sanofi-aventis have developed a fixed-dose combination (FDC) of two antimalarial compounds, artesunate and amodiaquine (ASAQ) that is easier to use and more affordable than any other combination currently available. DNDi developed the formulation combining the two active ingredients in a single tablet and carried out the initial pharmaceutical and clinical development, before choosing sanofiaventis as its industrial partner for further development. Sanofi-aventis developed the product at industrial level, carried out additional clinical studies, prepared the dossier for regulatory authorities and applied for WHO prequalification. Sanofi-aventis has launched this new FDC in malaria endemic countries and embarking on a large follow-up clinical trial program (‘ASAQ field monitoring program’) with DNDi and Medicines for Malaria Venture to collect good efficacy and safety data on this new medicine in ‘real life’ conditions, in several countries including Côte d’Ivoire, Liberia, Uganda and Senegal. This program is being set up in close coordination with the WHO. The medicine, now registered in 24 African countries was prequalified by the WHO in October 2008. The new formulation simplifies adult treatment to 2 tablets once a day for three days. The pediatric dose is also simplified: one tablet a day for three days. Tablets are soluble in water or in semi-liquid food, making them suited to the needs of children, the population most at risk of complications from malaria. Sanofi-aventis committed to sell the product ‘at no profit-no loss’ to health ministries in affected countries, intergovernmental institutions, NGOs and programs promoting access to drugs in pharmacies. A full treatment costs less than USD 0.50 for children less than 5 years old and less than USD 1 for older children and adults. In 2009, the first full year after WHO prequalification, 23 million treatments were sold at preferential prices to over 20 malaria-endemic countries.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

Sanofi-aventis - Semisynthetic Artemisinin Project

TLR9 Inhibitor for Cerebral Malaria

Malaria sanofi-aventis Amyris Biotechnologies, iOWH Since 2008 R&D R&D in USA www.sanofi-aventis.com, www.oneworldhealth.org

Malaria Eisai FioCruz, University of Massachusetts in USA Since 2006 R&D Brazil www.eisai.co.jp

In March 2008, sanofi-aventis entered into a partnership with the Institute for OneWorld Health (iOWH) and Amirys Biotechnologies, a US synthetic biology company, to develop semisynthetic artemisinin for use in the Artemisinin-Combination Therapies (ACTs) now recommended by WHO as first-line treatment for malaria.

Eisai Co., Ltd.’s ER-820446 is a selective inhibitor of Toll Like Receptor 9 (TLR9) signaling. TLRs are mediators of innate immunity. In vitro, ER-820446 inhibits CpG oligonucleotide (TLR9 agonist)mediated induction of transcription factors in TLR9 transfected cells and the production of proinflammatory cytokines in dendritic cells. In a short term in vivo model in mice, administration of ER-820446 prevented a systemic cytokine response to a s.c. challenge with CpG oligonucleotide. In a Plasmodium chabaudi malaria murine infection model, ER-820446 did not reduce parasitemia, but prevented spontaneous release of proinflammatory cytokines triggered in response to infection in vivo. In a Plasmodium berghei cerebral malaria murine model, prophylactic treatment with ER-820446 significantly reduced mortality due to cerebral malaria. Pre-clinical development activities have been initiated for ER-820446, in conjunction with researchers at the Oswaldo Cruz Foundation in Brazil and the University of Massachusetts in the USA.

This collaboration aims to create a complementary source of nonseasonal, high-quality and affordable artemisinin to supplement the current botanical supply, thereby enabling millions of people infected with malaria to gain consistent access to lower-cost, life-saving ACTs. Under the terms of the agreement, sanofi-aventis, iOWH and Amirys will jointly develop pilot and commercial scale manufacturing processes, with the goal of introducing low-cost, semisynthetic artemisinin into the supply chain in 2011. The project will be based on initial research conducted by the University of California, Berkeley and funded by the Bill & Melinda Gates Foundation. The specific input from sanofi-aventis will be to provide fermentation and chemistry process development expertise. If successful, this project will secure enough artemisinin to treat up to 200 million individuals each year with ACTs.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES

Neglected tropical diseases (non-exhaustive list) Buruli ulcer is a severe skin disease caused by a bacterium. When left untreated, the disease leads to extensive destruction of the skin and, in some cases, bone, eyes and other tissues. Buruli ulcer has been reported in over 30 countries; mainly in Africa. Chagas disease (American trypanosomiasis) is a parasitic disease resulting from the bite of a protozoan parasite or transfusion of infected blood. Patients with severe chronic disease become progressively ill and ultimately die. Chagas disease afflicts people in Latin America with 12-14 million infections and 100 million people at risk. Dengue is a mosquito-borne viral infection and an estimated 50 million cases occur worldwide every year. Dengue haemorrhagic fever is a complication characterized by high fever, haemorrhagic phenomena and circulatory failures. It is a leading cause of hospitalization and death among children in Asia. Dracunculiasis (guinea-worm disease) is an excruciatingly painful and disabling parasitic disease. It causes an intensely painful swelling, a blister, and then an ulcer accompanied by fever, nausea, and vomiting. Rural communities in Africa, with access only to unprotected water sources for drinking, are invariably affected. Human African trypanosomiasis (sleeping sickness) is spread by the bite of the tsetse fly. Untreated, the disease invariably progresses to body wasting, somnolence, coma and death. The disease affects some 70 000 people in Africa. Leishmaniasis is a parasitic infection transmitted by the bite of the sandfly. The disease has four forms ranging in severity from self-healing cutaneous ulcers to severe life-threatening infection. An estimated 12 million people are infected and around 1.5 to 2 million new infections occur each year. Leprosy has a notorious history as a cause of deformity, disability, loathing and fear. However, the disease is not highly infectious and is curable. If untreated, it can cause permanent damage to the skin, nerves, limbs and eyes. Today 116 out of 122 endemic countries have eliminated leprosy as a public health problem. Lymphatic filariasis is caused by thread-like parasitic worms and is transmitted by mosquitoes. The worst symptoms generally appear in adults: damage to the lymphatic system, kidneys, arms, legs or genitals. Over 120 million people are currently infected. Onchocerciasis (river blindness) is a parasitic disease caused by the filarial worm that is transmitted to humans through the bites of black flies. It causes visual impairment, including permanent blindness. Other devastating effects are intolerable itching and disfigurement of the skin. Some 37 million are estimated to be infected and over 99% of those affected live in Africa. Schistosomiasis (bilharzia) is a parasitic disease that leads to chronic ill health. An estimated 70 million people with urinary schistosomiasis in Africa alone suffer from blood in the urine, indicating damage of the bladder and urinary tract. Soil-transmitted helminthiasis (intestinal worms) is caused by ingestion of eggs from contaminated soil or by active penetration of the skin by larvae in the soil. Worm infections aggravate malnutrition and amplify rates of anaemia. More than 1 billion people - one sixth of the world’s population - are at risk of infection. Trachoma is an eye infection, which spreads from person to person and often begins during infancy or childhood and can become chronic. If left untreated, the infection eventually causes the eyelid to turn inwards. This ultimately leads to irreversible blindness, typically between 30 and 40 years of age. Trachoma affects about 84 million people of whom about 8 million are visually impaired. Yaws is a contagious infection, which is usually transmitted through direct skin contact and mainly affects children under 15 years of age. Without treatment, multiple lesions appear all over the body. Yaws is a significant public health problem in some countries in South-East Asia, Africa and the Western Pacific region. (Source: WHO Neglected Tropical Diseases Fact Sheet)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

At least 1 billion people – 1 person in 6 – suffer from tropical diseases such as Buruli ulcer, cholera, dengue, dracunculiasis (Guinea worm disease), leishmaniasis, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiasis, trachoma and trypanosomiasis. These diseases, many of which are vector-borne, primarily affect poor people in tropical and subtropical areas. Some affect individuals for life, causing disability and disfigurement, often leading to stigmatization. Others are acute infections, with transient, severe and sometimes fatal outcomes. With the end of the colonial era, developed countries lost interest in these diseases, research waned and they came to be known as “neglected diseases”. Thanks in part at least to committed public-private partnerships, these diseases are now receiving greater attention, both with regard to improved access to treatment and increased R&D activity. The pharmaceutical

industry is the third largest global investor in neglected disease R&D, behind the United States’ National Institutes of Health and the Bill & Melinda Gates Foundation. More than 14 million people have been cured of leprosy; the number of people infected with Guinea worm has dropped from 3 million to just 25,000 cases; blinding diseases such as onchocerciasis and trachoma are being brought under control; millions of people are now protected from disfiguring lymphatic filariasis. Schistosomiasis has been effectively controlled in Brazil, China and Egypt, and eliminated from Iran, Mauritius and Morocco. Intestinal helminths have been eliminated in South Korea and are under control in many endemic countries. These successes demonstrate that interventions against neglected tropical diseases are technically feasible, immediate, visibly powerful and highly cost effective.

(Sources: WHO Control of Neglected Tropical Diseases (NTD); WHO/CDS/NTD/2006.2, Neglected Tropical Diseases: Hidden Successes, Emerging Opportunities; G-Finder Neglected Disease Research and Development: How much are we really spending? 2009)

Weight of specific tropical diseases by death and by annual DALY1 losses, 2004 DALYs

Deaths per year

4.1 million

110’000

72.3 million

2 million

Dengue

663’000

18’000

Helminth Infections

12 million

47’000

(however some estimates suggest 49 million)

(however some estimates suggest 415’000)

Bacterial Pneumonia & Meningitis

93.3 million

3.9 million

Typhoid & Paratyphoid Fever

No reliable figures

Leprosy

194’000

5’000

Buruli Ulcer

No reliable figures

Trachoma

1.3 million

Rheumatic Fever

5.1 million

280’000

Total

188’957’000

6’360’000

Kinetoplastid Diseases Leishmaniasis Sleeping sickness Chagas disease

Diarrhoeal Diseases Rotavirus Cholera Shigella Enerotoxinegic E. coli Cryptosospridium Enteroaggregative E. coli Giardi

Schistosomiasis Hookworm Lymphatic filariasis Onchocerciasis Roundworm Tapeworm Strongyloidiasis Whipworms

1Disability

Adjusted Life Years (DALY) combines in one measure the time lived with disability and the time lost due to premature mortality. One DALY can be thought of as one lost year of ‘healthy’ life and the burden of disease as a measurement of the gap between current health status and an ideal situation where everyone lives into old age free of disease and disability. (Source: G-Finder Neglected Disease Research and Development: How Much Are We Really Spending? 2009)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

Bayer HealthCare & African Sleeping Sickness

Bayer HealthCare: Fight Against Chagas Disease

Sleeping sickness Bayer HealthCare WHO Since 2002 Access - Donation 8 developing countries www.bayerscheringpharma.de

Chagas disease Bayer HealthCare WHO Since 2004 Access - Donation Endemic countries in Latin America www.bayerscheringpharma.de

In 2002, Bayer HealthCare agreed to supply - at no cost and for an initial five-year period - as much of the sleeping sickness medicine Germanin® (suramin) as the World Health Organization (WHO) determines is needed to eliminate the disease. The initial donation comprised 50,000 ampoules. Bayer is also in favor of supporting an ‘Integrated Sleeping Sickness Initiative’ fostered by a broad base of institutions and covering all aspects of the disease from infection, diagnosis and therapy to prevention.

In April 2007, Bayer signed a new agreement to provide the World Health Organization (WHO) with 2.5 million Lampit® tablets and additional funding for the distribution of the drug. The latest agreement assures the supply of Lampit® until 2012.

The agreement was renewed in 2008, whereby Bayer will provide, free-of-charge, 50,000 ampoules of Germanin® to the WHO, over a five-year period.

To widen access of patients to affordable medicines, Bayer HealthCare signed agreements with the World Health Organization (WHO) in 2004 and 2005 for donations of its medicine Lampit® (nifurtimox) to combat Chagas disease, the form of sleeping sickness found in Latin America. A total of 500,000 tablets was given to the WHO, which informs the governments of disease endemic countries of the availability of the free supplies, including the procedure to be followed for obtaining such supplies, and decides about its distribution. The goal of the WHO is to distribute Lampit® in all 21 endemic countries in Latin America. Currently, the medicine is approved in Argentina, El Salvador, Honduras, Nicaragua, Chile, Guatemala and Uruguay. Lampit® will also be provided in small quantities, as needed, in some non-endemic countries, like Canada, France, Japan, Spain, UK and the USA.

Dr. Luis Alberto Benios, doctor in the Hospital of San Marcos de Sierra, explains the taking of Lampit® tablets to Yadira and her mother Catalina Nuñez. The 14 year old Yakira is affected with the Chagas disease. (Bayer HealthCare)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

Children Without Worms

Gilead - AmBisome for Leishmaniasis

Soil-transmitted helminthiasis Johnson & Johnson Task Force for Child Survival and Development Since 2007 Access - Donation 8 developing countries www.ChildrenWithoutWorms.org

Leishmaniasis Gilead WHO Since ? Access - Pricing, R&D Endemic countries www.gilead.com/access_developing_world

Globally, up to 400 million children suffer from Soil-Transmitted Helminthiasis (STH), an infection of intestinal worms, but fewer than 20% of at-risk children were reached with de-worming treatment in 2005, falling far short of the World Health Assembly´s target to treat 75% of at-risk children by 2010. STH is especially dire for children because it causes malnutrition, increases susceptibility to other serious infections, and stunts growth during a critical development period.

Gilead´s therapeutic AmBisome (amphotericin B) liposome for injection has shown potent anti-parasitic and fungicidal activity against multiple pathogens, including mucosal and visceral leishmaniasis in clinical studies.

STH has been identified by the WHO and the US Centers for Disease Control and Prevention as a ‘target of opportunity’, meaning that with existing diagnostic tools and treatments and greater support, it can be prevented, treated and controlled.

Gilead´s goal is to expand access to AmBisome for the treatment of leishmaniasis in settings where the disease has the largest impact. Gilead works closely with the World Health Organization and NGOs to provide AmBisome at a preferential price for the treatment of leishmaniasis in resource-limited settings. Gilead also actively supports multiple clinical research studies aimed at elucidating the best treatment course for visceral leishmaniasis.

In 2007, Johnson & Johnson partnered with the Task Force for Child Survival and Development to develop and launch a program to donate up to 50 million doses of mebendazole in 2007 to treat children with or at high risk for STH. Approximately 30 million doses were donated to strategic recipients in 2007. Mebendazole is one of a class of medicines known as antihelmintics that are used to treat numerous kinds of worm infections.

Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of certain species of sand fly. (Infectious Disease Research Institute)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

Global Alliance to Eliminate Lymphatic Filariasis (GAELF)

Guinea Worm Eradication Program (GWEP)

Lymphatic filariasis GlaxoSmithKline, Merck & Co. Inc. GAELF, WHO & other partners Since 1998 Access - Donation, Capacity Building - Support & Training 47 out of 80 endemic countries www.filariasis.org

Dracunculiasis (Guinea worm) Johnson & Johnson Carter Center, WHO & other partners Since 1986 Access - Donation, Capacity Building - Support, Education Ethiopia, Ghana, Mali, Sudan www.cartercenter.org/health/guinea_worm/index.html

The Global Alliance to Eliminate Lymphatic Filariasis (GAELF) was created to eliminate one of the world’s leading causes of disability and disfigurement as a public health problem by the year 2020. An estimated 120 million people in at least 80 countries of the world suffer from the disease, and one billion (20% of the world’s population) are at risk of infection.

Established in 1986 and operating under the auspices of the Carter Center´s Global 2000 Program, the Guinea Worm Eradication Program (GWEP) aimed to rid future generations of Guinea worm by the year 2005. This multilateral partnership brings together organizations like the WHO, UNICEF, the CDC and the World Bank, as well as national governments and the pharmaceutical industry in a program combining eradication efforts, training and research. To accelerate the eradication of Guinea worm disease, the partners:

Initiated by the World Health Organization (WHO) and GlaxoSmithKline in 1998, the Global Alliance has evolved into a global partnership between international organizations in the public and private sectors, academia and non-governmental organizations working in partnership with ministries of health in tropical countries where lymphatic filariasis (LF) is endemic. Merck & Co., Inc. joined the elimination effort in 1998, when it widened the scope of its Mectizan® Donation Program to include LF in African countries where river blindness and LF co-exist. The WHO recommends that lymphatic filariasis be prevented with a combination of albendazole (donated by GSK) with either DEC or Mectizan® (donated by Merck). Drug administration for people living in endemic areas is recommended by WHO once a year for at least five years to break the cycle of transmission. In 2009, GSK donated 425 million treatments of albendazole to prevent transmission in 28 countries. To date, GSK has donated over 1.4 billion treatments to 50 countries. Over the 20 year life of the program, GSK expects to donate up to 6 billion preventative albendazole treatments across the LF endemic countries working to fight LF. Merck approved 110 million treatments of Mectizan® to LF elimination programs in 19 African countries and Yemen in 2009, bringing the cumulative total to more than 414 million. Merck and GSK have also provided financial grants to support partners in research programs, coalition building, workshops and communications. In the ten years since its initiation, the GAELF has become the most rapidly scaled-up medicine administration program in public health history. The WHO reported that during 2008, over 496 million people were treated worldwide. In a study published in October 2008 in PLoS Neglected Tropical Diseases, researchers found that the LF elimination effort has prevented 6.6 million children from acquiring the disease.

• Maintain a community-based surveillance system with monthly reporting of cases, supervision, and integration of surveillance for other major preventable diseases (where appropriate and feasible); • Target specific interventions (provision of safe water, health education, community mobilization, filter distribution, and treatment of selected water sources); • Maintain global and national dracunculiasis databases; • Monitor the epidemiological situation and map all endemic villages; • Conduct advocacy for eradication of the disease; • Certify dracunculiasis eradication country-by-country worldwide. Today, through the joint efforts of many partners, the incidence of this disease has been reduced worldwide by 99%, from an estimated 3.5 million cases in 1986 in 20 countries to 3,190 reported cases in 2009 (provisional numbers) in 4 countries (Sudan, Ghana, Mali, Ethiopia). Today, the last 1% of the disease is being fought. Johnson & Johnson has donated enough medical supplies, such as Tylenol®, forceps and gauze, to treat more than 3,000 villages in the endemic countries. In 2007, J&J donated medical supplies to the GWEP, for use in Sudan, the country most affected by Guinea worm. The donation included Tylenol® painkiller, to make the excruciating process of removing the worms from victims more bearable; Neosporin® and Savlon® antiseptics for disinfecting the wounds; and scissors, gloves, tape, gauze and sterile bandages for wrapping the wounds.

The International Trachoma Initiative is working to eliminate blinding trachoma in Vietnam by 2010. (Mark Tuschman, Pfizer)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

International Trachoma Initiative (ITI)

Leprosy Elimination

Trachoma Pfizer Edna McConnell Clark Foundation & other partners Since 1998 Access - Donation, Capacity Building - Support & Training, Education 18 developing countries www.trachoma.org

Leprosy Novartis WHO Since 2000 Access - Donation, Capacity Building - Support 66 developing countries www.novartisfoundation.org

The International Trachoma Initiative (ITI) was founded in 1998 by Pfizer and the Edna McConnell Clark Foundation to treat and prevent blinding trachoma, the world’s leading cause of preventable blindness. In March 2009, ITI and the Task Force for Child Survival and Development announced that they will join forces to scale up efforts to eliminate trachoma. ITI supports the implementation of the World Health Organization’s (WHO) recommended SAFE strategy, a comprehensive public health approach that combines treatment and prevention, including sight-saving Surgery, mass treatment with the Pfizer-donated Antibiotic Zithromax®, Facial cleanliness education, and Environmental improvements to increase access to clean water and improved sanitation. ITI’s goal is to eliminate blinding trachoma, resulting in improved health and livelihood in some of the world’s poorest countries. ITI supports the WHO’s Alliance for Global Elimination of Trachoma by 2020 (GET 2020) as well as Vision 2020: The Right to Sight. Other ITI partners include: AmeriCares, the Carter Center, Helen Keller International, Lions Club, the United Nations Children’s Fund (UNICEF), WaterAid, and World Vision.

Recommended by the World Health Organization (WHO), multidrug therapy (MDT) cures patients, interrupts the transmission of leprosy and prevents disabilities. Novartis developed two of the three medicines in MDT and has provided MDT, free of charge, for all patients in the world through the WHO since 2000. This is a core element in the WHO Elimination Strategy of creating awareness of the early signs, improving patients´ access to free diagnosis and treatment, and close monitoring.

The International Trachoma Initiative involves the following activities: • Provide patients in developing countries with antibiotics and providing surgery to treat advanced cases of trachoma; • Educating communities about trachoma prevention and training health care workers to conduct surgeries for advanced trachoma cases; • Providing training and technical assistance to support national trachoma programs; • Advocating for increased funding for trachoma programs and catalyzing partnerships to work towards trachoma elimination. Since 1998, Pfizer has provided over 145 million treatments of Zithromax® for treatment and prevention of the disease in 18 countries. With Pfizer’s support, ITI has trained thousands of healthcare workers who have performed more than 416,000 surgeries to treat advanced cases of trachoma. With the support of the ITI, Morocco became the first country to complete the campaign for trachoma control in 2006, and is now working toward WHO certification to signify that blinding trachoma has been eliminated as a public health problem.

More than 14 million people have been cured of leprosy since 1985, over 4.5 million of them with drugs provided free of charge by Novartis. Two decades ago, leprosy was a public health problem in 122 countries. Today the disease has been eliminated as a public health problem (i.e. reaching a prevalence rate of less than one case per 10,000 inhabitants) from all but 3 countries (Brazil, Nepal and Timor Leste). Since 2000, the Novartis Group (Novartis Pharma, Novartis Foundation for Sustainable Development and Sandoz) has been providing high-quality multi-drug therapy (MDT) free of charge to all leprosy patients in the world through the World Health Organization (WHO). The MDT donation is administered under the terms of a Memorandum of Understanding that continues until the end of 2010. Novartis has expressed its willingness to help anyone affected by this disease until leprosy is eradicated. Novartis and the foundation also provide the funds for managing the donation, transport, insurance and independent quality control of MDT. The value of the Novartis MDT donation from 2000 to 2009 was USD 60 million. The Novartis Foundation has supported national health ministries, the WHO and NGOs in field programs since the mid-1980s. It pioneered the use of social marketing to combat the stigma of the disease. The concept of generating and meeting demand for leprosy treatment is now an integral part of the WHO leprosy elimination strategy. The Novartis Foundation has also helped simplify the provision of disability prevention services in communities. Many of the approaches devised by the Novartis Comprehensive Leprosy Care Association in India have now been incorporated in the government and NGO disability care packages. The small remaining number of patients has changed the challenge of fighting leprosy. New approaches have to be developed to move towards a world free of leprosy. The Novartis Foundation started a world-wide study to shed light on what is needed to further improve the control of leprosy, with special emphasis on improving early detection.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

Merck Mectizan® Donation Program

Merck Praziquantel Donation Program

Lymphatic filariasis, onchocerciasis Merck & Co. Inc. WHO, World Bank & other partners Since 1987 Access - Donation, Capacity Building - Support & Training 33 endemic countries in Africa, Latin America, the Middle East www.mectizan.com

Schistosomiasis Merck KGaA WHO Since 2007 Access - Donation 8 African priority control countries www.merck.de

Onchocerciasis, or river blindness, is a leading cause of infectious blindness in the developing world. The Merck Mectizan® Donation Program (MDP) was launched in 1987, when Merck & Co., Inc. announced that it would donate Mectizan® (ivermectin), for the treatment of onchocerciasis to all who needed it for as long as needed. A multi-sectoral partnership was established with governments in countries where onchocerciasis is endemic, their ministries of health and other national and international stakeholders, including the World Health Organization, to ensure appropriate infrastructure, distribution and support. The Mectizan® Donation Program is the longest-running, disease-specific drug donation program and public/private partnership of its kind in history, and is widely regarded as one of the most successful public/private health collaboration in the world.

According to the World Health Organization (WHO), up to 300 million people suffer from schistosomiasis, a worm disease caused by schistosomes, parasitic worms that multiply as swimming eggs in certain fresh water snails. Human infection occurs when the skin comes into contact with schistosome parasites released into the water by infected snails. The parasites migrate to the liver, mature into adult worms and reproduce, with their eggs being ejected from the body in the feces. Schistosomiasis causes anemia, stunted growth and learning disabilities. It is the second-most common tropical disease in Africa after malaria and is also prevalent in Asia, the Caribbean, the Middle East and South America. Some 600 million people are at risk and around 200,000 people die of this disease every year.

Since the inception of the program in 1987, Merck has donated more than 2.9 billion tablets of Mectizan® for river blindness, with 800 million treatments approved since 1987. The program currently approves 100 million treatments annually through river blindness programs in Africa, Latin America and Yemen. In 2007, Merck re-affirmed its pledge to donate as much Mectizan® as necessary for the elimination of river blindness globally. With this renewed pledge, Merck’s donation of Mectizan® for river blindness is estimated to reach 100 million treatments annually by 2010. Also in 2007, Merck announced a donation of USD 25 million over eight years as part of an initiative with the World Bank to raise approximately USD 50 million in support of river blindness elimination in Africa. In 2007, public health officials announced that transmission of river blindness had been halted in Colombia: the first time that the disease has been eliminated as a public health problem on a country-wide basis anywhere in the world. Health officials also announced that river blindness transmission has been halted in certain endemic areas in Ecuador and Guatemala, and new cases of eye disease caused by river blindness have been eliminated in nine of the 13 foci in the Americas.

In April 2007, Merck KGaA signed a partnership agreement with the WHO to supply 200 million tablets of Cesol® 600 (praziquantel) for the treatment and prevention of schistosomiasis over a 10 year period. Some 27 million African school children will benefit from the Merck donation, with an estimated value of approximately USD 80 million, which is focused on Sub-Saharan African countries. Angola, Benin, Cameroon, Central African Republic, Madagascar, Senegal, Nigeria, Malawi, Mauritania, Tanzania, Mozambique and Zambia have been designated by WHO/AFRO for priority control of neglected tropical diseases (NTDs). Praziquantel is the most effective therapy to date for schistosomiasis infections - often even after just one dose - and it is well tolerated. It is therefore on the WHO list of essential drugs. The donation will address the issue of the affordability of praziquantel, which has been a barrier to access in poor communities and the main obstacle to implementing preventive anthelminthic chemotherapy in many African countries. Anthelminthic chemotherapy refers to drug treatment for worm infections, such as schistosomiasis, that disrupt the metabolism of these worms, which are known generally as helminths.

In 2008, it was announced that 31 percent of the formerly at-risk population in the Americas is no longer at risk of contracting the disease. Also in 2008, the Pan American Health Organization passed a resolution to interrupt transmission of the disease in the Americas by 2012. The success of the program in Latin America means that 74,476 people in 190 communities are now free of the threat of river blindness. While much progress has been made in the treatment and progress toward elimination, a number of additional challenges remain that Merck and its partners are actively addressing.

A young girl taking her medicine in Madagascar. (Merck KGaA)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – Access & Capacity Building

Sanofi-aventis Sleeping Sickness Program

Sanofi-aventis ‘Most Neglected Diseases’ Program

Sleeping sickness sanofi-aventis WHO & other partners Since 2001 Access - Donation, Capacity Building - Support, R&D Sub-Saharan African countries www.sanofi-aventis.com

Buruli ulcer, Chagas disease, leishmaniasis sanofi-aventis WHO & other partners Since 2006 Access - Pricing, Capacity Building - Support Brazil, Chad, Ethiopia, Panama, Sudan, Togo, Middle-East countries www.sanofi-aventis.com

Sleeping sickness has reemerged in Africa as a major health threat. In 2001, sanofi-aventis committed USD 25 million over the years 2001-2006 to help the World Health Organization (WHO) to implement a strategy of adequate medicine supplies, disease surveillance and management, plus R&D for new treatments.

As part of its 5-year agreement with the World Health Organization (WHO) in 2006 to extend its partnership in sleeping sickness (see separate entry), sanofi-aventis also undertook to support a collaborative program with WHO to improve treatment for some ‘most neglected diseases’, namely leishmaniasis, Chagas disease and Buruli ulcer.

After five years, WHO and sanofi-aventis´ efforts were estimated to have saved 110,000 lives. In 2006, the company renewed its contract with the WHO and expanded it to address several additional ‘most neglected diseases’ (see separate entry). It has committed to provide a further USD 14 million over the years 2006-2011, with continued medicines donation for sleeping sickness, and funding for training, control & diagnostic programs. It is also working to make eflornithine a more ‘ready to use’ and safer treatment. By the end of 2008, more than 1,250,000 vials of eflornithine, pentamidine and melarsoprol had been distributed . Since the peak of 37,000 patients in 1998, 3 years before the signing of the WHOsanofi-aventis partnership, the number of patients diagnosed and treated each year has been declining, down to less than 11,000 in 2008. Sanofi-aventis delivered donated medicines to Médecins sans Frontières logistics and funds their storage and distribution, on behalf of the WHO, to national control programs and to NGOs. Since 2006, donated drugs have been distributed by the WHO to 37 countries 20 endemic and17 non-endemic countries, in Europe, Asia, and the Americas; Sanofi-aventis funds disease management and control programs, including screening of populations in endemic areas, medical staff training, and surveillance of resistance to treatments. Thanks to this program, screening and treatment teams were back in the field in more than 25 sub-Saharan countries, including Angola, Cameroon, Chad, Central African Republic, the Democratic Republic of Congo, Uganda and the Republic of Congo.

Sanofi-aventis is providing USD 6.4 million to WHO over 5 years for development of training, diagnostics and optimization of treatment for leishmaniasis. It will transfer the worldwide production of its leishmaniasis medicine Glucantime® to its Brazilian subsidiary, to optimize the product price. Sanofi-aventis provides Glucantime® at a price of USD 1.20 plus transport and duties per ampoule to all developing countries. In 2008, sanofi-aventis also helped the WHO with import licenses in some critical endemic countries. Sanofi-aventis’ Humanitarian Partnership Department is developing a joint leishmaniasis control program with the Aggeu Magalhaes Research Center and the Oswaldo Cruz Foundation to set up a screening, care and follow-up program for 4,000 poor families in Pernambuco, to fight leishmaniasis and other endemic diseases in the region, such as tuberculosis and dengue. Other programs on leishmaniasis are also being developed with the governments of Panama and Bolivia. Sanofi-aventis is also giving WHO USD 2 million for new programs to intensify disease management of Buruli ulcer and Chagas disease and USD 4 million to support field activities of its Innovative and Intensified Disease Management program. In addition to the above-mentioned agreement with WHO, sanofiaventis has partnered in 2007 with Handicap International to set up a five-year national campaign in Togo to reduce the death rate and the serious post-disease effects caused by Buruli ulcer. In 2008, 98 health professional were trained, and 194 patients treated under this program.

Sanofi-aventis also helped fund development of new therapies through the UNDP-World Bank-WHO Special Program for Research and Training in Tropical Diseases (TDR). These included an oral form of eflornithine (stopped in 2007) and a combination of eflornithine from sanofi-aventis and nifurtimox from Bayer HealthCare (‘NECT’). With successful results in clinical trials, the development of this combination treatment has been completed and it is now being used to treat sleeping sickness- see Nifurtimox-Eflornithine below.

Using a blood sample to diagnose sleeping sickness in a mother and her baby. (Sanofi-aventis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – R&D

Eisai - DNDi Chagas R&D Collaboration

GlaxoSmithKline - DNDi Collaboration

Chagas disease Eisai DNDi Since 2009 R&D Latin American countries www.dndi.org

Chagas disease, leishmaniasis, sleeping sickness GlaxoSmithKline DNDi & other partners Since 2008 R&D R&D in Spain & UK (Pre-clinical) www.dndi.org

In September 2009, Eisai Co., Ltd. and DNDi, a non-profit independent foundation based in Geneva, Switzerland, signed a collaboration and license agreement for the clinical development of Ravuconazole for the treatment of Chagas disease. Ravuconazole, an anti-fungal drug discovered and developed by Eisai, has been shown in in vitro and in vivo to have activity against the pathogen responsible for Chagas disease.

In March 2008, GlaxoSmithKline (GSK) and the Drugs for Neglected Diseases initiative (DNDi) announced a collaborative research effort targeting visceral leishmaniasis (kala azar), human African trypanosomiasis (sleeping sickness), and Chagas disease.

Under the terms of the agreement, Eisai will provide E1224, the pro drug of ravuconazole, as well as its scientific expertise to DNDi for their clinical development to assess the safety and efficacy of this drug. Eisai will also have the option to become the industrial partner with DNDi to manufacture, register and make available E1224 at an affordable price to the public sector in endemic countries.

The collaboration, which has been established for an initial period of two years, will focus on identifying and developing compounds from existing GSK programs and will leverage the expertise of researchers at GSK´s Tres Cantos facility and leading academic centers like the London School of Hygiene & Tropical Medicine (LSHTM). The collaboration has been formed to address unmet patient needs, as current treatments for these diseases have significant drawbacks, such as difficulty of administration, severe side effects, length of treatment, cost and emerging parasitic resistance.

Phase I studies have already been completed in the USA, demonstrating a well-tolerated safety profile and long half life. Phase II studies will be initiated during 2010 by DNDi in Latin American countries. Eisai will support DNDi by supplying E1224. Transmitted by the bite of the kissing bug or vinchuca, Chagas disease is a public health problem particularly in the poor areas of Latin America and the Caribbean. About eight million people are believed to carry it, and about a third of these will develop serious heart or intestinal damage that could lead to death if left untreated. Two drugs, discovered decades ago with limited efficacy at the chronic phase of the disease and poor tolerability profile in adults, are currently available. The development of a new treatment which could be effective for the chronic phase of the disease, particularly in adults, would therefore represent an important advance.

Chagas disease is a public health problem particularly in the poor areas of Latin America and the Caribbean. (Greg Goss, Eisai)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – R & D

GlaxoSmithKline Proprietary Knowledge Pool

GlaxoSmithKline´s Sitamaquine for Leishmaniasis

Tropical Diseases GlaxoSmithKline Bio Ventures for Global Health & other partners Since 2009 R&D South Africa www.gsk.com

Leishmaniasis GlaxoSmithKline Various partners Since 1995 R&D India, Kenya www.gsk.com

Being more flexible with intellectual property could stimulate research and help to speed up development of medicines for neglected tropical diseases (NTDs).

Sitamaquine is GlaxoSmithKline´s potential new once-a-day oral treatment for visceral leishmaniasis. This disease affects half a million people a year in the developing world and is usually fatal if untreated.

In March 2009, GlaxoSmithKline created a neglected tropical disease (NTD) pool to stimulate research into medicines for the16 NTDs defined by the US Food and Drug Administration (FDA). To initiate the pool, GSK published details of over 800 of its patents and patent applications for small molecule pharmaceuticals which it identified as being potentially useful for the treatment of the target NTDs. Since then, GSK has had ongoing discussions with other companies, the scientific and research community to expand the pool and Bio Ventures for Global Health (BVGH), who have taken over administration of the pool from January 2010, to give it greater independence. The impact of the pool is dependent on the contribution of pharmaceutical and biotechnology companies, universities and other stakeholders.

Data from two Phase II proof-of-concept studies in Kenya and India are encouraging overall. After a 28-day course, 85% of patients remained cured at six months. Sitamaquine was generally well tolerated by patients in these studies. However, there were some concerns regarding renal adverse events seen in a few subjects, some of which appear to be treatment-related. Interpretation of these data is complicated, in particular because VL itself is associated with renal impairment. Before proceeding to Phase III trials, GSK set up a Phase IIb study to compare the safety and tolerability of a 21 day course of sitamaquine with that of intravenous amphotericin B. Early results showed comparable efficacy to previous studies, despite the shorter course, and sitamaquine was very much better tolerated than amphotericin. A small number of patients had mild, reversible renal side effects. GSK is currently in discussions with potential partners with a view to progressing development. The company is also targeting VL through their partnership with the Drugs for Neglected Diseases Initiative. A new treatment for visceral leishmaniasis is urgently needed, since current medicines are either impractical or becoming ineffective due to drug resistance, or are simply unaffordable.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – R&D

GlaxoSmithKline’s Tres Cantos Open Lab for DDW R&D

Merck & Co., Inc. – DNDi Master Agreement

Tropical Diseases GlaxoSmithKline MMV & TB Alliance Since 2009 R&D R&D in Spain www.gsk.com

Chagas disease, leishmaniasis Merck & Co. Inc. Drugs for Neglected Diseases initiative DNDi Since 2008 R&D R&D in various places www.dndi.org.

GlaxoSmithKline has an R&D facility in Tres Cantos, Spain, which has been dedicated to developing new treatments to combat diseases of the developing world (DDW) since it was established in 2001. Since that time, GSK has worked in a number of Public Private Partnerships (PPPs) with more than 100 scientists at the site partly funded by GSK’s partners. In 2009, GSK announced its intention to open up the Tres Cantos facility further, to become a global centre of excellence that brings new partners to the facility and stimulates research and collaboration on neglected diseases where research is still too fragmented.

In June 2009, Merck & Co., Inc. and the not-for-profit product development partnership Drugs for Neglected Diseases initiative (DNDi) announced a master agreement to support discovery and development of improved treatments for a wide range of neglected tropical diseases (NTDs).

GSK has launched an open lab at Tres Cantos, to create up to 60 spaces for scientists from around the globe. GSK will not initiate the projects but will encourage universities, not-for-profit partnerships and other research institutes to bring forward proposals for new collaborative projects, between the scientists’ home laboratory and GSK at Tres Cantos. Visiting researchers will have access to facilities, scientists and know-how. All projects will have clear objectives and the shared aim of discovering new medicines for neglected diseases. To meet the needs of the new researchers, GSK is expanding facilities at Tres Cantos and establishing a not-for-profit foundation with an initial investment of £5 million.

The agreement covers a wide range of NTDs including visceral leishmaniasis and Chagas disease that infect millions of people. As with many other NTDs, adequate treatments suitable for poor populations are lacking. Current therapies may be toxic, prohibitively expensive, or difficult to administer, particularly in resource-poor settings. Under the terms of the agreement, Merck will contribute small molecule assets and related intellectual property via a non-exclusive, royalty-free license to DNDi to conduct early development programs for drug candidates for treatment of NTDs, with the primary goal of manufacture and distribution of drugs at low cost to the public sector in resource-poor countries. Merck and DNDi will share joint intellectual property on drug candidates generated through early development, and Merck will retain the option to undertake late clinical development and registration of candidate medicines.

GlaxoSmithKline has an R&D facility in Tres Cantos, Spain, which has been dedicated to developing new treatments to combat diseases of the developing world (DDW). (GSK)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – R &D

Merck Serono Collaboration with TDR

Next-Generation Onchocerciasis Treatment R&D

Malaria, schistosomiasis, sleeping sickness Merck KGaA TDR & other partners Since 2004 R&D Developing countries www.merck.de

Onchocerciasis Pfizer TDR Since 1998 R&D Democratic Republic of Congo, Ghana, Liberia www.pfizer.com

There is a great need for new medicines for treating tropical disease. Even today, tropical parasitic diseases such as malaria, leishmaniasis, African sleeping sickness (HAT) or Chagas disease still represent a major health threat for much of the world’s population. They lead to millions of deaths per year and massive socio-economic effects in many countries. New medicines should be focused on the needs of target patients, and be suitable for use in the field. They need to be cost-effective, orally bio-available and stable under extreme conditions of heat and humidity.

Pfizer is collaborating with the UNICEF-UNDP-World Bank-WHO Special Programme for Research and Training in Tropical Diseases (TDR) to evaluate moxidectin for the potential to be a macrofilaricidal agent for onchocerciasis (river blindness). This collaboration was initiated by Wyeth, which was acquired by Pfizer in October 2009.

The Merck Serono division of Merck KGaA is headquartered in Geneva - the ideal place to run international projects with the World Health Organization (WHO) and the UNICEF-UNDP-World BankWHO Special Program for Research and Training in Tropical Diseases (TDR). In 2004, Merck started a project in collaboration with World Health Organization (WHO) to train two visiting scientists in drug discovery, screening compounds from the library against tropical diseases. Since 2006, TDR, a Special Program for Research and Training in Tropical Diseases, has sponsored a “Medicinal Chemistry Workstation” at Merck Serono, a team now composed of three postdoctoral researchers in medicinal chemistry and in drug metabolism and pharmacokinetics, to find new lead molecules against tropical diseases. The team is supervised by experienced Merck Serono scientists and has access to the company’s entire drug discovery infrastructure and expertise to help to advance their projects.

Data from the Phase II Proof-of-Concept study in Ghana, although still blinded, suggests microfilaricidal activity among all study groups, and a favorable safety profile. In consultation with independent experts, it was agreed that these data warrant evaluation of moxidectin in a Phase III study. This study is currently enrolling. With funds provided by Wyeth, TDR has completed clinical trial capacity building for the Phase III study, including building/renovation and equipping of one clinical research center in Liberia and two clinical research centers in the Democratic Republic of Congo, and extensive training of study staff. Pfizer is providing substantial funding support to TDR to ensure successful implementation and completion of the Phase III studies.

In 2009, the WHO sponsored team discovered a new lead against malaria which demonstrated good in vivo activity in the disease model of malaria with curative action, while significantly increasing the survival of an infected animal. The compound is oral available, relatively inexpensive to produce and has several favourable in vitro/in vivo parameters, making this compound a promising candidate for further development. In parallel with its work on the malaria project, the project team also extended its activities to identify in vivo active, orally available molecules for further development against African sleeping sickness disease and schistosomiasis. So far, more than 250,000 compounds have been tested against molecular targets for tropical diseases at Merck Serono. Chemists have synthesized around 2,000 new compounds for testing in in vitro or in vivo assays for their anti-parasitic activities at TDR partner sites.

A new clinical trial research centre stands, ready to start operations. (Kuesel, WHO/TDR)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

TROPICAL DISEASES – R&D

Nifurtimox-Eflornithine for Sleeping Sickness with TDR

Pfizer Collaborative Programs for Parasitic & Worm Diseases

Sleeping sickness Bayer HealthCare, sanofi-aventis TDR, DNDi & other partners Since 2003 R&D Democratic Republic of Congo, Uganda www.bayerscheringpharma.de, www.sanofi-aventis.com

Chagas disease, leishmaniasis, malaria, onchocerciasis, schistosomiasis, sleeping sickness Pfizer TDR, MMV, DNDi & other partners Since 2006 R&D R&D in Australia, Korea, UK (Preclinical) www.pfizer.com/responsibility

Bayer HealthCare and sanofi-aventis provided financial support for development of new therapies for sleeping sickness (Human African Trypanosomiasis or HAT) through the UNDP-World Bank-WHO Special Program for Research and Training in Tropical Diseases (TDR). R&D projects supported include an oral form of eflornithine, manufactured by sanofi-aventis, and a combination of eflornithine and nifurtimox - the active ingredient of Lampit®, originally used to treat Chagas disease.

Pfizer is working to advance tropical disease research by providing access to research tools for developing country researchers and large chemical libraries for screening to identify quality lead compounds as starting points for the development of new, improved medicines to fight neglected diseases.

Bayer HealthCare provides nifurtimox free in the quantities required for the clinical trials and sanofi-aventis is providing eflornithine ampoules, also free of charge thanks to its partnership with WHO. Other partners involved include the Drugs for Neglected Diseases initiative (DNDi), Epicentre, Médecins sans Frontières (MSF) and the Swiss Tropical Institute. The Nifurtimox-Eflornithine Combination Trial (NECT) enrolled 280 HAT patients and was completed in 2008 after a total duration of five years. It compared the safety and efficacy of co-administration of the oral drug nifurtimox and the intravenous drug eflornithine, with eflornithine monotherapy, the current first-line treatment for the Stage 2 T. b. gambiense form of sleeping sickness. The trial conclusively demonstrated that NECT is as well-tolerated and efficacious as eflornithine monotherapy. NECT is a far more practical treatment than eflornithine monotherapy (which requires 56 injections over 14 days) because the number of injections is reduced to 14, the frequency of injections is halved, and the treatment duration is reduced to 10 days. In November 2008, DNDi submitted that nifurtimox, already classified as an essential drug to treat Chagas disease, be added to the WHO Model List of Essential Medicines (EML) for treatment of HAT, as a prelude to inclusion of the combination treatment. In May 2009, following a successful submission by DNDi, the NECT combination was added to the WHO Essential medicine list for the treatment of sleeping sickness, and the regimen is now being introduced into the endemic countries.

In October 2006, Pfizer initiated a collaborative program with the UNICEF-UNDP-World Bank-WHO Special Programme for Research and Training in Tropical Diseases (TDR) to speed the search for new medicines to combat some of the world´s most deadly parasitic diseases, including malaria, visceral leishmaniasis (VL), African trypanosomiasis (sleeping sickness, HAT), Chagas diseas, onchocerciasis and schistosomiasis. Under this arrangement, scientists in institutes affiliated with the TDR-sponsored Compound Evaluation Network have screened thousands of compounds from the Pfizer library for ‘hits’: signs of activity against a range of tropical parasites. Developing country researchers, supported by various TDR-sponsored groups, are working with scientists at Pfizer´s laboratories in Sandwich, UK and Kalamazoo, Michigan, to evaluate the ‘hits’ and from those select ‘lead’ compounds with the greatest potential to be developed into new medicines for parasitic disease treatment and prevention. They are also being trained by Pfizer in the latest drug discovery research methods, before returning home to use their new knowledge and skills. In 2009, Pfizer expanded its collaborative research by signing agreements with the Medicines for Malaria Venture (MMV)and Drugs for Neglected Diseases initiative (DNDi), that provide these organizations with access to the Pfizer library to screen for compounds that have potential to be developed into new treatments for malaria, HAT, Chagas disease and VL. These additional screens will complement and extend the efforts already underway with TDR. Under these agreements, scientists in institutes affiliated with MMV and DNDi will test approximately 200,000 compounds for activity against specific parasites. Screening will be undertaken at the Eskitis Institute at Griffith University in Brisbane, Australia for malaria and HAT and the Institut Pasteur Korea, for VL and Chagas disease. Pfizer scientists will share their knowledge and expertise to select the most promising compounds from these screens for further testing and optimization.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

Ranbaxy R&D for Dengue

Singapore Dengue Consortium

Dengue Ranbaxy Government of India, ICGEB Since 2007 R&D India www.ranbaxy.com

Dengue Novartis Genome Institute of Singapore & other partners Since 2003 R&D R&D in Singapore www.nitd.novartis.com

In 2007, Ranbaxy announced a 3-year collaborative research with the International Centre for Genetic Engineering and Biotechnology (ICGEB), to develop an effective therapy for treatment of dengue infection. Project funding is provided by the Government of India.

The Singapore Dengue Consortium (SDC) was established in 2003 and has grown in the mean time to include 11 organizations together with NITD. The aim of the consortium is to explore ways to understand and better manage dengue infection, and ultimately minimize the incidence of dengue. In recent years, there has been an increased reporting of dengue incidence from various parts of the world; 50-100 million people get infected per year, of which 250500,000 with the potentially fatal hemorrhagic form of the disease. At present, there is no cure or vaccine for this disease.

Ranbaxy has adopted a two-pronged approach: Exploring the available indigenous herbal repertoire for anti-dengue activity. Twenty plants were selected based on traditional knowledge and literature search. Two plant extracts with promising anti-dengue activity against all four serotypes were identified. These are being developed for advanced pre-clinical studies. Screening of Ranbaxy´s compound library has generated a few early hits. These hits are being optimized using a rational drug design approach to create a lead compound which could be developed in to an effective antiviral medicine. Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy in 2008.

The SDC provides a platform for different parties to participate and share current work on dengue. The other consortium members include the DSO National Laboratories, national University of Singapore acting through its Duke-NUS Graduate Medical School, Experimental Therapeutics Centre, Genome Institute of Singapore, Institute of Molecular and Cell Biology, Nanyang Technological University, National Environment Agency, National Healthcare Group, National University of Singapore, Singapore Health Services and the Institute for Infocomm Research. The NITD is contributing its drug discovery know-how to find new therapies for dengue, complementing the contributions of other members of the consortium. The first task is the dengue virussequencing project, which will provide information on the entire virus genome together with annotation of clinical data and patient history. This information will be valuable for surveillance, as well as understanding the genetic variations of different serotypes. Long-term goals of those studies are to characterize virus- and hostspecific factors responsible for the onset of the disease, as well as to correlate viral genetic markers with the clinical severity of the disease.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES

Milestones in saving and improving lives through immunization Smallpox Smallpox was eradicated in 1977 after a 10-year WHO campaign. When the program began, smallpox threatened 60% of the world’s population and killed every fourth person infected. Polio Launched in 1988 by the WHO and partners, the Global Polio Eradication Initiative has reduced infections by more than 99% and some 5 million people have escaped paralysis. Measles Measles is virtually eliminated in the Americas. Measles deaths worldwide dropped by more than almost 40% 1999-2003, thanks to the WHO and partner organizations. Neonatal tetanus Neonatal tetanus mortality has been reduced by about three quarters. The estimated number of deaths has decreased from 800,000 in the 1980s to under 200,000 in recent years. Hepatitis B An estimated future 600,000 hepatitis B-related deaths (from liver cirrhosis and cancer) are now being prevented on an annual basis through infant vaccination. (Source: WHO immunization work: 2005 highlights, WHO/IVB/06.02)

Distribution of the estimated deaths from diseases that are preventable by vaccination in 2002 (WHO) death <5 years of age (000)

Diseases

deaths total (000)

Diseases for which vaccination is part of most national immunization schedules Measles Hib Pertussis Tetanus Yellow fever

540 386 294 198 15

610 386 294 213 30

Diphteria

Polio <1 Hepatitis B <1 Diseases for which a licenced vaccine is available

<1 600

Japanese encephalitis Meningococcal Rotavirus Pneumococcal TOTAL DEATHS FROM ALL CAUSES

14 26 449 1,612 57,029

5 10 402 716 10,468

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

Immunization reaches over 80 per cent of children worldwide and is one of the most successful and cost-effective public health interventions ever, eradicating smallpox, lowering the global incidence of polio by 99% since 1988, and achieving dramatic reductions in illness and death from diphtheria, tetanus and whooping cough. Largely as a result of vaccination, mortality due to measles decreased by 78 per cent globally between 2000 and 2008.

and cervical cancer (caused by human papillomavirus), which together kill more than a million people each year, most of them in developing countries.

Between 2 and 3 million deaths from diphtheria, tetanus, pertussis (whooping cough), and measles are estimated to be prevented annually as a result of immunization. Hepatitis B vaccination prevents an additional 600,000 future deaths (from liver cirrhosis and liver cancer) annually. However, an estimated 26.3 million of children under one year of age remained in need of immunization in 2006. The cost of not immunizing is higher because people who are not vaccinated as infants remain vulnerable for the rest of their lives.

In September 2005, the United Kingdom, France, Italy, Spain, and Sweden committed nearly USD 4 billion to immunization in developing countries over the next decade, using an innovative new mechanism called the International Finance Facility for Immunization (IFFIm). In March 2010, GlaxoSmithKline and Pfizer committed to a pilot Advance Market Commitment (AMC), another innovative finance mechanism set up by GAVI Alliance and the World Bank to make pneumococcal conjugate vaccine available to the poorest countries. Such instruments reflect a growing willingness on the part of developed countries to make significant financial resources available to meet important health needs in resource-poor countries.

New vaccines are being developed against major infectious diseases and several have just been licensed recently. Among the illnesses targeted are rotavirus diarrhea, pneumococcal disease,

Moreover, continuing efforts are under way to develop vaccines for AIDS, malaria, tuberculosis, dengue, leishmaniasis, and intestinal diseases, among others and to adapt new technologies to improve formulation and delivery.

(Sources: WHO/UNICEF GIVS Global Immunization Vision and Strategy, 2006-2015; Development of new vaccines (WHO fact sheet n°289); WHO Immunization Work: 2006-07 Highlights)

The status of vaccines innovation Presently Available Vaccines

R&D Pipeline Vaccines

Bacterial

Anthrax Cholera Diphteria Hib 1 Meningococcus 2 Pertussis

Pneumococcus 3 Q Fever Salmonella typhi (Typhoid) Tetanus Tuberculosis (BCG)

Chlamydia Clostridium difficile Escherichia coli Helicobacter pylori Meningococcus (B) Pneumococcus 4 Pseudomonas aeruginosa

Salmonella 5 Shigella Staphylococcus Streptococcus A&B Tuberculosis Yersinia pestis (Plague)

Viral

Cervical Cancer (HPV) 6 Hepatitis A Hepatitis B Herpes Zoster (Shingles) Influenza H1N1 Influenza H5N1 Influenza seasonal Japanese Encephalitis Measles Mumps

Poliomyelitis Rabies Rotavirus Rubella Smallpox Tick-Borne Encephalitis Varicella (Chicken pox) Yellow Fever

Cervical Cancer (HPV) 7 Cytomegalovirus Dengue Ebola Epstein-Barr Virus Hepatitis C Hepatitis E Herpes simplex Human Immunodeficiency Virus (HIV) Human metapneumovirus

Influenza universal Influenza H7N1 Influenza H9N2 Parainfluenza Respiratory Syncytial Virus (RSV) SARS-Associated Coronavirus 8 West Nile Virus

Parasitic

Hookworm Leishmania (Leishmaniasis)

Plasmodium falciparum (Malaria)

Therapeutic Bladder Cancer (BCG) and Other Vaccines

Acute Myelogenous Leukaemia Allergic Rhinitis (9) Alzheimer’s Disease Breast Cancer Cervical Cancer Colorectal Cancer

Glioblastoma Multiforme Melanoma Multiple sclerosis Nicotine Addiction Non small cell lung cancer Pediatric Tumors

Source: IFPMA Inquiry – April 2010 1 Haemophilus influenzae Type b 2 A, C, Y, W135 and combinations 3 7, 10 and 13 valent conjugate and 23 valent polysaccharide 4 15 valent conjugate 5 S. typhi, S. paratyphi and S. enteritidis 6 Human Papillomavirus, 2 and 4 valent 7 Human Papillomavirus, 9 valent 8 Severe Acute Respiratory Syndrome 9 Hay Fever

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

Bristol-Myers Squibb Foundation: Delivering Hope Hepatitis Bristol-Myers Squibb Various national & local foundations Since 2002 Capacity Building - Support & Training, Education China, India http://www.bms.com/foundation/reducing_health_disparities/hepatitis /Pages/default.aspx

‘Delivering Hope’ is a comprehensive effort to fight Hepatitis B and C in Asia, sponsored by the Bristol-Myers Squibb Foundation. Delivering Hope has drawn upon the proven models created by the Foundation´s work on HIV/AIDS in Africa to address a major health care challenge in resource-constrained settings. Support focuses on four areas: creating greater awareness of hepatitis and addressing the stigma associated with the disease; prevention, especially among groups most at risk; disease education and management training for health care workers; and operational research to develop data and demonstration projects to generate lessons that can be shared, adapted and applied in the future. These efforts are helping to develop a portfolio of projects that aims to raise the profile of the disease in Asia, inform health policy and national programs, build institutional and community capacity, and target prevention in the hardest-hit populations including children, blood donors and health care professionals. In many rural communities, lack of hepatitis awareness hinders prevention. The Foundation therefore is seeking to increase awareness among the general population and lay health care workers. In addition, programs in China and India focus on children as for a way of building family and community awareness. Since 2002, Bristol-Myers Squibb and the Bristol-Myers Squibb Foundation have provided USD 3.1 million in grants in China, already benefiting more than 700,000 people directly, and USD 1.9 million in India.

Vaccination is a cost-effective health measure. (Sanofi Pasteur)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

GAVI Alliance Childhood diseases Crucell, GlaxoSmithKline, Merck & Co. Inc., sanofi-aventis, Pfizer GAVI Alliance, WHO & other partners Since 2000 Access - Donation & Pricing, Capacity Building - Support & Training Low-income countries www.gavialliance.org

The GAVI Alliance was created to reduce childhood morbidity and mortality from vaccine preventable diseases by increasing immunization rates and improving vaccine access for children in developing countries, in response to stagnating global immunization rates and a widening gap in vaccine access in developing countries. The GAVI Fund provides financial support to low-income countries, based upon applications to and recommendations by the GAVI Alliance Board. The Alliance’s partners include industrialized countries vaccine manufacturers (Crucell, GlaxoSmithKline, Merck & Co., Inc., Novartis, Sanofi Pasteur, the vaccines division of sanofi-aventis, and Pfizer), developing countries vaccine industry, industrialized and developing country governments, UNICEF, the WHO, the World Bank, charitable foundations and NGOs. Industry partners invest in the development of new vaccines and in enhanced global vaccine manufacturing capacity, including facilities in developing countries. They also help to educate healthcare providers and develop technologies to facilitate vaccine distribution. Crucell support for GAVI includes supplying large quantities of the first internationally available thiomersal-preservative free, fully liquid pentavalent (5-in-1) vaccine Quinvaxem™ which protects children against 5 diseases (DTP-HepB-Hib) in one single shot. Country applications for Hib-containing combinations grew to their historical high in 2009 and over half a billion doses of liquid pentavalent vaccine have been requested for 2009-2012. Of the 1.37 billion vaccine doses GSK supplied in 2009, 50% went to GAVI countries and 80% went to developing countries. GSK has actively supported GAVI since its inception and was its main pentavalent and tetravalent vaccine supplier during GAVI Phase I. GSK has also developed new pneumococcal, rotavirus and cervical cancer vaccines, which will be made available in developing countries with help from GAVI. GSK was one of the first manufacturers to signon to the Advance Market Commitment for pneumococcal disease, committing to supply up to 300 doses of its vaccine Synflorix to developing nations over the next decade. GSK also is developing new vaccines for diseases which are future GAVI targets, including dengue and malaria.

As part of its support for the GAVI Alliance, the Merck Company Foundation funds the Merck Vaccine Network - Africa. Merck also provided 1 million doses of MMR II vaccine for mumps, measles and rubella to Honduras over a three-year period and donated hepatitis B vaccine in support of GAVI. Merck is also providing rotavirus vaccination for all infants in Nicaragua for a three-year period. In 2008, Merck contributed USD 2 million to the GAVI-supported Measles Initiative of the UN Foundation, for disease surveillance activities in Africa. Since 2001, the Measles Initiative has supported the vaccination of more than 600 million children in more than 60 countries. Sanofi Pasteur supports GAVI’s polio eradication efforts and has donated 120 million doses of oral polio vaccine (OPV) since 1997. It also supports the GAVI Yellow fever vaccine initiative for Africa. In 2007, Sanofi Pasteur sponsored the first technical conference on yellow fever, which drew 150 participants from Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Guinea, Mali, Senegal and Togo. In November 2008, GAVI accepted the proposal by Wyeth (subsequently acquired by Pfizer) to donate more than 3 million doses of its Prevnar® pneumococcal vaccine to protect children in Rwanda and the Gambia, countries with very high mortality from pneumococcal disease. Immunization began with “first dose in child” in Rwanda in April 2009 – the first time a pneumococcal conjugate vaccine was used in GAVI-eligible countries. Pfizer supports the AMC initiative and is working with UNICEF, GAVI and other international health partners on next steps in the AMC process relating to Pfizer’s newest pneumococcal conjugate vaccine, Prevenar 13, including a provisional Supply Agreement.

Vaccination drive against yellow fever in Togo. (Norbert Domy, Sanofi Pasteur)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

Global Polio Eradication Initiative

HPV Vaccine & Cervical Cancer

Polio sanofi-aventis WHO & other partners Since 1988 Access - Donation, Capacity Building - Support Afghanistan, Egypt, India, Indonesia, Nigeria, Pakistan www.polioeradication.org

Cervical cancer GlaxoSmithKline, Merck & Co. Inc. PATH Since 2005 Access - Donation & Pricing India, Peru, Uganda, Vietnam www.gsk.com, www.merck.com

In January 2004, a new plan was unveiled to immunize 250 million children in the remaining polio-endemic countries to eradicate finally a disease that once paralyzed hundreds of thousands of children each year. Working in cooperation, the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC) and the United Nations Children´s Fund (UNICEF) agreed to accelerate efforts targeted at eradicating polio.

Cervical cancer is the second most common cancer in women worldwide, with about 500,000 new cases and 250,000 deaths occurring each year. Almost 80% of cases occur in low-income countries, where cervical cancer is the number one cause of cancer in women. Virtually all cervical cancer cases (99%) are linked to genital infection with human papillomavirus (HPV), a family of virus types which also causes genital warts and other forms of cancer.

In 2002, Sanofi Pasteur, the vaccines division of sanofi-aventis, announced that it would donate 30 million doses of the Oral Polio Vaccine (OPV) to the Global Polio Eradication Initiative through 2005. Sanofi Pasteur, the longest-standing corporate partner in the Initiative, has donated 120 million OPV doses since 1997. At the WHO´s request, Sanofi Pasteur developed and licensed a new vaccine in record time in 2005 – Monovalent Oral Polio Vaccine 1 or MOPV1 – for use first in Egypt as a critical part of a new WHO strategy to end polio transmission. Sanofi Pasteur also provides bulk mOPV1 to a manufacturer in India, to fill and package for local use. In 2007, Sanofi Pasteur donated 270,000 doses of inactivated polio vaccine (IPV) to Indonesia for a WHO sponsored demonstration project of 5 years on IPV introduction in Yogayarta province.

PATH, the Program for Appropriate Technology in Health, is an international, nonprofit organization that creates sustainable, culturally relevant health solutions, and works to advance acceptable and affordable new technologies for low-resource settings. PATH is partnering with GlaxoSmithKline and Merck & Co., Inc., both of which have developed HPV vaccines, to conduct pilot HPV vaccination programs in adolescent females, looking at acceptance and accessibility. The countries selected are India, Peru, Uganda and Vietnam. The PATH project also looks at issues such as adapting vaccination schedules to fit with the school year, to maximize potential uptake. PATH has received a grant for this project from the Bill and Melinda Gates Foundation. GSK’s HPV vaccine, Cervarix™, received WHO Pre-Qualification in 2009, which allows its purchase by UN agencies on behalf of poorer countries. GSK works with partners to help improve access to its vaccines and is committed to ensuring pricing is not a barrier to access in the developing world. For example, it has made Cervarix™ available at substantially reduced prices – with price reductions of up to 60% – in a diverse array of countries, including several in Southeast Asia, South Africa and Colombia. GSK has long practiced tiered pricing for vaccines supplied to government-led programs, charging lower prices in poorer countries. GSK is also supporting HPV pilot projects; for example, it has donated more than 133,000 doses of Cervarix™ to PATH-led projects in Uganda and India (Gujarat). Merck & Co., Inc. provides its Gardasil® HPV vaccine at no-profit prices to the public sectors of GAVI-eligible countries. For other countries, Merck will offer tiered-pricing, largely based on their ability to pay. In 2008, CSL Ltd agreed to waive Merck’s royalties for sales of Gardasil® in the developing world, which should result in lower prices there. Gardasil® received WHO pre-qualification in May 2009, which will also help make it more accessible for developing countries. Through the Gardasil® Access Program, Merck has pledged to donate at least 3 million doses of Gardasil® to qualifying organizations in eligible lowest-income countries, where 80% of the world’s cervical cancer cases occur. The program will help them gain operational experience in the design and implementation of HPV vaccination projects. Approval has been given for donation of 496,000 doses of Gardasil® for Bhutan, Bolivia, Cambodia, Cameroon, Georgia, Ghana, Haiti, India, Kenya, Lesotho, Moldova, Nepal, Nicaragua, Papua New Guinea, Tanzania, Uganda and Uzbekistan.

Children at the India Polio Handicap prothesis school. (Sébirot, Sanofi Pasteur)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

Merck Vaccine Network – Africa (MVN-A)

Pandemic Influenza & Developing Countries

Vaccine-preventable diseases Merck & Co. Inc. Various partners Since 2003 Capacity Building - Training Kenya, Mali, Uganda, Zambia www.merck.com/mvna

Pandemic influenza Biken, GlaxoSmithKline, Roche, sanofi-aventis WHO & other partners Since 2006 Access - Donation & Pricing & Tech Transfer China, India, South Africa www.gsk.com, www.roche.com, www.pandemic-influenza

In sub-Saharan Africa, more than 7.8 million children each year do not receive the most basic vaccines. One major reason for low vaccination rates in developing countries, according to the World Health Organization, is the lack of skilled health care professionals. As part of Merck & Co., Inc.´s commitment to the GAVI Alliance, it established the Merck Vaccine Network - Africa (MVN-A) to develop sustainable immunization training centers in Africa. One of Merck’s major programs in Africa, MVN-A reflects the company´s commitment to improving access to medicines, vaccines and health care in the developing world.

Social factors make poor countries particularly vulnerable to an influenza pandemic and they are less able to afford vaccines and antiviral medicines.

In 2003, with funding from The Merck Company Foundation and after a competitive grant application process, MVN-A grantees established training programs in both Kenya and Mali. Based on their success, renewed funding was provided to both programs in 2007, enabling both MVN-A grantees to extend training to additional health workers in Kenya and Mali and explore innovative training methods to address emerging immunization management needs. Following a second competitive grant application process in 2007, The Merck Company Foundation provided supplemental funding to enable two new MVN-A grantees to establish immunization training programs in Uganda and Zambia. The four MVN-A training programs are led by partners including: Indiana University School of Medicine and Moi University School of Medicine (Kenya); University of Maryland School of Medicine’s and the Center for Vaccine Development and the Centre pour le developpement des vaccines, Centre national d´appui à la lutte contre la maladie (Mali); The Task Force for Global Health and Makerere University School of Public Health (Uganda); and Brighton and Sussex University Hospitals NHS Trust and the University of Zambia School of Medicine (Zambia). To date, more than 600 health professionals in Kenya. Mali, Uganda and Zambia have successfully completed MVN-A training, in vaccine management and immunization services. Trainees have returned to their home medical facilities to share their expertise and knowledge with fellow health care workers. In Kenya, MVN-A trainees in the Ministry of Health worked to coordinate health services support, including mass immunization campaigns to prevent outbreaks of measles and polio for large camps of internally displaced persons. In Mali, the Ministry of Health leveraged the MVN-A program to help train immunization managers in preparation for the accelerated introduction of a new Hib pentavalent vaccine (DTP-HepB+Hib), funded by GAVI. Since its successful expedited introduction in 2005, more than 675,000 Malian children have received this new combination vaccine.

GlaxoSmithKline (GSK) has invested over USD 2 billion in research and expanded production capacity for its antiviral medicine, Relenza®, and for its pre-pandemic and pandemic influenza vaccines. It has set a preferential price for Relenza® for LeastDeveloped Countries (LDCs) and has granted Simcere, China, a voluntary licence to make zanamivir and sell it in China, Indonesia, Thailand, Vietnam and all LDCs. In 2009 GSK signed an agreement to donate 60 million doses of our H1N1 vaccine to developing countries. Shipments are now underway to recipient countries and GSK has also agreed to donate two million treatment courses of Relenza® to the WHO for use in developing countries. To further ensure the vaccine is available to developing countries, GSK has allocated 20 per cent of H1N1 vaccine production capacity at their manufacturing site in Canada, to developing countries. Roche has significantly increased its capacity to make Tamiflu® (oseltamivir) antiviral medicine. It sells Tamiflu® at a reduced price for pandemic stockpiling and offers further price reductions to low income countries. Roche holds no patents on Tamiflu® in LDCs, whose governments are free to make generic versions. Roche has also granted sublicenses to Shanghai Pharmaceuticals and HEC Group, China and Hetero Pharmaceuticals, India, to make oseltamivir, and has given Aspen Pharmaceuticals, South Africa, information to facilitate local manufacturing of Tamiflu® for pandemic stockpiling by African governments. To date, Roche has donated 10.9 million treatment courses of Tamiflu® to WHO, including 650,000 pediatric treatments. In June 2009, Sanofi Pasteur, the vaccines division of sanofi-aventis, announced its commitment to donate 10% of its production (up to 100 million doses) of pandemic influenza vaccine to the WHO’s stockpile for developing countries. This donation, which is not strain specific, includes A(H1N1) 2009 influenza. It extends and replaces the company’s 2008 commitment to donate 60 million doses of A(H5N1) influenza vaccine over a three year period. Sanofi Pasteur’s Panenza® non-adjuvanted A(H1N1) monovalent influenza vaccines were prequalified for global use by the WHO in January 2010 – a key prerequisite for their distribution to developing countries. Other manufacturers are also increasing vaccine capacity in developing countries, building new plants or through local partnerships. These include Biken in Indonesia and GlaxoSmithKline in China.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

Pneumococcal Conjugate Vaccine Programs

Rotavirus Vaccine Program

Pneumonia GlaxoSmithKline, Pfizer GAVI Alliance, FioCruz, USAID & other partners Since 2009 Access - Donation & Pricing & Tech Transfer Brazil, Rwanda www.gavialliance.org, www.gsk.com, www.pfizer.com

Rotavirus-induced gastroenteritis GlaxoSmithKline, Merck & Co. Inc. GAVI Alliance, WHO & other partners Since 2003 Access - Donation & Pricing Brazil, El Salvador, Mexico, Nicaragua, Panama, Venezuela www.rotavirusvaccine.org

Pneumococcal disease takes the lives of 1.6 million people each year, including approximately 800,000 children before their fifth birthday. More than 90% of these deaths occur in developing countries. Its most common serious form, pneumonia, accounts for one in every four child deaths.

Rotavirus infection is the leading cause of severe diarrhea and vomiting (gastroenteritis) in children under two and is responsible for nearly 600,000 deaths among children under five – worldwide – each year. Eighty percent of rotavirus-related deaths occur in developing countries. With funding from the GAVI Alliance and the Vaccine Fund, the Program for Appropriate Technology in Health (PATH) established the Rotavirus Vaccine Program (RVP) in 2003. With its strategic partners, the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, RVP is working to accelerate introduction of the two available vaccines. In 2005, WHO moved to recommend rotavirus vaccination as a core childhood immunization. In late 2006, the GAVI Alliance committed to provide funding for its introduction in eligible countries around the world.

GlaxoSmithKline and Pfizer have developed pneumococcal conjugate vaccines which protect against this major health threat. On 23 March 2010, these two companies made unprecedented long-term commitments, via the GAVI Alliance’s Advance Market Commitment for pneumococcal disease, to supply these new vaccines to developing countries at a fraction of the price charged in industrialized countries. GAVI estimates that the introduction of suitable and affordable vaccines against this disease could save some 900,000 lives by 2015. GSK will supply up to 300 million doses of its vaccine Synflorix™, to GAVI over a ten year period. Synflorix contains 10 serotypes, three of which – 1, 5, and 14 – were required to be included in the AMC vaccine, due to their high disease burden in the developing world. GSK has committed to provide an average of up to 30 million doses annually and expects to deliver the first doses to Africa later this year. GSK has invested more than USD 400 million in a dedicated manufacturing plant in Singapore. Pfizer’s Prevenar® 13 contains 13 serotypes, which represent the most prevalent invasive disease-causing strains in young children worldwide. It has been approved for use in infants and young children in more than 40 countries. Pfizer is increasing its manufacturing capabilities to help ensure Prevenar® 13 availability through a combination of capital investment, process improvements and efficiency measures throughout the supply network. On 17 August 2009, GSK announced a partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz), under which GSK will provide Fiocruz with access to the technology behind its Synflorix™ conjugate pneumococcal vaccine. GSK will supply Synflorix™ to Fiocruz until the technology transfer is completed, allowing rapid incorporation of the vaccine into Brazil’s national immunization program. Prevnar® was originally developed by Wyeth, which was acquired by Pfizer in October 2009. Earlier that year, Wyeth donated 3 million doses of Prevnar® for use in Rwanda, as part of the first national pneumococcal immunization campaign undertaken in a GAVI-eligible country. The program was undertaken with the support of GAVI Alliance and USAID, and the first dose was administered by Rwandan Health Minister Dr. Richard Sezibera on 25 April 2009.

GlaxoSmithKline´s vaccine, Rotarix™ is a two-dose oral vaccine targeting one rotavirus strain. Early in 2007, GSK obtained WHO Prequalification for Rotarix™. GSK is helping Brazil to implement a universal mass vaccination program for rotavirus. The vaccine was included in the National Programme of Immunizations in 2006 and the partnership includes a technology transfer agreement with Brazil’s Oswaldo Cruz Foundation (Fiocruz) signed in 2007. Since 2007, GSK (via Fiocruz) has been the supplier of 50 million doses of rotavirus vaccine in Brazil. From 2012 Fiocruz will produce Rotarix™ for the Brazilian domestic market and manufacture Rotarix™ for GSK under contract for export. The deal is helping to ensure that around 17 million babies in Brazil will be protected by Rotarix™ over five years. The vaccination program has already resulted in an 85% reduction in rotavirus related hospitalizations, according to the Brazilian Ministry of Health. Merck & Co., Inc.´s Rotateq® is a three-dose, ready-to-use oral vaccine that protects against five common rotavirus strains. In 2006, Merck and the Nicaraguan Ministry of Health announced a new partnership to provide all eligible infants born in Nicaragua in a three-year period with free doses of Rotateq®. Since the partnership was launched in 2006, Merck has provided nearly 1 million free doses of Rotateq® to Nicaragua, with an estimated 27,720 doses administered every month. To date, more than 769,120 doses have been administered. The Nicaraguan ministry of health reports that 81 percent of eligible infants in Nicaragua were vaccinated in 2008. In addition, Merck is providing assistance in administrative, training and logistical aspects related to an expansion of Nicaragua´s immunization activities.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – Access & Capacity Building

Sanofi-aventis & EPIVAC

Sigma-Tau & AMREF: “Uganda Project”

Vaccine-preventable diseases sanofi-aventis GAVI Alliance, UNICEF, WHO & other partners Since 2002 Capacity Building - Training 11 African countries www.epivac.org

Vaccine-preventable disease Sigma-Tau AMREF Since 2008 Access - Donation, Capacity Building - Training Uganda www.sigma-tau.com

EPIVAC (from EPIdemiology & VACcinology) is a comprehensive, one-year, on-the-job professional training program in epidemiology, applied computing, vaccinology and management of health programs for public health officers in West Africa, culminating in an interuniversity diploma in ‘Organization and Management of Public Immunization Programs in Developing Countries’ awarded by the universities of Cocody-Abidjan (Ivory Coast) and Paris-Dauphine (France).

Sigma-Tau supports the African Medical Research Foundation (AMREF) in implementing the ‘Uganda Project’, a vaccination and medical training program in Northern Uganda, in the areas most affected by the civil war of the 1990s.

The program is a Sanofi Pasteur, the vaccines division of sanofiaventis, contribution to the GAVI Alliance. Implemented by the Agence de Médecine Préventive, the program was developed in partnership with national governments of eligible countries and the participating universities, in collaboration with the WHO, UNICEF, the French Ministry of Foreign Affairs, and other partners working in Africa. EPIVAC is coordinated with the GAVI subregional working group and complements other GAVI support to African countries.

The main aim of the project is to vaccinate more than 3,000 Ugandan children against the six most common childhood diseases (tuberculosis, diphtheria, tetanus, poliomyelitis, hepatitis B and measles). At the same time, it also aims to provide medical training for local health workers, thus furnishing both immediate and long-term support for health development.

EPIVAC seeks to strengthen the GAVI process within each country in coordination with the Interagency Coordinating Committee (ICC). The ICC assists in the selection of EPIVAC enrollees. EPIVAC not only utilizes classroom, on-the-job training, and distance learning, but also combines two subject matters that are usually taught separately: applied vaccinology and management sciences. Participants are trained while continuing to provide vital public health services to their communities. Studying on-the-job also enables learning to be put into practice immediately. The EPIVAC program monitors and evaluates the impact of training on immunization delivery and management in the district. Between 2002 and 2009, approximately 400 public health officers have been enrolled in EPIVAC training. Participants have been trained from Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Central Africa, Guinea, Mali, Mauritania, Niger, Senegal and Togo. Sanofi Pasteur is also supporting the EPIVAC Network (REI), which aims to bring together the graduates of the EPIVAC program for best-practice sharing and continuous education in vaccination and logistics.

EPIVAC training program in support of GAVI, Benin, Africa. (François Mireux, Sanofi Pasteur)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – R& D

Crucell Vaccine Research

Infectious Disease Research Institute (IDRI)

Ebola, HIV/AIDS, malaria, rabies, tuberculosis Crucell, sanofi-aventis Various partners Since 2002 R&D Developing countries www.crucell.com

Buruli ulcer, Chagas disease, Chlamydia, Leishmaniasis, leprosy, malaria, tuberculosis GlaxoSmithKline, Lilly IDRI & others partners Since 1994 R&D Brazil, India, Sudan, Venezuela www.idri.org

Crucell is committed to research and develop innovative vaccines and biologicals, to help developing countries improve their public health and reach the UN Millennium Development Goals. The company is actively involved in private-public partnership R&D initiatives aimed at making available vaccines against malaria, tuberculosis, Ebola and HIV/AIDS to the most needy populations in the world. Crucell also believes in the benefit of collaboration with other vaccine manufacturers, and has recently engaged in co-development of antirabies monoclonal antibodies with Sanofi Pasteur, the vaccines division of sanofi-aventis, thus making an important contribution to address this unmet public health need in developing countries.

The Infectious Disease Research Institute (IDRI) was established in 1994 as a not-for-profit US scientific organization to develop vaccines, therapeutics and diagnostics for a range of diseases of the developing world. IDRI collaborates with and is partially funded by GlaxoSmithKline and Eli Lilly and Company. • Buruli Ulcer: IDRI scientists are interested in leveraging expertise in mycobacterial diseases (diseases from the same family of bacteria that cause tuberculosis and leprosy) to assist members of the Global Buruli Ulcer Initiative (GBUI) and BU research community; • Chagas: IDRI’s research on Trypanosoma cruzi, the parasite that causes Chagas disease, has emphasized diagnostic tests, vaccines and therapeutics to treat Chagas disease. In collaboration with GSK, IDRI scientists have developed an effective blood test for Chagas disease, which is now being used in South America; • Chlamydia: IDRI is working with GSK to create and test a vaccine to help prevent chlamydia. Chlamydia is usually an asymptomatic disease, so those who are infected do not always seek available antibiotic treatment; • Leishmaniasis: In March 2000, IDRI received a USD 15 million grant from the Bill and Melinda Gates Foundation to fund development of a leishmaniasis vaccine. IDRI, working with GSK, developed the world’s first defined vaccine candidate for leishmaniasis, which has been tested in the USA, Peru, Brazil and Colombia, and is currently being tested in India, Sudan, and Venezuela. IDRI has one diagnostic test for leishmaniasis which has US FDA approval and is now used extensively in India. It is working on another, for canine leishmaniasis, with Fiocruz in Brazil; • Leprosy: In a partnership with the American Leprosy Missions, IDRI has embarked on an aggressive program to develop an effective vaccine and better diagnostic tests for leprosy; • Malaria: Using its adjuvant and formulation capabilities, IDRI has joined forces with the PATH Malaria Vaccine Initiative and others in the global effort develop a safe and effective malaria vaccine; • Tuberculosis: IDRI’s research efforts to fight tuberculosis encompass vaccine discovery, drug discovery and diagnostics, including work with the Aeras Global TB Vaccine Foundation.

Crucell is committed to research and develop innovative vaccines and biologicals, to help developing countries improve their public health. (Crucell)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – R &D

MSD-Wellcome Trust Hilleman Laboratories

Novartis Vaccines Institute for Global Health (NVGH)

Vaccine-preventable diseases Merck & Co. Inc. Wellcome Trust Since 2009 R&D India www.hillemanlaboratories.in/

Typhoid fever, paratyphoid fever, shigella, other vaccine-preventable diseases Novartis Associazione Sclavo, Wellcome Trust Since 2008 R&D – Pediatric R&D R&D in Italy www.nvgh.novartis.com

In September 2009, the Wellcome Trust and Merck & Co., Inc. announced the creation of the MSD Welcome Trust Hilleman Laboratories, a research and development joint venture with a notfor-profit mission to focus on developing affordable vaccines to prevent diseases that commonly affect low-income countries.

Novartis Vaccines Institute for Global Health (NVGH) is a research institute with a non-for-profit mission to develop effective and affordable vaccines for neglected infectious diseases of the developing world.

The joint venture is the first in which a research charity and a pharmaceutical company have jointly created a separate entity with equally shared funding and decision-making rights. The heart of this concept is the creation of a sustainable R&D organization that operates like a business, but with a not-for-profit operating model, to address the vaccine needs of low-income countries. As well as developing new vaccines in areas of unmet need, the Hilleman Laboratories will also work on optimizing existing vaccines, an important and powerful way of increasing the impact of vaccination in resource-limited settings. The Hilleman Laboratories will be based in India to facilitate engagement and partnership with a broad range of experts in vaccine research, policy and manufacturing to develop and mature its R&D pipeline. While an initial portfolio of projects will be selected only after international consultation and careful technical assessment, examples of the kinds of programs being considered include developing vaccines that do not require refrigeration and a vaccine against Group A streptococci, which causes more than 500,000 deaths per year worldwide.

Inaugurated in February 2008, NVGH is a separate organization with its own facilities, while being co-located on the campus of the Novartis Vaccines & Diagnostics’ commercial vaccine organization in Siena, Italy. NVGH’s focus is to work with collaborators on scientific aspects, then develop laboratory concepts into a vaccine that can be manufactured reliably and efficiently to produce a quality, low-cost vaccine. With funding partners, NVGH substantially reduces development risks and cost of new vaccines for the developing world to both improve availability of new vaccines and make them affordable NVGH’s current projects are in the area of diarrheal and enteric diseases. These diseases, responsible for more than 4.5 billion cases of diarrhea a year globally, have a particularly high burden in infants and children in developing countries. The NVGH typhoid vaccine is being funded in part by Associazione Sclavo, a non-profit organization in Siena who received funding from Fondazione Monte dei Paschi and Regione Toscana for this project. The Wellcome Trust is funding part of the NVGH bivalent vaccine, which will combine the typhoid and paratyphoid fever vaccines into one product.

Novartis Vaccines Institute for Global Health (NVGH) is a research institute with a nonprofit mission dedicated to the transnational R&D of vaccines for diseases of the developing world. (Novartis)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

PREVENTABLE DISEASES – R& D

Pediatric Dengue Vaccine Initiative (PDVI) Dengue GlaxoSmithKline, sanofi-aventis PDVI Since 2001 R&D – Pediatric R&D Thailand www.pdvi.org

Dengue fever is the second most widespread tropical disease after malaria. The Pediatric Dengue Vaccine Initiative (PDVI), a Bill and Melinda Gates funded initiative of the International Vaccine Institute, in Seoul, Korea, was established in 2001 to accelerate the development of a dengue vaccine that is appropriate, safe and accessible to poor children in endemic countries. Some of the Initiative’s goals include: Country surveys to define better the burden of dengue illness; Support R&D and enhance developing country science capacity; A scientific blueprint for a safe, effective and affordable pediatric dengue vaccine. No specific treatment is currently available and vector-control strategies have been insufficient. Dengue vaccines offer an impending solution to control this major global health problem and there are several robust dengue vaccine candidates, but many challenges remain. A focused effort should achieve a safe, broadly protective dengue vaccine for children in a matter of years. The Initiative is supported by governments of endemic countries, academic research centers in the USA and South-East Asia and the pharmaceutical industry, including Sanofi Pasteur, the vaccines division of sanofi-aventis, and GlaxoSmithKline. In 2006, Sanofi Pasteur and the PDVI announced a collaborative partnership to prepare for the possible introduction of a Dengue vaccine and to make it widely accessible for prevention of Dengue. At the forefront of dengue vaccine development with an active R&D program, Sanofi Pasteur´s lead candidate dengue vaccine entered efficacy studies in children in Thailand in 2009, and several other studies are currently underway in Asia and the Americas.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

The timeframe for developing a new vaccine is usually longer than that for developing a new medicine. (GlaxoSmithKline)

Developing World Health Partnerships Directory ÂŠ IFPMA 2010 â&#x20AC;&#x201C; www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH

Neonatal and maternal mortality are related to the absence of a skilled birth attendant

(Source: The World Health Report 2005, Make every mother and child matter)

Developing World Health Partnerships Directory ÂŠ IFPMA 2010 â&#x20AC;&#x201C; www.ifpma.org/healthpartnerships

Each year 3 million babies are stillborn, nearly 4 million die within 28 days of coming into the world, and a further 9.2 million children die before their fifth birthday. Moreover, children suffer from the same illnesses as adults but they are more seriously affected by certain conditions such as respiratory tract infections, malaria and diarrheal diseases. Financial resources are needed to increase priority interventions for these preventable, manageable and treatable conditions. Maternal mortality—the death of women during pregnancy, childbirth, or in the 42 days after delivery—remains a major challenge to health systems worldwide. There were 343,000 maternal deaths worldwide in 2008, down from 526,300 in 1980. More than 50% of all maternal deaths were in only six countries (India, Nigeria, Pakistan, Afghanistan, Ethiopia, and the Democratic Republic of the Congo). In the absence of HIV, there would have been 281,500 maternal deaths worldwide. Substantial, albeit varied, progress has been made towards MDG 5 (improve maternal health). Although only 23 countries are on

track to achieve a 75% decrease in maternal mortality ratio by 2015, countries such as Egypt, China, Ecuador, and Bolivia have been achieving accelerated progress. Interventions that are known to be effective in lowering maternal and perinatal mortality and morbidity are not universally provided. Scaling-up the coverage of maternal and newborn health care provided by skilled personnel is expected to have a considerable impact in helping to achieve MDG 4 (reduce child mortality) and MDG 5 (improve maternal health). The main constraint is the shortage of skilled professionals: it is necessary to train nurses, midwives and health educators to provide skilled assistance during labor and delivery, as well as care for infants and children. Moreover, countries, donors and multilateral agencies must mobilize resources to strengthen health infrastructure: to create new hospitals, to upgrade equipment and facilities, and provide them with essential medicines.

(Sources: WHO The World Health Report 2005, Make every mother and child count; UNICEF The State of the World’s Children 2009, Maternal and Newborn Health; The Lancet, Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5)

Global distribution of cause-specific mortality among children under five

(Source: The State of the World’s Children 2006, Child Survival, UNICEF, December 2007)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Abbott Fund Program to Fight Malnutrition in Vietnam

Abbott Fund Program to Improve Children’s Health in Cambodia

Child & maternal health, malnutrition Abbott AmeriCares, Giao-Diem Humanitarian Foundation Since 2006 Access - Donation, Capacity Building - Training Vietnam www.abbott.com

Child & maternal health Abbott Angkor Hospital for Children in Cambodia, Direct Relief International Since 2006 Access - Donation, Capacity Building - Training Cambodia www.abbott.com

Children in Vietnam are afflicted with some of the most severe forms of malnutrition, an unacceptable reality caused by limited access to nourishing food and a lack of nutritional education. According to UNICEF, more than 25% of Vietnamese children under five are underweight and more than 10% of Vietnamese children suffer from vitamin A deficiency. To help improve the overall nutritional health of children in rural areas of Vietnam, the Abbott Fund is working with AmeriCares to support the Giao-Diem Humanitarian Foundation.

Malnutrition is a significant contributor of early morbidity and mortality among young children in Cambodia. According to UNICEF, the mortality rate for children under five increased from 115 per 1,000 live births in 1990 to 143 in 2005; nearly 45% of all children under five are underweight. Since 2006, Abbott and the Abbott Fund have partnered with Direct Relief International and Angkor Hospital for Children in Siem Reap in an effort to reverse these troubling trends.

Together, the Abbott Fund and its partners are improving the nutritional status of school age children in three rural provinces of Vietnam – Quang Tri, Hue, and Dong Thap – where childhood malnutrition rates are among the highest in the country. This successful initiative targets nutritional health early in life. Administered through a network of local schools, the program focuses on three main components: nutrition support with multivitamins and nourishing local food products; training and health education for teachers, staff and parents; and school infrastructure improvements. During the flooding and raining season, Abbott also donates pediatric nutritional products. In 2009, the Abbott Fund initiative reached 73 classrooms and more than 2,200 children. During the 2008-2009 school year the program reduced the prevalence of child malnutrition in three provinces from an average of 31% to 18%. In addition to improving the health and nutrition outcomes for enrolled children, Abbott´s support of the program contributes to Vietnam´s national efforts to meet the United Nations Millennium Development Goals. In association with Goal 1 on extreme poverty and hunger, Vietnam aims to reduce the proportion of people living under the food poverty line by 75% by 2010. In association with Goal 4 on child mortality, the partnership is helping Vietnam reduce the proportion of children under five who are malnourished down to 20% by 2010. This program serves as a sustainable model for improving pediatric nutrition in rural Vietnam. Abbott is currently supporting efforts by other organizations to replicate this model program at seven additional locations.

Abbott and the Abbott Fund have provided more than USD 2.3 million in grants and products to support the work of Angkor Hospital for Children, a pediatric teaching hospital providing free comprehensive care for children in Siem Reap and neighboring provinces. Direct Relief, a global humanitarian assistance organization, manages the distribution of Abbott´s grants and product donations. The Abbott Fund is focused on improving health professional and caregiver awareness, knowledge and ability to treat pediatric nutrition through formal training, local and regional educational workshops, cooking demonstrations and donations of essential products. With the Abbott Fund´s support, in 2009 Angkor Hospital for Children also sent 117 hospital staff to participate in college-level ‘train the trainer’ courses to strengthen the overall clinical teaching skills of the hospital´s nursing staff. In 2009, the Abbott Fund’s grant made it possible for the Angkor Hospital for Children to provide services to more than 124,000 children, all of whom were assessed for malnutrition. Of those assessed, 136 were identified and then treated for severe malnutrition. Additionally, with the Abbott Fund’s support, 1,700 families attended cooking classes through AHC and 4,000 families attended nutrition information sessions. In order to sustain what they had learned in the cooking and nutrition classes, AHC provided more than 3,000 families with locally grown food to put what they had learned into practice. Since the partnership began, more than 250,000 children have received nutritional assessments, more than 6,000 families have participated in nutrition information workshops, and more than 400 health professionals have received nutrition training. The program´s success has helped Angkor Hospital for Children serve as a role model for hospital nutrition programs in Cambodia.

In Vietnam, the Abbott Fund is helping improve the nutrition of children in rural schools by providing local foods; teachers, staff and parents also receive training and health education. (Abbott)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Abbott Fund Program to Improve Children’s Health in the Democratic Republic of Congo

Abbott Fund Program to Improve Maternal & Child Health in Afghanistan

Child & maternal health Abbott Église du Christ au Congo, IMA World Health Since 2007 Access - Donation, Capacity Building - Training Democratic Republic of Congo www.abbott.com

Child & maternal health Abbott Afghan Institute of Learning, Direct Relief International Since 2005 Access - Donation, Capacity Building - Training Afghanistan www.abbott.com

Years of civil war have had a devastating impact on the health and lives of women and children in the Democratic Republic of Congo. The country suffers from one of the highest maternal mortality rates in the world, at 1,100 deaths per 100,000 live births, the third highest infant mortality rate in Africa at 129 deaths per 1,000 live births, and 67% of pregnant women are anemic.

According to the World Health Organization, Afghanistan has the second highest maternal mortality rate in the world, with 1,900 deaths per 100,000 live births. In addition, one in four Afghan children will not live to see their fifth birthday. To improve the lives of women and children in Afghanistan, Abbott and the Abbott Fund are partnering with the Afghan Institute of Learning (AIL) and Direct Relief International to help reverse the country´s high maternal mortality rate, and increase the survival and overall health of infants and children.

Since 2007, the Abbott Fund is partnering with IMA World Health and the Église du Christ au Congo to help reverse these statistics. The partnership supports the training of health care professionals and water engineers, and provides essential supplies needed to deliver basic health care services, such as vaccinations, nutrition counseling, literacy training, screening and counseling on genderbased violence, and prenatal care, to more than 60,000 women and children in Equator Province. The Abbott Fund also is coordinating the donation of nutritional products, and rapid HIV/AIDS tests to help prevent the transmission of HIV from mother to child.

The Abbott Fund has provided more than USD 500,000 in grants and assisted in coordinating USD 4 million in product donations from Abbott to support the work of AIL, founded by Nobel Prize nominee Sakena Yacoobi, a long-time advocate for women´s rights in Afghanistan. Direct Relief International, a global humanitarian assistance organization, manages the distribution of Abbott´s grants and product donations to AIL.

Despite ongoing conflict in the targeted areas, which has caused the internal displacement of thousands of persons and cut off delivery and access routes, the program continues to deliver life-saving services. More than 100 community health care workers and 133 doctors and nurses have been trained this past year to diagnose and treat children in a community-care setting. More than 5,000 women have been educated through on-going gender-based violence campaigns and more than 1,700 women attended literacy classes.

With five clinics serving mostly rural areas in Afghanistan, AIL is staffed and operated by Afghan women. Abbott Fund support is focused on empowering Afghan women through the training of female nurses, midwives and health educators to provide skilled assistance during labor and delivery, as well as care for infants and children. The Abbott Fund also is supporting 5-day women´s health workshops that have provided health education directly to more than 376,000 Afghan women since 2005.

The Abbott Fund´s support is part of its effort to invest in creative programs that advance access to health care around the world, focused on finding sustainable solutions to make a lasting impact on people´s lives.

Abbott has donated products to improve maternal and child health, including rehydration solutions, antibiotics, multivitamins and nutritional supplements.

In the Democratic Republic of Congo, the Abbott Fund is piloting a comprehensive prenatal health initiative. (Abbott Fund)

Since the partnership began in November 2005, there has been a ten-fold increase in the number of healthy babies delivered at AIL’s clinics. More than 600,000 women and children have received services, and 60 nurses/midwives have been trained, with most now employed in clinics and hospitals. The Abbott Fund is supporting the training of 25 additional women in 2010-2011.

The Abbott Fund has helped Afghan women through the training of female midwives and by strengthening health care capacity to provide better services for women and children. (Abbott Fund)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Arpana Research and Charitable Trust

Bayer Schering Pharma & Family Planning

Child & maternal health Pfizer Arpana Research and Charitable Trust Since 2002 Capacity Building - Support India www.pfizer.com

Family planning Bayer HealthCare Governments, multilateral organizations & private organizations Since 1961 Access - Pricing, Capacity Building - Training, Education Worldwide www.bayerscheringpharma.de

One of the biggest obstacles to improving the health of women and children, the aim of UN Millennium Development Goals 4 and 5, is inadequate primary care capacity. Pfizer has been working the Arpana Research and Charitable Trust, an NGO operating in rural and urban India, since 2002. Pfizer’s funding and in-kind support is now focused on building technical capacity at Arpana Hospital, a 135-bed facility in rural Haryana, and in the NGO’s operations in two other Indian States.

For more than 46 years, Bayer Schering Pharma AG (part of Bayer HealthCare) has been supporting family planning programs in 132 countries with its high quality products in close co-operation with government organizations (BMZ - German Federal Ministry for Economic Cooperation and Development, KFW - German Development Bank, GTZ - German Association for Technical Cooperation, the UK´s DFID and DANIDA), multilateral organizations (UNFPA, the World Bank, the WHO, and USAID), and private organizations (International Planned Parenthood Federation, Population Services International, Marie Stopes, IMRES and Missionpharma).

A key focus of Arpana’s work is on expansion of its maternal and child health work, as well as gender empowerment interventions that include self help groups and micro-financing. Pfizer has worked with Arpana to create a self-sustaining business model in which fees from paying patients help to support low-income patients and community service programs. Additionally, Pfizer has connected Arpana to other funding sources, including government programs and multilateral entities, to promote sustainability and scale up of the NGO’s program within India. Key achievements within the rural program in Haryana include: • Decreasing anemia rates among pregnant women by 32%, and among adolescent girls by 51%; • Creating 1,046 home kitchen gardens that have helped reduce levels of malnutrition, and increasing household nutrition through the cultivation of local fruits and vegetables; • Reducing infant and maternal mortality rates, with a 20% reduction in low-birth-weight infants, a 20% increase in institutional deliveries and a lower prevalence of neural-tube defects; and • Improved awareness of the health care needs of pregnant women and children less than five years old, which has led to a 94% coverage rate of antenatal checkups.

In that time, more than 2.6 billion cycle packs of oral contraceptives have been provided to family planning organizations and users in the developing world. The product range include a wide choice of contraceptive methods, (mono- and triphasic combined oral contraceptives and progestogen-only products), injectables (one- and threemonthly), implants and intrauterine devices/systems. These products are of the same quality as those available on the private market but they are sold at no profit to organizations running family planning projects in developing countries. In 2009, Bayer contributed about 70 million cycles of oral contraceptives and more than 5.4 million injectables worldwide, as well as more 900,000 sets of implants. With its family planning programs, Bayer wants to help people to make informed and independent decisions concerning their family size, taking into account the best possible conditions for the future of their children. Family Planning reduces women´s exposure to health risks of unwanted childbirth and unsafe abortions. Bayer is committed to making universal access to fertility control means a reality by 2015, as recommended by the International Conference on Population and Development. Through its long-term commitment to family planning, Bayer is making a substantial contribution to the UN Millennium Development Goals, including empowering women, reducing child mortality and improving maternal health by 2015. Training programs for family planning providers are also part of Bayer´s commitment. Since sexual education is vital to contraception, Bayer supports programs like the CELSAM project (Centro Latinoamericano Salud y Mujer), providing detailed information on sexual education in all Latin American countries by radio, educational programs for schools and universities, telephone hotlines and information booths on the streets. In Asia, Bayer cooperates with APCOG (Asia Pacific Council on Contraception).

Since 1961, more than 2.5 billion cycle packs of oral contraceptives have been provided to family planning organizations and users in developing countries. (Kirsi Armanto, Bayer Schering Pharma)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Bidan Delima Midwife Training Program

Computerized Training for Management of Childhood Diseases

Child & maternal health Johnson & Johnson Indonesian Midwives Association Since 2003 Capacity Building - Training, Education Indonesia www.jnj.com

Child health Novartis WHO Since 2005 Capacity Building - Support Indonesia, Tanzania, Peru www.icatt-training.org, www.novartisfoundation.org

In Indonesia, 20,000 women die each year as a result of pregnancy or delivery, and 165,000 infants die before, during or directly after birth. Midwives are crucial to improving reproductive health services. Working with the Johns Hopkins University´s JHPIEGO unit, the Indonesian Midwives Association is trying to increase the standard of care among private practice midwives in the country. The Bidan Delima Program, a component of the Sustaining Technical Achievements in Reproductive Health/Family Planning project operated by IMA, was implemented in 2003.

Every year, almost 10 million children die before they reach their fifth birthday. Many of these deaths could be avoided if those children received timely and appropriate care. It is the goal of the World Health Organization (WHO) to reduce the infant and child mortality rate by two-thirds by 2015 (compared with 1990). One of the most promising instruments for achieving this goal is the Integrated Management of Childhood Diseases (IMCI), an approach to managing the most common diseases such as pneumonia, diarrhea, malaria, measles, or malnutrition.

Johnson & Johnson has supported this midwife training program since its inception in 2003. Since then, more than 1,200 midwives have been trained on the national clinical standards of midwifery. These standards cover family planning services, infection prevention, contraceptive technology and safe delivery care. The program also provides educational material to 28,000 additional midwives throughout the country. The Association was able to produce an updated version of its national safe delivery training video, which is used to train 76,000 practicing midwives in Indonesia.

To train healthcare personnel in IMCI and to respond to different realities in countries, innovative and flexible ways of learning and skills development have to be established. To that end, the Novartis Foundation for Sustainable Development has, in collaboration with the WHO, developed a computer-based learning program: the IMCI Computerized Adaptation and Training Tool (ICATT).

The 2008 program has trained 200 Bidan Delima facilitators in order to expand the number of candidates each year. The program spans 12 Indonesian provinces with 177 cities and involves more than 26,000 midwives. By improving the health care services offered to midwives in private practice, Bidan Delima aims to help reduce the maternal and neonatal mortality rate of urban births by 30 to 60% over the next five years.

In 2008, the ICATT software was sent to all IMCI-implementing countries. With the support of the Novartis Foundation, Peru, Tanzania and Indonesia have started the adaptation process from a generic version to a country-specific version. In those countries, the first ICATT training courses were conducted. Close monitoring will document the early findings in order to share them, with stakeholders who may be interested in the potential use of the tool in the future.

In Cambodia, the Abbott Fund is improving pediatric nutrition by educating health care workers on how to counsel families on the nutritional needs of their children and improving their children's health. (Abbott Fund)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Freedom of Breath, Fountain of Life

Fuyang AIDS Orphan Salvation

Child & maternal health Johnson & Johnson Chinese Ministry of Health & other partners Since 2004 Capacity Building - Training, Education China www.jnj.com

Child health Johnson & Johnson Fuyang AIDS Orphan Salvation Association Since 2006 Capacity Building - Support, Education China www.jnj.com, www.faaids.com

Each year in China, as many as 125,000 babies may succumb to neonatal asphyxia, the inability to breathe at or immediately after birth. Johnson & Johnson Pediatric Institute, LLC, has joined with the Chinese Ministry of Health, the American Academy of Pediatrics, the Chinese Society of Perinatal Medicine and the Chinese Nursing Society to form the ‘Freedom of Breath, Fountain of Life’ national neonatal resuscitation program.

Founded in December 2003, the Fuyang AIDS Orphan Salvation Association (AOS) addresses the social stigma and discrimination associated with HIV/AIDS. With support from Johnson & Johnson, this NGO serves the needs of more than 500 children affected by HIV/AIDS in An Hui Province in eastern China. AOS assists more than 200 families in 20 different villages, providing stipends for basic health and education needs, clothing, food, vocational education and emotional support. AOS strives to reduce social stigma by encouraging meaningful dialogue within Chinese communities to raise public awareness about HIV/AIDS.

The program aims to reduce infant mortality through education, with a goal of ensuring that there is at least one trained person is present at every hospital birth by 2010. In just a few years, the program has trained health care professionals saving the lives of countless babies who would have otherwise died. Since 2004, the program has trained more than 27,000 medical professionals, in more than 6,400 hospitals, in 20 provinces across China, in the techniques of neonatal resuscitation.

Since 2003, AOS has rescued approximately 500 children affected by HIV/AIDS, most of them orphans. Johnson & Johnson supports three key AOS initiatives: • Sponsoring children to attend vocational schools to help prepare them for better job opportunities and economic independence; • Providing transportation for infected children to obtain treatment and nutritional support; • Operating a summer camp for AOS children ages 5 to 16 who are infected or affected by HIV/AIDS.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Ghazipur Children’s Hospital

GlaxoSmithKline & Integrated Management of Childhood Illness

Child health Pfizer Sabera Foundation Since 2004 Capacity Building - Support India www.pfizer.com

Maternal, neonatal & child health GlaxoSmithKline WHO, UNICEF & other partners Since 1996 Capacity Building - Support & Training, Education Ethiopia, Ghana, Kenya, Namibia, Nigeria, South Africa www.gsk.com

Pfizer Spain is supporting the Sabera Foundation, which runs a small Children´s Hospital in Ghazipur, in the outskirts of Calcutta in India. The hospital provides specialized residential health care and rehabilitation services for the children of poor families. Pfizer helps fund maintenance of the building and the hospital´s operating expenses infrastructures and makes available the company´s expertise in health care. Therapeutic areas covered include physiotherapy, tuberculosis and ophthalmology. The hospital also provides out-patient support to the surrounding community.

The World Health Organization (WHO) and UNICEF developed Integrated Management of Childhood Illness (IMCI) as an improved delivery strategy for child survival interventions. GlaxoSmithKline has been involved with IMCI since 1996 when it initiated an unique partnership with the South African Ministry of Health. Since then, GSK has entered into public-private partnership agreements with WHO, UNICEF, National Ministries of Health and/or NGOs for the implementation of the IMCI strategy or components thereof in Ethiopia, Namibia, Nigeria, Ghana and Kenya.

As a part of its corporate social responsibility strategy, Pfizer allows its employees to work at the Ghazipur Hospital, performing support, management and medicine distribution activities for two to four weeks, as well as helping with rehabilitation tasks. To date, 74 Pfizer volunteers have participated in this program.

IMCI aims to reduce morbidity and mortality due to the major killer diseases for children under five: malaria, diarrhea, malnutrition, measles, pneumonia, HIV/AIDS and neonatal causes. The strategy includes three main components: 1) improving the case management skills of health workers; 2) strengthening the health system; and 3) improving key household and community practicesthat have the greatest impact on child survival.

The Children’s Hospital in Ghazipur, Calcutta, provides specialized residential health care and rehabilitation services for the chlidren of poor families. (Pfizer)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

GlaxoSmithKline: Namibia Sanitation & Hygiene Program

GlaxoSmithKline´s Midwife Training in Vietnam

Child Health GlaxoSmithKline Namibia Ministry of Health, UNICEF Since 2008 Capacity Building - Support Namibia www.gsk.com

Child & maternal health GlaxoSmithKline Tu Du Hospital in Vietnam Since 2004 Capacity Building - Training Vietnam www.gsk.com

Nearly 1.3 million of Namibia’s population of just over 2 million do not have access to proper toilet facilities, including 84% of all people living in rural areas. Diarrhea is the second highest cause of pediatric admissions in Namibia and is responsible for more than 30% of deaths in children under the age of five. In order to achieve the UN Millennium Development Goals (MDGs), the Namibian government’s aim for 2015 is to ensure that at least 62% of people will have access to adequate sanitation.

Since 2004, GlaxoSmithKline has been supporting a unique training program based in Tu Du Hospital, Ho Chi Minh City, Vietnam. The project is training birth attendants to provide maternal healthcare services in rural villages and aims to reduce childbirth complications and decrease newborn fatalities from the current unacceptably high level of 6%.

In line with GlaxoSmithKline’s Corporate Social Responsibility commitment to support the MDGs (especially those focused on child survival), a partnership agreement was signed in October 2008 during the first ever Global Handwashing Day, with UNICEF, Ministry of Health & Social Services of Namibia and GSK. GSK committed GBP 125,000 to this project of the period 2008-09.

Supported by Tu Du medical and nursing staff, and housed within a residential training centre built by GSK, the trainees spend four months gaining practical knowledge of maternal and child healthcare. Over 500 midwives have now graduated with a government-recognized qualification. Each midwife has been equipped with a medical pack and some are provided with a motor scooter to facilitate access to remote areas.

The project goal is to support the development of a National sanitation promotion campaign, and a National policy, strategy and action plan on Sanitation & Hygiene Promotion in Namibia. The aim of the campaign is to raise awareness about the benefits of hand washing and improved sanitation. The campaign has two major components; firstly, to target the entire population, with a focus on mothers and other caregivers of children under the age of five, and secondly, to focus specifically on schools and school-age children, who themselves are often caregivers of their younger siblings.

IMCI aims to reduce morbidity and mortality due to the major killer diseases for children under five: malaria, diarrhea, malnutrition, measles, acute respiratory infection and HIV/AIDS. (GlaxoSmithKline)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

GlaxoSmithKline´s PHASE Program

Global Campaign to End Fistula

Child health GlaxoSmithKline AMREF, Earth Institute, Save the Children, national MoHs Since 1998 Education 13 developing countries www.gsk.com

Maternal health Johnson & Johnson UNFPA & other partners Since 2004 Capacity Building - Training, Education Ethiopia, Tanzania www.fistulafoundation.org/hospital, www.americansforunfpa.org, www.ccbrt.or.tz

GlaxoSmithKline´s Personal Hygiene & Sanitation Education (PHASE) project is helping to reduce diarrhea-related disease by encouraging school children to wash their hands. GSK established PHASE in 1998 and has so far invested over USD 7 million in the program. PHASE is run in partnership with AMREF, Save the Children and Earth Institute at Columbia University, as well as national Ministries of Health and Education in countries where the program is active.

Fistula is a serious and painful disorder that develops when blood supply between organs or vessels is cut off during prolonged obstructed labor. Johnson & Johnson works with organizations in Africa to prevent and treat fistula.

The program has had impressive results so far. For example, a study by AMREF in Kenya showed that after four years, 88% of children from participating schools washed their hands after using the toilet, compared with 46% from non-participating schools. PHASE was extended to Millennium Villages in Malawi and Senegal during 2008 and now operates in a total of 13 countries. The aim is for the program to reach over 1 million children by next year. GSK has a PHASE steering committee with representatives from its partner organizations to help expand the program into more countries. In 2009, PHASE was extended to the Philippines and Rio de Janeiro in Brazil.

In Eritrea, it helps the Global Campaign to End Fistula, led by UNFPA (United Nations Population Fund), which seeks to make this problem as rare in the developing world as it is in industrialized countries today. This project focuses on addressing obstetric fistula by increasing the caesarean section rate and the number of fistula repairs, thereby contributing to the ultimate goal of reducing maternal mortality and morbidity. Addis Ababa Fistula Hospital is a key partner in the Global Campaign to End Fistula. It is the only health care facility in Ethiopia dedicated to victims of fistula, Johnson & Johnson supports outreach efforts to treat this condition and to educate women in remote areas about the importance of quality pre-natal and obstetrics care. The hospital treats more than 1,000 women each year throughout Ethiopia and serves as a training center for fistula surgery. Johnson & Johnson also partners with the Comprehensive Community Based Rehabilitation center in Dar es Salaam, Tanzania (CCBRT), to provide fistula surgeries to nearly 200 women a year. In Ethiopia, Johnson & Johnson also supported in 2008 an accredited degree program at the Hamlin College of Midwifery for 40 rural women studying to become midwives.

GlaxoSmithKline’s PHASE project is designed to reduce diarrhea by teaching children to wash their hands and other sanitation measures. (GlaxoSmithKline)

Johnson & Johnson supports the Addis Ababa Fistula Hospital in Ethiopia. (Johnson & Johnson)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Global Fund for Women

Home-Based Newborn Care (HBNC) Initiative

Maternal health, women´s health Johnson & Johnson Global Fund for Women Since 2005 Education Kenya, Nigeria, Uganda www.globalfundforwomen.org

Maternal health Johnson & Johnson UNICEF Since 2008 Capacity Building - Training India, Nepal, Pakistan www.jnj.com

The Global Fund for Women (GFW) advocates for and defends women´s human rights by making grants to support women´s grassroots organizations around the world. The GFW works to promote economic security, awareness of the endemic problems of violence against women, education, health, and leadership.

The Home-Based Newborn Care (HBNC) initiative aims to train a sufficient number of community midwives in the most underserved areas to save newborns’ lives. After taking a series of intensive courses, the community midwives can provide a continuum of quality care from pregnancy through birth and early infancy. The care includes drying the newborn, keeping the baby warm, initiating breastfeeding, giving special care to low-birth weight newborns, and diagnosing and treating common infant infections.

Maternal prenatal care and reproductive health are of especially great concern. Estimates are that 500,000 women worldwide die each year in childbirth and another 18 million are left disabled or chronically ill. Johnson & Johnson provides support, through the GFW, to a dozen community-based groups that address maternal health issues in multiple African countries, including Kenya, Nigeria, and Uganda

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The HBNC initiative has trained the first 32 community midwives in two pilot areas of Punjab, Pakistan’s most heavily populated province, where only 33% of births take place in the presence of a skilled birth attendant. To further improve the health care for newborns and mothers, several midwifery homes have also been built. With the newly built facilities, each community midwife is now able to provide clean and safe deliveries to communities with populations of 10,000. By the end of 2009, 190 skilled community midwifes had been deployed in five districts.

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

CHILD & MATERNAL HEALTH – Access & Capacity Building

Integrated Midwives Association of the Philippines

International Rescue Committee

Child & Maternal health Johnson & Johnson Integrated Midwives Association of the Philippines Since ? Capacity Building - Training Philippines www.jnj.com

Child health Johnson & Johnson International Rescue Committee Since 2004 Capacity Building - Support, Education 25 developing countries www.theirc.org

Johnson & Johnson supports training of IMAP midwives. More than 170 have been trained in the past few years.

The IRC is a global leader in emergency relief, protection of human rights, post-conflict development, resettlement services, and advocacy for those affected by conflict and oppression in more than 25 developing countries. Johnson & Johnson provides support to help the IRC build schools, and train police, peacekeepers, and relief workers in best practices for assisting victims of trauma.

Johnson & Johnson supports the UNICEF Safe Motherhood Initiative program at the Fabella Memorial Hospital in the Pilippines. (Janea Wiedmann, Johnson & Johnson)

Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships

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CHILD & MATERNAL HEALTH – Access & Capacity Building

It´s Worth Dreaming Project

Pankararu Health & Culture Project

Child & maternal health Pfizer Instituto Kaplan Since 2004 Education Brazil www.pfizer.com

Child & maternal health Pfizer Associação Saúde Sem Limites Since 2005 Capacity Building - Training, Education Brazil www.pfizer.com

An initiative of the Instituto Kaplan with the support of Pfizer, the ‘It´s Worth Dreaming Project’ fights unplanned pregnancy among adolescents in the State of São Paulo. In 2008, approval was given to implement the initiative in all public schools of the State. By 2010, 37,000 education professionals will have been trained and 1.7 million students reached, in 645 municipalities.

Pfizer and Associação Saúde Sem Limites (Unlimited Health Association) have been working together on The Pankararu Health and Culture Project since 2005. The project provides 5,000 Pankararu Indians in townships located in the Borborema Mountain Range, in the arid interior of Pernambuco State, with basic health care information. Pfizer provides both financial and technical support to the program.

The project was first launched in 2004 in 14 municipalities in the Ribeira River Valley region, which has the lowest Human Development Index rating in the state. Since then, the Project has accomplished a 91% reduction in unwanted pregnancies and assisted more than 11,000 adolescents. It´s Worth Dreaming Project workshops ask young people to define their life goals and then encourage them to achieve them. This helps adolescents to understand better the consequences of unplanned pregnancy in their lives and become more motivated to learn about and practice safe sex. The Vale Sonhar game helps teachers and community agents to explore this theme with youngsters.

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The Pankararu population also suffers from long droughts, intense social discrimination, clan conflicts and territorial disputes. To address these issues, the project has launched initiatives including diagnosis of the primary illnesses afflicting the population and training Indigenous Health Agents. The young population is also impacted by the project by means of activities focused on sexual education and family planning. One of the initiatives is a program to assist traditional midwives and pregnant women. From 2007 to 2008, the project trained 60 traditional midwives, who provided more than 1,600 prenatal medical appointments and, on average, assisted more than 400 women. The project has also trained 40 Pankararu Indians to act as Indigenous Health Agents. Since the beginning of the project, not a single death has been registered during pregnancy, upon delivery or following a birth.

CHILD & MATERNAL HEALTH – Access & Capacity Building

Ranbaxy Community Health Care Society

Renascer: Helping Poor Mothers in Brazil

Child & maternal health Ranbaxy Rural communities throughout India Since 1994 Capacity Building - Support & Training, Education India www.abbott.com

Maternal health Johnson & Johnson Renascer Since 2005 Education Brazil www.criancarenascer.org.br

Ranbaxy set up the Ranbaxy Community Health Care Society (RCHS) in 1994 as a professionally managed independent, nonprofit body. RCHS grew out of the work of the Ranbaxy Rural Development Trust, created by the company in 1979 to deliver primary health care to the underserved and underprivileged in Indian society and contribute to the national objective ‘Health For All’.

Renascer is a Brazilian NGO which provides medical and educational aid to mothers with chronically ill children living below the poverty line. The program addresses the specific needs of health, education, income, housing and citizenship. During 17 years of operation, Renascer has helped 2,500 families with more than 8,600 children break the cycle of poverty and illness. The Renascer model has been so successful that it has inspired the development of 17 similar independent programs throughout Brazil.

RCHS adopts a focused, integrated approach to basic health care issues its service areas. To help plan needs-based intervention strategies, RCHS monitors and records events such as live births, infant deaths, maternal deaths and abortions. It has identified the main causes of infant and maternal mortality in RCHS areas as low birth weight, diarrhea, pneumonia, birth asphyxia, hypothermia, anemia in pregnancy, including obstetrical causes like sepsis or hemorrhage. Special attention is given to oral rehydration salts for diarrhea, and early diagnosis and appropriate treatment of pneumonia. To help bring down infant and maternal mortality rates in RCHS areas, the organization works with at-risk groups to prevent low birth weight and anemia in pregnancy, including referral services for dealing with obstetrical emergencies.

Johnson & Johnson funds a key component of the Renascer model - education. Mothers are taught how to create healthy environments and given the skills to do so. Monthly sessions address issues of health education, disease prevention, child development, and domestic abuse. When family goals are met, the women graduate from the program prepared to provide for their families on their own.

RCHS found that more than 70% of births in its service areas were conducted at home by untrained or improperly trained dais (traditional midwives). While lack of skills was causing many neo-natal deaths, the dais were accessible and acceptable to pregnant women. A two-phase intervention strategy was adopted, where RCHS Medical officers were trained to train the dais and then went out to deliver that training to dais in the community. RCHS has also established various community groups for women, dais, anganwari (childcare) workers, volunteers, adolescents and breast-feeding to promote community involvement and self-sustainability. Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy in 2008.

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CHILD & MATERNAL HEALTH – Access & Capacity Building

Safe Motherhood Initiative

Sanofi-aventis Children´s Programs

Maternal health Johnson & Johnson UNICEF Since 2004 Capacity Building - Support & Training India www.unicef.org

Child health sanofi-aventis Various partners Since 1994 Access - Donation, Capacity Building - Support 10 developing countries www.sanofi-aventis.com

One quarter of all women who die from complications of pregnancy or childbirth around the globe are in India. In two states, Madhya Pradesh and Rajasthan, the Maternal Mortality Ratio (MMR) is 379 deaths per 100,000 live births and 445 deaths per 100,000, respectively. Both numbers are significantly higher than India’s already high national average of 305 deaths per 100,000 live births. About half of all maternal deaths are attributed to hemorrhage and anemia, both of which can be prevented. Unfortunately, poor maternal health care and inadequate emergency obstetric care put babies at risk, too.

Sanofi-aventis supports a number of projects in developing countries, the main purpose of which is to help improve children´s health. These include:

To help address these issues, Johnson & Johnson partners with UNICEF/Safe Motherhood Initiative to increase access to good health care, giving mothers better care early and infants a healthy start in life. The UNICEF/Safe Motherhood Initiative provides extensive technical support, leadership and training programs to midwives, female health workers and staff nurses in Madhya Pradesh and Rajasthan. The initiative also ensures that skilled caregivers are available for the community 24 hours a day at nine health care facilities where the staff has received birth attendant training; seven more centers are to follow. Additionally, UNICEF helped initiate an emergency transport program to take pregnant women to the hospital. As a result of to the UNICEF/Safe Motherhood Initiative, the percentage of institutional deliveries in the Guna district of Madhya Pradesh has risen from 35% in 2004-2005 to 76% in 2006-2007, meaning that many more mothers are being cared for by skilled birth attendants. The Fatehegarh Health Center, for example, handled 230 deliveries, up from zero in 2006. As part of UNICEF’s overall efforts, in Madhya Pradesh 22 government agencies are part of a 24-hour emergency transport initiative, and in Rajasthan more than 100 vehicles are available for this service. More than 300 women have received emergency obstetric care through this transport service.

Setting up a 4 years pilot program with The Chain of Hope to improve prevention of childhood rheumatic fever in Cambodia´s rural Pursat province; In Vietnam, sanofi-aventis is helping the Sister Elisabeth Association to build a dispensary in an orphanage for sight-impaired children, to build a school for street children (to help fight against prostitution) and to create sculpture and sewing workshops to generate income for the very poor; Sanofi-aventis is helping to provide social and medical support to the homeless, in particular children in Huaycan, Peru, in Bucharest, Romania and in Moscow, Russia, in partnership with Samusocial International; In Haiti, sanofi-aventis has helped set up of a medical and psychosocial program for street children in Port-au-Prince in partnership with Aide Médicale Internationale; In Philippines, Chameleon Association protects and rehabilitates girls aged 5 to 18 who have been mistreated and sexually abused. In addition to corporate-level help, sanofi-aventis and Sanofi Pasteur Philippines support Chameleon through local fund-raising and vaccination campaigns among young girls and the center´s staff; In Senegal, sanofi-aventis has partnered the Kinkeliba association for its training program of bush doctors: fund of courses for final year medical students and for post-doctoral students working on such subjects as parasitology, pharmaceutics and biology; Sanofi-aventis is partner to the Les Enfants du Noma association which helps children affected by this terrible disease in Burkina Faso and Mali. Noma is a disease of poverty, which affects 500,000 children each year worldwide in Africa, Asia and South America. This bacterial infection disfigures the face, mainly in young children from birth to the age of six. Those who survive suffer from serious facial mutilation, leading to speech and eating problems.

Health depends on many factors, including access to clean water, sanitation, adequate nutrition and basic education. (GlaxoSmithKline)

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Save the Children

Unamos al Mundo por la Vida

Child health Johnson & Johnson Save the Children Since 1998 Education Philippines, Thailand, Vietnam www.jnj.com, www.savethechildren.org

Child health Johnson & Johnson Unamos al Mundo por la Vida Since 2005 Education Venezuela www.unamosalmundo.org

Since 1998, Johnson & Johnson has partnered with Save the Children in efforts to educate children and their families in the Philippines, Thailand and Vietnam about child development, health and nutrition.

Johnson & Johnson partners with Unamos al Mundo por la Vida, an organization dedicated to recruiting and educating children who beg in the streets of Caracas, Venezuela. Many of these children are homeless or live in extreme poverty, lacking opportunities to fulfill their basic needs. Program funding goes to a health clinic and shelter where these children receive basic medical, dental and psychosocial care, as well as meals, education and entertainment. Unamos al Mundo por la Vida estimates that approximately 3,500 children benefit from this program every year.

The partnership´s first project involved integrating personal, community and environmental hygiene instruction into school curricula in Thailand. Johnson & Johnson has provided more than USD 1.1 million in grants, contributions, matching gifts and in-kind gifts. Project Pampalusog works with residents and schools in the community of Masville in the Philippines to improve the health and nutrition of school children. Launched in June 2004, the project has increased awareness by children and their families living in Masville of health and diseases, particularly worm infection and some reproductive health risks. Through practical skills in recognizing and preventing the spread of diseases, improving delivery of health and nutrition services, and forming partnerships for better sanitation practices, the project has inspired the community in creating a vision for healthy children living in safe and healthy environments. Since its inception, worm infections have been reduced from 50% in 2004 to 17% in 2007. In addition, the community has improved drainage and sanitation systems and increased recycling and composting.

In Venezuela, Johnson & Johnson supports Unamos al Mundo por la Vida, which provides safe shelter, health care, education and food for children who come from poor settings. (Kelly Shimoda, Johnson & Johnson)

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CHRONIC DISEASES

Global deaths by causes, all ages, 2005

Chronic diseases

(Source: WHO Preventing Chronic Diseases: A Vital Investment, 2005)

106

Some 35 million deaths are attributable to chronic diseases each year; this is 60% of all deaths worldwide. Principal chronic diseases include cardiovascular disease (17 million deaths), cancer (7 million deaths), chronic respiratory disease (4 million deaths) and diabetes (1 million deaths). About 80% of chronic disease deaths occur in low and middle income countries and the number of people, families and communities affected is increasing. The impact of chronic diseases in these countries will increase as they progressively control infectious diseases. A significant proportion of chronic disease morbidity and mortality can be prevented if medications are made accessible and affordable, which is a challenge in countries with large populations of very poor people.

highly cost-effective. Public-private partnerships have a crucial role to play in accelerating progress with regard to specific diseases. Nevertheless, access to medicines is not the only key to achieving success: inadequate access to good-quality health services, including diagnostic and clinical prevention services, is a significant cause of the social and economic inequalities in the burden of chronic diseases. Investment in chronic disease prevention programs and the development of services and infrastructure are essential for many low and middle income countries.

The chronic disease threat can be largely managed using existing knowledge and medicines. Many solutions are effective – and

(Sources: WHO Preventing Chronic Diseases: A Vital Investment, 2005)

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CHRONIC DISEASES – Access & Capacity Building

Abbott Fund Program to Improve Cardiac Care in Rwanda

Abbott Program to Advance Diabetes Care in Bolivia

Cardiovascular care Abbott Partners In Health Since 2008 Access - Donation, Capacity Building - Training Rwanda www.abbott.com

Diabetes Abbott Centro Vivir Con Diabetes, Direct Relief International Since 2006 Access - Donation, Capacity Building - Training Bolivia www.abbott.com

Since 2007, Partners In Health coordinated a heart failure treatment and prevention initiative in two district hospitals in Rwanda (Rwinkwavu and Kirehe). The heart failure treatment program supports nurse-driven clinics providing routine heart exams and medications, daily patient home visits by community health care workers, and collaboration with cardiac surgical teams.

Since 2006, Abbott and the Abbott Fund have partnered with Direct Relief International to support the education and outreach activities of Centro Vivir Con Diabetes, a non-governmental organization dedicated to low-income adults and children living with both type I and type II diabetes in Cochabamba, Bolivia.

In 2008, Abbott provided the Cardiac Health Initiative with Abbott’s i-STAT handheld analyzer, which provides clinic staff with rapid results for commonly ordered medical tests. Through these donated diagnostic instruments, Partners In Health was able to identify and treat 239 patients with heart failure to date, as well as identify and help manage care for patients with renal failure and other complex needs in rural parts of Rwanda.

The Abbott Fund has provided grants to support diabetes education, expand public outreach campaigns, train health care personnel in diabetes management, and establish and expand the number of core diabetes educators. Abbott also has donated glucose screening and monitoring equipment, and disease-specific nutritional products. Since the partnership began, there has been a 260% annual increase in detections of diabetes. The patients that have been diagnosed have been counseled on how to manage their disease and encouraged to seek follow-up care through the Centro Vivir Con Diabetes.

In Bolivia, the Abbott Fund is improving the quality of life for people living with diabetes by providing diabetes education, expanding public outreach campaigns and training health care personnel in diabetes management. (Abbott Fund)

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AstraZeneca Breast Cancer Program in Ethiopia

Bayer HealthCare Nexavar® Access Program

Breast cancer AstraZeneca Axios, Ethiopian Cancer Association, Ethiopia Ministry of Health Since 2005 Access - Donation, Capacity Building - Support & Training Ethiopia www.astrazeneca.com

Oncology Bayer HealthCare Various partners Since 2007 Access - Donation Asia-Pacific region www.bayerscheringpharma.de

In Ethiopia, AstraZeneca has been working since 2005 to help build local capability in managing breast cancer – the second most common cancer among young women in the country. The company´s partner in this project is Axios, an organization that works with the private sector to advance healthcare in developing countries.

In 2007, Bayer HealthCare, in partnership with local authorities and charitable organizations, started the first patient access program for Nexavar® (sorafenib) in Asia for the treatment of renal cell carcinoma and is planning further implementation in this region. Bayer HealthCare donates its medicine Nexavar® to facilitate access for patients who cannot afford the cost of a full course of therapy.

In the developing world, the incidence of cancer is increasing. It is predicted that 20 million more people will be diagnosed by 2010, and 70% will live in countries that between them will have less than 5% of the resources for cancer control. At the outset of the Ethiopia Breast Cancer Program, the country had only one cancer specialist for the entire population; there was no mammography; no easy access to chemotherapy or hormonal agents; no cancer screening and no national treatment protocols. The program has focused on strengthening diagnosis and treatment capabilities at Tikur Anbessa University Hospital in Addis Ababa. In the last three years, with company help, the hospital has become a centre of reference for breast cancer treatment across Ethiopia. Activities have included developing treatment guidelines, strengthening the referral system, setting up an institutional-based cancer registry, raising awareness of the facilities amongst healthcare professionals and providing training for other physicians in Ethiopia. AstraZeneca´s breast cancer medicines, tamoxifen and anastrazole, are also being donated.

In 2008, Bayer HealthCare initiated another patient access program for Nexavar®, for the treatment of hepatocellular carcinoma, after its approval for this indication. After a patient is diagnosed with renal cell or hepatocellular carcinoma carcinoma, he or she is referred to a specialist center, which evaluates the patient´s eligibility for participation in the facilitated access program. If they are eligible for assistance, based on their financial situation, the patient will receive the medicine free-of-charge, either immediately or after an initial period of treatment.

The impact of the program has been broader than anticipated for what was intended as a small, targeted pilot. By collaborating with the Ministry of Health and other health institutions and by working with the Ethiopian Cancer Association to help strengthen awareness, the benefits reach farther than Tikur Anbessa Hospital. This is a sustainable model that could be replicated in other countries and other disease areas. Benefits to the patient have included reduced time between diagnosis and surgery, down from 12–18 months in 2006 to 3–6 months in 2009.

A female patient undergoes an ultrasound examination in the Breast Imaging Department at Tikur Anbessa University Hospital in Addis Ababa. (Doug Rea, AstraZeneca)

Prof. Ming Li, Chief Physician at Beijing Cancer Hospital in China, during his round on the oncological ward. Patients here are treated with the anticancer drug Nexavar, among others. (Bayer HealthCare)

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CHRONIC DISEASES – Access & Capacity Building

Cancer Awareness Leadership Initiative (CALI)

Changing Diabetes in Children®

Cancer Novartis Global Health Council & other partners Since 2009 Capacity Building Developing countries www.globalhealth.org

Diabetes Novo Nordisk, Roche WDF, Health Ministries, patient organizations Since 2008 Access - Donation, Capacity Building - Support & Training 6 developing countries www.novonordisk.com

The objective of the Cancer Awareness Leadership Initiative (CALI) is to raise awareness and quantify the burden of cancer in the developing world, to help encourage capacity development by bringing disparate parties together to explore ways to collaborate on cancer treatment programs. For example, Novartis and the Global Health Council (GHC) collaborated with the African Organization for Research and Treatment in Cancer (AORTIC) to sponsor a medical education module during an AORTIC conference in Dar-es-Salaam, Tanzania, in 2009. The education module, which was offered free of charge, was designed to improve the clinical skills and knowledge base of participating African oncologists.

The Changing Diabetes® in Children program is part of Novo Nordisk’s Access to Diabetes Care strategy and aims at improving availability, accessibility, affordability and quality of diabetes care for children with type 1 diabetes in least developed countries, via partnerships. It also contributes to the achievement of the UN Millennium Development Goals, especially Goal 4: Reduce child mortality and Goal 8: Develop a global partnership for development. In each country, the program works with local partners within the framework of defined national health policies, while seeking to build on the overall capacity in the field of diabetes care.

CALI also sponsored a survey of GHC members to determine the types of cancer they were addressing in developing countries, while GHC conducted a literature review of articles and papers on the cancer burden in developing countries, to help document the prevalence of cancer in developing countries. In 2010, CALI is hosting six workshops and forums on the burden of cancer. One forum will be dedicated to cervical cancer, the most common reproductive cancer in the developing world. The workshops will focus on the burden of disease, existing infrastructure, the stigma associated with cancer, screening and low-cost treatments such as acetic acid. CALI is the recipient of a grant that will continue for two more years, with an increased focus on collaboration and capacity building.

The program, which runs over a 5-year period in each country, has three overall objectives: • Improve the health and quality of life of children with type 1 diabetes; • Strengthen the capacity of the healthcare systems; • Sensitize national stakeholders to the specificities of type 1 diabetes in children. Program components include: • Improvement of existing infrastructure and supply of medical and laboratory equipment to establish centers for the treatment of children with type 1 diabetes; • Training of healthcare professionals and diabetes educators to develop diagnostic abilities and the expertise to treat children with type 1 diabetes. Development of training material specifically adapted to a developing country setting, taking into account the reality in which healthcare professionals operate; • Provision of insulin free-of-charge, and blood monitoring glucose equipment and supplies to children and adolescents enrolled in the program for a period of 5 years; • Development of diabetes education material for children and their families adapted to the local context, including education sessions and children camps to support better self-monitoring; • Implementation of a patient registry system to enable systematic data collection and patient follow up; • Insights gained through the Program will be extracted and shared to the benefit of the development of health care systems in developing countries in general. The program is currently implemented in six countries: Bangladesh, Cameroon, Democratic Republic of Congo, Guinea, Tanzania and Uganda.

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China Diabetes Education Program

Circle of Care: Mental Health in Malaysia

Diabetes Lilly, Roche Becton Dickinson BD, Project HOPE Since 1998 Capacity Building - Training, Education China www.projecthope.org

Mental health Johnson & Johnson Circle of Care Since 2004 Education Malaysia www.jnj.com

The China Diabetes Education Program (CDEP) is a Project HOPE initiative that was launched in 1998. In May 2007, corporate partners Becton Dickinson (BD), Eli Lilly & Company and Roche Diagnostics announced a two-year extension in their support for this program.

Since its inception three years ago, Circle of Care has helped more than 1,000 families in Malaysia cope with mental illness. Individuals released from mental health institutions are often unable to reintegrate into society because of stigma. Circle of Care provides job placement support programs in nine cities, while families educated about mental illness and are connected to local support groups through the Family Link program. Johnson & Johnson supports Circle of Care´s efforts to educate and support families through Family Link, assist patients in finding jobs and re-entering their communities.

The CDEP provides comprehensive diabetes training to local medical and healthcare providers – known as ‘Trained Trainers’. To date, Trained Trainers working in 800 local hospitals and community care centers have successfully trained nearly 37,000 medical professionals and educated about 170,000 diabetes patients. The program has established diabetes training centers, using modern training methods, and developed diabetes education and training materials that are supported by the Chinese Ministry of Health. The two-year extension of the program will allow CDEP to further increase public awareness of diabetes and the importance of better diabetes care. It will also provide an opportunity for CDEP to help the Chinese government in its efforts to provide better community care, with a special focus on diabetes.

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CHRONIC DISEASES – Access & Capacity Building

Glivec® International Patient Assistance Program (GIPAP™)

Hypertension Program in China

Leukemia Novartis Axios International, Max Foundation Since 2002 Access - Donation 80 developing countries www.novartis.com, www.maxaid.org

Hypertension Pfizer Shanghai Center for Disease Control and Prevention Since 2006 Capacity Building - Training, Education China www.pfizer.com

Novartis partners with physicians and international health organizations to facilitate access to its breakthrough cancer therapy Glivec® via the Glivec® International Patient Assistance Program™ (GIPAP™). This global access program provides Glivec® at no cost to patients with certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) who otherwise would not have access to treatment.

In 2006, Pfizer initiated a pilot Disease Management Program (DMaP-pilot) with the Shanghai Center for Disease Prevention and Control (CDC) to help manage and reverse hypertension and related cardiovascular risk factors, Cardiovascular disease is the leading cause of death and disease burden in urban centers in China, and the program is aligned with the Chinese government’s aims to develop the national health care system at the community level and to cope with the heavy burden of chronic diseases.

GIPAP™ was initiated in 2002, and operates in about 80 developing countries in Africa, Asia, Eastern Europe, South America and the Caribbean that have no comprehensive reimbursement system or available generics. Patients must be properly diagnosed, not covered by local reimbursement or insurance, and have no other financial resources. Since the program´s launch, Novartis has provided Glivec® at no cost through GIPAP™ to more than 35,000 patients in more than 80 countries. In 2009, Novartis provided USD 912 million worth of Glivec® to more than 33,000 patients who otherwise would not have been able to afford treatment. Unlike many donation programs, GIPAP™ is based on a ‘patientdirect’ model, providing delivery of Glivec® to patients by their treating physicians. GIPAP™ also provides patients with access to support groups, treatment and disease information, education and emotional support. GIPAP™ operates through a global network of almost 1,000 registered physicians and more than 300 qualified treatment centers, including the leading oncology treatment centers and medical opinion leaders in each country.

The DMaP-pilot phase began in July 2006 in 4 community health centers in downtown Shanghai, helping them to manage systematically more than 1,400 hypertension patients. Throughout 2007, the DMaP-pilot achieved good clinical results and cost-effectiveness. These results were confirmed by a third party evaluation. Pfizer again partnered with the Shanghai CDC for a one-year DMaP extension agreed in August 2008. This enabled the DMaP to be extended to all of Shanghai. This expansion started in September 2008, supported by significantly increased input from the local government. More than 13,000 hypertension patients were enrolled in in 49 community healthcare centers.Data for the 1-year evaluation of the DMaP-extension was collected at the end of 2009 and a final evaluation report is expected in March, 2010.

Novartis´ main partners in GIPAP™ are The Max Foundation (TMF) and Axios International. Novartis is responsible for program development, drug donation and provision of medicine to treatment centers. TMF, a non-profit organization, is responsible for verifying and screening patients for eligibility, case management and providing emotional support and education in about 35 developing countries. In 45 other countries, many in Africa, Axios implements, coordinates and supervises the GIPAP™ process by working with institutions on enrollment of patients and handling logistics of product importation and delivery. The impact has been especially significant where local health authorities and civil societies are working together to improve facilities and educate patients and their families, thereby providing resources to offer integrated patient care.

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CHRONIC DISEASES – Access & Capacity Building

IDF BRIDGES Program

India Diabetes Educator Project

Diabetes Lilly International Diabetes Federation Since 2007 Education, R&D Worldwide www.idf.org

Diabetes Bayer HealthCare, Lilly Becton Dickinson BD, Project HOPE Since 2007 Capacity Building - Training India www.projecthope.org

Eli Lilly and Company has agreed to support the International Diabetes Federation´s program ‘Bringing Research In Diabetes to Global Environments and Systems’ (BRIDGES) with USD 10 million funding over seven years. The BRIDGES grant research program will provide the opportunity to ‘translate’ lessons learned from clinical research to those who can benefit most: people with diabetes. Lessons learned through the supported research projects provide the opportunity to steer, for example, the development of treatment routines and effective behavioral interventions, leading to relevant, evidence-based health care and improved outcomes for people with diabetes.

In November 2007, Bayer HealthCare, Becton Dickinson (BD) and Eli Lilly and Company agreed to support Project HOPE´s ‘India Diabetes Educator Project’. This four-year, multi-million dollar collaborative program aims to help health care workers in India reduce morbidity and mortality related to diabetes and to combat the rapidly growing threat of diabetes there. With an estimated 40.9 million people currently living with the condition, India leads the world in the prevalence of diabetes.

Diabetes continues to be a growing pandemic and is the world´s fourth leading cause of death by disease. Diabetes affects more than 240 million people worldwide and is expected to affect 380 million by 2025. Over the last several decades, a revolution in science has contributed to a greater understanding of the disease and the development of new cutting-edge therapies. Still, diabetes prevalence, morbidity and mortality have continued to grow rapidly. A steering committee appointed by IDF will determine the amounts and types of grant awards. Projects designed to test pharmaceuticals or disease mechanisms are not eligible for funding through this program.

The India Diabetes Educator Project offers a comprehensive and sustainable approach that will provide diabetes training to more than 5,000 health care professionals, including nurses, dieticians and nutritionists in India. The project includes mentoring support for newly trained Diabetes Educators and also addresses the role of the educator in empowering the patient to take responsibility for daily self-care and to help prevent the onset of diabetes among those at risk. The training will be based on the International Curriculum for Diabetes Health Professional Education developed by the International Federation Consultative Section on Diabetes Education (IDF-DECS), adapted for use in India. Implementation of this curriculum will help establish a consistent and standardized protocol for diabetes treatment throughout the country, with the goal of improving patient quality of life and increasing positive self-care behaviors and control of diabetes.

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CHRONIC DISEASES – Access & Capacity Building

Novo Nordisk: Differential Pricing on Insulin

Novo Nordisk: Haemophilia Foundation

Diabetes Novo Nordisk Health Ministries Since 2001 Access - Pricing 36 developing countries www.novonordisk.com

Haemophilia Novo Nordisk Health Ministries, health care professionals & patient organizations Since 2005 Capacity Building - Support & Training, Education 25 developing countries www.nnhf.org

Among the targets for UN Millennium Development Goal 8 is a call for partnerships with pharmaceutical companies to provide access to affordable essential drugs in developing countries. Since 2001, Novo Nordisk has offered human insulin to the public health systems in Least Developed Countries (LDCs) at prices which do not to exceed 20% of the average price in Europe, Japan and North America. In 2009, Novo Nordisk offered this pricing scheme to all 49 LDCs, of which 36 used it to buy insulin at or below this price, compared to 32 in 2008.

The Novo Nordisk Haemophilia Foundation (NNHF) was created in 2005 to address the significant need to improve haemophilia treatment in developing countries, where it is not a healthcare priority and many patients go undiagnosed or are inadequately treated. Consequently, life expectancy for people with haemophilia is low and treatment with clotting factors is suboptimal. NNHF is an independent trust, located in Zurich, Switzerland, and funds programs to improve hemophilia care, treatment and awareness in the developing world.

There are 13 LDC countries in which Novo Nordisk is not selling insulin at all. In several cases, the government has not responded to the offer, either because there are no private wholesalers or other partners with which to work, or because wars or political unrest have made it impossible to do business.

NNHF programs include awards, fellowships and development projects for patient education, doctor, nurse and laboratory staff training, as well as setting up diagnostic facilities and creating patient registries. NNHF works in developing or European transition countries where some haemophilia treatment is already present and can form the basis for sustainable projects.

Unfortunately, there is no way to guarantee that the price at which Novo Nordisk sells the insulin will be reflected in the final price on the pharmacist´s shelf. Pilot projects were launched in 2008 in five countries – Cameroon, the Democratic Republic of Congo, GuineaConakry, Mozambique and Tanzania – to investigate barriers to purchasing insulin at the preferential price. Novo Nordisk is working with Ministries of Health and business partners in these countries to influence the distribution process so that the preferential price benefits people with diabetes. Measures include reducing insulin prices on the private market, initiating discussions with local agents to reduce mark-ups, and working with governments to centralize insulin procurement. Based on the outcome of the pilots, these measures will be applied in other LDC countries.

NNHF cooperates with partners in these countries, such as health ministries and other healthcare authorities or institutions, nongovernmental and patient organisations, healthcare professionals and other foundations. Typical examples of NNHF programmes funding are: • Awareness creation, Awards; • Capacity building, Fellowships; • Diagnosis & Registries. NNHF cooperates with partners in these countries, such as health ministries and authorities, non-governmental and patient organizations, health care professionals, other foundations and trusts.

A Novo Nordisk employee working as a volunteer in a clinic in Malaysia. (Novo Nordisk)

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Novo Nordisk: World Partner Project

Piramal: HelpyourbodyTM Chronic Disease Campaign

Diabetes Novo Nordisk Health Ministries & local NGOs Since 2001 Capacity Building - Training, Education 7 developing countries www.novonordisk.com

Arthritis, cardiac disease, diabetes, hypertension Piramal Healthcare WHO, Indian Ministry of Health & other partners Since 2008 Capacity Building - Training, Education India www.piramalhealthcare.com, www.helpyourbody.com

The diabetes pandemic will undoubtedly affect developing countries’ ability to grow and develop. The World Partner Project (WPP) was launched in 2001 to establish a foundation on which developing countries can build their own diabetes healthcare strategies and ultimately improve access to proper care. The WPP works with local partners, usually health ministries and/or patient organizations, and is funded by a grant from Novo Nordisk.

India is the chronic disease capital of the world. The number of diabetics in the country is expected to rise from 40 million today to 70 million by 2025. In the same period, hypertensive cases are expected to rise from 118 million to 213.5 million, and cases of osteoarthritis from 15 million to 60 million. Genetic causes, obesity, stress, inappropriate dietary habits and a lack of exercise predispose India to such chronic ailments in a relatively young population. HelpyourbodyTM is an Indian nationwide campaign launched by the Piramal Group to help reduce the projected increases in the incidence of chronic diseases, notably type 2 diabetes, hypertension, cardiac problems and arthritis, by:

WPP and its partners have driven 31 projects in seven focus countries (Bangladesh, China, El Salvador, India, Malaysia, Tanzania and Zambia), organizing clinics, providing distance learning for healthcare professionals, educating people with diabetes and raising diabetes awareness. The countries were selected by WPP after analysis of the diabetes care situation in each country, diabetes awareness and knowledge, and diabetes care infrastructure. All projects must be sustainable: they must be affordable and practical enough for longterm operation.

• Highlighting the risk of chronic diseases, especially to lower income groups; • Educating about disease prevention and management; • Helping to sustain a healthy lifestyle: regular check-ups, nutrition and exercise at health camps; • Building activist communities. Experts in cardiology, endocrinology and orthopedics have developed India-specific guidelines for better management of various chronic disorders. Some 4,000 HelpyourbodyTM activists have enrolled 20,000 doctors, who are conducting detection camps across India to disseminate knowledge and induce action from the recipient population. Ninety diagnostic centers across 47 Indian cities are providing specialized tests for chronic illnesses and limited free testing. In November 2009, HelpyourbodyTM launched a Mumbai initiative, to enroll 3,500 doctors across Maharashtra and Tamil Nadu. Piramal Chairman Mr. Ajay G. Piramal said: “If existing interventions are used together as part of a comprehensive integrated approach by the government, the private sector and the civil society, the goal of preventing chronic diseases can be achieved.” HelpyourbodyTM has also partnered with the Self Employed Women´s Association (SEWA), whose health workers have been trained by the HelpyourbodyTM team to create awareness and prompt the target population to pursue medical intervention so as to manage their lifestyle disorders better. A pilot is being conducted by the health workers across Ahmedabad district, targeting 1,000,000 people. The Associated Chamber of Commerce and Industry of India (ASSOCHAM) is also a partner in the HelpyourbodyTM campaign, which is also supported by the WHO and Indian Government.

Display of prevention messages developed by medical students. (Piramal Healthcare)

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Pfizer Global Health Partnerships

Sanofi-aventis: Diabetes Prevention

Oncology, tobacco control Pfizer Various partners Since 2006 Capacity Building - Support & Training, Education 30 developing countries www.pfizerglobalhealth.com

Diabetes sanofi-aventis Handicap International, Santé Diabète Mali Since 2006 Capacity Building - Support 8 developing countries www.sanofi-aventis.com

Pfizer has a responsibility to direct its resources and expertise to address the world’s most enduring health challenges. Cancer is one of these challenges and Pfizer recognizes that only by working together with those who share a vision of a healthier world can we make a significant impact toward eradicating this disease that has outlived too many generations.

In 2006, sanofi-aventis launched pilot programs to help improve diabetes disease management in developing countries, in conjunction with the NGO Handicap International, Santé Diabète Mali and other local NGOs in Africa, Asia and Latin America. Several projects were set up in 2007 in Burundi, India, Kenya, Madagascar, Nicaragua, Philippines and Thailand. The program aims to help local health care systems to manage the disease better, prevent the onset of complications and so avoid the subsequent need for surgical interventions such as amputation.

Pfizer’s Global Health Partnerships (GHP) Program is one approach it is taking to tackle the global cancer epidemic. Through GHP, Pfizer is investing USD 47 million over four years (2007-2010) in the growth of 32 promising cancer- and tobacco-control organizations united by the shared mission of accelerating the pace of progress in the fight against cancer. In 47 countries, 30 of which are low or middle income, our partners are leaders in their regions, employing new approaches to reducing cancer or tobacco use. Together, our partners explore promising practices and innovations to deliver on the promise of a healthier world for generations to come.

Since the beginning of the program, Handicap International has trained 600 health professionals, who in turn have treated 3,000 patients.

One of the most important goals of GHP is to foster a culture of results-oriented discovery and innovation. While each partner is encouraged to innovate and test new models, they also receive critical assistance from the Johns Hopkins Bloomberg School of Public Health to improve the implementation, measurement, and evaluation of their work. The Global Health Partnerships involves: • Building the evidence for enhancing care; • Screening to save lives; • Navigating patients through complicated systems of care; • Building awareness about the harm of tobacco use; • Developing tobacco control capacity; • Protecting nonsmokers from secondhand smoke; • Helping smokers quit.

Education program about diabetes in Mali. (Gil Corre, sanofi-aventis)

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Treating diabetes in the Philippines. (Handicap International, sanofi-aventis)

CHRONIC DISEASES – Access & Capacity Building

Sanofi-aventis: Impact Epilepsy Program for Developing Countries

Sanofi-aventis: Mental Health Disorders (Schizophrenia)

Epilepsy sanofi-aventis Santé Sud, IENT, KAWE, IFMT Since 2004 Access - Pricing, Capacity Building - Training Cambodia, Kenya, Laos, Madagascar, Mali www.sanofi-aventis.com

Schizophrenia sanofi-aventis Health Ministries & universities Since 2008 Access - Pricing Mauritania, Morocco, Vietnam www.sanofi-aventis.com

Sanofi-aventis, one of the major actors in the fight against epilepsy in the developed world, is also committed to the treatment of epilepsy worldwide using its two major treatments, Gardenal® and, more importantly, Depakine® / valproate Winthrop within a tiered pricing policy.

Sanofi-aventis, one of the major actors in the central nervous system therapeutic field in the developed world, is developing new programs to help provide better care for schizophrenia - one of the most severe mental disorders – in developing countries. There, these psychotic patients not only suffer from the disabling and potentially life-threatening symptoms of their illness, but they are also victims of ignorance, discrimination and social stigma. Sanofi-aventis, which has a broad portfolio of anti-psychotics medicines, is committed to help treat this disease with its Largactil®, Nozinan®, Piportil L4® and Solian® products.

In Mali, sanofi-aventis is working with Santé Sud and the Association des Médecins de Campagne (AMC) which have created the Réseau Action Recherche contre l´Epilepsie (RARE). More than 2,500 patients have been diagnosed and treated, thanks to these NGOs´ highly motivated general practioners whose close relation with patients is a key success factor, helping to destigmatise this disease. This program started at the end of 2007 in Madagascar with the training of 10 GPs and the creation of a specific network, the REM (Réseau Epilepsie Madagascar). Five further programs are underway: • Kenya (with the Kenya Association for the Welfare of People with Epilepsy): in 2009, 295 health care professionals have been trained thanks to the multi-partnership developed by the KAWE and 11,000 patients treated;

Two pilot programs have been set up in Mauritania and Morocco in cooperation with the national health ministries and universities, combining information, education and communication, training and medicines at preferential prices. The program has also been endorsed by the World Association for Social Psychiatry (WASP). The first stage of a similar program has been ongoing in Vietnam since the end of 2008.

• Ghana, with the International League Against Epilepsy that trained 174 health professionals; • Cameroon where an agreement has been signed mid 2009 with the Ministry of Health to develop a new program; • Cambodia, where support has been provided to create the first association in the country to combat epilepsy. Five training sessions have been already developed and 108 health professionals from 10 provinces have been trained; • Laos with the IFMT (French Institute of Tropical Medicine).

Child under treatment for cancer in Honduras. (Gil Corre, sanofi-aventis)

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Sanofi-aventis: My Child Matters

Staying Away from Tobacco for a Healthy Life

Childhood cancers sanofi-aventis International Union Against Cancer UICC Since 2004 Capacity Building - Training, Education 21 developing countries www.sanofi-aventis.com

Tobacco control Pfizer Beijing University Medical School Since 2006 Capacity Building - Training, Education China www.pfizer.com

In 2004, sanofi-aventis and the International Union Against Cancer (UICC) launched a mobilization and awareness program called ‘My Child Matters’, to fight against childhood cancers in emerging countries. The objective is to encourage institutions (hospitals, NGOs, etc.) to develop pragmatic approaches to improve awareness, early diagnosis, access to care and treatment, pain control and better management of the social and cultural aspects of the disease for both children and families.

China, with approximately 350 million smokers, produces and consumes more cigarettes than any other country in the world. Pfizer China anticipated its parent company´s global tobacco control initiative (see Global Health Partnerships) by supporting the Chinese government´s efforts to promote smoking cessation through a series of community awareness and education programs, notably a threeyear smoking cessation initiative by the Beijing University Medical School called ‘Staying Away from Tobacco for a Healthy Life’.

This program has already been launched in 16 developing countries – Bangladesh, Bolivia, Egypt, Honduras, Indonesia, Kenya, Mali, Morocco, Peru, Philippines, Rumania, Senegal, Tanzania, Ukraine, Venezuela and Vietnam – via 26 pediatric oncology projects. In 2008, 8 new childhood cancer projects have been launched in Burkina Faso, Colombia, Côte d’Ivoire, Pakistan and Paraguay.

In 2006, Pfizer organized an anti-smoking poster design competition with the Medical School of Beijing University, with an evaluation panel of officials from the Ministry of Health and China´s Center for Disease Control, as well as faculty members. Winning designs were distributed to 4,000 health care professionals in the University´s affiliated hospitals. Pfizer also distributed 10,000 copies of the Tobacco Control Manual to university faculties and health professionals within the University.

In 2008, 12,875 children benefited from this program and 2,849 health professional were trained.

In 2007, Pfizer and Beijing University hosted a four day Tobacco Control Summer Camp for students from 16 leading medical schools nationwide in China. In 2008, a smoke free hospital initiative was launched in 20 hospitals in Beijing and Shanghai.

Diabetes screening camps help raise awareness and detect many cases of diabetes. This one took place in Kenya, arranged by WDF partner Diabetes Management & Information Centre. (Novo Nordisk)

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The World Diabetes Foundation Diabetes Novo Nordisk WHO & Health Ministries Since 2002 Capacity Building - Support & Training 83 developing countries www.worlddiabetesfoundation.org

The World Diabetes Foundation (WDF) was established by Novo Nordisk in 2002 through a grant of up to DKK 650 million, to be spent over a 10-year period. In March 2008, the shareholders approved an additional endowment of up to DKK 575 million, for a total of up to DKK 1.2 billion (USD 227 million) in the period 20012017. The WDF has grown into a leading international funding agency, devoted solely to funding projects for diabetes care and prevention in the developing world. To date, WDF has funded 219 projects in 90 countries, focusing on diabetes awareness, education and capacity-building. At present, 156 projects are ongoing. Diabetes screening, awareness camps and clinics supported by the WDF bring diagnostic equipment and trained staff to detect diabetes and easily preventable and treatable complications, such as diabetic foot problems and eye complications such as retinopathy, cataracts and glaucoma that can lead to unnecessary blindness. To date, at least 4,320,950 people have been screened for diabetes in 7,454 screening camps. More than 258,000 (documented cases) people have been treated at the 1,848 established clinics and microclinics funded by the Foundation. More than 47,700 cases of diabetic retinopathy have been detected. Training health care professionals in proper screening and care of diabetic foot and eye conditions is essential for preventing avoidable amputations and blindness. To date, the WDF has supported the training of 18,782 doctors, 15,527 nurses and 37,269 paramedics.

Patients with diabetes in Malaysia. (Novo Nordisk)

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ADDITIONAL HEALTH INITIATIVES

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In 2008, the World Health Organization called for a revitalization of primary health care, a people-centered approach, as an efficient and cost-effective way to strengthening health systems in vulnerable societies. Many programs implemented by the research-based pharmaceutical industry are dedicated to improving health in developing countries through better primary health care, health promotion and prevention, community engagement and empowerment, rather than tackling specific diseases. These initiatives aim to improve general health practices, make them more sustainable and therefore help build health independence. Capacity building programs aim to strengthen the ability to deliver effective health care, primarily by training local doctors, nurses, midwives or other health workers and by providing them

with distance learning tools to help them update their professional knowledge. Some capacity building programs also providing material support such as laboratory equipment or renovation of health center buildings. Other programs are designed to improve the efficiency and integrity of supply chains for medicines and other medical products, including helping to fight against counterfeits. Many programs also aim to educate patients or the general population about various health threats. Some programs provide health care and other forms of support to abandoned or orphaned children, while others are aimed at helping patients and former patients to re-enter their communities.

Developing World Health Partnerships Directory ÂŠ IFPMA 2010 â&#x20AC;&#x201C; www.ifpma.org/healthpartnerships

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Arogya Parivar Program – A Rural Health Initiative

AstraZeneca Product Donations

Multiple diseases Novartis Rural Connect Since 2006 Access - Pricing, Education India www.novartis.com

Multiple diseases AstraZeneca Since 2000 Access - Donation Developing countries www.astrazeneca.com

In 2006, Novartis’ Consumer Health and Sandoz divisions launched an initiative in India to address the neglected health needs of rural populations. The Arogya Parivar (healthy family) program started with pilot sites in the states of Uttar Pradesh and Maharashtra. It combines healthcare education with access to affordable medicines through local pharmacies. The initiative aims to build a sustainable business that improves access to healthcare among the underserved millions in rural India by providing locally available and affordable health solutions. This ‘social business’ approach represents a mix of corporate citizenship and creative entrepreneurship.

AstraZeneca´s product donation and patient assistance programs make its medicines available to those who cannot afford them, either free-of-charge or at reduced prices. In 2009, AstraZeneca donated a total of USD 786 million in product. The total spend on charitable contributions was USD 96 million (this includes the figure for ‘employee commitment’ which is defined as ‘total company spend to support employee working days committed to company endorsed community activities’. The Employee Commitment figure does not represent a value assigned to the employee time committed).

In the pilot phase, products focused on tuberculosis, other respiratory infections, coughs, colds, allergies, skin and genital infections, malnutrition in mothers and children, diabetes, intestinal worms and digestive problems - all important health challenges in these communities. The intent is to collaborate with third parties to broaden the product portfolio to include medicines for additional therapeutic areas and items such as anti-malarial bed-nets. To be included, products need to be easy-to-use, relevant and have instructions in local languages. Packages are reduced in size so that weekly individual treatment costs are kept below USD 1.25. As of end of 2009, the portfolio included 56 products addressing 11 disease areas. Because transport and communication in rural India are difficult, a decentralized model was adopted, organizing the 500 health advisors and supervisors in autonomous ‘cells’. They are not Novartis employees, but are trained to ethical standards set by Novartis. The initial phase of Arogya Parivar l addressed 120 of India’s more than 600 districts, selected using criteria ranging from population and purchasing power to transportation infrastructure and density of private doctors. By the end of 2009, Arogya Parivar had increased the number of cells to cover a population of around 42 million villagers (28,000 villages) in 13 states and 190 districts. The system includes 22,00 rural physicians and 18,000 pharmacies linked to cities for their supplies. Arogya Parivar health advisors speak to villagers about diseases and help them recognize symptoms. Periodic health camps bring in doctors to do examinations and make referrals to a treating doctor. A single health camp can attract from 200 to 2,000 people.

Women field workers in rural India. (Novartis)

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Boehringer Ingelheim Cares Foundation

Boehringer Ingelheim : Strengthening Healthcare Capacity

Multiple diseases Boehringer Ingelheim Since 2002 Access - Donation Over 100 developing countries www.boehringer-ingelheim.com

Multiple diseases Boehringer Ingelheim Botswana & Papua New Guinea Ministries of Health & other partners Since 2005 Capacity Building - Support & Training Botswana, South Africa, Uganda, Venezuela http://www.boehringeringelheim.com/wecare/en/subpages/our_worldwide.asp

The Boehringer Ingelheim Cares Foundation in the USA provides product donations to assist patients in need worldwide through its partnerships with AmeriCares, Catholic Medical Mission Board, Direct Relief International, MAP International and National Children’s Cancer Society. These donations assist in times of disaster, daily struggle or civil conflict around the world and across the USA. The BICF is also a member of the Partnership for Quality Medical Donations, a partnership of non-governmental organizations and pharmaceutical and medical supply manufacturers committed to advancing effective drug and medical supply donation practices.

For years, Boehringer Ingelheim has been involved in health educational activities and training of health personnel in the field of HIV/AIDS and other diseases in various parts of the world. Opened in 2005, the Boehringer Ingelheim Training and Facilitation Unit in Gaborone, Botswana trains general practitioners, physicians, occupational health specialists, nurses, pharmacists, pharmacy technicians, medical store managers and healthcare managers. In 2006, the first pharmacy student from Botswana started at Rhodes University, Grahamstown, South Africa under a Botswana government program funded by Boehringer Ingelheim. Beneficiaries are required to work in the public sector after completing their studies. Boehringer Ingelheim also helped the Government of Botswana to build an Infectious Disease Care Clinic (IDCC) at Gumare which opened in 2007. The Boehringer Ingelheim Lung Institute at the University of Cape Town has been set up to support clinical trials in infectious and respiratory diseases. Through its Student Education Program with the University of Cape Town, South Africa, Boehringer Ingelheim provides full financial support for medical students from disadvantaged backgrounds. In Uganda, the company helps the Community Health and Information Network (CHAIN) in HIV/AIDS prevention, and care and treatment seminars and training. This has helped to strengthen the advocacy strategies at national and community level. The aim is to broaden CHAIN´s activities among vulnerable populations. In Venezuela, the company provides training to the doctors at the respiratory care centers in Chacao neighborhood and the Pérez de León Hospital in Caracas. The hospital also receives free medicines and equipment.

Capacity building programs aim to strengthen the ability to deliver effective health care by training health workers, providing material support and improving the efficiency of supply chains for medicines. (Keri Oberg, Boehringer Ingelheim)

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Bristol-Myers Squibb Medical Product Donations

Ghana Surgical Skills Training Center

Multiple diseases Bristol-Myers Squibb 9 specialized NGO partners Since ? Access - Donation Developing countries www.bms.com/foundation/reducing_health_disparities/donations/

Multiple diseases Johnson & Johnson International Aid, West African College of Surgeons Since 2005 Capacity Building - Training Ghana www.jnj.com

Bristol-Myers Squibb has a long history of partnering with non-profit organizations, donating medical products to support long term health care programs in developing countries as well as addressing immediate needs to provide emergency disaster relief.

Trauma is a major health care problem and one of the leading causes of death in West Africa. In 2005, International Aid, Johnson & Johnson and the West African College of Surgeons opened the Ghana Surgical Skills Training Center at Korle bu Hospital in Accra, and conducted the first Advanced Trauma Operative Management (ATOM) course in West Africa. Since then, the center has hundreds of surgeons in the region. The center is now offering 16 different courses and engaging with several prestigious academic institutions.

During the past six years, BMS has donated USD 256 million of medical products, valued at wholesale, to support programs throughout the world. In 2009, BMS product donations totaled over USD 13.2 million. BMS donations have reached more than 125 countries. The company´s efforts usually are undertaken in collaboration with national ministries of health and local non-profit community organizations. The program supports community-based outreach programs aimed at enhancing health care access and prevention. Most importantly, health care product donations address needs at the community level in resource-limited communities, with limited access to comprehensive health care. The BMS donation program also helps to transport medicine to remote locations and to administer medicines appropriately.

ATOM is guided by three key objectives: 1) improving the level of care for severely injured trauma patients in West Africa, 2) forging professional exchanges between trauma surgeons in the U.S. and surgeons in West Africa, and 3) training surgeons in West Africa on the techniques of advance trauma operative management. ATOM-certified surgeons are using their newly acquired skills to transform the way patients receive care in Ghana and West Africa, saving more lives and improving the health of the patients. This model program has recently been opened to surgeons from East Africa.

There are two main areas where the company´s product donations are used: Health Care Infrastructure Support: With a number of international non-profit organizations, this program supports a wide range of community-based health care infrastructure initiatives in regions around the world; Disaster Relief: This effort is focused solely on supplying needed medicines following major disasters, either natural or man-made (see Emergency Relief Efforts).

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GlaxoSmithKline & Leonard Cheshire Disability in Sri Lanka

GlaxoSmithKline: Nurse Training in Tamil Nadu

Disability GlaxoSmithKline Leonard Cheshire Disability Since 2004 Capacity Building - Support Sri-Lanka www.gsk.com

Nurse training GlaxoSmithKline Direct Relief International, Sri Ramakrishna Math Since 2007 Capacity Building - Training India www.gsk.com

GlaxoSmithKline supports Leonard Cheshire Disability (LCD) in Galle, southern Sri Lanka. Following the devastating tsunami in 2004, LCD set up the Disability Resource Centre, the first of its kind in the area to support disabled peoples access to health and rehabilitation services, inclusive education and livelihood opportunities.

In the aftermath of the devastating Indian Ocean tsunami of 2004, GSK is providing USD 133,509 of funding from June 2007 to June 2009 to help Sri Ramakrishna Math, a local NGO in the Chennai region of Tamil Nadu, to enroll an additional 420 local girls in its Nursing Training Course. Sri Ramakrishna Math Chennai, in partnership with Direct Relief International, had already conducted extensive relief work in the area immediately after the tsunami, providing medicines, food, shelter and clothing.

Part of the project focuses on increasing young disabled people´s involvement in the community, mobilizing them to campaign for a better future. Achieved through self-help groups, it will allow them to advocate for their own rights. This will be complimented with a push to help improve partnerships with local governments and non-governmental organizations (NGO), ensuring the long-term sustainability of disabled facilities. Help from GSK will enable Leonard Cheshire Disability to support 500 people with disabilities access crucial faculties and services. It will also increase awareness of these services to 1,000 family members of people with disabilities. It is further hoped that 200 young people with disabilities will take part in their ‘Young Voices Programs’, a global initiative campaigning for the implementation of the United Nations Convention on the Rights of People with Disabilities.

The impact of the tsunami in the coastal regions was significant, with an estimated 500 fatalities and 150,000 people displaced from their homes, which created a huge extra demand for trained health professionals. Sri Ramakrishna Math Chennai developed its Nursing Assistant Training Course to help address staffing shortages and strengthen the local healthcare infrastructure as part of a long-term relief and rehabilitation strategy. The girls are selected from very poor, outlying agricultural and fishing villages. Many of them have completed their secondary schooling but, due to family financial restrictions, are unable to continue further. In most cases, they are the first in their families to receive higher education and the nurse training gives them hope of employment outside the depressed traditional fishing and agricultural industries. The success of the project is reflected in the high demand for their skills on completion of their training. The newly-qualified nurses have been quickly absorbed into nearby hospitals, where they are able to earn a decent salary and receive free room and board, thus raising their own economic status.

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GlaxoSmithKline: Reinvestment in LDC Communities

GlaxoSmithKline: Saloum Islands Health Project, Senegal

Healthcare infrastructure GlaxoSmithKline WHO, UNFPA & other partners Since 2009 Capacity Building - Support & Training Cambodia, Democratic Republic of Congo, Ethiopia, Myanmar, Rwanda, Sudan www.gsk.com

Multiple Diseases GlaxoSmithKline Senegal Ministry of Health Since 2007 Capacity Building - Support & Training Senegal www.gsk.com

GlaxoSmithKline has committed to reinvest 20% of its profits from sales of its medicines in Least Developed Countries (LDCs) back into projects that address priority healthcare challenges, provide support to governments to remove barriers that stop patients accessing quality healthcare, and strengthen basic healthcare infrastructure.

The Saloum Islands, which have a population of 30,944 inhabitants spread across 16 islands, have the worst health indicators in Senegal and have also experienced severe cholera epidemics. The situation is made worse by conditions of poor hygiene and low health coverage due mainly to the remoteness of the islands.

In 2009, GSK selected six LDCs for reinvestment: Cambodia, Democratic Republic of Congo, Ethiopia, Myanmar, Rwanda and Sudan. The initial activities are targeted primarily on improving maternal, newborn and child health – high priorities for the ministries of health and essential for achieving the Millennium Development Goals (MDGs), specifically goal four (reduce child mortality) and goal five (improve maternal health).

The Saloum Islands Health Care partnership Project between GlaxoSmithKline and the Ministry of Health and Medical Prevention of Senegal was started in July 2007 for an initial three year period. GSK has committed GBP 500,000 over four years, 2007-11.

In total, GSK reinvested GBP 512,000 in 2009 and allocated another GBP 300,000 to programs that are yet to start. Activities include expanding a network of business format franchise nurse-run clinics to improve access to quality basic healthcare and essential medicines in Rwanda, water sanitation programs in the schools of suburban areas in Myanmar and a one year program in 2010 to provide motorcycle ambulances for pregnant women in Sudan.

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The aim of the project is to support and strengthen the primary health care delivery system at district level, to increase access to quality healthcare in the rural communities of Dionewar, Djirnda and Bassoul. Interventions and activities address the specific healthcare needs and priorities as identified by the district health services, in consultation with the communities. These include improving sanitation and water supply on the islands, training healthcare workers, deployment of additional staff (e.g. midwives), training of volunteer sanitation and hygiene officers, setting up health committees, installation of solar panels to supply electricity for clinics, upgrading of health huts, procurement of equipment and medicines and purchase of emergency ambulance boats. Two years into the project, sanitation coverage has increased from 32% to 80%.

ADDITIONAL HEALTH INITIATIVES – Access & Capacity Building

Global Pharma Health Fund

Health Training at Egypt´s National Training Institute

Multiple diseases Merck KGaA Global Pharma Health Fund & multiple partners in recipient countries Since 1985 Capacity Building - Support 65 developing countries www.gphf.org

Multiple diseases Pfizer Egypt Ministry of Health, Project HOPE Since 2006 Capacity Building - Training Egypt www.pfizer.com

The Global Pharma Health Fund e.V. (GPHF) is a charitable organization initiated and funded exclusively by donations from Merck KGaA, Darmstadt Germany. In 2007, it took over the work of the former German Pharma Health Fund, which was set up in 1985. The organization aims to improve health care in the context of development assistance, in particular the use of the GPHF-Minilab® in the fight against counterfeit drugs. GPHF-Minilab® is a mobile mini-laboratory for rapid drug quality verification and counterfeit medicines detection protecting the health of millions of people anywhere in developing countries. It allows quick, reliable testing of more than 52 standard medicines, showing whether or not the right quantity of active ingredient is present. They have been selected on the basis of prevailing prescription practices, public health interest and existing counterfeit case reports, the current short list consisting of common antimicrobials, antihelminthics, antiretrovirals, antimalarials, antituberculosis and some other medicines. The GPHF-Minilab® is specifically designed for use in developing countries which are heavily affected by counterfeit medicines and lack facilities for effective medicine testing. To date, more than 350 Minilabs have been supplied to health facilities in more than 70 countries already mostly in Africa and Asia.

Pfizer works with the Egyptian Ministry of Health and Project HOPE to equip Egypt´s National Training Institute (NTI) to provide state-ofthe-art training for physicians, nurses and health professionals in Egypt and the Middle East in Infection Control, Family Medicine, Ophthalmology, Urology, General Surgery, Research Methodology, and Healthcare Management. Pfizer also helped upgrade laboratories and training equipment. Nearly 15,000 physicians have been trained through 220 training courses and 21 symposia. Project HOPE has asked Pfizer to help extend the project for an extra year, to expand the current Emergency Medical Services modules (Basic Life Support and Advanced Cardiac Life Support), to cover Emergency Medical training, including Mass Casualty management and Pediatric Emergency Services. As Project HOPE supported the NTI´s accreditation by the American Heart Association, Pfizer will support additional accreditations related to these new courses. Pfizer will also support the development of distance learning options for new and existing courses. Pfizer will also help introduce leadership and management training in the NTI training curriculum. In 2007, NTI established some revenue generating capacity but these efforts need to be expanded and so Pfizer will help to develop a sustainability strategy and plan for the NTI.

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Healthy Communities, Healthy Ecosystems

Initiative Accès: Access to Primary Health Care in Mali

Multiple diseases Johnson & Johnson WWF & other partners Since 2003 Education Democratic Republic of Congo, Kenya, Nepal www.jnj.com, www.wwf.org

Multiple diseases Novartis Mali Ministry of Health, Mali Ministry of Social Development Since 2001 Capacity Building - Support & Training Mali www.novartisfoundation.org

Since 2003, J&J has supported the innovative ‘Healthy Communities, Healthy Ecosystems’ projects run by the World Wide Fund for Nature (WWF) in East Africa, the Congo Basin and the Eastern Himalayas. Over the past year in the Congo, the WWF has conducted sex education and HIV/AIDS training in eight villages, established five wildlife management committees as well as two primary schools reaching 400 students. A Congo community health center also was renovated and restocked. In Nepal, improved cooking stoves have been installed to reduce pressure on forests and improve community health. J&J funding also has assisted in protecting freshwater streams from degradation in Khata, Nepal.

Since 2001, the Novartis Foundation for Sustainable Development partners with the Ministries of Health and Social Development to improve the access to primary health care services in rural areas of Mali. Poor rural populations in Mali are faced with multiple obstacles when seeking healthcare such as mobilizing resources within their family and community to be able to overcome the great distance to the nearest health center.

Recent activities in Kenya include building a dispensary clinic for target communities, provision of safe drinking water and family planning education by newly trained health care workers from the Ministry of Health and Family Health International. Mobile clinics reach villages that have no access to quality health care, and people are receiving prenatal and postnatal care, immunizations, nutritional counseling and education about environmental health and conservation efforts.

To test a new approach, the Novartis Foundation has contributed to the establishment of a health insurance scheme in the Municipality of Cinzana of the Ségou region (the country’s largest rural community). From the onset, the range of offered services included quality health services (preventive and curative) as well as geographical accessibility to increase the attractiveness of enrollment. This pilot project is today regarded as a reference for the whole country of Mali, because the Cinzana health insurance scheme is the largest rural insurer in the Ségou region. Since 2007, the foundation, in cooperation with the regional authorities for health and social development, has expanded its activities to 12 health zones in the region of Ségou, covering 170,000 people in 210 villages. The main components of the Initiative consist of improving the quality of care, strengthening the organization and management of the health centers and enhancing the accessibility of services in the villages through health insurance schemes. Furthermore, the project further improves the affordability of health services by providing access to micro-credits for women and by supporting incomegenerating activities such as jatropha, poultry and milk production.

In addition to fighting counterfeits, JPMA helps address other issues related to the quality of pharmaceuticals, including unregistered products, improperly labeled products and substandard registered products. (JPMA)

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Johnson & Johnson Burn Treatment Center (JJBTC) in Soweto

JPMA: Anti-Counterfeiting Program in Cambodia

Multiple diseases Johnson & Johnson Chris Hani Baragwanath Hospital Since 1990 Capacity Building - Support & Training South Africa www.jnjsouthafrica.co.za/co_social.asp, www.chrishanibaragwanathhospital.co.za

Multiple diseases JPMA Cambodia Ministry of Health, Kanazawa University Since 2006 Capacity Building - Support & Training Cambodia www.jpma.or.jp/english

In 1990, the company built the Johnson & Johnson Burn Treatment Centre at the Chris Hani Baragwanath Hospital in Soweto, South Africa. The JJBTC has 24 beds for adults and 26 beds for children, an operating room, and multi-disciplinary facilities and treats about 1,500 people a year. This state-of-the-art unit treats more than 1,500 patients annually for serious and complicated burns, and has succeeded in reducing the mortality rate among critically ill patients. J&J continues to support the facility with management support, essential equipment, quality products, and education for nursing and medical personnel. Less visible, but of equal importance, are the investments and expertise provided at the community level with the establishment of clinics and training of caregivers.

The Japan Pharmaceutical Manufacturers Association (JPMA), Kanazawa University and the Cambodian Ministry of Health started a joint project to combat counterfeit medicines in Cambodia in 2006. Surveys conducted from 2006 to 2010 have detected counterfeit drugs sold without packaging and substandard drugs, mainly from local manufacturers and sold via illegal pharmacies. The surveys also revealed that the national drug registration system was not functioning satisfactorily, with drugs marketed without registration, labeled with incorrect registration numbers, or registered but non-compliant with specifications. The JPMA is helping to build the capacity of the Cambodian National Health Product Quality Control Center (NHQC) by transferring pharmaceutical evaluation technologies, the donation of analytical instruments, and on-site guidance by Japanese experts in pharmaceutical science and technology and quality control. It is also pursuing collaborative research to correct or improve the problems and issues associated with the counterfeit drug problem. To that end, the JPMA has made a number of specific proposals to the the Cambodian Ministry of Health. The Cambodian counterpart of JPMA has acknowledged the counterfeit drug problem and is exerting its best efforts to solve the problem. Since the current project was started in 2006, the number of unregistered drugs and illegal pharmacies has decreased. The JPMA considers it feasible to improve the current regulatory situation in Cambodia by closely monitoring the distribution of drugs in the market, to generate information which could help reinforce the drug registration system, license approval system, and GMP compliance.

The Japan Pharmaceutical Manufacturers Association (JPMA), Kanazawa University and the Cambodian Ministry of Health started a joint project to combat counterfeits medicines in Cambodia. (JPMA)

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JPMA: Strengthening Quality Control in Asia

LEEM Quality Control Program

Multiple diseases JPMA Thailand Ministry of Health, WHO Since 1989 Capacity Building - Support & Training Bhutan, Cambodia, Laos, Thailand www.jpma.or.jp/english

Multiple diseases LEEM Centrale Humanitaire Médico Pharmaceutique CHMP Since 2006 Capacity Building - Support 11 African countries www.leem.org, www.chmp.org

The Japan Pharmaceutical Manufacturers Association (JPMA) helps developing countries in Asia to establish efficient pharmaceutical distribution and quality control systems, via the following activities:

Counterfeit and substandard medicines are a major threat to health in developing countries, many of which lack the technical resources to identify inferior quality medicines. To help alleviate this situation, the association representing the R&D pharmaceutical industry in France, Les Entreprises du Medicament (LEEM), started a program in 2006 to allow developing countries to send samples of suspect medicines to France for analysis. To ensure impartiality, the LEEM pays for samples to be analyzed by an independent expert body, the Central Humanitaire Médico Pharmaceutique (CHMP).

Training in Japan: Since 1989, the JPMA has worked with the World Health Organization to provide annual Quality Control training courses in Japan for Asian government quality control personnel. JPMA provides practical training in medicines quality control at research laboratories and manufacturing plants, with the help of its member companies. This training strengthens the professional competence of Asian regulatory personnel and helps improve the quality of medicines in developing countries in Asia. To date, JPMA has provided training for 71 regulators; Contracted training in third countries: JPMA also provides training for government personnel from countries such as Bhutan, Cambodia and Laos in a third country, such as Thailand. This approach is used when there may be big differences between the standard of technical equipment in Japan and in the countries concerned. JPMA started in-country training in 2001 and has trained 24 regulators so far via this type of course; Donation of Analytical Instruments: A request from the Cambodian National Laboratory for Drug Quality Control for High-Performance Liquid Chromatographs equipment to improve controls for counterfeit and sub-standard medicines led to donations of analytical instruments by Eisai, Kyowa Hakko, Tanabe and JPMA. Retired employees helped set up the devices and train Cambodian staff to use them;

The program focuses on francophone countries in Africa and is primarily addressed to health ministries, national medicine authorities and state purchasing centers. To date, samples have been provided by Burundi, Chad, Comoros, Congo, Egypt, Gabon, Guinea, Guinea Bissau, Madagascar, Mauritania and Togo. Samples submitted for evaluation must be either antiretrovirals or medicines purchased on the street. In period 2007-08, a total of 116 samples were analyzed; and the results showed that a non-conformity rate of 22%, up from 18% for the 2006-07 period. The 2009-10 exercise is not yet complete, but for the 58 samples analyzed in 2009, the ratio of non-conforming products had increased to 43%. The biggest categories of medicines submitted for analysis are antimalarials, followed by antiinflammatories, anti-fever medications and pain killers.

Supply of Reference Substances to ASEAN Countries: Reference substances are extremely pure active ingredients of drugs that are indispensable for assaying the content of pharmaceutical substances in medicine. Since 1992, JPMA has provided free reference substances to support a UN/WHO program which helps ASEAN countries to assay commercially available medicines. This project is now managed by the Bureau of Drugs and Narcotics (BDN), Thai Ministry of Public Health. JPMA now funds acquisition of substances from within the ASEAN region.

JPMA helps developing countries in Asia to establish efficient pharmaceutical distribution and quality control systems. (JPMA)

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Medical Product Donations Fellowship Program

Merck Medical Outreach Program

Multiple diseases Johnson & Johnson PQMD Since ? Capacity Building - Support Ghana & other countries www.jnj.com

Multiple diseases Merck & Co. Inc. Various US-based voluntary organizations Since 1958 Access - Donation Developing countries www.merck.com

In countries where pharmaceuticals, medical equipment, and other supplies are difficult to acquire on a regular basis, medical products donations become a major means of obtaining these critical commodities. The Partnerships for Quality Medical Donations (PQMD) estimates that in countries where medical products are in short supply, medical donations account for as much as half of all medical supplies. Johnson & Johnson supports the Medical Product Donations Fellowship Program. The fellowship supports research in evaluating current distribution techniques of medical product donations and identifying new distribution approaches in Ghana and other donor nations.

Founded in 1958, the Merck Medical Outreach Program (MMOP) is the primary mechanism through which Merck donates its pharmaceuticals and vaccines for humanitarian assistance in the developing world and in support of disaster relief and emergency situations worldwide. This program enables Merck to donate critical pharmaceutical and vaccines to a limited number of qualified, US-based, private voluntary organizations (PVOs) for use in their on-going, humanitarian programs in the developing world. Donations of Merck medicines (with the exception of Mectizan® (ivermectin) and Gardasil® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine Recombinant] for which there are separate and dedicated programs) are made primarily through six qualified PVOs - AmeriCares, Catholic Medical Mission Board (CMMB), Direct Relief International, IMA World Health, MAP International and Project HOPE. In 2009, Merck donated USD 45.7 million in market value of medicines and vaccines through well-established partnerships to help patients throughout the developing world. These donations supported sustained chronic-care health activities,,enabled immunization programs, provided disaster assistance worldwide and reached many thousands more worldwide through the ongoing medical programs of our partner private voluntary organizations (PVOs). In addition, Merck donated USD 606 million worth of Mectizan® (ivermectin) for the treatment of river blindness and the prevention of lymphatic filariasis through the Merck Mectizan® Donation Program and USD 26 million worth of Gardasil® through the Gardasil® Access Program.

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ADDITIONAL HEALTH INITIATIVES – Access & Capacity Building

Nurse Training in East Africa

Nurse Training in Somalia

Multiple diseases Johnson & Johnson Aga Khan University Since ? Capacity Building - Training Kenya, Tanzania, Uganda www.agakhanhospitals.org/nairobi/index.asp

Multiple diseases Johnson & Johnson SOS Children´s Villages Since ? Capacity Building - Training Somalia www.sos-usa.org

Johnson & Johnson supports the Advanced Nursing Studies (ANS) and the Enrolled Nurses to Registered Nurses (ER-RN) programs at the Aga Khan University Health Sciences campus in Nairobi, Kenya. The program provides quality education and greater standards of evidence-based care to nurses and midwives from Kenya, Tanzania, and Uganda, to further develop their professional skills. The training, which includes some distance-learning approaches, prepares nurses to become registered nurses. More than 500 nursing students have benefited from this program.

When the civil war broke out in Somalia in 1990, SOS Children´s Villages started a major medical emergency relief and food program. The SOS Hermann Gmeiner School was converted into an emergency clinic where adults and children injured in the war were cared for, and the mother and child clinic became part of the emergency relief program. To date it remains the only functioning maternity ward and gynecological care facility in the country. In order to provide SOS as well as other interested youths in Somalia with a professional training, the SOS Vocational Training Centre offers a three-year stateapproved training for nurses or midwives. Johnson & Johnson is funding several SOS programs including a nursing class in Mogadishu, which provides training for 20 student nurses in surgery, orthopedics, trauma, midwifery and HIV/AIDS prevention education. The company supports further health programs in a number of other SOS sites in Africa.

The R&D-based pharmaceutical industry also supports primary health care programs and capacity building, including the training of doctors and nurses. (Boehringer Ingelheim)

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Red Cross Children’s Hospital, Cape Town

Regional Hospital Management Program

Multiple diseases Johnson & Johnson Red Cross Children’s Hospital Cape Town Since ? Capacity Building - Support & Training, Education South Africa www.jnj.com

Multiple diseases Johnson & Johnson Singapore Management University Since 1997 Capacity Building - Training Asia www.jnj.com

The Red Cross Children’s Hospital is a leading center for pediatric services located in Cape Town that provides comprehensive health care to children and adolescents. Johnson & Johnson supplies educational, product and financial support. The company also funded the development of an educational center at the hospital, which educates hospital staff, as well as members of the Western Cape community on health-related issues.

The Johnson & Johnson Regional Hospital Management Program helps Asian hospital managers to improve their management and operations skills so their hospitals can deliver better health care services. Based in Singapore, the Regional Hospital Management Program is run jointly with Singapore Management University. Each year, professors from leading Singaporean and US teaching institutions review modern hospital management principles and techniques with 50 senior hospital administrators from different Asian countries during a five-day seminar. Since its inception in 1997, 368 hospital administrators from 305 different health care institutions have participated in the program.

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ADDITIONAL HEALTH INITIATIVES – Access & Capacity Building

Otsuka Welfare Clinic

Phelophepa Healthcare Train

Multiple diseases Otsuka Pharmaceutical Local partners Since 2003 Capacity Building - Support Pakistan www.otsuka-global.com

Multiple diseases Roche Colgate, Transnet Foundation Since 1994 Capacity Building - Support South Africa www.roche.com

In June 2003, Otsuka Pharmaceutical set up the ‘Otsuka Welfare Clinic’ to help serve the health needs of refugees in Peshawar, in Pakistan´s Northwest Frontier District state. Medical doctors, pharmacists, nurses and other medical professionals provide free treatment each day to some 300 patients requiring medical assistance.

The Phelophepa healthcare train provides basic healthcare services to poor patients in remote rural areas of South Africa. The train is now 16 cars long and provides a pharmacy, cancer screening and education, psychology and dental and eye clinics, as well as diabetes and smear tests. It serves more than 45,000 people a year and has reached nearly 13 million in total since its inception in 1994. The train is run by the government-owned Transnet group. The Transnet Foundation funds about two-thirds of the train´s running costs and provides staff, rail access and rolling stock. Roche is the lead outside sponsor which includes other corporations such as Colgate. Phelophepa also improves rural health education through its EduClinic. Sixteen people are nominated at each stop to complete fiveday courses in basic health and hygiene. Many are traditional healers, people who could have felt threatened by the train´s work. Examinations and screenings are free, but nominal fees are charged for services such as prescriptions and glasses. A fund of pooled donations means, however, that no one unable to pay is refused treatment.

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Roche Employee Secondment

Tanzanian Training Center for International Health

Multiple diseases Roche Various local partners Since 2006 Capacity Building - Support Developing countries www.roche.com

Multiple diseases Novartis Swiss Tropical and Public Health Institute, Tanzania Ministry of Health Since 2003 Capacity Building - Support Tanzania www.healthtrainingifakara.org

In 2006, Roche launched a secondment policy to enable its employees to contribute their skills and expertise to help developing countries. The policy allows Roche employees to experience a unique personal development opportunity while contributing their skills and expertise to help make a real difference in health related projects in the world´s poorest countries. The Roche Secondment Policy is open to full-time employees who have had a minimum of five years service with Roche. Each secondment lasts 3-18 months, with secondees continuing to receive their salary from Roche during this period.

Skilled human resources are the backbone of any performing healthcare system. Many developing countries, however, face a big shortage of qualified healthcare personnel. The Tanzanian Training Centre for International Health (TTCIH) aims to strengthen the Tanzanian healthcare system through sustainable human resources development. Together with Tanzania’s Ministry of Health and Social Welfare and the Swiss Tropical and Public Health Institute, the Novartis Foundation for Sustainable Development developed a comprehensive concept to redesign the former Clinical Officer Training Center (COTC) in Ifakara. Apart from renovation and improvements in equipment, management was strengthened and a solid governance system was established.

In 2009, we approved one new secondment. A manager from Roche Germany was seconded to a project focused on diabetes in Ethiopia.

The TTCIH is steered by a semi-autonomous Board of Governors with members from both the public and private sector. It offers not only high level medical training (Assistant Medical Officer program), but also has an extended course program, specifically in mother and child health. To increase its financial self-reliance, the center offers its training facilities to external course providers. In 2009, the training center’s net income amounted to USD 260,000 from course fees, rent (accommodation, seminar rooms) and other services – excluding grants from third parties. Apart from financial self-reliance, the ultimate goal is also to develop the TTCIH into one of the leading training centers in Tanzania and East Africa.

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136

The research-based pharmaceutical industry has historically played an important role in providing relief to people affected by disasters – both natural (drought, earthquakes, floods, storms, tsunamis, etc.) and man-made (wars and other conflicts) – which can have a particularly devastating impact on poor developing countries. In emergency situations, survivors face the threat of fastspreading diseases, generally resulting from a lack of proper sanitation, reduced or inadequate supplies of clean water and the lack of adequate medical facilities. To meet immediate lifesaving needs, pharmaceutical companies move quickly to provide doses of lifesaving emergency medicines (antibacterial and antibiotic medicines, insulin, vaccines, etc.), and also help to train local health workers, to help avert major disease outbreaks in the affected communities.

inappropriate and caused disposal problems for recipient communities. To help ensure that only medicines which are needed are sent to a particular disaster site, and in the right quantities, many pharmaceutical companies have longestablished working partnerships with specialized aid NGOs. These include Americares, Direct Relief International, Catholic Medical Mission Board, Heart to Heart International, International Aid, International Health Partners, IMA World Health, MAP International, Medical Teams International, Project HOPE and TULIPE. Pharmaceutical companies are also committed to helping address longer-term health concerns related to disasters and work closely with government authorities and disaster relief organizations to determine ongoing requirements.

Coordination of emergency aid is essential; in the past, wellmeaning but inexperienced donors sent medicines that were

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Emergency Relief Efforts (This list provides an overview of individual company actions around the world. It is not intended to be exhaustive.)

Abbott

• In Bolivia in April 2009, Abbott and other pharmaceutical companies helped the non-profit organization Direct Relief International respond to an outbreak of dengue fever and Coqueluchoide Syndrome, a respiratory illness similar to whooping cough. The outbreaks occurred following flooding of the country's Beni River during heavy rains. Abbott contributed more than USD 56,000 worth of antibiotics that will help provide treatment for 3,000 cases of Coqueluchoide Syndrome.

www.abbott.com

• In response to the earthquake in Haiti in January 2010, Abbott provided USD 5 million in grant funding and donations of critical diagnostic, nutritional and pharmaceutical products, working directly with humanitarian aid organizations including Direct Relief International and Partners In Health. Abbott products were on the ground and in use immediately following the earthquake in Haiti as a result of earlier efforts in 2009 to work with Direct Relief to strategically pre-position essential products in Haiti to prepare for potential natural disasters. As a result of this work, several health centers in Haiti were able to provide an initial quantity of Abbott rehydration solutions, antibiotics and nutritional products to people in need following the earthquake. Abbott continues to work with partner organizations to assess and respond to ongoing needs for longer-term recovery efforts.

AstraZeneca www.astrazeneca.com

• In 2009, when typhoons Ketsana and Parma hit the Philippines, causing widespread devastation, AstraZeneca donated medicines to the relief effort and 15 employees did voluntary work with the Philippine army, helping over 1,000 flood victims. The company responded similarly with donations to the local relief effort when earthquakes hit Indonesia and when the typhoon struck Taiwan, AstraZeneca Asia Pacific made a USD 200,000 donation to the local Red Cross. • At a global level, the company also made a further contribution of USD 240,000 to the Red Cross Center in Kuala Lumpur, Malaysia, established in 2006 by the Red Cross with USD 700,000 of funding from AstraZeneca. The Center continues to play an important role in disaster relief in the Asia Pacific region. With pre-positioned emergency supplies, the Center was able to respond quickly to the events in 2009, distributing hygiene kits to thousands of people in need in the affected areas. AstraZeneca’s 2009 donation, coupled with one of USD 200,000 that the company made in 2008, has enabled the Red Cross to maintain appropriate levels of emergency relief stock at the Center. • In January 2010, following the earthquake in Haiti, AstraZeneca donated medicines and contributed a total of USD 500,000 to the British Red Cross Emergency Appeal. The company also committed an additional USD 500,000 to support a longer-term disaster recovery program that will give the people of Haiti the help they need to re-build their lives and their communities.

Bayer HealthCare

• Bayer HealthCare provides emergency assistance for victims in disaster areas.

www.bayerscheringpharma.de

Boehringer Ingelheim www.boehringer-ingelheim.com

Bristol-Myers Squibb www.bms.com

• The Boehringer Ingelheim Cares Foundation (BICF) in the USA provided product donations to AmeriCares, Catholic Medical Mission Board, Direct Relief International and MAP International to support emergency relief efforts in Haiti, following the earthquake in January 2010. The BICF will continue to work with our partners and the Partnership for Quality Medical Donations to assess ongoing needs in Haiti.

• In 2010, Bristol-Myers Squibb donated nearly USD 6 million in medicines, including antibiotics and analgesics, in response to the earthquake in Haiti. In addition, the Bristol-Myers Squibb Foundation committed more than USD 700,000, including cash donations to the American Red Cross, the Catholic Medical Mission Board and Partners in Health, while providing a two-for-one match for U.S. and Puerto Rico employee donations to organizations assisting in relief efforts. The Bristol-Myers Squibb Foundation also committed a special match for U.S. and Puerto Rico employee donations to organizations assisting in relief efforts in response to the earthquake in Chile. • The Foundation also focuses on providing funding support to international relief partners to facilitate their timely responses with humanitarian aid to unforeseen natural disasters. Cash donations to Project HOPE helped victims of the the 2009 earthquake in Indonesia; those to Direct Relief International were instrumental in addressing natural disasters in the Philippines, Vietnam and Indonesia by providing water, health care, shelter and sanitation; and aid to AmeriCares have helped prepare for future emergencies in India, Sri Lanka, El Salvador and Turkey.

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• In response to the several natural disasters in South East Asia in 2009 - floods in Philippines, Vietnam, Laos and Cambodia, the tsunami in Samoa and earthquake in Indonesia - GlaxoSmithKline supported recovery efforts through product and in-kind donations, employee and matched giving contributions, volunteer efforts and cash donations. The value of aid provided (cash, product and in-kind donations) for all countries stands at USD 2.01 million. GSK is also supporting longer-term recovery efforts, for example, GSK Indonesia is working with one of our partners, AmeriCares, to provide a new water facility and medical assistance to a hospital in Padang, Indonesia. GSK Vietnam is also working with the Red Cross with on longer-term recovery efforts focusing on rebuilding and repairing health centers and providing healthcare treatment for victims of storm damage in Vietnam.

GlaxoSmithKline www.gsk.com

• Following the earthquake in Haiti in January 2010, GSK medicines valued at USD 1.4 million were provided from stocks held in warehouses of non-profit partners, such as AmeriCares, Direct Relief International, Health Partners International of Canada and International Medical Assistance. These medicines were mainly oral and topical antibiotics, including Bactroban, Zovirax, Augmentin, Ceftin, Zinacef and Zantac. As Haiti’s needs continue to evolve, GSK has not placed a limit on the value of its product donations. The company has also committed approximately USD 408,000 (GBP 250,000) to the British Red Cross to help meet the water and sanitation needs of those affected by the disaster.

• Following the earthquake of January 2010, the Johnson & Johnson Family of Companies has contributed to the disaster relief effort in Haiti with cash and product donations. Beyond supporting immediate needs, Johnson & Johnson is supporting long-term recovery and rebuilding efforts focused on health care services addressing the needs of women and children.

• Following the major earthquake that struck Haiti in January 2010, Japanese pharmaceutical companies provided cash, medicines and other assistance worth more than USD 8 million. Pharmaceutical companies contributing to this aid included Astellas, Chemo-Sero-Therapeutic Research Institute, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Kissei, Kyowa Hakko Kirin, Maruishi, Maruho, Minophagen, Mitsubishi Tanabe, Nippon Shinyaku, Nippon Kayaku, Novartis Pharma K.K., Ono, Otsuka, Pfizer Japan, Sanofi-Aventis K.K., Santen, Sanwa Kagaku Kenkyusho, Shionogi, Takeda, Toyama Chemical, Wyeth K.K. (now part of Pfizer) and Yakult Honsha.

Johnson & Johnson www.jnj.com

JPMA www.jpma.or.jp/english

• Following the earthquake in Haiti in January 2010, Lilly provided USD 250,000 in cash to support relief efforts. Its employees have contributed a further USD 225,000 to date, which the company will match dollar-fordollar. Lilly has also shipped product donations worth USD 4.4 million, notably antibiotics, insulin and neuroscience medications. In addition, the company contributed USD 100,000 for earthquake relief in Chile.

• Following the 8.8 magnitude earthquake that struck off the coast of the Maule Region of Chile on 27 February 2010, Merck made a contribution of USD 100,000 to support relief efforts by the American Red Cross and World Vision.

Lilly www.lilly.com

Merck & Co. Inc. www.merck.com

• Following the devastating earthquake that struck Haiti on 12 January 2010, Merck has made an initial contribution of USD 450,000 to assist relief efforts through the American Red Cross, U.S. Fund for UNICEF, Save the Children, The Jewish Renaissance Foundation, Project HOPE and Be The Change International. Merck is also donating needed medicines through the Merck Medical Outreach Program. To date, Merck partners Direct Relief, Catholic Medical Mission Board, AmeriCares and MAP International have already shipped or are planning to ship USD 2.6 million (market value) of donated Merck products. • Merck also is allowing eligible employees who are licensed health professionals, allied health services providers or qualified translators (Creole/French) to take one paid week of release time to participate in disaster relief efforts with approved non-profit organizations on the ground in Haiti.

• Merck KGaA has contributed to the international relief effort following the earthquake in Haiti in January 2010 with a donation of 17,000 bottles of the company’s antibiotic Cephoral.

• In 2009, Novartis donated USD 32 million to major humanitarian organizations for emergency relief operations. Novartis has also provided USD 3.5 million worth of emergency assistance following the earthquake in Haiti in January 2010, including employee matching contributions.

Merck KGaA www.merck.de

Novartis www.novartis.com

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Novo Nordisk www.novonordisk.com

• After the earthquake in Haiti in January 2010, Novo Nordisk and Project Hope organized help for people with diabetes. Novo Nordisk’s contribution included 50,000 vials of insulin. In addition, Novo Nordisk donated USD 100,000 to the Danish Red Cross to support their relief work in Haiti. • Following the torrential rains in Karnataka and Andhra Pradesh states in India in October 2009, the Novo Nordisk employee volunteer program “Take Action!” collected and arranged for the basic necessities like food, drinking water, clothing and medical supplies for more than 500 families. A large number of employees volunteered to distribute aid in the affected areas. • In response to the earthquake in Padang Sumatra Barat, Indonesia in September 2009, Novo Nordisk employees raised funds and collected clothes which were eventually donated to the victims via the Indonesian Red Cross Society. The Take Action! Team cooperated with local NGOs in providing emergency services, building temporary houses, schools and camps.

• Pfizer responded to several disasters in 2009 with financial and product donations, as well as Pfizer employees’ time. When Typhoon Morakot hit Taiwan in September 2009, Pfizer provided USD 300,000 in support to the Red Cross of Taiwan and United Way of Taiwan. Pfizer employees also made cash contributions. In September 2009, Pfizer provided USD 100,000 in cash support to aid the relief efforts following flooding in the Philippines. This support was directed to ABS-CBN Foundation, GMA Kapuso Foundation, Philippine National Red Cross and World Vision. In October 2009, Pfizer responded to the earthquakes in Indonesia with a USD 50,000 cash contribution to UPLIFT International. The company also provided significant support to the colleagues and their families living in the affected area. Finally, Pfizer launched a relief support program with the Ministry of Health of the Republic of Indonesia and a state-owned insurance company P.T. Askes, that donated antibiotics, anti-inflammatories, pain killers, infant formulas and follow-on milk.

Pfizer www.pfizer.com

• Pfizer’s contribution to aid recovery and relief efforts in earthquake-ravaged Haiti consists of a package of product and monetary donations totalling USD 5 million in combined contributions, including USD 4.7 million in medicinal product donations to the following NGO partners: The Red Cross, Health Partners International of Canada, Americares, Project Hope, Direct Relief International and Heart to Heart. A cash donation of USD 250,000 has been evenly split between the U.S. Fund for UNICEF and CARE. Additionally, Pfizer employees and retirees in the United States and Puerto Rico have contributed at least USD 370,000 which has been matched by the Pfizer Foundation, in line with Foundation guidelines.

• Roche is making substantial contributions to assist relief efforts following the earthquake in Haiti in January 2010, including the donation via local authorities and specialized NGOs of critical medicines which will assist more than 8,000 patients.

Roche www.roche.com

sanofi-aventis www.sanofi-aventis.com

• To address emergency and post-emergency needs after the earthquake in Haiti on 12 January 2010, sanofi-aventis mobilized rapidly alongside its partner associations: Aide Médicale Internationale, CARE, Red Cross, Handicap International, Médécins du Monde and UNICEF, all specialized in emergency relief operations and already present in Haiti. • To help them launch emergency relief actions, sanofi-aventis provided initial funding of EUR 100,000 and organized a sizeable donation of medicines and vaccines. To date, 440,713 boxes of medicines and 568,300 doses of vaccines (with a market value of EUR 11.2 million) have been delivered. Sanofiaventis also allocated an exceptional EUR 1 million for the long-term support of its partners. • An appeal was also launched among company employees and subsidiaries around the world, inviting everyone to participate in the wave of solidarity for the people of Haiti. This raised EUR 450,000 from the employees in 33 countries, matched by the company, and certain affiliates. • A grand total EUR 2,015,000 has now been sent to the six NGO / IGO partners.

TULIPE (LEEM) www.tulipe.org

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• TULIPE is a non-profit organization created in 1982 by the French pharmaceutical association, Les Entreprises du Médicament (LEEM). It brings together NGOs, government and industry to provide appropriate medicine donations in emergency situations. It has developed special medical kits for use by NGOs and the French Ministry of Foreign Affairs, adapted to their first-aid teams´ needs. In 2009, thanks to its 58 pharmaceutical company members, TULIPE provided medicines worth EUR 897,900 at wholesale prices corresponding to 1,505,000 treatments, including emergency medical kits to meet a variety of needs, for earthquake in Indonesia, for the cyclone in Philippines and for refugees in Palestine and Sri Lanka.

COMPLETED PROGRAMS

Abbott

• Through a partnership with AmeriCares, Dartmouth University, and the University Clinical Center of Kosovo (UCCK), Abbott supported efforts to improve neonatal survival in Kosovo. The Abbott Fund provided AmeriCares with funding to help equip four patient units in the Neonatal Intensive Care Unit at the UCCK in Prishtina, where a third of all infants in Kosovo are born. Funding also supported an education exchange on neonatal resuscitation and stabilization. Results from 2007 showed a 15% decline in the neonatal mortality rate.

• AstraZeneca’s partnership with the African Medical Research Foundation (AMREF) initially focused on TB control and management in the Eastern Cape of South Africa, heavily affected by TB, HIV and malnutrition. AstraZeneca and AMREF worked with local communities in the Chris Hani district, helping them to take action to promote good health and wellbeing. The program has seen increased knowledge, detection and defaulter tracing. The program came to an end in 2007.

www.abbott.com

AstraZeneca www.astrazeneca.com

• In July 2003, AstraZeneca made a GBP 60,000 grant to BookPower, a non-profit organization which provides medical and nursing text books at a subsidized price to students in English-speaking Africa, the Indian sub-continent and the Caribbean. The AstraZeneca grant funded medical texts on Cardiology, Endocrinology, Gastroenterology, Immunology and Infection. The program ended in 2005. • Promoting Safe Motherhood in India: from 2005 to 2009, AstraZeneca worked with the Federation of Obstetric and Gynaecological Societies of India (FOGSI) to improve female and maternal health through educational activities, including professional conferences and public awareness campaigns.

• Thane, India, Bayer HealthCare donated enough polio vaccines to immunize 170,000 children, an Bayer HealthCare initiative that helped the WHO program defeat polio in the region. www.bayerscheringpharma.com

• The BMS Foundation has supported various efforts to fight HIV/AIDS outside Africa, including Baylor College of Medicine’s training programs for health professionals in Ukraine and Mexico. With Miramed, it supported education programs in Russia and a pilot medical protocol for rescued sex trafficking victims. In Thailand, grants to the Population and Community Development Association and the Thai Red Cross helped increase HIV/AIDS awareness in vulnerable populations. It has also supported pediatric HIV/AIDS training in Vietnam.

Bristol-Myers Squibb www.bms.com

• The BMS Foundation helped the Catholic Medical Mission Board and the Pan American Health Organization to scale up the Integrated Management of Childhood Illness (IMCI) in five Latin American and Caribbean countries. The grant ended in 2006. • The BMS Foundation helped the China Foundation for Hepatitis mount a two-year pilot program to prevent mother-to-child transmission of hepatitis B and helped the Chinese Ministry of Health and the Chinese Liver Foundation conduct rural hepatitis vaccination campaigns.

• Afrikids is an NGO working in Ghana which helps to protect vulnerable children’s rights, delivers basic care, improves local facilities and offers education and micro-finance programs. GlaxoSmithKline supported Afrikids for 4 years from 2003, especially Operation Sirigu, which helped reduce the child abuse, abandonment and infanticide that have been related to the “spirit child” phenomenon.

GlaxoSmithKline www.gsk.com

• In February 2008, Phase III clinical trials showed that Dacart™ (chlorproguanil/dapsone/artesunate), a candidate anti-malarial combination developed by GSK and Medicines for Malaria Venture, could significantly reduce hemoglobin in patients with glucose-6-phosphate dehydrogenase deficiency (which affects 10-25% of people in sub-Saharan Africa). Consequently, GSK and MMV terminated development of Dacart™ GSK also withdrew its Lapdap™ chlorproguanil/dapsone combination. This disappointment highlights the complexity and risk of pharmaceutical R&D, but GSK remains committed to fighting malaria. • From 2001 to 2009, GlaxoSmithKline helped Mildmay International to strengthen HIV/AIDS healthcare in sub-Saharan Africa, through provision of appropriate training in Kenya, Nigeria, Tanzania, Uganda and Zimbabwe.

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Japan Pharmaceutical Manufacturers Association (JPMA) www.jpma.or.jp/english

Merck & Co., Inc. www.merck.com

• JPMA member companies Astellas, Asubio Pharma, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Meiji Seika, Mitsubishi Tanabe, Otsuka, Shionogi and Takeda worked with the Japanese Ministry of Health, Labor and Welfare, and the TDR Special Program for Research and Training in Tropical Diseases in the JPMW Alliance, formed in October 1999, to help malaria R&D. Nearly 30,000 compounds were screened, of which 372 showed activity against malaria. Of these, 14 showed enough promise to merit further research. This project finished in 2005.

• The Enhancing Care Initiative (ECI) was launched in 1998 with a five-year, USD 5 million grant from the Merck Company Foundation, as a multidisciplinary collaboration to improve the care of people living with HIV/AIDS in resource-limited settings, run by the Harvard AIDS Institute and the Francois-Xavier Bagnoud Center at the Harvard School of Public Health. It worked in Brazil, Puerto Rico, Senegal, South Africa and Thailand. See www.eci.harvard.edu. • Schering-Plough, now part of Merck & Co., Inc., worked with the Ministry of Health and other partners in Venezuela to establish a donation program for Hepatitis-C, providing PegIntron® medicine and Protein Chain Reaction confirmatory tests, plus community education programs. • In 2005, Schering-Plough, now part of Merck & Co., Inc., established a program with the Department of Public Hygiene and Prevention to strengthen sexual and reproductive health services and education in Laos. The company contributed USD 270,000 up to 2008. • Schering-Plough’s Organon division, now part of Merck & Co., Inc., started the “Development of Sexual and Reproductive Health Services for Thai Adolescents” program in 2004, to promote improved sexual and reproductive health among adolescents in Thailand. • From 2001-2008, Merck partnered with the International Council of Nurses (ICN) and Elsevier Science, the world´s largest publisher of nursing books, to created the ICN/Merck Mobile Library Program, which provided traveling libraries of health education and reference materials help nurses working in remote areas of the of developing countries gain access to critical quality healthcare information.

Merck KGaA www.merck.de

Novartis www.novartis.com

• The “Staying Healthy with Diabetes” program in Indonesia aimed to promote early diagnosis and integrated efforts to prevent complications to improve the quality of life for people with diabetes. In 2004 and 2005, the Merck KGaA team in Indonesia successfully screened more than one million people for diabetes.

• From 1996 to 2006, Chiron Vaccines, now Novartis Vaccines, donated 33.3 million doses of polio vaccine for international vaccination campaigns to support the Global Polio Eradication Initiative. • Novartis used to donate intraocular lenses to NGOs for cataract surgery for patients with inadequate means in developing countries. However, the division responsible for these lenses has been divested from the Novartis group.

Pfizer www.pfizer.com

• PEER (Providing an Enabling Environment for Research in health) was a joint R&D program by the Pfizer Philippines Foundation, the Philippine Council for Health R&D and the University of the Philippines National Institutes of Health, sponsoring Filipino research into various diseases including childhood obesity, diabetes, tuberculosis and mycrobacterial infections. • Pfizer worked with the Mexican Diabetes Association in Mexico City to help educate families with youngsters with Type II diabetes to live with the disease. • In 2002, Wyeth, now part of Pfizer, contributed USD 1 million to the Global Polio Laboratory Network. Wyeth has also donated 10 million doses of vaccine for Haemophilus influenzae type b to immunize 3.3 million children. • Wyeth, now part of Pfizer, has helped fund various clinical trials for its pneumococcal conjugate vaccine in developing countries, including the Gambia and South Africa, working with the UK Medical Research Council, the Bill and Melinda Gates Foundation, the US National Institutes of Health, the US Agency for International Development, the World Health Organization (WHO) and the South African Medical Research Council.

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COMPLETED PROGRAMS

• The Cambodia Treatment Access Program (CTAP) was launched in 2003 by the Cambodian Ministry of Health, the National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales in Australia and Roche, to widen access to HIV healthcare, including antiretrovirals and train healthcare professionals in Cambodia. Roche provided funding and ARVs for use in the program. The Cambodian Government honored the partners with an Award of Recognition, in view of CTAP’s considerable impact on HIV/AIDS treatment in the country, where HIV prevalence is now in decline.

Roche www.roche.com

• CARE, the Cohort program to evaluate Access to antiretroviral treatment and Education, was designed to provide antiretroviral medicines to people living with HIV/AIDS and serve as a model for providing HIV healthcare in resource-limited countries worldwide. The program was launched in 2001 by PharmAccess Foundation and Roche in Cote d’Ivoire, Kenya, Senegal and Uganda. Funding, diagnostic and monitoring tests, as well as support for training of healthcare professionals and education for patients, were provided by Roche, which also donated ARVs for use in the program.

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Acknowledgements This publication is the fruit of the labors of many people, but the IFPMA would particularly like to thank the following persons for helping to provide information: Abbott AstraZeneca BayerHealth Care Boehringer Ingelheim Bristol-Myers Squibb Crucell Eisai Esteve Gilead GlaxoSmithKline Johnson & Johnson JPMA (Japan) LEEM Lilly Merck & Co., Inc. Merck KGaA Novartis Novo Nordisk Otsuka Pfizer Piramal Ranbaxy Roche sanofi-aventis Sigma-Tau TULIPE ViiV

Matthew Bedella Neil Mulcock Diana Scholz, Denise Renmann, Ulrike Schroeder Michael Rabbow Christine Newman Olga Popova Simon Collier Daniel Ortiz Llagues James Read Amanda Atkinson Pamella Kyagonza Hiroyuki Funakoshi Béatrice Kressmann Tristan Piguet Patricia Fricke, Brenda Colatrella Frank Gotthardt Lyse Beauregard-Zollinger Craig Ludwig Hiroyuki Funakoshi (JPMA) Deirdre Peterson Pankaj Dikholkar Shailesh Pednekar Maria Vigneau, Vivian Beetle Alain Aumonier Marco Corsi Christine Perrier Scott Purdon

Photos All photos are reproduced with the permission of the company and/or copyright holder concerned. These are named in brackets after the caption.

Copyright May 2010 – International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Layout by Imprimerie Genevoise SA, Geneva.

Developing World Health Partnerships Directory

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2010