Express Pharma December 16-31, 2013

VOL .9 NO.4 PAGES 76

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Market ‘India will become free from NTDs by 2020’ Management Redefining CSR Research New human peptide may help treat diabetes 16-31 DECEMBER 2013, ` 40

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CONTENTS Vol 9 No.4 DECEMBER 16-31, 2013

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

MARKET

REDIFINING CSR

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

Companies Bill 2012’s two per cent mandate for CSR has evoked mixed reviews from the pharma industry.Some have welcomed the move, while some feel that CSR shouldn’t be forced.However,theyare unanimous in their opinion that there is a need to make the rules more transparent | P26 P34: CLINICAL UPDATE Bone Therapeutics initiates a phase IIb/III trial

P35: RESEARCH UPDATE

PHARMA ALLY

38

‘WE WILL BE WORKING HARDER TO ACHIEVE STRONGER GOALS’

40

‘EVERYTHING YOU WRITE IS INSTANTLY ELECTRONICALLY RECORDED’

44

SAFEDUCATE LAUNCHES LEARNING FORUM ALONG WITH CILT

Auxilium drug to treat bent penis condition gets FDA nod

P71: AWARD Glenmark Pharmaceuticals wins Thomson Reuters India Innovation Award

P72: APPOINTMENT Anita Tripathy named president of inVentiv Health India

9

‘INDIA WILL BECOME FREE FROM NTDS BY 2020’

14

UK PARTNERS WITH BIOASIA AS PRINCIPAL COUNTRY PARTNER

16

VENUS REMEDIES SIGNS MOU FOR ELORES FIRM

24

CPHI - INDIA, P - MEC-INDIA SHOW PATH FOR SUCCESS

TURN TO PAGE 13 TO FIND SPECIAL DEALS

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

2013: The beginning of the end?

Or a new beginning? his year has been about change;

T

per cent of their net profit on social causes to

mostly on the regulatory front;

invest in such causes. For the companies, the

both global and at the national

challenge going forward will be to sustain the

level. The new pricing policy, a

efforts. An equal effort will have to be made

slew of changes on the clinical

on the government's part to monitor that the

research front and landmark judgements on the

money is well spent and does not remain merely a

intellectual property side have ensured that 2013

reporting necessity.

will be remembered as a watershed year in the

Individuals too are stepping up to the

Indian pharma industry.’ Is it the beginning of the end? Or a new beginning? The debate between the naysayers and the optimists continues. But one thing is for sure: Mahatma Gandhi's quote of being the change you want to see, endures even today. For the last issue of 2013, Express Pharma spotlights corporate groups in the lifesciences sector as well as individuals who have tried to be the change themselves.

Our Management section cover story analyses how corporates like Jubilant Life Sciences, Novartis India and Sanofi India have made corporate social responsibility a part of their strategy; indeed part of their corporate DNA.

challenge of bringing about change. Our Pharma

For the last issue of 2013, Express Pharma spotlights corporate groups in the lifesciences sector as well as individuals who have tried to be the change themselves

Life cover story profiles some high powered celebrities who have associated themselves with pharma companies and health-related causes, in order to promote awareness. It’s easy to change minds, but changing mindsets is much more difficult. Kudos to icons like 'Flying Sikh' Milkha Singh, Bollywood supermom Aishwarya Rai Bachhan, Bollywood heartthrob John Abraham, renowned ex-cricketer Rahul Dravid and others who are using their celeb status for these causes.

With that, we close this year and look forward to greeting you in 2014 ... with a 2014 forecast from some of the top analysts in the industry.

Many of these did not need the amendment in the

VIVEKA ROYCHOWDHURY Editor

Companies Bill 2012 mandating a spend of two

viveka.r@expressindia.com

6 EXPRESS PHARMA December 16-31, 2013

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MARKET I N T E R V I E W

‘India will become free from NTDs by 2020’ India is in a position to elevate Neglected Tropical Diseases (NTDs) and build awareness on how their control and elimination will enable its citizens to lead healthy, productive live. Dr Neeraj Mistry, Managing Director of the Global Network for NTDs speaks with Usha Sharma and reveals that one person can be protected per year against the seven most common NTDs

Give us a brief introduction about ‘END7 campaign.

END7 campaign is an awareness campaign seeking to eliminate the seven most common neglected tropical diseases (NTDs) by 2020.

NTDs are parasitic and bacterial infections transmitted through mosquitoes or flies and contaminated water or soil.

The seven most common NTDs – lymphatic filariasis (elephantiasis), river blindness (onchocerciasis), snail fever (schistosomiasis), trachoma, hookworm, whipworm (trichuriasis) and roundworm (ascaraisis) – account for 90 per cent of the global NTD burden. NTDs afflict one in six people worldwide, including half a billion children who are living in marginalised communities on less than $1.25 a day. NTDs cause blindness, swelling, pain, and stigmatisation, trapping people in a cycle of poverty and disease.

END7, which is run by the Global Network for Neglected Tropical Diseases (Global Network), an initiative of the Sabin

Vaccine Institute, uses the power of social media and compelling digital communications to build awareness for NTDs among the general public and encourage people to take action. END7 also calls upon global political and philanthropic leaders, as well as national governments in endemic countries, to make the modest funding commitments to help cut the transmission cycle of NTDs. The END7 campaign seeks to raise the profile of NTDs with the public and key decision makers so that people can be reached in dire need of treatment and spur sustainable economic growth. The momentum and funds generated by END7 supporters thus far has enabled to reach an expansive network of individuals, directly provide treatments to communities, and encourage donor and endemic countries to invest in NTDs. END7 is the first global public awareness campaign seeking to eliminate NTDs.

We encourage the pharma industry to continue their deep commitment to alleviate the suffering caused by NTDs by also carrying out new research and development initiatives

Tell us about its on-going activities?

By 2020, it is being anticipated that the next major milestone in public health will be the control and elimination of the seven most common NTDs impacting more than one billion of the world’s poorest people.

END7 contributes to seven active project countries worldwide and anticipates expansion to additional countries by the end of the year. In India and around the world, we are working closely with our implementing partners to bring existing NTD control programmes to scale, integrate NTD control with other global health interventions such as water, sanitation and hygiene (WASH) efforts; nutrient supplement programmes; bed net distribution; and maternal and child health care. Our advocacy work relies on innovative digital and social media strategies; corporate, celebrity, and public-private partnerships; and mass-level viewer ship of our online content to reach and captivate diverse

audiences. For instance, in March 2013, END7 released a hard-hitting video, “How to Shock a Celebrity”, which included six celebrities from around the world and captured the attention of hundreds of thousands of people globally and compelled them to donate to the NTD cause.

In India what strategies do you have for END7 campaign?

In India, END7 seeks to raise the visibility of NTDS by educating the general public about the need to participate in national NTD control programmes and encouraging government officials to scale up their NTD programmes. END7 will rely on celebrity ambassadors, corporate and public-private partnerships, and other promotional activities to educate local communities about the effectiveness and importance of NTD preventive treatments, raise funds to deliver medicine to the most remote communities and strengthen political commitment. We are also

9 EXPRESS PHARMA December 16-31, 2013

MARKET PROPORTION OF GLOBAL BURDEN OF NTDS BY COUNTRY looking for India’s leadership to demonstrate models by which NTD programmes can truly go to scale. That scaleup model is what we’d like to share with other countries scaling up themselves.

How successful is the END7 campaign in India?

The END7 campaign in India will elevate NTDs by raising funds and building awareness on how their control and elimination. One of the most cost-effective public health interventions in existence today, it will help meet national and global development targets. By building up awareness, END7 will help promote the social uptake and endurance of government programmes.

Investing in the health and well-being of the most marginalised communities in India through ultra low-cost interventions can help create more expansive economic growth; improve maternal and child health; and increase school attendance.

How grave is NTD's situation in India?

Nearly 35 per cent of the global population infected with NTDs resides in India. Currently, India accounts for 27 per cent of the world’s soil-transmitted helminth burden, with over 240 million Indian children in need of deworming medicine.

India also accounts for 40 per cent of the global burden for lymphatic filariasis.

Which diseases fall under the NTD category? In India which diseases are likely to grow aggressively and why?

The most prevalent NTDs in India are soil-transmitted helminths (STH) and lymphatic filariasis (LF).

Other NTDs are also endemic in parts of India, including trachoma, kala azar (also known as visceral leishmaniasis), leprosy, rabies and dengue. India has already eliminated two

10 EXPRESS PHARMA December 16-31, 2013

2.3% Tanzania

2.5% Myanmar 2.7% China 2.8% Philippines

27.9 % All other countries

2.8% Ethiopia 3.2% DRC 5.4% Bangladesh

6.5% Nigeria

8.3% Indonesia 35.6% India

(2011 Data from the World Health Organization)

NTDs, guinea worm and yaws. To address soiltransmitted helminths and lymphatic filariasis, India is managing comprehensive, state-by-state programmes.

The national lymphatic filariasis elimination programme is the largest in the world, reaching approximately 300 million people each year with preventive treatment. India has also just launched two of the world’s largest integrated de-worming initiatives, aiming to protect 220 million school-age children and 120 million adolescents each year from soil-transmitted helminths.

To support India’s efforts to expand existing programmes and make the case for investment in NTDs, the Global Network and END7 is focused on building awareness, mobilising resources, and working with government, nongovernmental organisations, corporate and celebrity partners.

You were the Vice president of the Global Business Coalition (GBC) on HIV/AIDS, tuberculosis

and malaria. Give some insight on handling the situation in the Indian subcontinent?

During my tenure at the Global Business Coalition (GBC) on HIV/AIDs, tuberculosis and malaria, I worked with corporations, multi-lateral and bilateral agencies, and diverse sectors to increase public health investments and publicprivate partnerships (PPP) to help stimulate improvement in the health and socio-economic status of people worldwide. I saw the power of bringing different groups and individuals together to achieve common development goals and ensure sustainable progress, and I have since sought to apply a similar approach in my work at the global network.

In India, I believe that it is critical for diverse sectors, government, organisations, and individuals the pharma industry, ministries of health, business leaders and celebrities for instance to make the cost-effective investment of building awareness about NTDs, mobilising resources to

ensure that preventive treatment reaches the most marginalised communities, and ultimately ensuring the control and elimination of NTDs by 2020. With the Indian government’s leadership, support from the private sector, and on-going advocacy work, I believe that India will be in a position to achieve new milestones in the control and elimination of NTDs. The Government of India has taken up an initiative to fight against NTDs. What suggestions would you like to give to the government?

At the Global network, we believe that India’s leadership and success will be central to achieving global and regional goals to control and eliminate the most common NTDs by 2020. By tackling NTDs, India will help achieve more inclusive and expansive economic growth for its citizens, which in turn will positively impact the global economy. Finally, the government’s successful efforts can only go so far without engaging the general

public to comply with drug treatment programmes and take advantage of the availability of medicines that are distributed in many cases for free to communities.

This will require greater engagement and social marketing at the community levels to demonstrate the importance of everyone taking these medicines.

Which public private partnerships have been formed in India to eliminate NTD's from India?

GSK is donating albendazole for lymphatic filariasis and soiltransmitted helminth control in India, as well as other countries, through the WHO. The deep commitment of non-governmental organisations such as Deworm the World and foundations such as the Michael and Susan Dell Foundation have also supported school-based deworming programmes to protect millions of Indian children against soiltransmitted helminth infections. A faith-based organisation called the Church’s Auxiliary for Social Action (CASA) has also supported NTD education efforts and has helped teach people living with chronic lymphatic filariasis infection how to alleviate suffering and prevent disability. By engaging with different individuals, organisations, and Indian government bodies to drum up interest in and commitment to investing in NTDs in India, END7 intends to expand innovative public-private partnerships that will accelerate the pace of improving the health of the Indian people.

Since July 2010 you have been associated with the Global Network for NTDs. Tell us about your endeavours against NTDs in India?

In India, the Global

MARKET Network advocates for Indian government officials to continue making investments in NTDs that will lead to the improved health, well-being and productivity of its citizens.

The Global Network works closely with the WHO, international and Indian nongovernmental organisations, such as Deworm the World, and officials and technical experts overseeing the NTD programmes of the Ministry of Health and Family Welfare (MoHFW). In 2011, the Global Network collaborated with Deworm the World and Indian government officials to implement a school-based deworming programme in the state of Bihar. The programme successfully provided deworming

The national lymphatic filariasis elimination programme is the largest in the world, reaching approximately 300 million people each year with preventive treatment. India has also just launched two of the world’s largest integrated deworming initiatives, aiming to protect 220 million school-age children and 120 million adolescents each year from soil-transmitted helminths treatment for 17 million school-age children in over 67,000 schools in one of the world’s largest school-based programmes ever conducted.

In 2012, Rajasthan carried out a deworming programme targeting 16 million children

from 90,000 government schools and 70,000 community health centres to reduce the effects of anaemia and malnutrition that soiltransmitted helminth infections have on children.

Rajasthan’s reach was

impressive and the huge collaboration that helped make the deworming successful: Rajasthan’s Departments of Education, Health and Women and Child Development; Deworm the World, Michael and Susan

Dell Foundation and UNICEF. The Global Network’s advocacy work encourages India to scale up treatment programmes, expand data mapping to better understand the current burden of NTDs across the country and continue the momentum of previous successes in the elimination of certain NTDs. The Global Network believes that India is in a position to elevate NTDs and build awareness on how their control and elimination will enable its citizens to lead healthy, productive lives.

The Indian government is targeting that by 2020 the nation will become free from NTDs. Do you think a

11 EXPRESS PHARMA December 16-31, 2013

MARKET results.

set deadline can be met?

We believe that India can meet the 2020 deadline. India is at the tipping point of achieving NTD control and elimination goals. It already runs some of the largest national NTD programmes in the world and is poised to scale up programmes, close the treatment gap and continue expanding momentum. By increasing its commitment to invest in and build awareness on NTDs, India will be able to make great progress. Fortunately, we also have the necessary treatment available, thanks to donations from many pharmaceutical companies.

Still, it will be critical for the Indian government to ensure that the investments of the last decade in the fight against NTDs continue to last through renewed commitment and innovation during the last mile of achieving elimination. To support the Indian government’s efforts to scale up treatment, educate the public, and reach marginalised communities, END7 will work to build awareness and help sustain government programmes.

We are committed to leading NTD advocacy efforts in India and globally for the control and elimination of these diseases and we are optimistic that India and other countries around the world can meet

12 EXPRESS PHARMA December 16-31, 2013

India is at the tipping point of achieving NTD control and elimination goals. It already runs some of the largest national NTD programmes in the world and is poised to scale up programmes, close the treatment gap and continue expanding momentum this deadline.

Why has less research been carried out in this field?

How can we encourage the institutes and companies to work enthusiastically in these areas?

It is only over the last decade that NTDs have started receiving increased global recognition, but scientists, doctors, governments, and other institutions have already produced substantial important research on the impact and reach of NTDs throughout the world.

The case for investing in NTDs is a simple one: NTD treatment is one of the most cost-effective public health interventions in existence today. For just 50 cents, we can treat and protect one person per year against the seven most common NTDs. Tackling NTDs also provides a return on investment for nearly every

major development goal. By treating NTDs, which cause tremendous pain and suffering and keep people out of work and school, countries can help spur increases in school attendance, improve worker productivity, enhance earning potential and lead to an overall improvement in well-being.

ing Sri Lanka, Cambodia, Laos, and Vietnam. Countries such as Japan and South Korea were formerly endemic for these diseases and have successfully controlled and eliminated them.

(Figure 1: Proportion of Global Burden of NTDs by Country)

How serious is this issue in Asia Pacific and which are the countries are seriously affected from this endemic?

Asia and the Pacific account for almost two-thirds of the world’s population at risk for lymphatic filariasis and half of the world’s children at risk for soil transmitted helminths. India, Indonesia, Philippines, Bangladesh, China, and Myanmar have the highest burden in Asia, and account for almost 60 per cent of the global burden (see chart). Many endemic countries are making tremendous strides, includ-

What is your agenda for this year and how closely are you working with the Indian government to achieve this?

END7 works with an extensive network of partners around the world to make certain that we’re on pace to control and eliminate the seven most common NTDs by 2020. Each of our partnerships contributes a unique skill and area of expertise that when working together, enables the national and state NTD programmes to deliver effective programmes and achieves

What is your message for the pharma industry?

The fight against NTDs requires diverse sectors that can each contribute particular skills and competencies. The pharma industry has already demonstrated that it is an instrumental partner in the global effort to control and eliminate NTDs by 2020.

Notably, in the largest partnership to date, the London Declaration on NTDs, 13 pharma companies committed to donating 14 billion doses of pills by the end of the decade, and because of their generous donations, it costs only 50 cents to treat and protect one person per year against the seven most common NTDs. We encourage the pharma industry to continue their deep commitment to alleviate the suffering caused

by NTDs by also carrying out new research and development initiatives that will help us stay ahead of how our existing effective treatments evolve. What’s important to remember is that no one sector alone can achieve the control and elimination of NTDs, but rather we must all unite through close coordination and collaboration to realise our 2020 goal. In addition to pharma donations and R&D programmes, global partners, including endemic countries, must also work together to enhance strategies for implementing effective supply chain logistics, treatment distribution, and monitoring and evaluation programmes.

Community engagement and awareness is also critical to ensure that people understand the benefits of NTD treatment, which will help generate demand and support for countries like India to maximise their commitments to control and eliminate NTDs. u.sharma@expressindia.com

COMPANY WATCH

Strides Arcolab completes sale of Agila Specialties division to Mylan $250 million to be payable upon satisfaction of certain regulatory conditions STRIDES ARCOLAB has completed sale of its Agila Specialties Division to Mylan for a total consideration of up to $1.75 billion. Since the initial announcement of this transaction the Board of Directors approved final transaction terms to include the following: A hold back of $ 250 million contingent upon satisfaction of certain regulatory conditions. Consequent to the warning letter received by the company for one of its units in Bangalore, Strides has agreed to a hold back of $250 million, which will be contingent upon satisfaction of certain regulatory conditions related to the injectable facilities in India. The company expects those conditions will be satisfied in 2014.

Since the initial announcement of this transaction, Strides now expects an additional expenditure of $150 million. This includes cost towards acquisition of additional assets from its erstwhile partners and an estimated remediation cost related to its regulatory commitments post the warning letter.

Arun Kumar, Founder and Group Chief Executive Officer said, “We are confident that Agila will play a significant role in Mylan’s growth strategy to become a global injectable leader. I am personally delighted that Mylan’s passion for its people will augur well for all the 1800 plus employees of Strides Group who are becoming part of the Mylan family with this acquisition.”

Jefferies International acted as exclusive financial advisor to Strides Arcolab on the sale of Agila. Moelis & Company acted as independent financial advisor to the Board of Strides Arcolab and also provided a fairness opinion in connection with the transaction.” Herbert Smith Freehills and DSK Legal acted as the company’s legal counsels on the transaction.

EP News Bureau – Mumbai

13 EXPRESS PHARMA December 16-31, 2013

COMPANY WATCH

UK partners with BioAsia as principal country partner Cipla acquires Croatiabased Celeris

Partners with BioAsia as principal country partner UK IS looking to forge closer ties with India which is considered to be a growing power in lifesciences industry. As part of this process, UK has now partnered with BioAsia as the Principal Country Partner for the 11th edition of the event, BioAsia 2014. The event will address aspects relating to the increasing disease burden, the need for more efficacious and affordable healthcare solutions, innovative products and operating models that could optimise R&D cost while increasing efficiencies, and innovative financing models.

Shakthi M Nagappan, Chief Executive Officer, BioAsia, said, “We are glad to have UK as our partner. India and UK have lot to offer to each other in lifesciences sector.

Both the countries understand the importance of innovation in life sciences which is also our theme for BioAsia 2014. Overseas organisations own more than over 35 per cent of patents in the UK compared to 12 per cent in the the US and less than four per cent in Japan. So we are sure this association will prove fruitful for both the parties.”

BioAsia 2014 will be held at the Hyderabad International Convention Centre Hyderabad from February 17 to 19 February 2014. The 10th edition of this industry event witnessed partnership with countries like Spain and Australia.

With the partnership of UK, BioAsia 2014 will witness delegates, regulatory body repre-

14 EXPRESS PHARMA December 16-31, 2013

Financial figures for the acquisition were undisclosed sentatives, industry captains, high profile speakers, etc, from both the countries participating in the event.

“Britain and India are natural cultural, social, commercial and scientific partners.

Our aim is to build a stronger, wider, deeper relationship based on shared culture, values, and strategic interests.

BioAsia has evolved over the past decade to present more opportunities to expand business and to enhance bilateral relationships. With the focus being on innovation in the eleventh BioAsia, it makes it even more appropriate for the UK to partner. UK and India have inherent strengths in life sciences and bringing them together will drive significant developments in the life sciences and healthcare sector,”said Andrew McAllister, British Deputy High Commissioner.

McAllister pointed out the key highlights of UK life-

sciences industry. “We are making it more attractive for companies to invest in the UK innovation through the introduction of schemes like: the Patent Box, which from April last year will have a 10 per cent rate of corporation tax for profits attributed to patents; by improving the R&D Tax Credits for SMEs; and by creating a more enabling regulatory environment. Joint investment in research has increased substantially over the last three years, making it the fastest growing bilateral research relationship for the UK. The portfolio of agreed joint funding on research now totals £150 million, up from just £1 million four years ago,” he added.

“UK is by far the most popular business destination in Europe for Indian companies. 700 out of the 1,200 Indian firms in the EU operate from the UK. A number of

Hyderabad-based life sciences and pharmaceuticals companies have set up successful businesses in the UK and are growing. Examples include Dr Reddy’s, Aurobindo Pharma, Vivimed Labs and Nandan Biomatrix among others. The biotechnology sector is one of the fastest growing knowledgebased sectors in India. So definitely there is ground for cooperation and synergy,” said K Pradeep Chandra, Principal Secretary, Dept of Industries, Government of Andhra Pradesh.

BioAsia 2014 will provide the right global platform for the country partners to interact with the lifescience leaders and key stakeholders. The key elements of these interactions will be breakfast meetings, b2b partnering meetings, delegations and trade body level meetings.

CIPLA'S WHOLLY-OWNED subsidiary Cipla Holding has acquired Croatia-based firm Celeris, distributor of its products in that country. According to a PTI report, Cipla, however, did not share the financial figure for which it has made the acquisition.

“Cipla Holding, a whollyowned subsidiary of the company, has acquired 100 per cent stake in Celeris, Croatia,” Cipla said in a filing to the Bombay Stock Exchange. The company is the distributor of Cipla’s products in Croatia, it added.

Commenting on the development, Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “Following our ambition to front end and establish a platform to market our own products, Celeris represented an opportunity for a ready-made platform, especially for our respiratory launches in Europe.”

EP News Bureau – Mumbai

EP News Bureau – Mumbai

COMPANY WATCH

Jubilant Life Sciences receives ANDA approval for Quetiapine Fumarate tablets Is indicated for the treatment of schizophrenia, and for the treatment of acute manic episodes associated with bipolar disorder JUBILANT LIFE Sciences has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for Quetiapine Fumarate tablet, 25 mg (base), the generic version of AstraZeneca’s Seroquel, which is an atypical antipsychotic medication indicated for the treatment of schizophrenia, and for the treatment of acute manic episodes associated with bipolar disorder.

The current total market

The current total market size for this product as per IMS is $59 million per annum. This product is expected to be launched in Q4 FY14 size for this product as per IMS is $59 million per annum. This product is expected to be launched in Q4 FY14. As on September 30, 2013, Jubilant Life Sciences had a total of 676 filings for formulations of which 218 have been approved in various regions of the world.

This includes 58 ANDAs filed in the US and 48 dossier filings in Europe.

EP News Bureau – Mumbai

15 EXPRESS PHARMA December 16-31, 2013

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COMPANY WATCH

Venus Remedies signs MoU for Elores with South African pharmaceutical firm Expects to generate a cumulative revenue of $20 million within five years of the launch VENUS REMEDIES has signed a memorandum of understanding (MoU) with South African pharmaceutical firm Austell Laboratories to exclusively outlicense its flagship product, Elores, in South Africa.

A novel antibiotic adjuvant entity that effectively counters serious hospital-acquired infections caused by multidrug-resistant extended-spectrum betalactamase (ESBL) and metallo-beta-lactamase (MBL)producing gram negative bacteria, Elores is likely to be launched in South Africa by mid-2015, said Pawan Chaudhary, Chairman and Managing Director, Venus Remedies The overall systemic antibacterial market of South Africa is worth $275 million and growing at a compound annual growth rate (CAGR) of 10.5 per cent.

Elores will cater to the needs of about 40 per cent segment of

this market. “Venus Remedies is projected to generate a cumulative revenue of $20 million within five years of the launch of Elores in South Africa,” said Chaudhary.

Globally, the systemic antibacterial market, which is growing at a CAGR of 7.2 per cent, is set to reach $44 billion by 2016.

The infections caused by multidrug-resistant ESBL/MBL-producing gram negative bacteria which Elores is capable of fighting comprise 25 per cent of this market, thus creating a tremendous opportunity for Venus Remedies.

The Patna Technology Expo was organised by the Federation of Indian Chambers of Commerce and Industry (FICCI) in association with the Department of Science and Technology (Government of India), Lockheed Martin Corporation, Indo-US Science and Technology Forum,

Venus Remedies has already filed the common technical document for Elores in Europe and is planning to take this product to other international markets with the support of Lockheed Martin Foundation, Union Department of Science and Technology, FICCI and all other associated bodies Stanford Graduate School of Business and the IC2 Institute, University of Texas, Austin. The event offered a unique platform to the top innovators to showcase their innovations and sign global marketing deals.

Dr Manu Chaudhary, Direc-

tor, Research, Venus Medicine Research Centre, who received the cash prize for Elores as the 'Number 1 Innovation of 2013', said, “We are delighted to be a part of this unique endeavour that not only identifies and appreciates the innovative tech-

nologies with commercial potential but also supports the innovators of these technologies by providing them entrepreneurship training and business development assistance for successful commercialisation in the global marketplace.”

She said, Venus Remedies had been participating in this innovation growth programme since 2010 and had received gold medals for its research products Ampucare, a wound-healing drug, and Trois, a nano-technology emulsion for arthritis, in 2010 and 2011, respectively. It has already filed the common technical document for Elores in Europe and is planning to take this product to other international markets with the support of Lockheed Martin Foundation, Union Department of Science and Technology, FICCI and all other associated bodies.

EP News Bureau – Mumbai

EMAapproves newtuberculosis drug delamanid Otsuka’s phase III clinical trials for delamanid are now underway THE EUROPEAN Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a conditional marketing authorisation for delamanid, only the second new TB drug to be developed in 50 years. It is hoped that the new drug, marketed by the Japanese company Otsuka, will be pivotal in improving treatment for drug-resistant forms of tuberculosis, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB).

16 EXPRESS PHARMA December 16-31, 2013

Current treatment regimens for drug-resistant forms of the disease--which are highly toxic, lengthy, expensive and effective only half the time-are entirely insufficient to mount an effective response to the disease.

Otsuka’s phase III clinical trials for delamanid are now underway. The CHMP decision means that the drug can be marketed in European Union Member States for the treatment of adult patients with pulmonary infections due to multidrug-resistant tuber-

culosis when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability.

Some EU countries, including Bulgaria, Estonia, Latvia, Lithuania and Romania, have very high rates of MDR-TB. Commenting on the approval, Dr Jennifer Cohn, Medical Coordinator, MSF Access Campaign said, “EMA’s approval is a landmark decision and a critical step towards better options for people in desperate need of more effective and safer treatments for drug-

resistant tuberculosis, but this is only one piece of the solution.

What patients really need are all-new multidrug regimens, and clinical trials to test delamanid with other TB medicines are urgently needed if we are to radically improve treatment options.”

To accelerate access and fully realise the potential of this new drug, Cohn emphasised the need for “open collaboration to test new multidrug regimens.” She also stressed that the drug needed to be registered widely espe-

cially in high-burden countries, with assurances that the drug won’t be priced out of reach of national TB programmes.

“In the meantime, seriously ill patients who have exhausted all other treatment options could be helped today if early access to the drug was made available through ‘compassionate use’ programmes, and we hope Otsuka considers opening such a programme,” she concluded.

EP News Bureau – Mumbai

COMPANY WATCH

Lilly enters branded generics market with launch of Lil Therapeutics Announces launch of drugs in breast cancer and colo-rectal cancer segment ELI LILLY and Company India has entered the branded generics segment with the launch of Lil Therapeutics, an expansion of its oncology division that will help expand delivery of cancer drugs to patients at an affordable cost.

India is the first country to witness the launch of branded generics from the house of Lilly. Today, Lilly launched four new drugs, Lilbecep

(Epirubicin), Lilmantro (Anastrozole) and Lilxapla (Oxaliplatin) and Lilrincan (Irinotecan) for the treatment of patients with breast cancer and colo-rectal cancer respectively. These molecules are well established and time tested across the treatment algorithm of oncology.

Lilly has been dedicated to delivering solutions that ac-

celerate the pace and progress of cancer care and enhance the lives of people living with cancer. In India, Lilly has cultivated a strong equity in the lung cancer segment with innovative brands Gemcite and Alimta. With launch of Lil Therapeutics, Lilly aims to expand patients’ access to high-quality cancer drugs.

Commenting on the development, Edgard A Olaizola,

Managing Director, Eli Lilly says, “Lilly is committed to improving outcomes for individual patients around the world. We understand that cancer medicines of the highest quality continue to be an unmet need in India and as a responsible organisation, we have been working over the years to make cancer drugs affordable to better serve Indian patients. This launch

reaffirms our commitment to reach more patients and play a leading role in fighting cancer in this country.”

He also mentioned, “Though Lilly is launching branded generics in the oncology segment, we will continue to discover and develop innovative new therapies for patients worldwide.”

EP News Bureau – Mumbai

17 EXPRESS PHARMA December 16-31, 2013

COMPANY WATCH

Cadila Pharmaceuticals and UK’s HelperbyTherapeutics in pact Helperby will supply Cadila Pharmaceuticals with antibiotic resistance breakers CADILA PHARMACEUTICALS and UK-based antibiotics discovery company, Helperby Therapeutics have signed a joint agreement on antibiotic drug resistance research and development. This is a major announcement in the fight against resistance with the discovery of patented ‘resistance breaker’ compounds.

These new compounds are called antibiotic resistance breakers. When an antibiotic resistance breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria. Antibiotic resistance breakers can potentially rescue several different classes of antibiotics. Furthermore, this approach requires the development of fewer novel compounds, is less risky and less costly than the traditional 'one antibiotic' route.

Elaborating on this tie up, Dr

...LAUNCHES ‘MYCIDAC-C’ THE DRUG is a first in the class active immunotherapy as well as drug targeting Desmocollin-3. It is a breakthrough in the management of squamous cell NSCLC. There has been no significant innovation in management of squamous NSCLC since the introduction of platinum containing doublet in 1983. Besides affordability and other advantages, Mycidac-C has no systemic side effects during the treatment. Mycidac-C is to be used with platinum containing doublet therapy. Mycidac-C can be administered easily by trained paramedics, thus further reducing the cost of hospitalisation associated with other cancer therapy.

Speaking at the launch, Dr Rajiv I Modi, Chairman and Managing Director, Cadila Pharmaceuticals said, “It has taken us over a decade, a huge investment and a dedicated research and development team to develop this unique drug. We expect it to be available in the Indian market by December 2013. Thereafter, we will introduce it in other regions like SAARC countries and European markets over the next five years.”

Dr T Ramasami, Secretary to the Government of India, Department of Science and Technology also commented, “Lung cancer is a major killer among all cancers. In this scenario, Mycidac-C is a new hope for the patients suffering form lung cancer, particularly for Indian patients.”

EP News Bureau – Mumbai

Rajiv I Modi, Chairman and Managing Director, Cadila Pharmaceuticals said, “This discovery will open new avenues

against resistant organisms and is very timely in view of global concerns about rapidly growing bacterial resistance against cur-

rent antibiotics. Cadila Pharmaceuticals’ collaboration with Helperby can help the mankind win the battle against the mi-

crobes and hopefully save millions of lives in coming years.”

Helperby will supply Cadila Pharmaceuticals with antibiotic resistance breakers whilst Cadila Pharmaceuticals will develop the combinations with old antibiotics. Helperby, a spin-out of the UK’s University of London, St George’s Hospital has been working for the past 12 years on ways to tackle antibiotic resistance and has discovered a new series of potent, fastacting drugs which rescue old antibiotics. Instead of targeting multiplying bacteria, the research team focused on nonmultiplying, dormant bacteria.

Developing antibiotics that specifically target these root-like bacteria has never been done before - in fact conventional methods of screening have consistently missed these promising candidate drugs.

EP News Bureau – Mumbai

Indegene launches US-based healthcare business division Will focus on engagement, quality, big-data, and payment transformation driven by US health reform INDEGENE ANNOUNCED its formal entry into the US payer and provider market through Indegene Healthcare (www.indegenehealthcare.com), the company’s new healthcare business division. Indegene Healthcare will leverage the company’s rich clinical and scientific expertise, engagement and analytics platforms, robust proprietary IP portfolio, and a global asset base to enable payers and providers thrive in the changing healthcare environment.

Dr Rajesh Nair, President, Indegene said, “Our solutions for the US healthcare market

18 EXPRESS PHARMA December 16-31, 2013

Indegene Healthcare will leverage the company’s rich clinical and scientific expertise, engagement and analytics platforms, robust proprietary IP portfolio, and a global asset base to enable payers thrive in the changing healthcare environment draw upon our significant clinical domain expertise, proprietary consumer and patient frameworks, multichannel assets, as well as a robust data analytics foundation. We have made significant investments

building out a comprehensive suite of proprietary products and solutions in the areas of patient and member engagement, quality improvement, health reform transformation support, care management,

and analytics.”

Headquartered in Iselin, NJ, Indegene Healthcare will focus on customers across North America, and existing payer and provider customers will now be serviced through Inde-

gene Healthcare.

According to Manish Gupta, Chief Executive Officer, Indegene, “Indegene Healthcare has embedded, within the division, multiple IP and delivery capabilities, including clinical and analytics expertise, multichannel engagement platforms, as well as an optional hybrid delivery structure to provide a scalable model. We expect our customers to benefit from this integrated approach and take full strategic advantage of the changes in the marketplace.”

EP News Bureau – Mumbai

COMPANY WATCH

Lupin receives FDAapproval for Generic Trizivir tabs LUPIN HAS received final approval for its Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base) / 150 mg / 300 mg from the United States Food and Drugs Admin-

istration (FDA) to market a generic version of ViiV Healthcare’s (ViiV)Trizivir Tablets, 300 mg (base)/150 mg/ 300mg.

Lupin’s Abacavir Sulfate, Lamivudine, and Zidovudine

Tablets, 300 mg (base) / 150 mg/ 300 mg is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection. Lupin was the first appli-

cant to file an ANDA for Trizivir tablets and as such will beentitled to 180 days of marketing exclusivity. Trizivir tablets, 300 mg (base)/ 150 mg/300mg had annual US

sales of approximately $ 111.6 million (IMS MAT Sep, 2013).

EP News Bureau – Mumbai

Glenmarklaunches Hydrocortisone Butyrate cream in the US GLENMARK GENERICS, USA, the subsidiary of Glenmark Generics, has launched Hydrocortisone Butyrate cream USP, 0.1 per cent in the US. The company received approval from the US FDA for Abbreviated New

Drug Application (ANDA) for its generic version of Locoid Lipocream on September 27, 2013.

Glenmark is entitled to 180 days of exclusivity with respect to its Hydrocortisone Butyrate cream, as it is the

first generic company to file an ANDA for the product. Hydrocortisone Butyrate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults and the treatment of

mild to moderate atopic dermatitis in patients three months to 18 years of age. According to IMS Health sales data for the 12 month period ending September 2013, Hydrocortisone Butyrate cream garnered annual sales of

approximately $ 36.8 million.

Glenmark’s current portfolio consists of 90 products authorised for distribution in the US marketplace and 56 ANDA’s pending approval with the US FDA. EP News Bureau – Mumbai

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Get the SeerPharma ‘Confidence in Compliance’ SeerPharma is Asia-Pacific’s premier consultancy with solutions across QA, GMP & GxP compliance, training, risk management, validation, IT, productivity and automated quality management systems.

Training conducted by David Spaulding, Training Manager and Senior Consultant at SeerPharma with over 30 Years in the pharmaceutical and medical device industries including senior manufacturing and commercial roles at GSK Australia.

Course Fee: GMP Introductory Course (3 Days) – Rs.16,854/GMP Advanced Course (2 Days) – Rs.13,483/GMP Introductory & Advanced Course (5 Days) – Rs.28,090/(Inclusive of Service Tax @12.36%) Certificate will be awarded to all participants

For details and course content see: http://labnetworx.com/gmptraining http://www.seerpharma.com.au Phone: +91-85273-17888 Email: gmp@labnetworx.com

19 EXPRESS PHARMA December 16-31, 2013

MARKET DEALTRACKER

Increasing product offerings with focus on significant opportunityfor future revenue growth drives M&Aactivity M&A activity in the pharma sector decreases in volume terms and increased in value terms

M&A (including private equity) trend analysis M&A ACTIVITY in the pharmaceutical sector was focused on strengthening product portfolios as companies look for significant revenue synergy opportunities.

In line with the above trend, Ireland-based Shire agreed to acquire ViroPharma, a US-based rare disease biopharmaceutical company, for approximately $4.2 billion. This transaction is consistent with Shire’s objective of strengthening its rare disease portfolio and also enhances its short and longterm revenue growth profile.

This acquisition is expected to create a $2 billion rare disease revenue base, while delivering strong growth prospects.

With this acquisition, Shire will gain access to CINRYZE, a leading brand for the prophylactic treatment of Hereditary Angioedema (HAE). CINRYZE, designated as an orphan drug and approved in October 2008, has grown rapidly since its launch in 2009 to generate revenues of $321 million in the US in 2012. CINRYZE has US orphan drug exclusivity which expires in 2015 and US biologics data exclusivity until 2020.

In another key deal, Salix Pharmaceuticals agreed to acquire Santarus, a specialty biopharmaceutical company, for approximately $2.6 billion.

The transaction solidifies Salix’s lead position as the largest specialty pharma company in the Gastrointestinal (GI) market with access to a strong GI

20 EXPRESS PHARMA December 16-31, 2013

the sector recorded deals worth $11.4 billion, against the previous six months’ average of $9 billion.

The Indian pharma sector witnessed two deals during November 2013, while the previous six months witnessed no activity at all.

Among them, US-based investment firm Kohlberg Kravis Roberts & Co’s agreed acquisition of a minority stake in Gland Pharma, an Indian generic injectable pharmaceutical products company, for approximately $200 million, is notable.

Source:

Venture funding Venture financing trend analysis

Companies in the pharma sector raised $262.3 million during November 2013, against the previous six months’ average of $241.9 million. In terms of volume, the sector recorded 17 venture funded deals, when compared to the previous six months’ average of 21.8 transactions.

Notes

Source:

portfolio comprised of UCERIS, ZEGERID, GLUMETZA, CYCLOSET and FENOGLIDE. This acquisition provides Salix with an experienced specialty sales force to significantly expand its

gastrointestinal product sales.

M&A activity in the pharma sector decreased in volume terms and increased in value terms, when compared to the average of the previous six months (May

– October 2013). According to Datamonitor’s Medtrack database, the pharma sector recorded 26 M&A transactions in November 2013, against the previous six months’ average of 31.6 transactions. In value terms,

Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. Inhouse analysts and researchers add key insights and conclusions to provide you with the primary

MARKET Top M&A deals (Nov 2013) Rank

Date

Target

Acquirer

Deal value ($m)

1

Nov 11, 2013

ViroPharma Incorporated (US)

Shire plc (IE)

4,200.00

2

Nov 7, 2013

Santarus, Inc. (US)

Salix Pharmaceuticals, Ltd. (US)

2,600.00

3

Nov 19, 2013

Patheon Inc. (US)

JLL Partners; Royal DSM N.V.

1,950.00

4

Nov 5, 2013

Paladin Labs, Inc. (CA)

Endo Health Solutions Inc. US)

1,600.00

5

Nov 19, 2013

EOS S.p.A. (IT)

Clovis Oncology, Inc. (US)

420.28

6

Nov 27, 2013

Gland Pharma Limited (IN)

Kohlberg Kravis Roberts & Co. L.P. (US)

200.00

7

Nov 26, 2013

Jennerex Biotherapeutics, Inc. (US)

SillaJen, Inc. (KR)

150.00

8

Nov 20, 2013

Callidus Biopharma, Inc. (US)

Amicus Therapeutics, Inc. (US)

130.00

9

Nov 18, 2013

GANYMED Pharmaceuticals AG (DE)

ATS Beteiligungsverwaltung GmbH; MIG Verwaltungs AG; 60.74 FCPB Gany GmbH

10

Nov 7, 2013

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical China New Enterprise Investment Co., Ltd. (CN) Co., Ltd. (CN)

a25.40

Source:

Top venture financing deals (Nov 2013) Rank

Date

Target

Investors

Deal value ($m)

1

Nov 25, 2013

Editas Medicine (US)

Flagship Ventures; Polaris Venture Partners; Third Rock Ventures, LLC; Partners Innovation Fund

43.00

2

Nov 15, 2013

Catabasis Pharmaceuticals, Inc. (US)

Lightstone Ventures; SV Life Sciences; Clarus Ventures, LLC; MedImmune Ventures, Inc.; Advanced Technology Ventures; (Other) 32.40 Undisclosed Investors

3

Nov 18, 2013

MISSION Therapeutics, Ltd. (GB)

Pfizer Venture Investments; Sofinnova Partners; Imperial Innovations; SR One; Roche Venture Fund

32.24

4

Nov 18, 2013

Aileron Therapeutics, Inc. (US)

Excel Venture Management; Apple Tree Partners; Roche Venture Fund; Novartis Venture Funds; Lilly Ventures; SR One

30.00

5

Nov 20, 2013

Pulmocide, Ltd. (GB)

Johnson & Johnson Development Corporation; SV Life Sciences; Fidelity Biosciences; Imperial Innovations Group PLC

27.38

Source:

and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen po-

22 EXPRESS PHARMA December 16-31, 2013

tential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and develop-

mental benchmarking.

Definitions 1. Deal value trend is based on

transactions where associate values have been disclosed.

2. Trend analysis excludes rumored and terminated deals.

3. Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

MARKET PRE EVENT

National annual conference of cancer NGOs and support groups to be held in Mumbai 165 NGOs from India, SAARC countries will participate in the event THE FIRST national annual conference of cancer NGOs and support groups will be held at Tata Memorial Hospital, Mumbai from December 19 to 21, 2013 under the name of Can-India Conclave. The conference will bring together 165 NGOs from India, several from other

SAARC countries and also participation from international cancer NGOs. Participation has been confirmed from NCI, USA, International Kidney Cancer Foundation, American Cancer Society, SIOP and Lymphoma Coalition). Key Indian organisations like HDFC Bank, Deloitte,

Edelweiss are supporting the event.

On December 19, 2013, a competition Can-Champ will be held wherein cancer survivors and patients will perform. On December 20, 2013, awards will be given under various categories to deserving cancer NGOs and

support groups, certified by Deloitte.

A high level panel discussion will be held on the same day at Auditorium Complex. The panel discussion 'Curbing CancerTsunami in India', will discuss the magnitude of the problem and strategy to address them.

This will be moderated by Hasit Joshipura, Managing Director, GSK Asia. Dr Rajan Badwe, Director of Tata Memorial Centre, Priya Dutt, film director Anurag Basu, actor Rahul Bose and Deepak Parekh, Chairman, HDFC will take part in the event.

EP News Bureau – Mumbai

POST EVENTS

Bangalore INDIANANO puts India on forefront of nanoscience and nanotechnology Showcases a plethora of discussions, lectures and presentations on nanoscience and nanotechnology THE 6th edition of Bangalore INDIA NANO, the annual Nanoscience and Nanotech event, organised by the Department of IT, BT and S&T, Government of Karnataka recently concluded on a high note. The event showcased a plethora of discussions, lectures and presentations on nanoscience and nanotechnology. The event was held under the able guidance of the Vision Group on Nanotechnology led by Prof CNR Rao, FRS, National Research Professor; Linus Pauling Research Professor; President, JNCASR; Chairman, Science Advisory Council to the Prime Minister of India; Chief Mentor Bangalore INDIA NANO; Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and MM Activ Sci-Tech Communications.

The event was inaugurated

Bangalore INDIA NANO conference has been unique in the sense that it combines academic, research and the industry, which brings products from the academic research to the industrial world

by Siddaramaiah, Chief Minister, Karnataka, in the presence of CNR Rao, Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology and (DPAR) e-Governance, Government of Karnataka, Prof AK Sood, Department of Physics, Indian Institute of Science (IISc), Bangalore. Prof CNR Rao Bangalore INDIA NANO Science 2013 Award was presented to Prof Ashutosh Sharma, IIT, Kanpur. Nobel laureate Prof Sir

Andre Geim, Regius and Royal Society Research Professor School of Physics & Astronomy, University of Manchester, UK was honoured.

Siddaramaiah reiterated Karnataka’s commitment to provide the necessary eco-system for the development of industry.

Several recommendations are being considered on initiatives for the growth and development of nano science and technology.

A report by MM Activ SciTech Communications on the previous five editions which en-

capsulates the evolution and surge of nanotechnology in India through the platform of the Bangalore INDIA NANO titled ‘Creating Growth Opportunities for Indian Nanoscience & Nanotechnology’ was released. A first of it’s kind ‘Indian Nanotechnology Industry & Institutions Directory’ compiled by CKMNT (Center for knowledge Management of Nanoscience & Technology), Department of Science & Technology, Government of India was released at the inauguration function. The nanotech

sector is rapidly growing and with India being one of the front runners in nanotech research, such a compilation would facilitate industry-academia collaboration, which is very critical for the development.

Bangalore INDIA NANO conference has been unique in the sense that it combines academic, research and the industry, which brings products from the academic research to the industrial world. The experts felt this was not a trivial task hence it was important for researchers and industry to present their work in a conference like Bangalore INDIA NANO and discuss it with stakeholders who can provide the means to go forward.

Cumulatively, organisations from 11 countries like The Netherlands, South Africa, the US, the UK, Japan, Germany,

23 EXPRESS PHARMA December 16-31, 2013

MARKET

Singapore, Israel, China, Austria and Canada participated in the event. The conference sessions under the guidance of Prof AK Sood, Chairman, Conference Executive Committee and its members focused on food & agriculture, healthcare and medicine, energy and water management, advanced materials.

The keynotes were addressed by Prof Reshef Tenne, The Drake Family Professor of Nanotechnology, Materials Scientist, Physical and Inorganic Chemist, Department of Materials and Interfaces, Weizmann Institute of Science, Rehovot, Israel; Prof Mercouri G Kanatzidis, Professor, Dept of Chemistry, Northwestern University, US; Dr Thomas Thundat, Professor, Dept of Chemical and Materials Engineering, Canada Excellence Research Chair in Oil Sands Molecular Engineering University of Alberta,

Canada; Prof Dr Horst Hahn, Executive Director, Karlsruhe Institute of Technology (KIT), Institute for Nanotechnology, Germany and Prof Ashutosh Sharma, Institute Chair Professor and CV Seshadri Chair Professor, Department of Chemical Engineering, Indian Institute of Technology, Kanpur.

This edition also featured a pre-conference tutorial which saw an active participation from researchers and students. Another initiative was ‘Nano for the Young’ session which had an overwhelming response, not only from students but from senior scientists.

Bangalore INDIA NANO 2013 featured 50 exhibitors from across the globe including Germany Pavilion and an exhibitor each from Korea and Japan. The special DST Nano Mission Pavilion was represented by 11 members. The exhibition turned out

to be an excellent platform for nanotech research fraternity, industry, start ups and corporates to connect for mutual benefit and showcase cutting-edge research work, innovative technologies and products for commercial applications. The exhibition attracted over 2000 visitors.

The leading exhibitors included Scrum from Japan; AXO Dresden, VDI Technologiezentrum, Germany Trade and Invest, Initiative Nano In Germany from Germany; Nano Technology Research Association from Korea; and Agilent Technologies, Tata Chemicals, Bruker, Horiba Scientific, Indian Oil R&D, Amity University, VTU, UK Trade and Invest, leading IITs, Jain University, Indian Institute of Science, Institute of Nano Science and Technology, Inventys Research Company, Jawaharlal Nehru Centre For

Advanced Scientific Research (JNCASR), Labindia Nanobio Process, Mosiab Technologies, National Mineral Development Corporation (NMDC), UK Trade & Investment, and Visvesvaraya Technological University (VTU) from India.

Best Exhibitor Awards 2013 were given to four exhibitors; The Germany Pavillion for Content & Information category, TATA Chemicals for Interactive & Best Managed category, IIT Madras for Creative Design and Indian Oil R&D for innovative display.

The Bangalore INDIA NANO Innovation Award 2013 was given to RESIL CHEMICALS for their Antibacterial nanosilver synthesis technologies for textile products and the Malhotra Weikfield Foundation Nano Science Fellowship Award 2013 to Five researchers for their papers.

Young scientists and Researchers from various institutions and international Universities showcased several new concepts and ideas in the Poster Session. Overall 115 posters were displayed by the researchers.

The Best Poster Awards 2013 was bagged by K Gopalakrishnan of JNCASR for the poster titled 'Extraordinary Supercapacitor Performance of Heavily Nitrogenatedgraphene Oxide, the second place was bagged by Ranjith Ramachandran from Amrita Centre for Nanosciences & Molecular Medicine, placed third was P Vineeth Mohanan from IISc and the fourth and fifth place was bagged by Deepak Kumar Khajuria AlAmeen College of Pharmacy and Parth Dadhania from Indian IIT respectively.

EP News Bureau – Mumbai

CPhI - India,P- MEC-India showpath for success The 2013 edition witnessed participation from 1000 plus exhibitors from 95 countries Sachin Jagdale & Usha Sharma Mumbai HUGE CROWDS thronging stalls and booths, inquisitive visitors making inquiries about products is a usual sight at the CPhI-P-MEC India. This year's exhibition too stood up to its reputation, which was visited by industry professionals and experts from India and overseas. Exhibitors were particularly delighted as this event largely helps them to consolidate their client lists. The 2013 edition witnessed participation from 1000 plus exhibitors from 95 countries, and was attended by nearly 30,000 attendees from 109 countries.

One of the exhibitors, Ashvin Patel, Business Director, IMCD India, said, “At CPhI India we get quality people, which matters the most to us. New clients are always important but we also

24 EXPRESS PHARMA December 16-31, 2013

This year’s exhibition too stood up to its reputation, which was visited by industry professionals and experts from India and overseas want to retain our persent customers. We want to grow with both our new and existing customers.”

Vijay Ramanavarapu, Procurement Head, Granules India, echoes Patel's views. He said, “CPhI India is an useful event for Granules because it is an opportunity to meet with our customers and suppliers.” He adds, “Given how there are multiple CPhI events around the world, we can constantly connect with our key customers and suppliers which helps us facilitate our business. CPhI is also useful to understand market dynamics as well as meeting new suppliers and customers.”

ACG has always remained one of the most visited and sought after stalls at P-MEC. While reiterating that such events do give a chance to meet customers, Dr Shirish Dhande, Executive Director and Chief Executive Officer, ACG Pam Glatt Pharma Technologie informs that P-MEC India also allows industry professionals to learn and keep abreast of new technologies. He says, “We get to meet international and domestic clients at P-MEC India. Besides retaining old customers we always get new customers as well.

Here at P-MEC, we get to know new perspectives of our clients about our machinery. As every

year, this year too, we are getting good response from our clients.”

Visitors also attended technical seminars. Speakers from India and abroad presented their views on different topics. One of the speakers, Dr Pramod Kharatmol, Application Scientist (Bioprocess Development), Avantor Performance Materials India, opined about the importance of such seminars. He says, “The technical seminars always give more knowledge in less time. Also, they represent the current, most demanding trends in the market. Technical seminars increase the awareness of industrially driven objectives and they are very useful for col-

laborations and getting acquainted ourselves with new necessary things.”

Arjun Khurana, Managing Director, Officina Farmaceutica Italiana (OFI) said, “For us, participating in CPhI India has become a nice opportunity to meet global exhibitors at a single platform.”

Sunny Bali, Deputy Manager International Marketing, IOL Chemicals and Pharmaceuticals mentioned, “This is a great platform to connect with our customer and initiate for newer one.

We have been participating in this event for almost seven to eight years now and seen growing this event every year. We are exporting our products to 60-70 countries and this gives us an opportunity to meet our old clients and distributors. For us this years CPhI India experience was good. During the show, we have received a good number of business inquiries and post the

MARKET

event we will work on these.”

Girish M Dhameja, Exports Manager, Coral Laboratories opined, “This year we have seen quality crowd during the (CPhI India) show. I am very optimistic this time and hoping that it will capitalise my investment which I have already invested in participating the event. For me this is a quite enriching and learning experience.”

Suresh Pareek, Managing Director, Ideal Cures said, “The size of the (CPhI India) event is getting larger year by year and since 2008 we have been facing infrastructure problems. In the evening it becomes chaotic and very difficult to reach our destinations. Apart from this, this is

a good event to meet our old customers and gradually the show is becoming a meeting point.

This year we have launched our new mobile app and we have received good response for it from our customers and visitors.

When we compare the global CPhI with CPhI India we feel there is less participation from North America, Europe and African countries.”

Vikas Acharya, Director India, Gerresheimer Pharmaceutical Packaging, said, “From day one itself we have received overwhelming response at our stall.

We feel that this time and basically this show is becoming networking platform for people like us. Also, we felt that visitors do

not come with serious business in mind. However, we are happy because we had pre-planned our meetings for all three days and accordingly we maintained and managed to get maximum out of it. Also, I like to highlight that inspite of spending so much amount for participating in the show there is no proper logistical support.”

Rahul Dev, Vice President Operations India, Datwyler opined, “This year we have registered a good turnout. In fact, on the first day of the show, the number of participants were overwhelming which we were actually not anticipating. I strongly feel that UBM has to seriously look after the infrastruc-

ture part. When we talk about the CPhI - P-MEC show, we talk about high-end technologies, life saving drugs but when we go out of the event venue we really get scared with the traffic conditions. International visitors have had a really bad experience and feel that the China event is any time better.”

Melanie Cacciottolo, Global Marketing Manager - Pharma Nutrition and Functional Ingredients, Kerry Ingredients and Flavours, said, “Like every year, this year too we have received a good amount of crowd at our store. During the event, we came to know about new technologies which were introduced in the market and other things associ-

ated with the pharma industry. I feel that this event is becoming one stop solution. I suggest that UBM should look around for a bigger venue as the event is growing every year and considering this they should work on finding new venues.”

Thus, barring logistical issues, the feedback from this year's CPhI India and P MEC India were extremely positive. The organisers have a year to work out these wrinkles and given their global track record, the 2014 event promises not just to be bigger but also a smoother experience.

Sachin.jagdale@expressindia.com u.sharma@expressindia.com

EVENT BRIEF DECEMBER - FEBRUARY 17

5th FICCI-HADSA Nutraceutical Conference

5TH FICCI-HADSA NUTRACEUTICAL CONFERENCE Date: January 17, 2014 Venue: Sci-Tech, Jogeshwari, Mumbai Summary: The objective of this conference is to enable nutraceuticals stakeholders to understand the'Business Dynamics of Nutraceuticals in India’. Discussions will be held on issues such as implications of regulations, product development, supply chain management, commercialisation and financial challenges.

The summit aims to provide an opportunity to the Indian nutraceutical / dietary supplements industry to network and interact with various representatives of government and semi-gov-

17

11th edition of BioAsia

ernment institutions along, with other stakeholders from private sector, financial institutions, R&D to further resolve challenges being faced by this industry.

Contact details Nandini Aggrwal Asst Director - Wellness and Nutraceuticals Federation Of Indian Chambers Of Commerce & Industry 33-B, Krishnamai Sir Pochkhanwala Road Worli, Mumbai - 400030.

Tel: (022) 2496 8000 Mob: 9869132887 Email: nandini.aggrwal@ficci.com

11TH EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre

Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’.

BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas.

The goal is to highlight innovation as the driver of the lifesciences economy in the coming years.

In addition, a parallel event AgBioAsia focusing on health and nutrition with the

24

CPhI Quality by Design

theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA).

Contact details Paridhi Gupta Tel: 040 66446477

CPHI QUALITY BY DESIGN Date: February 24 – 26, 2014 Venue: Kuala Lumpur, Malaysia Summary: CPhI – Quality by Design will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical

industry in Asia to implement QbD to compete in the global arena. This event is a unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how.

URL: http://www.qualitybydesignasia.com/?utm_campaign=EVENTLI STING&utm_medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&utm_content=URL&utm_term= Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

25 EXPRESS PHARMA December 16-31, 2013

MANAGEMENT

26 EXPRESS PHARMA December 16-31, 2013

Companies Bill 2012’s two per cent mandate for CSR has evoked mixed reviews from the pharma industry.

Some have welcomed the move, while some feel that CSR shouldn’t be forced.

However, they are unanimous in their opinion that there is a need to make the rules more transparent

By Sachin Jagdale

The government is well-meaning in its endeavour to make CSR more of a compulsory social responsibility for corporates as opposed to corporate social responsibility which is voluntary in nature Ranjit Shahani Vice Chairman and Managing Director, Novartis India

There is no need to make compulsory what is already logical, and that meets the objectives of beneficiaries and the organisation Aparna Thomas Senior Director- Communications (India & South Asia) & Public Affairs and Corporate Social Responsibility (India), Sanofi India

Redefining CSR

T

he Indian government has framed several public policies to address the various social issues in the country. However, the government wants the corporate sector in India as well to get involved to a certain extent in the upliftment of the society.

Indian Government's Companies Bill 2012 expects pharmaceutical companies to spend

two per cent of their net profit for the community. The companies on the government’s radar are those with a net worth of `500 crores or turnover of ` 1,000 crores or an average net profit of ` five crores in the last three financial years. As several industry players are already very active in Corporate Social Responsibility (CSR), enforcing the clause of mandatorily spending two per cent of their profits has not gone down well with everyone. It has also raised several serious queries.

Should CSR be made voluntary?

According to Ranjit Shahani, Vice Chairman and Managing Director, Novartis India, the government's intentions are good and everybody should do their share for the wellbeing of the society. However, he also points out that CSR should not be forced and it should come from organisation's own drive or will. By forcing it, organisations will end up doing things just for the sake of doing them.

Shahani says, “Society has two kinds of norms, those that

should and must be mandated and those that are better kept voluntary and self-regulated.

The government is well-meaning in its endeavour to make CSR more of a compulsory social responsibility for corporates as opposed to corporate social responsibility which is voluntary in nature.”

However he also adds, “CSR requires a human touch and this would be missing if it were to be mandated for then it will be reduced to a ticking of the box to ensure that it has been done. It would be better for

companies to be actively encouraged to exercise their social responsibility. It is important for all stakeholders to come together to work for the overall good of society.”

Shahani insists that finally the primary responsibility for its people lies with the government.

As mentioned earlier, there are pharma companies who are already investing a considerable portion of their net profit for the CSR activities.

Jubilant Life Sciences is one of them.

27 EXPRESS PHARMA December 16-31, 2013

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CSR INITIATIVES BY NOVARTIS This company has been active in the area of CSR since the year 2007, much before the CSR Bill became an Act under the Companies Act 2013.

Vivek Prakash, General Manager, CSR, Jubilant Life Sciences says, “As Jubilant’s engagement with the community goes back a long way, we welcome the government’s mandate for CSR spending by Indian companies as it constitutes in being a good corporate citizen. We are glad that our approach towards CSR is in alignment to the prerequisites as listed in the Companies Act 2013. Today, CSR is way beyond philanthropy and is a much wider concept than before.

It is no more about giving profit rather it is about responsibly sharing a portion of the company’s profit to bring inclusive growth.”

Choice should be yours?

The pharma companies also feel that they should be allowed to support the CSR initiatives of their choice because then they can deploy their own skill sets and resources in the best possible way. Making companies toil on something that they do not have skills or resources for, would not lead to effective CSR. Infrastructure, different cultural values, work force, finances etc are some of the factors that should be taken into account before assigning CSR responsibility to the company.

So, allowing companies to choose their own field of CSR may perhaps guarantee better CSR implementation.

Shahani says, “Why just

Making companies toil on something that they do not have skills or resources for, would not lead to effective CSR

28 EXPRESS PHARMA December 16-31, 2013

Glivec International Patient Assistance Program (GIPAP): This program was set up by Novartis to provide access to Glivec to those patients suffering from CML or GIST. Currently 95 per cent of patients i.e. more than 16,500 patients prescribed Glivec receive it completely free of charge.

Since inception of the programme in 2002, the company has so far distributed Glivec valued at more than $ 1.7 billion absolutely free of charge.

Novartis Comprehensive Leprosy Care Association set up by the Novartis Foundation for Sustainable Development in 1989 provides patients access to treatment and disability management and facilitates physical and social care. Novartis is committed to eliminating leprosy from the world through its donation to WHO of the drugs required to treat leprosy. India, with 70 per cent of the world’s cases of leprosy, is the largest beneficiary of these drugs.

The generics arm of Novartis, Sandoz, sponsors two Child Support Centres and a Vocational Training Centre as well as a Women’s Empowerment Centre near their facilities at Turbhe and Kalwe in association with the NGO Arambh.These centres have helped children who are otherwise used as child labour and also helped increase the employability of people from the surrounding slums.

The Indian School of Business scholarship: A yearly scholarship of ` 12 lakh is divided among three needy women students with excellent academic credentials coming from middleclass backgrounds. Novartis has been doing this for the last eight years.

Akanksha: For several years now Novartis has participated in the Standard Chartered marathon with the amount committed to an Akanksha centre for the education and health of underprivileged children.

Garden: Novartis agreed to develop and maintain a garden on a plot of land belonging to the Nehru Centre.The company spent ` 45 lakhs to develop the garden and is committed to maintaining it for a period of thirty years until 2031 and thereafter on mutually agreeable terms.This has provided succour to a greenery starved Mumbai and serves as a healthy lung to this concrete jungle.

The company believes it owes it to society to sensitise its own employees on areas related to Corporate Social Responsibility. Novartis Community Partnership Day is a worldwide initiative aimed at helping local communities in useful, practical ways, in social or environmental projects.

It usually takes place around 23rd April, the date of the Ciba-Sandoz merger that marked the creation of Novartis. In India hundreds of employees are involved in community work over a whole week in April.

CSR INITIATIVES BY SANOFI INDIA Community programmes ■ Saath 7 – Patient support in diabetes management for over nine years.

■ Close to our manufacturing plant in Ankleshwar, we have associated with SEWA Rural hospital for blood sugar level testing of the local community.

■ Commitment to the health of children near Sanofi’s Goa manufacturing site through regular health check-ups and referral of cases to tertiary care centers. Our Goa plan employees also volunteer at these camps.

■ Employee Volunteer Groups – Sanofi mentors underprivileged children in Mumbai schools through the programme ‘Gyan Express’. The employee volunteers have also been involved in planting saplings.

■ Employee donations – Contributing clothes and money to survivors during natural calamities Community partnerships ■ Childline (Call: 1098) – A 24-hour free helpline service for children ■ Aiding the government in diagnosing, treating and controlling tuberculosis through an NGO called InterAide.

pharma companies, all companies should be allowed to choose the area where they are best able to make a difference.”

Aparna Thomas, Senior Director- Communications (India & South Asia) & Public Affairs and Corporate Social Responsibility (India), Sanofi India feels, “In order to be effective, CSR must be integrated with the company’s business. The activities undertaken should be mutually beneficial for the business entity, its stakeholders and the community, for it to be sustainable and meaningful. As an integrated healthcare company, we have long engaged in multiple initiatives that are relevant to our business, our customers and stakeholders, and that testify to our deeprooted sense of corporate responsibility.”

CSR focus: Narrowed or comprehensive?

For companies like Novartis, Jubilant Life Sciences or Sanofi India, CSR is nothing new. For last many years, these companies are voluntarily involved in the activities meant for society’s wellbeing. However, the government's decision directs the corporate sector to focus on particular areas of socialdevelopment.

Though areas specified by the government cover many important fields of development, many companies might be already working on social issues that are not mentioned in government's directive.

So, what would be the fate of such endeavours and their beneficiaries? Would the companies have to put in more time, efforts and most importantly money for fulfilling the government’s mandate?

According to Shahani, much of the work that is being done by companies will continue and will in fact expand.

“Our approach is of a partnership and we are glad that when the CSR Bill was passed, we did not have to move out from any of our existing projects. The scope of activities, under the Act, is very elaborative and the areas where we have been focusing – health, education and livelihood are included

Today, CSR is way beyond philanthropy and is a much wider concept than before.

It is no more about giving profit rather it is about responsibly sharing a portion of the company’s profit to bring inclusive growth Vivek Prakash General Manager, CSR, Jubilant Life Sciences

in the list of Schedule VII of Section 135,” says Prakash.

Thomas opines, “Typically, companies in the healthcare business have CSR focus and activities in areas that are linked to health (e.g. education, awareness and screening) and their concerned stakeholders.

Hence, there is no need to make compulsory what is already logical, and that meets the objectives of beneficiaries and the organisation.”

Expanding horizons Pharma companies have never said no to CSR. Almost all of them justify the stand taken by the government, which is quite expected also.

However, there are very few companies which have taken their CSR activities to the national level. If a company wants to earn profits by doing business all over India then the scope of their charity should also be across India. A large chunk of pharma companies have limited their CSR work around areas which are in the close vicinity of their manufacturing plants or corporate offices. Any kind of charity is welcomed, but such pharma companies should now spread their noble initiatives beyond their company locations. sachin.jagdale@expressindia.com

MANAGEMENT I N T E R V I E W

It is high time that CCI takes steps to curb anti-competitive settlements Approximately 10-15 cases of 'Pay for Delay' exists around the world and these numbers will increase in future given the recent enforcements by EU, US and UK Competition Authority. In India, CCI has not come out with any specific regulations for the pharma industry but internal studies and ongoing market research predicts that it may institute cases suo motu against some pharma companies suspecting of having entered into such deals under Section 3 (3) (dealing with cartel) and section 4 (dealing with abuse of dominant position) of the Competition Act,2002. MM Sharma, Head-Competition Law and Policy, Vaish Associates Advocates speaks to Usha Sharma about the strategy What is meant by the term ‘Pay for Delay’? How frequently is the strategy used in the pharma industry? Do Indian players also use this strategy?

Pay for Delay means that patent holder drug makers (originators) use a number of strategies to extend the exclusivity period of their patented drug in order to prevent the market entry of generic drug suppliers (generics) on or before the expiry of their patents.

One such tactic adopted by originators is paying the generics for delaying entry of the generic drug and thereby buying time of

exclusive supply for the originator's drug. It is not yet confirmed with any evidence whether this practice is adopted in India by the Indian domestic pharma companies or not.

However, European Commission in 2009, started an investigation into the Indian generics Unichem Laboratories, Matrix Laboratories and Lupin along with the originator French firm Les Laboratoires Servier for potentially delaying the generic entry of perindopril by entering into various patent settlement agreements. On June 19, 2013, the European Commission

29 EXPRESS PHARMA December 16-31, 2013

MAMANAGEMENT

imposed a fine of euro146 million on nine drug makers including Ranbaxy, for blocking the entry of cheaper generic drug suppliers to the market.

Pharma companies get 20 years of patent life, then why do they still resort to this strategy?

This strategy is adopted to avoid costly and lengthy patent litigation between originators and generics, who, respectively, would defend and refute the evergreening of the originator’s patent. The motivation of the originator comes from the fact that drugs are generally left with only eight years of exclusivity after they enter the market. A patent's life is 20 years. This period includes, but is not limited to, the period of establishing validity of the patent after it has been filed, which may take 12 years on an average.

These deals are a win-win for the generics as much as they are for the originator. The originators' drug prices stay high and the profits of the originators' monopoly are shared with the generics.

Some original research companies as well as generic companies have resolved their patent disputes through settlement agreements that compensated generics for substantially delaying the entry of low cost generic drugs on to the market.

Any agreement that eliminates potential competition and envisages sharing the resulting profits is at the core of what the competition laws prescribes. How then is this practice still in use globally?

Yes. This practice is popular because such agreements between originator and generic companies, which are an extension of the original

30 EXPRESS PHARMA December 16-31, 2013

licensing agreements for the commercial exploitation of the original patent, were not viewed earlier as anticompetitive in the US and enjoyed a sort of antitrust immunity. Since the recent judgement in Actavis, in June 2013, this position is slowly going to change as such agreements will now be viewed as anti-competitive and examined by the ‘rule of reason’ approach globally.

'Pay for Delay' brings monopoly in the market which has a direct impact on patients. What do you have to say on this?

Pay for Delay deals, in effect, buy the originator protection from competition, at the expense of the consumer, whose access to lower-priced generic drugs is delayed, sometimes for many years. Consumers miss out on low cost generic drugs, which may be as much as 90 per cent less than originators' prices. For instance, if the originators' medication costs $330 a month during its exclusivity period, it may be sold by generics for as little as $3 a month after the expiry of the exclusivity period. Empirical evidence shows that the average price of a drug can drop by 90 per cent in the first two years after the entry of the first generic in the market.

A day after the US Supreme Court ruled that US antitrust enforcers can pursue 'Pay for Delay' cases in the pharma industry, on June 19, 2013 the European Commission imposed a fine of euro 146 million on nine drug makers including Denmark's Lundbeck, India's Ranbaxy, the UK's Arrow generics and US Zoetis Products, among others, for blocking entry of cheaper generic drug suppliers to the market.

A patent's life is 20 years.

This period includes, but is not limited to, the period of establishing validity of the patent after it has been filed, which may take 12 years on an average.

These deals are a win-win for the generics as much as they are for the originator MM SHARMA, Head-Competition Law and Policy, Vaish Associates Advocates

Will such action by regulators dissuade pharma companies from pursuing the pay for delay strategy in the future?

Hopefully yes. Rationally, any competition authority will now view such agreements seriously and besides passing a cease and desist order against infringer company may also impose heavy penalty which is most likely to act as a deterrent factor. Recidivist company will be fined double the penalty imposed earlier.

Some Competition Authority like US treat such repeat offence as criminal in nature.

'Pay for Delay' deals are considered to be a bad choice and it is assumed that the competition authorities across the globe are now anticipating the need to tackle the repercussions of similar deals in their own jurisdictions. Why is it so?

How do regulatory authorities plan to compete with this phenomenon?

Pay for Delay deals, being very lucrative for both the originator and the generic companies, are likely to be viewed seriously in all jurisdictions, including India. In the recent study initiated by the Competition Commission of India (CCI) this must have been included.

To tackle this menacing problem, which most likely has global dimensions since the originator companies are mostly in the developed world and the generics are mostly in the developing economies like India and China, competition authorities may take help of the provisions such as antitrust cooperation memorandum of understanding (MoUs) to be signed with their counterparts in the other jurisdictions to tackle this menace.

Indian pharma companies have established their presence in the global market through generic drugs. In this scenario will the 'Pay for Delay' strategy be the best choice for Indian players?

Financially, it may be the best choice for some drug makers but it’s prohibited under Indian Competition Law. How does 'Pay for Delay' strategy affect competition in the pharma sector and which regulations have been outlined by the CCI for the pharma industry?

'Pay for Delay' strategy is harmful not only to the drug producers in the Industry as it de-motivates new research for new molecules due to heavy reliance on ever greening of molecules etc. at the same time it is very harmful for the consumers.

CCI has not come out with any specific regulations for the pharma industry till now but, on the basis of its internal studies and ongoing market research, it may institute cases suo motu against some pharma companies suspecting of having entered into such deals under Section 3(3) (dealing with cartel) and section 4 (dealing with abuse of dominant position) of the Competition Act, 2002.

How many 'Pay for Delay cases' have been registered in the pharma sector in last three to five year period and is it likely that these numbers will increase in future?

Approximately 10-15 cases around the world. No case has been registered in India so far. Numbers will increase in future given the recent enforcements by the EU, the US and the UK Competition Authority.

MANAGEMENT

CCI also has the power to make recommendations to Central Government to project the need for a tighter law, like the Medicare Prescription Drug Improvement and Modernization Act 2003 (MMA) of the US

What regulatory reforms would you like to suggest to curb 'Pay for Delay' strategies in the Indian context and why?

According to me, the strict enforcement of the relevant provisions of the Competition Act, 2002 (the Act) by CCI is the only solution. There are ample provisions in the Act to deal with such anti-competitive agreements under the garb of protecting patent rights. Other mild method such as guidelines etc. may not work in the Indian context, as per my experience of trying to spread the message of competition through competition advocacy,while working in CCI, prior to the commencement of the enforcement in May, 2009. CCI also has extraterritorial jurisdiction to undertake an inquiry into such an agreement or an abuse of dominance that may have been executed outside of India so long as there is an effect on competition felt within India.

(Section 32 of the Act). Hence, in my view, it is high time that the CCI take concrete steps by considering launching a sector inquiry into the industry to curb such anticompetitive settlements.

Besides, effective enforcement of the existing statutory provisions of the Act, CCI also has the power to make recommendations to Central Government to project the need for a tighter law, like the Medicare Prescription Drug Improvement and Modernization Act 2003 (MMA) of the US. (In order to bring these illegal practices out of the shadows, US Congress, on recommendations

from the FTC, enacted the Medicare Prescription Drug Improvement and Modernization Act 2003 (the MMA) under which pharma companies are required to file certain agreements with the FTC and the US Department of Justice within ten days of their execution) given its mandate of “protecting and promoting� competition, under its competition advocacy initiatives (Section 49 of the Act).

The CCI could also take advantage of its antitrust co-operation pacts with its counterparts. In the past year, the CCI has signed a MoU on Antitrust Co-operation with the Federal Antimonopoly Service of Russia, the US Department of Justice/FTC and the Australian Competition and Consumer Commission.

According to a media report, the CCI is also in the final process of signing a similar MoU with European Union and the UK's OFT. The MoU provide for the sharing of information on significant developments in competition policy and enforcement developments in the respective jurisdictions, including co-operation in appropriate cases.

Pharma companies are also advised to make an internal assessment of their conduct and practices by undertaking an effective competition compliance mechanism before they fall foul of the CCI. As it is said, prevention is always better than the cure. u.sharma@expressindia.com

31 EXPRESS PHARMA December 16-31, 2013

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INSIGHT

Bribery and corruption in public procurement in India: Aunique approach Arpinder Singh, Partner & National Leader – Fraud Investigation and Dispute Services, EY (India) and Rajiv Joshi, Director – Fraud Investigation and Dispute Services, EY (India) speak about how public procurement process does not get affected by practices such as collusion, bid rigging, fraud and corruption

CURRENTLY, THE public procurement process of Indian life sciences sector appears to be infected with a new and unique approach to bribery and corruption.

Globally, public procurement typically refers to the purchase of goods or services by the Government or a public sector organisation or unit. It generally accounts for a considerable share of the public expenditure of Governments.

With such significant volumes of purchase, a sound procurement system becomes crucial to ensure proper usage of taxpayer’s funds, national security, safety, the health of citizens, and the quality of infrastructure and services in the country.

To meet this objective, Government institutions adopt the ‘tendering process,’ which is an attempt to have a transparent and efficient procurement system. Tendering refers to procurement of products by purchasers on the basis of a, often strictly defined, tendering procedure and in most cases granting the tender to the supplier who offers the lowest price or, more frequently, to realise the best value for money. It is therefore important that the procurement process does not get affected by practices such as

32 EXPRESS PHARMA December 16-31, 2013

collusion, bid rigging, fraud and corruption.

Process of tendering in the life science sector in India Various channels of tendering are typically adopted in India. The most common channels to invite tenders include the Open Tender Enquiry (OTE) and Limited Tender Enquiry (LTE). In OTE, all eligible suppliers are free to apply to the tender, as compared to a LTE, which is usually applica-

ble in cases where a pool of vendors has been established for a particular commodity or service. It is the common practice of ministries or government departments, which are concerned about safety, expediency and security of maintaining a list of empanelled or registered suppliers on technical and financial grounds. Such empanelled or registered suppliers are preferred throughout the tendering process.

Now consider public sector

tendering in the life science sector in India, which has players engaged in manufacture, testing, sale, distribution of drugs and medicines, and medical equipment, as well as clinical tests, diagnostics, and so on. Consider a purchaser such as a government institution or a public hospital, which floats an OTE. Each tender has a unique and often complicated tendering process, requirements, expectations, and timelines, which are defined in the tender floater document. To

suitably understand the purchasers’ requirement, the bidder engages an exclusive agent who acts as a liaison between the bidder and the purchaser.

The agent could be an existing distributor of the bidder or an independent service provider.

In accord with his engagement with the bidder, the agent understands the purchaser’s requirement, expectations, tendering process and timelines and uses this information to help the bidder make a tender application. He then liaises with the tendering authorities to obtain timely feedback on status of the tender application, and facilitates acceptance of the bidder’s tender application.

In lieu of his services, the agent receives, what is commonly known in life sciences parlance as an overriding commission (ORC). What is noteworthy here is that the role of the agent is transcending information and documentation from the bidder to the tendering authorities, and that he plays no role in physical movement of goods or services. In an ideal situation, an ORC agent does all the activities from the bidding process to the last stage, which is collecting payment from the purchaser after supplies have been made. How-

MANAGEMENT

ever, in this scenario, the agent is merely a puppet. All the activities are done by the supplier, the agent is only used as a channel to pay bribes. In our experience, ORC agents in India receive a commission ranging from 10 per cent to as high as 40 per cent of the order value won against tenders. In contrast, the authorised dealers or distributors of life science companies typically receive 10 per cent as their trade margin. Activities performed by dealers range from buying a company’s products, stocking inventory, transporting and selling to consumers, client servicing and so on. Our recent investigative experience elucidated the possible use of excess funds with ORC agents for unduly influencing tendering authorities to win tenders.

Irregular payments in public contracts across the globe According to the 2005 Executive Opinion Survey of the World Economic Forum1, public procurement was identified as a government activity that is most vulnerable to corruption.

As a major interface between the public and the private sectors, public procurement provides multiple opportunities for public and private players to divert public funds for private gain.

Irregular payments in public contracts The survey respondents were asked: “In your industry, how commonly would you estimate that firms make undocumented extra payments or bribes connected with awarding of permits/ utilities/ taxation/ awarding of public contracts/ judiciary (1 = common, 7 = never occur)?”

Iceland topped the list with a score of 6.7 (7 being 'never occur'), India ranked 51 with a score of 4.3, and Bangladesh came last at 125 with a score of 2. Evidently, this act of improper payments to government officials is in violation of the anti-bribery and corruption

laws applicable to most companies in one way or the other — be it the famous Foreign Corrupt Practices Act (FCPA), UK Bribery Act (UKBA) or local anti-bribery and corruption governing laws.

Bribery in tendering process in India: A case study While kickbacks to public officials, collusion, market sharing, bid rigging, and formation of cartels are known, what is innovative is the nexus between the bidder, ORC agent and officials of tendering institution to receive significant kickbacks. While our recent investigative experience in India is on similar lines, consider the following scenario for illustration purposes to elucidate the modus operandi: A public hospital invites LTE from its chosen vendors for a medical product ‘Medica’.

One of the vendors, ‘Supplier’ who manufactures ‘Medica’ is desirous of winning this tender.

Supplier engages ORC agent ‘ORCA’ to liaise with the Purchaser for a commission of 30 per cent of the tender value.

The selling price of the product, Medica, is neither regulated nor bound under the maximum retail price requirement by the law. Each Medica deal entered by the supplier is at a contractual rate, which varies from transaction to transaction.

For the current tender floated, the Supplier compiles the requisite documentation, which ORCA submits to Purchaser quoting the price for supply of Medica at say $20 per unit. This price is quoted by the Supplier with complete knowledge that the Purchaser does not have a price validation team, which will validate this price with market sources. Furthermore, for immaculate paper work, a copy of the reference order from an alternate government hospital, 'Governica' is attached with the Purchaser’s order for Medica in favour of the Supplier at $20 per unit. Eventually, the tender

ARPINDER SINGH,

PRACHI KHANDELWAL,

Partner & National Leader – Fraud Investigation and Dispute Services, EY(India)

Manager – Fraud Investigation and Dispute Services,EY(India)

is awarded to Supplier for supply of Medica at $20 per unit.

One would think that the officials of the Purchaser will receive a considerable kickback of the tender value for this deal. However, a simple reference check at Governica would have revealed that a purchase order was awarded for supply of Medica to the supplier at $1.8 per unit and that the Supplier had forged a copy of the original purchase order of Governica to inflate the price from $1.8 per unit to $20 per unit.

The considerable gap between $20 per unit and $1.8 per unit was used to accommodate hefty commission of 30 per cent to ORCA. Supplier’s accounting records simply reflect the commission payment, thus doing away with the requirement to record illegitimate payment. The commission created in the hands of ORCA was devoured by the officials of the Purchaser, sales staff and management of the Supplier along with a slice for ORCA staff in lieu of confidentiality.

bribery and corruption statutes. How then does a wellmeaning and control-driven company safeguard its business? Unearthing the racket perpetuated by the Supplier’s management could be an arduous task considering its wellplanned schemes and nearly flawless documentation available with Supplier.

While the premise here was based on a much-focussed experience tweaked for illustration, its recurrence in the industry cannot be negated.

What can be done by companies such as the Supplier’s and public institutions inviting bids for considerable quantities is to set up specially trained and independent in-house teams, or engage an independent third party, which specialises in forensic due diligence. It can undertake the following: ■ From the Supplier’s perspective ❙ Undertake an ex-ante due diligence of the ORC agent ❙ Validate price and quantities of high value tenders to public institutions and compare these with the purchase orders submitted to the company ❙ Verify that the payment made to ORC agent is in line with agreed payment terms ■ From Purchaser’s perspective ❙ Obtain ex-ante confirmation on authenticity of reference order Furthermore, the Supplier can, prior to on-boarding ORC agent, do a check to ensure that ORC agent’s remuneration

Cure to the affliction: Prevention Apart from extra legal implications and divergence of tax payer’s money, companies such as Supplier’s become targets of regulatory authorities including the Department of Justice (DOJ), the Securities and Exchange Commission (SEC) and the Serious Fraud Office (SFO) for violation of FCPA, UKBA and local anti-

is in line with the fair market value for proposed services.

Documenting in adequate detail the justification for engaging service providers and the exact scope of work to be undertaken by the ORC agent is also a appropriate method to establish clarity of purpose and amount of remuneration agreed. In addition, mandating the ORC agent to maintain an activity log for the task performed, and a routine audit of the ORC agent’s utilization of ORC payments are likely to help demonstrate to the ORC agent the Supplier’s intent of professional and ethical business practices.

The Supplier can go further and reduce its reliance on service providers by establishing an in-house department to assist in identifying tenders and provide support in submission of tender applications, negotiation with tendering authorities and later, to follow-up on payments from the purchaser.

While a reactive treatment to identify and penalise illegal payments, activities and people can be adopted; perhaps a control-based preventive approach may sufficiently demotivate and hinder individuals with malicious intent to execute extra legal activities. However, demonstration of legal intent and a strong control framework will help strengthen the company’s case and minimise resulting penalties levied by regulating bodies such as DOJ and SEC for anti corruption and violation of bribery laws.

(Prachi Khandelwal, Manager – Fraud Investigation and Dispute Services, EY (India) has also contributed to the article) Note: Views expressed in this article are personal to the authors.

Reference Source: Integrity in public procurement, Annexure A, Irregular payments in public contracts, Page 121

33 EXPRESS PHARMA December 16-31, 2013

RESEARCH CLINICAL UPDATE

RESEARCH UPDATES

Bone Therapeutics initiates a phase IIb/III trial Receives approval from Competent Authorities in Belgium, France and the Netherlands BONE THERAPEUTICS, the regenerative therapy company addressing unmet needs in the field of orthopaedics via a minimally invasive approach, has received clearance from the Competent Authorities in Belgium, France and the Netherlands to initiate a phase IIb/III trial with its autologous cell therapy product, PREOB, for the treatment of non-union fractures.

First patients have already been treated in Belgium.

PREOB is a first-in-class autologous osteoblastic/bone forming cell product. It is positioned as a first-line treatment for non-union fractures as it is administered via a minimally invasive approach directly into the fracture site, thereby avoiding the need for open surgery.

The pivotal phase IIb/III, multi-centre, randomised, open-controlled study will determine the efficacy and safety of PREOB in the treatment of hypotrophic non-union fractures of long bones. PREOB will be compared to bone autograft in a non-inferiority design including a 12 month follow-up.

176 patients will be randomised in two groups in a 1:1 ratio (88 patients in the PREOB group vs. 88 patients in the bone autograft group).

Efficacy and safety will be checked at each scheduled visit over the 12 month follow-up period for all patients using clinical (i.e., pain and function) and radiological evaluation. An in-

34 EXPRESS PHARMA December 16-31, 2013

terim analysis is planned at the midpoint of the study.

Non-union is a serious fracture complication where the normal process of bone healing is interrupted. In general, if a fracture is still evident at six months post injury, it will remain unhealed without specific treatment. Current standard of care involves invasive surgeries with a high risk of complications. Bone Therapeutics’ cell therapy product, PREOB, could help treat 350,000 patients annually in Europe and North America alone. PREOB is also being evaluated in an ongoing phase III trial for the treatment

of osteonecrosis.

Enrico Bastianelli, Chief Executive Officer, Bone Therapeutics commented, “We are delighted to have started this pivotal trial of PREOB for the treatment of non-union fractures, an area of significant unmet medical need. For Bone Therapeutics’ to have two pivotal phase IIb/III trials running simultaneously is quite an achievement. Alongside our allogeneic product pipeline, today’s trial start further strengthens our position as a regenerative therapies leader in the field of orthopaedics.”

EP News Bureau - Mumbai

Newhuman peptide mayhelp treat diabetes A humanin analogue increa sed insulin secretion leading to an increase in glucose metabolism within beta cells A NEWLY-DISCOVERED peptide produced by the human body could lead to powerful treatments for some people living with diabetes, scientists have found. In experiments in mice, a humanin analogue (a peptide molecularly similar to humanin) increased insulin secretion leading to an increase in glucose metabolism within beta cells.

“Diabetes is a major disease that is expected to affect more than 500 million people in the next two decades,” said Radhika Muzumdar, study author from the Departments of Paediatrics and Medicine in the Divisions of Endocrinology and Geriatrics at Children's Hospital at Montefiore at the Albert Einstein College of Medicine in Bronx, New York.

“Humanin could be a potential weapon in our arsenal in the fight against this global problem,” she said. To make this discovery, Muzumdar and colleagues tested the effects of humanin on insulin secretion in rats and mice; in

groups of cells called islets from the pancreas that contain beta cells; and in cultured mouse beta cell lines.

In rats, administration of a humanin analog increased insulin levels in the blood in response to high blood glucose levels. The humanin analog increased insulin secretion in islets from both normal mice as well as islets from diabetic mice. Researchers confirmed that humanin increases insulin secretion in isolated beta cells. The work also demonstrated that this was closely linked to energy production from metabolism of glucose in beta cells. In addition, when the metabolism of glucose in beta cells was blocked, humanin did not increase insulin secretion. Finally, humanin levels naturally decline with age, suggesting that humanin or its analogues may benefit patients with other conditions as well, such as stroke, heart disease and Alzheimer's.

The study was published in The FASEB Journal.

PTI

Humanin levels naturally decline with age, suggesting that humanin or its analogues may benefit patients with other conditions as well

RESEARCH RESEARCH UPDATES

FDAapproves Gilead’s $1,000-a-day hepatitis C pill Most patients will be treated with the $1,000-a-day drug for 12 weeks US REGULATORS approved Gilead Sciences Inc's Sovaldi as a potentially easier cure for chronic infection with the liverdestroying hepatitis C virus.

The once-a-day pill is the first approved to treat certain types of hepatitis C infection without the need for interferon, an injected drug that can cause severe flu-like symptoms. Hepatitis C, which is often undiagnosed, affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.

Most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000, according to Gilead spokes-

woman Cara Miller. "Today marks a landmark advance in the treatment of hepatitis C, opening up new opportunities to stop the spread of this virus and the ravages of this disease," Dr John Ward, director of the Centers for Disease Control and Prevention's division of viral hepatitis, said.

Last year, the CDC recommended that all baby boomers, born from 1945 to 1965, be tested for the virus. Introduction of blood and organ screening in the 1990s has dramatically lowered infection rates for younger generations. Gilead said Sovaldi, also known as sofosbuvir, can be used in combination with ribavirin, an older antiviral pill, for patients with

genotypes 2 and 3 infections, which account for about 28 per cent of US patients infected with the virus. For patients with genotype 1, which accounts for about 70 per cent of US infections, the new drug must still be used with both interferon and ribavirin, although it can be considered for use in patients with genotype 1 infections who cannot use interferon. Patients with the much less common genotype 4 infections will also be treated with a three-drug combination.

The Gilead drug's approval was supported by several studies showing that it helped to eradicate the virus in significantly more patients, with fewer side effects, than the cur-

rent drug regimen. Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or "nukes," designed to block a specific protein that the hepatitis C virus needs to copy itself.

Analysts, on average, have forecast Sovaldi sales of $1.9 billion next year, according to BMO Capital Markets.

Gilead has said it plans to file in the first half of next year for FDA approval of an all-oral regimen for genotype 1 patients. Companies including Bristol-Myers Squibb, AbbVie and Boehringer Ingelheim are also spending millions to develop new hepatitis C treatments.

Reuters

Auxilium drug to treat bent penis condition gets FDAnod Treatment for Peyronie’s would consist of a maximum of four treatment cycles US HEALTH regulators approved Auxilium Pharmaceuticals Inc's Xiaflex injections to treat a condition that causes a painful curvature of the penis called Peyronie's disease. It marks the second US approval for Xiaflex, which in 2010 received a Food and Drug Administration nod to treat Dupuytren's contracture a condition in which hardening of the connective tissue collagen in the hands bends fingers toward the palm, leaving a patient unable to straighten their hand or use their fingers properly.

Xiaflex is now the first

FDA-approved non-surgical treatment option for men with Peyronie's disease who have a plaque buildup in the penis that results in a curvature deformity of at least 30 degrees upon erection, the agency said.

The drug is injected directly into the collagen buildup to break it down in order to help restore normal function to the penis or hands.

Cowen and Co is forecasting that Peyronie's approval will add $100 million to annual Xiaflex sales by 2018. Treatment for Peyronie's would consist of a maximum of four treatment cycles, the FDA said. Each treat-

ment cycle consists of two Xiaflex injections directly into the collagen-containing structure of the penis, and one penile modeling procedure a massaging of the treated area by a health care professional to help further break down the plaque or scar tissue.

In clinical trials, Xiaflex significantly reduced penile curvature deformity and related bothersome effects compared with a placebo, the FDA said. A potential serious side effect of treatment with Xiaflex is penile fracture - a rupture within the penile shaft. As a result, a condition of the approval is the im-

plementation of a Risk Evaluation and Mitigation Strategy (REMS).

The REMS requires participating health care professionals to be certified by completing training in the administration of Xiaflex for Peyronie's disease. The REMS also requires health care facilities to ensure that Xiaflex is dispensed only for use by certified health care professionals, the FDA said. The most common adverse reactions associated with Xiaflex for Peyronie's treatment include penile bruising, swelling and pain.

Reuters

35 EXPRESS PHARMA December 16-31, 2013

RESEARCH RESEARCH UPDATES

New data backs promise of long-acting Sanofi insulin Paris AN IMPROVED version of Sanofi's diabetes drug Lantus is better than the old one at controlling blood sugar levels and comes with fewer hypoglycemic events, new late-stage trial data showed.

The treatment is one of several drugs Sanofi is betting on to defend its No.2 spot on the world's $42 billion diabetes market as its superstar product Lantus, the world's most prescribed insulin, will lose patent protection by 2015. The

long-acting insulin, known as U300, requires less frequent or lower dosing than Lantus and offers a more consistent insulin release. It is similar to Novo Nordisk's Tresiba (degludec), also in development.

Analysts expect Sanofi to seek regulatory approval for U300 in the US and Europe next year and for the drug to reach global sales of $872 million by 2017, according to forecasts compiled by Thomson Reuters Cortellis. The detailed Phase III results unveiled at the World Diabetes Congress in

Melbourne showed U300 was better than Lantus at controlling blood sugar lows at night, a common side effect in diabetics treated with insulin. The drug also lowered the incidence of hypoglycemic events at any time of the day across the six-month study period.

U300 met its goal in three other Phase III clinical trials, showing similar blood sugar level control as Lantus in patients with type 2 diabetes not previously treated with insulin and uncontrolled on oral medication, as well as in patients

with type 1 diabetes already treated with insulin.

Lantus, also known as insulin glargine, was developed in the 1990s and is currently Sanofi's top-selling drug. It reaped around 5 billion euros ($6.78 billion) in revenue last year. Sanofi needs a successor for the drug and is also developing a pen-shaped device, known as LixiLan, that combines Lantus with Lyxumia, another diabetes treatment belonging to a class of drugs known as GLP-1 analogues.

The successful launch of

both U300 and LixiLan could strengthen Sanofi against rival drugs such as Novo Nordisk's Tresiba (degludec) and IDegLira, a combination of Tresiba and Victoza.

Novo Nordisk, the global leader in diabetes, faced a setback earlier this year when the US Food and Drug Administration asked for further clinical studies for Tresiba, delaying its potential launch on the world's largest pharmaceutical market until 2017 at the earliest.

Reuters

GSK,Theravance asthma drug shows Novartis bone marrow cancer drug meets goal improved lung function in study in late-stage study

GLAXOSMITHKLINE and Theravance said that their combination therapy met the main goal of improving lung function in asthma patients in a late-stage trial. The therapy consists of the corticosteroid, fluticasone furoate, which reduces inflammation, and a long-acting beta-agonist, called vilanterol, which is designed to open the airways. The drug, already approved in the US to treat chronic obstructive pulmonary disease (COPD) under the brand name Breo, proved more effective than fluticasone furoate alone for patients with moderate to severe asthma at the end of a 12-week treatment period.

The drug is inhaled through a palm-sized device called Ellipta. It is approved for both COPD and asthma in Europe, where it is sold as Rel-

36 EXPRESS PHARMA December 16-31, 2013

Zurich

var. The most common side effects reported in the treatment period included headache, upper respiratory tract infection and influenza. The drug is one of two new medicines GSK is relying on to reinvigorate its

respiratorybusiness as the company's $8 billion-a-year blockbuster Advair faces the threat of generic competition in the years ahead.

Reuters

AN EXPERIMENTAL drug from Novartis to treat a type of bone marrow cancer met its primary goal in a late-stage study, the Swiss drugmaker said. A Phase III trial found the drug, dubbed LBH589 when combined with bortezomib and dexamethasone, significantly extended progression-free survival in patients with relapsed or relapsed and refractory multiple myeloma compared to bortezomib and dexamethasone alone.

Multiple myeloma is a cancer that starts in plasma cells in bone marrow and disrupts the production of normal blood cells. It affects approximately 1 to 5 in every 100,000 people worldwide each year and typi-

cally occurs in those aged over 50. Novartis said the drug has the potential to become one of the first in a new class of treatments for the incurable disease.

"Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma," said Novartis Global Head of Oncology Alessandro Riva.

LBH589 works by blocking a key cancer cell enzyme which causes cell stress and leads to death of these cells. Full results of the data will be presented at an upcoming meeting, Novartis said. German Biotech company MorphoSys and Celgene are also working on treatments for multiple myeloma.

Reuters

RESEARCH RESEARCH UPDATES

Researchers unlock newmeans of growing intestinal stem cells Studying these cells could lead to new treatments for diseases ranging from gastrointestinal disease to diabetes RESEARCHERS AT MIT and Brigham and Women’s Hospital have shown that they can grow unlimited quantities of intestinal stem cells, then stimulate them to develop into nearly pure populations of different types of mature intestinal cells. Using these cells, scientists could develop and test new drugs to treat diseases such as ulcerative colitis.

The small intestine, like most other body tissues, has a small store of immature adult stem cells that can differentiate into more mature, specialised cell types. Until now, there has been no good way to grow large numbers of these stem cells, because they only remain immature while in contact with a type of supportive cells called Paneth cells.

In a new study which recently appeared in the online edition of Nature Methods, the researchers found a way to replace Paneth cells with two small molecules that maintain stem cells and promote their proliferation. Stem cells grown in a lab dish containing these molecules can stay immature indefinitely; by adding other molecules, including inhibitors and activators, the researchers can control what types of cells they eventually become.

“This opens the door to doing all kinds of things, ranging from someday engineering a new gut for patients with intestinal diseases to doing drug screening for safety and efficacy. It’s really the first time this has been done,”

says Robert Langer, the David H Koch Institute Professor, a member of MIT’s Koch Institute for Integrative Cancer Research, and one of the paper’s senior authors.

Jeffrey Karp, an associate professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, is also a senior author of the paper. The paper’s lead author is Xiaolei Yin, a postdoc at the Koch Institute and Brigham and Women’s Hospital.

The inner layer of the intestines has several critical functions. Some cells are specialised to absorb nutrients from digested food, while others form a barrier that secretes mucus and prevents viruses and bacteria from entering cells. Still others alert the immune system when a foreign pathogen is present.

This layer, known as the intestinal epithelium, is coated with many small indentations known as crypts.

At the bottom of each crypt is a small pool of epithelial stem cells, which constantly replenish the specialised cells of the intestinal epithelium, which only live for about five days. These stem cells can become any type of intestinal epithelial cell, but don’t have the pluripotency of embryonic stem cells, which can become any cell type in the body.

If scientists could obtain large quantities of intestinal epithelial stem cells, they could be used to help treat gastrointestinal disorders that damage the epithelial layer. Recent studies in ani-

mals have shown that intestinal stem cells delivered to the gut can attach to ulcers and help regenerate healthy tissue, offering a potential new way to treat ulcerative colitis.

Using those stem cells to produce large populations of specialised cells would also be useful for drug development and testing, the researchers say. With large quantities of goblet cells, which help control the immune response to proteins found in food, scientists could study food allergies; with enteroendocrine cells, which release hunger hormones, they could test new treatments for obesity.

“If we had ways of performing high-throughput screens on large numbers of these very specific cell types, we could potentially identify new targets and develop completely new drugs for diseases ranging from inflammatory bowel disease to diabetes,” Karp says.

In 2007, Hans Clevers, a professor at the Hubrecht Institute in the Netherlands, identified a marker for intestinal epithelial stem cells — a protein called Lgr5. Clevers, who is an author of the new Nature Methods paper, also identified growth factors that enable these stem cells to reproduce in small quantities in a lab dish and spontaneously differentiate into mature cells, forming small structures called organoids that mimic the natural architecture of the intestinal lining.

Reuters

EU agencystarts in-depth reviewof Ariad leukaemia drug London EUROPEAN REGULATORS have started an in-depth review of the benefits and risks of Ariad Pharmaceuticals Inc's leukaemia medicine Iclusig.

The European Medicines Agency (EMA) said the probe would look particularly at the risk of blood clots or blockages in the arteries or veins associated with the medicine. Last month, the EMA reviewed the latest evidence about the drug and recommended continued

use of Iclusig, though with a number of restrictions to help minimise risks.

That contrasts to the situation in the US, where the drug has been suspended due to safety concerns. Explaining the decision to launch the latest review, the EMA said a number of issues required further investigation and this had prompted the European Commission to ask for a further in-depth look at the drug.

Reuters

Cubist says urinarytract infection drug succeeds in study CUBIST PHARMACEUTICALS said its experimental treatment for a type of urinary tract infection showed it was as effective as an approved antibiotic. The main goal of a latestage trial was to show whether the treatment, a combination of ceftolozane and tazobactam, eradicated the infection and cured patients five to nine days after the last dose.

The most commonly reported adverse events of the treatment were headaches, constipation, hypertension, nausea and diarrhea. Cubist said it was concluding another late-stage study with the drug in patients with complicated intra-abdominal infections, and expects to report results in late December.

Reuters

37 EXPRESS PHARMA December 16-31, 2013

PHARMA ALLY I N T E R V I E W

‘We will be working harder to achieve stronger goals’ Knauer is globally considered as an authority in the field of High Pressure Liquid Chromatography (HPLC). Dr Birger Holz, Knauer - Germany, Authorized Signatory and Head of Sales, reveals more to Sachin Jagdale

Tell us about HPLC columns that your company distributes in the Indian market?

Knauer is a 51-year-old company specialising in Osmometers, various combinations of LC systems eg: UHPLC, Analytical HPLC, Semi– Prep HPLC, Preparative HPLC, purification systems & LC columns for all the above instrumentation. We are in the LC column business for more than 30 years and our current range of LC columns include: Analytical /semiprep/preparative columns Eurospher I, Eurospher II columns, UHPLC / BlueOrchid / Bluespher columns BlueShell (Core shell) columns, Eurocel (Chiral) columns, Eurokat (Food analysis) columns, Bio chromatography columns & Ion chromatography columns.

How have your solutions/ products evolved over the years in the Indian market?

The Indian market is extremely sensitive to the developments taking place in the international market. The reason being India is closely associated with the US, Europe and Australia with respect to R&D interaction

38 EXPRESS PHARMA December 16-31, 2013

and penetration into these countries through mergers and acquisitions. As a consequence the Indian customer or user is fully aware of the technological developments taking place worldwide and in particular the US, European, Australian and Japanese markets. This puts a lot of pressure on Indian companies which have to withstand the competition from the various pharmaceutical segments worldwide. However, the advantage is that the Indian market segment is directly exposed to the developments taking place worldwide.

Further, since most of the Indian manufacturers are also exporters to the developed countries, they have to be extremely competitive in terms of quality, consistency and competitiveness while supplying intermediates and APIs to the global markets.

Do you have any India specific challenges?

The single most complex India specific challenge is to be competitive in the price front and for this, we depend on our distribution channels on viz M/s. Great Scientific Supplies for analytical HPLC

columns, Chromline for Analytical HPLC / Osmometers and Chemito Technologies for Preparative HPLC.

The single most complex India specific challenge is to be competitive in the price front and for this, we depend on our distribution channels DR BIRGER HOLZ Knauer Germany,Authorized Signatory and Head of Sales

India is not that R&Dfriendly nation. Indian biotech industry also constitutes hardly 2 per cent of the global biotech market. Do you think this will hamper HPLC columns' growth prospects?

KNAUER’s Indian distributors sell columns into the pharma, universities and other research institutes. The biotech industry is also our target with increasing activities. Altogether the influence on the columns business growth is present but will not too much hamper.

HPLC columns are generally considered expensive.

How have you worked on this aspect to make them cost effective?

KNAUER strives to keep the sales price on a reasonable level, especially under the level of the large players in the field. From time to time it can happen that we have to commit to higher discounts. In this case, we recommend purchase of larger volume of

columns to receive a better price.

Besides the above, we worked on new technologies like short columns, narrow ID columns so that the solvent consumption is reduced drastically resulting in solvent saving & offering eco-friendly solutions to the end user.

Who are your key clients in India?

Being a strong European player in the LC systems and LC column market, almost all the European pharma manufacturers like M/s.

Sandoz / Novatis/Elli Lilly and the subcontractors/ collaborators in India are automatically our customers.

We have been supplying columns and LC systems either directly or indirectly to the leading multinational companies in India besides the local companies like M/s.

Cipla/ Dr.Reddy’s/ Hetro Drugs/ Bliss Pharma/Vishal Pharma & Ruchi Soya.

Success of any product depends more on repeat orders and not on new orders. What is your experience in this regard?

Continued on Pg 40

PHARMA ALLY I N T E R V I E W

‘Everything you write is instantly electronically recorded’ Scotland-based This-tel, is poised to enter the Indian healthcare market, with its digital pen to transform healthcare. The pen allows written information to be scanned and transmitted to a central server. The company will collaborate with Indian-based IT firm Crane Global Solutions to distribute its products in India. M Neelam Kachhap chats with Steve Forsyth, Founder CEO, This-tel to know more about the innovative technology

How does This-tel digital pen work?

The pen works and feels like a traditional pen, but captures everything you write as digital data in real time, with built-in Bluetooth and USB capabilities keep you connected, requiring minimal to no additional training or changes to your business processes required.

■ Write on any surface: With the natural feel of a regular pen you can write on any surface that has the proprietary microdot pattern.

This unique pattern works with the pen’s built-in camera to determine precise positioning on any surface, ensuring fast and accurate data capture. From whiteboards and paper sheets, to tablets and displays, or even a variety of mobile devices, the pen tips are suited to fit the desired surface, allowing you to always write digitally.

■ Precision positioning: The digital pens provide exact positioning on any microdot patterned surface, be it paper forms, whiteboards or glass displays. Additionally, pressure and absolute time for each position are all recorded.

When this signature information is combined with our world-class handwriting

recognition capabilities, the resulting editable text far exceeds any other OCR solution.

■ Transfer in real time, anywhere: Captured data can be sent in real time via Bluetooth to different devices, such as computers, servers and mobile phones, or synchronised via USB on a computer with data delivery to e-recipients and decision makers in seconds.

■ Reliable and durable: With more than 10 years of experience providing easy-touse, intuitive, reliable and durable digital pens for an array of purposes and environments, This-tel is the one to trust.

What are the hardware and software requirements for using This-tel digital pens?

The system is a B2B software as a service (SaaS) solution and can be installed on the clients servers or they can use our hosted service, at the user end all that is needed is an internet ready hosted device (Mobile, tablet or PC) that the pen can connect to via it USB cradle or Bluetooth.

How does this technology help healthcare professionals?

Innovation in data

For India it is sold through our strategic partner Crane Global Solutions in Hyderabad.

Our expectations is to roll it out to every government and private health facility in India.

STEVE FORSYTH, Founder CEO,This-tel

capturing by a doctor, nurse, ANM etc. by providing the flexibility to continue using paper-based forms while still enabling electronic data capture in a form which allows data mining. Imagine if everything you wrote with pen and paper was captured and saved digitally.

For healthcare professionals the benefits are obvious: ■ There is very little training needed – after all, it’s pen and paper ■ The time saving due to no manual data input means lower costs and more time available to spend with patients ■ Pen and paper are lightweight, easy to carry, and always ready to use ■ Because you are not stuck behind a computer, you can enjoy a more natural patient interaction.

Our technology simplifies life by: ■ Converting text or forms filled out by hand into digital data within seconds ■ Downloaded directly to your database for instant, accurate records without having to manually input them ■ You still have the paper copy so you have duplicate records – all with the same effort

Doctors: There is no need for training or to change habits or behaviors – just keep using pen & paper as you do now, and everything you write is instantly electronically recorded.

Healthcare managers: It improves overall efficiency of your facilities, saves money, and frees staff to help ensure that more patients can benefit from the highest standards of care.

Nurses: It lets you electronically record everything in one step instead of two, requires no training and frees up more time for you to work with patients Mobile care workers: Digital pen and paper gives you better mobility, improves your connection with patients and saves you a lot of time.

What are the advantages of using your product?

■ Decreases consultation and administrative time for both new and existing patients.

That implies that staff and clinicians have the capacity to accommodate and see an additional patients.

■ Presents the most costeffective strategy to prevent, and early diagnosis and treatment of diseases ■ Integrates healthcare at all levels and also private

39 EXPRESS PHARMA December 16-31, 2013

PHARMA ALLY

practitioners and major providers of healthcare ■ Gives more control over concerns regarding ethics, medical negligence, commercialisation of medicine, and incompetence ■ Reduces the cost of medical care and thereby reduces the threat to healthy doctor relationship ■ Increasing speed and efficiency of data capture and easily digitise information ■ Being simple to implement at clinical sites and cost effective for sponsors ■ As data can be converted different formats and sent over net in encrypted form, performing data analytics is just clicks away and also maintaining confidentiality ■ Reduces the time to a huge extent.

■ Have both the hard copy and electronic version of that hard copy close to instantly ■ Maintenance of data integrity and accuracy ■ Track not only how many calls they respond to but what exactly occurs during the transportation to the hospital process ■ Also enables staff to : ❖ Be more in control of the administrative time ❖ Less stressed ❖ Have more personable approach in their work with the patient Tell us about the pilot run at the cancer hospital at Hyderabad.

It is a comprehensive tertiary cancer centre, serving not only the state of Andhra Pradesh and also to the

neighbouring states. It provides free treatment to approximately 10,000 new patients and 50,000 follow-up patients every year.

The pilot run included: ■ Using Digital Writing Solution, it seamlessly mapped both old and new patient records by unique patient identification number.

On fly submission, using digital pen of claims data for patients enrolled in both government and nongovernment healthcare schemes.

■ The various aspects of computerisation of total work right from registration of the patient into hospital to claim submission. The solution will

also look into aspects of computerisation of all services i.e. OP counter, IP counter, casualty, labs, radiology and billing (as mentioned in the scope).

■ Track material right from their procurement to dispensing to the patient based on his/her healthcare schemes. Track medical equipment utilisation for both material and resource.

■ On fly generation of MIS reports, both pictorial and tabular form to be submitted to government health department.

currently use this product?

The pen came into the market in 2001 and is presently used in hospitals in Europe, US South America and Asia.

When did this pen come into the market?

How many hospitals

What is your expectation from the Indian market for this product?

Where can an Indian doctor buy this product and how much does it cost?

The product is sold as a B2B product to government’s national health authorities and private hospitals world wide but for India it is sold through our strategic partner Crane Global Solutions in Hyderabad.

Our expectations is to roll it out to every government and private health facility in India.

How will this technology evolve in future?

The future is already here as we have future proofed the solution and you can now complete handwritten forms on mobiles, tablets, PCs. So our user can now fill in forms on paper or digitally from wherever they find themselves, so whether it’s a hospital facility or a remote rural locations we can transfer the data directly to databases and decision makers in seconds. mneelam.kachhap@expressindia.com

Continued from Pg 40

‘WE WILL BE WORKING HARDER ...

We are proud to inform that we have been consistently receiving repeat orders. This does not mean that there is no scope for improvement. As a matter of fact, during my present visit we had organised a distributor meet for KNAUER`s HPLC columns

40 EXPRESS PHARMA December 16-31, 2013

through M/s. Great Scientific and I was amazed at the new markets which we have opened up through the distribution channel. This means we will be working harder to achieve stronger goals and we will be reworking our strategies in the light of the information

generated through the distributor meet.

What are your future plans for the Indian market?

Our plan is focusing even more on the promotion of the preparative HPLC, HPLC columns and modules to be

used in different application areas than HPLC. We will have to rework our strategies within India to cover the different market segments and this is going to be the next challenge for our growth.

What is Knauer's market

share in India?

The market share of KNAUER columns in India is about five per cent. The market share of analytical HPLC is about three per cent and the market share of preparative HPLC is about 25 per cent. sachin.jagdale@expressindia.co

PHARMA ALLY VALUE ADD

Generic vs innovator: An in-vitro bioequivalence study using G3-ID Malvern Aimil Instruments in this article describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID can be applied to chemically identify and isolate particles of interest within a formulation

A GENERIC drug is defined as being ‘identical or bioequivalent to a brand name drug’ 1.

Generic is also a term applied to a drug marketed under its chemical name alone without any advertising, such as when a patent expires but a drug company wishes to continue to sell a product as a generic version.

Generic drugs approved by the US Food and Drug Administration (FDA) need to meet the same rigid standards as the innovator drug.

It must: ■ Contain the same active ingredients as the innovator ■ Be identical in strength ■ Have the same use indications ■ Be bioequivalent ■ Meet the same batch requirements for identity, strength, purity and quality ■ Be manufactured under the same standards of FDA good manufacturing practice regulations In 1984 the US Drug Price Competition and Patent Term Restoration Act standardised the procedure for generic drug recognition. An applicant files an Abbreviated New Drug Application (ANDA) and has to demonstrate to a specified, previously approved ‘reference

Image 1: Morphologi G3-ID

listed drug’2. Once an ANDA is approved, the FDA adds the drug to the Approved Drug Products list also known as the ‘Orange Book’ which shows the link between the generic and the reference listed drug (innovator). In order to show that a generic drug is bioequivalent to an innovator drug it must display comparable bioavailability when studied under similar ex-

perimental conditions3.

Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug product and become available at the site of drug action and bioequivalence refers to equivalent release of the same drug substance from two or more drug products or formulations4. The premise underlying this 1984 law is that

bioequivalent products are therapeutically equivalent and, therefore, interchangeable.

The Morphologi G3-ID Automated Particle Analyser The Malvern Morphologi G3-ID (Image 1),combines the capabilities of a Morphologi G3 particle analyser with a Raman spectrometer option resulting

in a single platform measuring particle size, shape and chemical identity. The Raman spectrometer uses a 785 nm laser allowing the spectral range 150 cm-1 to 1850 cm-1 to be acquired with a 4 cm-1 spectral resolution. The spectrometer accessory is coupled using fibre optics to the Morphologi G3 allowing Raman spectra to be acquired.

41 EXPRESS PHARMA December 16-31, 2013

100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 Raman Shift(cm’’)

API 2

In addition to reporting the standard morphological parameters, the Raman capability on the Morphologi G3-ID enables the chemical identification of particulates in a dispersed sample. In a situation where particles in a multi-component sample all present a similar morphology, chemical information might be the only way to distinguish between the particles of interest for evaluation.

The extra chemical information permits creation of chemical classifications from which component- specific particle size distributions are determined. This can provide extra compositional information about samples that can be invaluable in research and development or investigative situations.

Malvern Instruments received samples of innovator and generic tablets of a dual active pharmaceutical ingredient (API) product. The interest was in investigation of the particle size distribution (PSD) of each of the APIs upon tablet disintegration as this would be expected to have a significant effect on the subsequent bioavailability of the drug.

API 1

PHARMA ALLY

100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 Raman Shift(cm’’) Figure1: Reference API Spectra

Method The tablets provided contained the same dosage for the two APIs. Both of which were practically insoluble in water.

This was therefore used as the dissolution/disintegration media, with the presumption being that the API particles would remain mostly undissolved. One tablet of each (generic and innovator) was dissolved in 100 ml of water. 2 ml was subsampled and diluted with a further 20 ml of water. 2 ml of this suspension was pipetted onto an aluminium coated microscope slide and allowed to dry overnight.

The particle size and shape data were collected and analysed with automated image analysis, with settings determined and stored as a standard operating procedure. A

42 EXPRESS PHARMA December 16-31, 2013

Figure2: Scattergram of API score values and example images from each class

spectral reference library was created for the sample by taking point spectra of the ‘pure’ components, Figure 1.

For this analysis, the size range of interest was between 1 and 10 μm and Raman spectra were acquired from only particles in this size range. The particle spectra were preprocessed to minimise baseline variation then correlated to the spectral

reference library. The more similar a particle spectrum is to the library component, the closer the correlation score is to 1. Final particle classification was based on their designated chemical identity and the particle size distribution.

Results Based on an analysis of morphological parameters

from the particle image results alone, the two APIs could not be differentiated. The particles were too similar in shape.

The inclusion of Raman spectroscopic information for chemical identification readily differentiates between the two APIs, as demonstrated in Figure 2. This scattergram plots the correlation scores for the two API components

against one another. API 1 and API 2 are clearly separated via the Raman data. Also shown in the figure are example particle images.

Once the two API populations can be differentiated, it then becomes possible to determine the individual PSDs from the blends. Figure 3 shows the overlay of the circular equivalent diameter (CED) distribu-

PHARMA ALLY Innovator API 2(____) 1.2

1.0

Generic API 2(__) Innovator API 2(____) Generic API 2(__)

0.8 %

0.4

0.2

0.0

1

10

10

CE Diameter (um)

Figure 3: Overlay of API PSDs for both tablets

Conclusion

API 1

13.59%

8.122%

Innovator Generic

86.41%

API 2

tion by number of each API from the chemically defined populations. There appears to be fewer small particles of API 1 in the generic tablet than the innovator tablet. The API 2 PSDs appeared to overlay well for the two different tablets.

Figure 4 and Figure 5 show classification charts comparing the two API classes for the two tablet types in percentage count and percentage volume, respectively. The tablets contain equal amounts of each API in their formulations, but the innovator appeared to contain a higher proportion of API 2 compared to API 1 than the generic tablet, for the samples analysed.

A comparison of these in vitro results to in vivo data could provide further information as to whether this observed difference effects the actual bioavailability of the generic drug product and hence its bioequivalence to the innovator product.

0.6

91.88%

0

10

20

30

40

50

60

70

80

90

100

Peroentage count to toal included

Automated particle imaging and Raman spectroscopy in one instrument allows Morphologically Directed Raman Microscopy to be performed. This allows the individual components present within a blend or mixture to be independently characterised and compared.

Such a tool can be used to gain better product understanding across many areas of the pharma industry from regulatory to troubleshooting. It is not, however, limited to pharmac alone and is also applicable to other samples which have Raman spectra.

Figure4: Classification chart showing API classes by percentage count

23.04%

10.42%

Innovator Generic

76.96%

API 2

In addition to reporting the standard morphological parameters, the Raman capability on the Morphologi G3-ID enables the chemical identification of particulates in a dispersed sample

89.58%

0

10

20

30

40

50

60

Peroentage volume to toal included

Figure 5: Classification chart showing API classes by percentage volume

70

80

90

REFERENCES 1.“Food and Drug Administration. Generic Drugs: Questions and Answers” Food and Drug Administration, August 2011, http://www.fda.gov/drug s/resourcesforyou/cons umers/questionsanswers/ucm100100.htm 2.http://en.wikipedia.org/ wiki/Generic_drug#cite_note-26 3. “Orange Book Annual Preface.

Statistical Criteria for Bioequivalence”. Approved Drug Products with Theraputic Equivalence Evaluations 29th Edition, U.S. Food and Drug Administration Center for Drug Evaluation and Research, 18-062009 4.Federal Food, Drug and Cosmetic Act, section 505(j)(8)

43 EXPRESS PHARMA December 16-31, 2013

PHARMA ALLY NEWS

Safeducate launches learning forum along with CILT More than 25 representatives from the industry were present to honour the occasion

SAFEDUCATE, A SPECIALIST in supply chain and logistics training, recently launched the Safeducate–CILT Learning Forum at their corporate office in New Delhi. More than 25 representatives from the industry were present to honour the occasion.

Divya Jain, Chief Executive Officer, Safeducate said, “The idea behind this initiative is to encourage meaningful dialogue between senior professionals from supply chain and logistics industry about the various issues prevailing in the industry.

This forum helped in creating a platform for these industry professionals, where they could share their expertise in tackling various challenges associated with the industry. It ended up being a fantastic learning op-

portunity for everyone.”

She further added, “Going forward, this initiative will provide a strong base to the industry people to voice their concerns, and come up with feasible

and long-term solutions to address the technological, administrative and infrastructural challenges within the supply chain.”

The participants in the event included senior representatives

from CILT India (The Chartered Institute of Logistics & Transport), Bird Group, Freight Forwarders Association of India, Inter India Group, TCI Supply Chain Solutions, Agarwal

Packer & Movers, SKF India, among others.

The forum included speakers like Ritesh Bhatia, Business Partner – Brattle Foods and Naresh Jawa, Managing Partner – Fresh Supply Chain. The topics for the discussion in the forum included ‘Best Practices in Logistics’ and ‘Integration of services’. The speakers suggested that the best practices are always a balance between the feasibility of design and challenges of implementation.

Jain concluded, “This forum will now be a monthly affair, wherein the turnout from the industry is expected to grow significantly and Safeducate will extend its support for more of such forums which would serve the industry cause.”

EP News Bureau-Mumbai

Newbiosupplies portal Rasayanika launched It offers price comparison option to the customers A NEW price comparison portal for bio-supplies, Rasayanika (www.rasayanika .com), has been launched. With the concept of ‘CompareChoose-Buy’, the portal already has over 220 different brands and it aims to be a one stop solution to scientists, researchers and core biotech R&D companies. The platform offers a clear cut price comparison, and helps the bio-supplier companies to

44 EXPRESS PHARMA December 16-31, 2013

generate more sales enquiries for their product.

Shekhar Suman, serial entrepreneur and Managing Director, Rasayanika stated, “Today there are various alternatives to the reagents, chemicals, instruments available in the bio supplier market. While on one hand there is lack of awareness, on the other hand buyers are unaware of actual prices and that’s where they end up paying more to the

existing retailers. Rasayanika platform is going to change this with clear cut comparison in between existing retailers and cheaper alternatives.”

Rasayanika is a platform where various reagent manufacturers, their products and instruments with price catalogue are put on view. Grouped under antibodies, assay kits, lab instruments, proteins and software categories, are various products

with manufacturer details and accessible price listing respectively. It aims to offer a comprehensible and perceptible stage, providing the user with ‘compare and choose’ convenience prior to purchase.

Rasayanika is the brainchild of brother and sister duo and serial entrepreneurs, Neha Suman and Shekhar Suman who also run the bioscience portal ‘BioTecNika’, which has been ac-

tive since 2006. Suman stated, “Our purpose was to introduce the scientists with a portal where they would be able to explore, analyse and then procure laboratory utilities after a proper comparison among the suppliers. Rasayanika provides the user with a detailed description of every product including the manufacturer details and price offered.”

EP News Bureau-Mumbai

PHARMA ALLY NEWS

Honeywell announces new appointments Names Jim Bujold as President, SE Asia and Anant Maheshwari as President, Honeywell India

HONEYWELL ANNOUNCED the appointment of Jim Bujold as President, Southeast Asia, and Anant Maheshwari as President, Honeywell India. Maheshwari, who has been the Managing Director of Honeywell Automation India since March 2010, will succeed Bujold who is currently the President, Honeywell India.

Both Bujold and Maheshwari will transition into their new roles on January 1, 2014.

“These senior leadership changes reflect not only a robust leadership talent pipeline, but also our relentless focus on achieving an outstanding growth trajectory in our High Growth Regions (HGR),” said Shane Tedjarati, President of Global High Growth Regions, Honeywell.

“We are confident that both Bujold and Maheshwari will play big roles in Honeywell’s presence in the region. Jim has done a terrific job over the past three years in driving growth for Honeywell in India. His move to a larger, regional role aligns with the company’s focus on key HGR countries in Southeast Asia. The company projects these HGRs to contribute more than 60 per cent of the world’s growth during the next decade,” Tedjarati added.

“Anant takes over a strong organisation in India, one of our priority HGRs, and we’re confident that his leadership abilities will continue to drive growth in the country.”

As the President, Honeywell, Southeast Asia, Bujold will oversee Honeywell’s operations

Anant Maheshwari

Jim Bujold

in Singapore, Malaysia, Thailand and Philippines. During his three-year tenure, Bujold brought to Honeywell India a global outlook, strategy and vision, with a rich and diverse experience spanning more than three decades.

Maheshwari has spent close

to a decade in Honeywell in a number of leadership roles of increasing responsibilities. His new role builds upon his successes in leveraging the region’s growth potential, building strategic relationships and driving a One Honeywell approach to create a powerful customer

value proposition.

Both Bujold and Maheshwari will partner with Honeywell’s businesses to seek new growth opportunities and identify potential synergies in the region.

The company also named Vikas Chadha Managing Director, Honeywell Automation India, effective January 1, 2014.

Honeywell Automation India is an approximately $300 million company listed on the Bombay and National stock exchanges and Honeywell’s largest entity for its Automation and Control Solutions(ACS) business in India. Chadha is currently Regional General Manager for ACS’ Honeywell Building Solutions business in India.

EP News Bureau-Mumbai

Quintiles launches Data-driven Trial Execution New offering improves the quality and predictability of clinical development while reducing overall trial costs by up to 25 per cent QUINTILES HAS launched its comprehensive, fully-integrated Data-driven Trial Execution offering, which leverages the concept of risk-based monitoring to improve clinical trial delivery. While the industry’s current approach to riskbased monitoring focuses solely on clinical trial monitoring, Data-driven Trial Execution combines study startup, project management, clinical monitoring, data management and analytics to optimise trial conduct while meeting regulatory demands

and quality requirements for Good Clinical Practice (GCP).

“Our customers are seeking to manage clinical trials with greater efficiency, seamless execution and predictive insights that enable them to respond faster and make better-informed decisions,” said Paula Brown Stafford, President of Clinical Development, Quintiles. “Data-driven Trial Execution is the first in a series of standardised offerings that Quintiles plans to bring to market, and is our answer

to optimised trial execution that has the potential to improve quality while reducing overall trial costs by up to 25 per cent.”

Quintiles is an industry leader in risk-based monitoring, having delivered more than 80 projects involving risk-based monitoring principles and processes across more than 20,000 sites and 200,000 subjects. Quintiles Data-driven Trial Execution builds upon that experience and represents a true shift in clinical trial oversight, intro-

ducing a central data surveillance team that performs ongoing reviews of data to monitor risk and facilitate the right action at the right time.

Data-driven Trial Execution is powered by enhancements to the award-winning Quintiles Infosario platform, adding advanced analytics that provide biopharmaceutical customers with a real-time view of a study’s status and progression for enhanced transparency and collaboration across stakeholder groups. With the Infosario

platform, Quintiles project teams can gather insights of critical data in a single, 360degree view allowing for early identification of risks and potential issues with automated triggers and alerts that guide action plans. Project teams now have real-time visibility to critical information across programmes, including projected study visits, to enhance study execution, improve predictability and maximise customer investments.

EP News Bureau-Mumbai

45 EXPRESS PHARMA December 16-31, 2013

PHARMA ALLY NEWS

Patient safety highlighted in quality standards for labelling of ferrules and cap overseals The standard indicates that ferrules and cap overseals must remain clear of any markings, including logos, except those intended to prevent an imminent life-threatening situation THE STANDARD indicates that ferrules and cap overseals must remain clear of any markings, including logos, except those intended to prevent an imminent life-threatening situation.

The standards explicitly state that warning messages, such as ‘Warning - Paralyzing Agent’ or ‘Dilute Before Using’ are the only markings that should appear on ferrules and cap overseals subject to General Chapter <1> Injections, providing an additional layer of protection for healthcare practitioners prior to administering an injectable drug to a patient.

Under the standards, if a

nurse, physician or pharmacist sees a warning on a ferrule or cap overseal, he or she will know immediately that it is a vital, possibly life-saving piece of information that must be observed and acted upon before administering the drug to the patient.

The standard indicates that ferrules and cap overseals must remain clear of any markings, including logos, except those intended to prevent an imminent life-threatening situation. Products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent.

The standards also require

that such warnings to be printed in a contrasting colour and be clearly visible under ordinary conditions of use. Other requirements include restricting the location of information that is important but less urgent to be located elsewhere on the vial. This would include, for example, lot numbers, product or company names, and logos. If no urgent warning is necessary, the top surface must remain blank to help ensure that urgent warnings on other injectable medications are readily noticed.

The standards are the result of careful reviews and consultation between USP

and medical, nursing and pharmacy practitioners, the US Food and Drug Administration and other stakeholders. They were first published in the 2011 US Pharmacopeia and the National Formulary (USP–NF)—USP’s compendia of public quality standards— with a delayed official date of December 1, 2013, to allow manufacturers time to comply with the standard.

While these labelling standards for ferrules and cap overseals became official in General Chapter <1> Injections in USP–NF, the location of the standard will shift to General Chapter <7> Labelling, which is

intended to be made applicable to all articles in USP-NF. This new general chapter has been proposed in the November–December 2013 issue of Pharmacopeial Forum—USP’s free-access, online publication for posting proposals and receiving public comments to its developing standards, and provides definitions and standards for labelling of official articles.

The official date of the section currently in <1> on Labeling of Ferrules and Cap Overseals is not affected by the proposed General Chapter <7> (comment deadline is January 31, 2014).

EP News Bureau-Mumbai

ONFAB announces joint venture with Schematic Engineering Industries To effectively apply flexible containment as a technology for pharmaceutical companies UK-BASED ONFAB and Hyderabad-based Schematic Engineering Industries are in a strategic alliance which is poised to enhance the financial and operational aspects of the pharmaceutical companies and set them on par with their international counterparts.

While ONFAB with its containment and manufacturing expertise will meet all the market needs, Schematic Engineering Industries will utilise its established sales force and excellent service reputation to turn this venture into a win-win situation.

Market research indicates

46 EXPRESS PHARMA December 16-31, 2013

that the flexible containment as a technology is not being applied appropriately thus depriving users of huge monetary gains. This can be detrimental when Indian pharma producers are competing for overseas contracts and trying to attract new processes into their facilities. The Alliance of ONFAB and Schematic Engineering Industries is all poised to reverse this situation in a span of two years.

Coinciding with this joint venture, ONFAB announced the setting up of its new facility in Bangalore where glove bags and flexible containment will

be manufactured. With an aim to reduce the lead time and cost for their customers, this facility has been established with a capability of seven units per week. Schematic Engineering Industries will utilise its existing Hyderabad facility to manufacture the accessories and support structure for flexible containment equipment.

Oliver Nulty, Managing Director, ONFAB said, “We understand the critical factors that must be taken into account when evaluating a containment requirement and providing the best possible solution. We are delighted to find a suitable

partner in Schematic Engineering Industries who not only share our value but is as determined to establish flexible containment as a technological force to reckon with. Speaking about their new manufacturing facility, he said, “We have made a significant capital investment to make this venture happen and are committed to further investment as the Business in India grows and flourishes.”

Shreepad Hegde, Managing Director, Schematic Engineering Industries said, “We are pleased to join hands with ONFAB who have a wealth of experience working for flexible con-

tainment for pharmaceutical companies worldwide. I am confident that our partnership will deliver both immediate and long-term benefits to the pharma companies in India.

Speaking about the company’s vision, he said, containment, reliability and flexibility are the fundamental guiding principle of our design. Our aim is to become a globally preferred manufacturer and supplier of containment applications. Joining hands with ONFAB is a significant step towards this direction.”

EP News Bureau-Mumbai

PHARMA ALLY PRODUCT

In- Sight Track & Trace Systems by Cognex IN-SIGHT Track & Trace is powered to create a complete identification and data verification solution for labels on pharmaceutical and medical device packaging. It is considered as a complete identification and data verification solution for healthcare serialisation.

& skew ■ Detects label misalignment and skew ■ Supports bundle aggregation ■ Easy to integrate ■ Easy to use Cognex InSight Track & Trace Systems is a complete identification and data verification solution for healthcare serialisation. It also helps in Reading GS1- 128, GS1 DataBar; Verifying GS1 Healthcare data standard & Supporting FDA 21 CFR Part 11 with change tracking, double blind and secondary authentication

Key features: ■ Reads 2-D and 1-D barcodes: Data Matrix, GS1-128, GS1 DataBar, securPharm and Pharmacode ■ Verifies correct ID code contents, including compliance with the GS1 Healthcare data standard ■ Supports FDA 21 CFR Part 11 validation compliance with change tracking, double blind and secondary authentication ■ Provides Data Matrix Mark Quality Assessment during production to detect changes in print quality ■ Verifies the accuracy of printed text

Contact details Cognex Sensors India Regus, Level 6, Pentagon Towers, P2 Magarpatta City, Hadapsar Pune: 411 028 Tel: 020 40147840; Fax: 020 66280011 Email: vaggu.sunil@cognex.com Whites Road, Royapettah, Chennai - 600 014 Tel: Board: 28543031/28543032/ 28543033/28543034. Fax: 28543035 E-mail: raghu.pillai@expressindia.com

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express Limited., Business Publications Division, 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar The Indian Express Limited, Business Publications Division, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Dr Raghu Pillai The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor,

BANGALORE Khaja Ali The Indian Express Ltd. Business Publications Division, 5th Floor, Devatha Plaza 131, Residency Road, Bangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express Limited Business Publications Division Express House NH-6 , Mouza - Prasastha &Ankurhati, PO - Salap

P.S.- Domjur Dist - Howrah -711409 T No: 91- 33-66043842 Fax: +91 -33-66043825 Cell : 09831182850 Email:ajanta.sengupta@expressindia.com

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Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

47 EXPRESS PHARMA December 16-31, 2013

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EXPRESS PHARMA

December 16-31, 2013 63

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CELEBS CALL FOR

CHANGE Realising the phenomenal potential of celebrities to shape public opinion, the healthcare industry too has been wooing the stars to champion various causes. We profile some stars associated with such worthy ventures to seek insights into their motivations behind supporting these causes

BY USHA SHARMA

64 EXPRESS PHARMA December 16-31, 2013

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65 EXPRESS PHARMA December 16-31, 2013

cover ) ‘Flying Sikh’ Milkha Singh urges docs to “put on their running shoes”

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Builds up a strong case for physical fitness

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UBBED the 'Flying Sikh', by Pakistani president, General Ayub Khan, for his speed on the track, Milkha Singh's journey as an athlete was effectively captured on-screen in the Bollywood blockbuster, Bhaag Milkha Bhaag.

The film chronicles the many obstacles in Singh's life, from the horrors of Partition, his gruelling training workouts as well as the crushing disappointments of races lost by a second.

Singh has associated himself with many fitness/exercise initiatives in the past and the film seems to have spurred more such opportunities, as evidenced by his backing for the launch of the Ranbaxy Diabetes Care initiative at the annual conference of the Research Society for Study of Diabetes in India (RSSDI) held

66 EXPRESS PHARMA December 16-31, 2013

recently at Greater Noida, India.

The Ranbaxy Diabetes Care initiative, a new team launched specifically for diabetes, reportedly goes beyond medicines, propagating holistic diabetes care, with healthy life style — healthy food, regular exercise to provide physical and mental fitness, compliance to medicines and doctors’ advice etc.

Speaking at the RSSDI conference, Singh pointed out that doctors are role models for patients, and exhorted them to put on their running shoes and create awareness at the level of healthcare professionals which can be further translated to patients. He went on to build up a strong case for physical fitness as it "plays a vital role in fighting the adversities in life and gives mental

strength to bounce back. This is especially true for a disease like diabetes can be effectively managed through lifestyle modifications."

Reflecting the ideology Explaining why Singh was chosen to send this message, Rajeev Sibal, Vice President and Head-India Region, Ranbaxy Laboratories said, "He is an iconic figure and truly reflects the ideology that we believe at Ranbaxy Diabetes Care i.e. physical fitness gives strength to fight adversities in life. Also, since doctors are role models for patients, Singh is an inspirational figure to drive this message through them while also inspiring doctors to remain physically fit themselves."

Singh's connection to the cause is on two counts: firstly, it was for the cause of fitness and health and secondly, it addresses doctors who are care takers for patients fitness.

Ranbaxy Diabetes Care initiative aims to promote health and wellness among the community, educate doctors in physical training, empower diabetic patients to cope with the complications of diabetes and provide support for healthy lifestyle choices. According to a press release, the initiative will provide continued access to affordable high quality generic diabetes medicines to patients across India.

Singh was also seen at IOACON 2013, the 58th Annual Conference of the Indian Orthopaedic Association (IOA) held in Agra recently. The event saw orthopaedic experts come together to deliberate upon the latest advancements, research and best practices in the field of orthopaedics. As the Chief Guest, Singh in his speech, stressed on the importance of fitness for a good quality of life and spoke about the role of injuries in a sportsman’s life and how he managed to stay fit despite being injured several times in his sporting career.

Strengthening the cause Enlisting the support of personalities like Milkha Singh who ‘walk the talk’, is expected to give the much needed boost to fitness and urge people to opt for a healthier way of living.

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'Say no to tobacco', urge celebs Gul Panag and Rahul Dravid

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Call for youth participation to ensure tobacco free 21st century

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OBACCO consumption and smoking are causes for serious health concerns in India. The Tobacco Control Policy Evaluation Project India revealed that “tobacco use accounts for nearly half of all cancers among males and a quarter of all cancers among females and it is estimated that there will be 1.5 million tobaccorelated deaths annually by 2020.”

Celebrities have often been blamed for glamourising smoking and tobacco consumption through their endorsements and roles played on television and films.

As a result, The Ministry of Health and Family Welfare (MoHFW) has even notified that films, endorsements showing smoking or tobacco consumption onscreen have to mandatorily carry a health

warning as well.

Yet, saying that all the celebrities are unaware of their responsibilities would be untrue.

Actress Gul Panag and former Indian cricket team captain, Rahul Dravid have ardent supporters of anti-tobacco campaigns and have been working to spread awareness about the harmful effects of consuming tobacco and smoking .

Call for youth participation Dravid has been selected as the brand ambassador for the National Tobacco Control Campaign while Panag raised her voice against tobacco and lent her support to the 'No More Tobacco in 21st Century' (NMT 21C) campaign, an initiative

by Public Health Foundation of India (PHFI).

Panag said, “I'd like to congratulate the Public Health Foundation of India on envisioning the 'No More Tobacco in the 21st Century' campaign global youth movement for a tobacco free future. It is a much needed initiative in a youth dominated demographic such as ours.

Specially when, it is the youth that the advertisers of tobacco products target. An effective public countermeasure is the need of the hour to take on the cash rich and sometimes devious advertising ploys of companies that sell tobacco products.”

A collective responsibility Panag continued, “I urge youth

icons in every walk of life to lead by example and step forward to join the NMT 21C and help amplify its reach. The impact of youth icons on such a movement can be catalytic. Of course it does mean placing the burden of social responsibility on the shoulders such icons. It does mean, questioning their own individual choices when it comes to tobacco usage. But those of us who are privileged to have had more than their fair share of good fortune and are in a position to influence young members of our society - should and must come forward to embrace this responsibility and see it as an opportunity to give back to the society.”

Dravid, supporting the endeavour said, “As a sports person, I would like to see every Indian healthy and fit. Tobacco harms health and steals fitness. All forms of tobacco use are dangerous and deadly. Please stay away from tobacco, if you want to lead a healthy life. No More Tobacco in 21st century appeals to me. The World Health

Organisation (WHO) warns us that a billion people will die because of tobacco, in the 21st century. We must make sure this does not happen by removing tobacco from our lives. No More Tobacco in the 21st century! For this, young people must take the lead.”

Panag's recommendation to all law makers and future law makers is to help strengthen implementations of Framework Convention on Tobacco Control (FCTC) and Cigarettes and Other Tobacco Products Act (COTPA) in the near future and also proactively think of measures that go beyond these frameworks.

Both Panag and Dravid have also been involved in other activities for the benefit of the society. Dravid supports the Children's Movement for Civic Awareness (CMCA) and AIDS Awareness Campaign. Panag has lent a hand to spread breast cancer awareness, campaigned for better sanitation facilities and better health for underprivileged children.

67 EXPRESS PHARMA December 16-31, 2013

cover ) John Abraham joins Cure International India's 'Treat Clubfoot Today' campaign

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Spreads the message that clubfoot is treatable but can lead to permanent deformity if neglected

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OLLYWOOD heartthrob, John Abraham is a man with multiple facets to his personality. As a model, actor, producer, and director, he has donned several hats with considerable success.

One such role is that of a social activist. He has lent his name and support to several noteworthy causes including People for the Ethical Treatment of Animals (PETA) and Habitat for Humanity which campaigns for "simple, decent, and affordable" housing. In April 2013, on behalf of PETA, Abraham wrote a letter to the Minister for Environment and Forests, Jayanthi Natarajan, asking that she make all circuses in India animal-free.

Campaigning for clubfootfree India Recently, he has signed up as

the Goodwill Ambassador for 'Treat Clubfoot Today', an initiative by Cure International India in partnership with Rotary International and NRHM, Government of India. In India, everyday over 150 children are born with clubfoot, a congenital deformity that affects one foot or both. John Abraham joins CURE International India Trust (CIIT) in enlightening the public that clubfoot can be treated and neglected clubfoot leads to lifetime disability. CURE India is also facilitating free non-surgical treatment across 90 designated Clubfoot Clinics in NCR of Delhi, Karnataka, Tamil Nadu, Bihar, Kerala, Maharashtra, Jharkhand, Madhya Pradesh, Rajasthan, Odisha, Uttar Pradesh, Assam, Meghalaya, Nagaland, Mizoram, Manipur, Tripura and Arunachal

Pradesh.

Speaking about his association with the 'Treat Clubfoot Today' campaign, the Bollywood actor stated, "Every child has the right to lead a normal life. That is why I decided to become the Brand Ambassador for Clubfoot. I am fortunate that I am in a position where I can lend face value and help propagate this campaign.

I thank you for giving me the opportunity to champion this cause."

Living up to his heritage Abraham attributed his willingness and interest for social causes to his upbringing. He said that his parents have always been people who believed in giving back to the society and have inculcated the same attitude in him. "My mother takes care of children affected by cancer twice a week, feeds stray dogs twice a week and takes care of the aged twice a week. My father is an architect and builds homes for earthquake affected people," he said.

68 EXPRESS PHARMA December 16-31, 2013

He also informed that it was his mother who urged him to take the initiative to curb clubfoot in India.

In a lighter vein he said, "I told Santhosh (Dr Santhosh George, Director, CURE International India) when he met me that I am a Mama's boy and have been ordered by my mother to lend my support to the cause.” “I told him, please use me and actually abuse my image; just use it wherever you want to, because anything that needs the championing of cause requires for us to be present,” he added.

Abraham also said that he is proud to be associated with the venture and mentioned that he want to see India free of disability from clubfoot and he will support the campaign to get all children born with clubfoot reach the nearest free clubfoot clinics.

It is to be expected that his involvement in the fight against ignorance of clubfoot will benefit thousands of children to lead a productive normal life.

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Aishwarya Rai Bachchan and Lisa Ray vouch for stem cell therapy

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Claim it is a great gift for a child that would last a lifetime

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ELEBRITIES supporting a social cause is nothing new. Lately several well known personalities have offered their support to issues related to health which in turn has given an added impetus to the campaign and garnered the attention of the masses. Several times, a celebrity chooses to champion a particular cause because of his/her personal experience/s. Aishwarya Rai Bachhan and Lisa Ray are cases in point.

Both of the actresses have been very vocal about stem cell therapy and its benefits. As an intervention strategy that involves introducing new adult stem cells into damaged tissue in order to treat disease or injury, it is being touted as a great alternative for treatment of several genetic diseases, cancers, and blood disorders.

Lisa Ray went in stem cell therapy after being diagnosed with multiple myeloma, a cancer of the white blood cells known as plasma cells, and claims that it has proved to be very beneficial in her case.

Since then she has been advocating the use and advantages of stem cell therapy. She is associated with LifeCell, a leading private stem cell bank and stem cells solutions provider in India.

They are credited with bringing the the concept of umbilical cord stem cell banking to India.

Advocating this concept, Ray said, “Stem cells are becoming the cornerstone in modern medicine for the treatment of several medical conditions today. As more and more medical conditions come

within the realm of being treatable with stem cells, these wonder cells are now being perceived as lifesavers. It is imperative that parents make use of this wonderful technology of stem cell banking at the time of their baby's birth, to preserve the nature-endowed gift of umbilical cord stem cells. This is a wonderful once-in-a-lifetime opportunity that children of this generation have, to enjoy protection for a lifetime.”

“As a beneficiary of stem cells I have experienced their miraculous powers to renew one's health and life. I urge every parent-to-be to consider stem cell banking before their little one arrives. It is a simple decision and also a once-ina-lifetime opportunity to preserve stem cells in the most painless way.

The time of your baby's birth would be the most beautiful moment of your life and umbilical cord stem cell banking can add the sheen to it for a lifetime. Your baby stays protected from over 80 medical conditions and you take can pride of having given her the best gift that lasts a lifetime,” she informed.

Aishwarya Rai Bachchan is another celeb who has lent her name and support for stemcell preservation. She and her husband chose to get their daughter's stem cells preserved at LifeCell. Recently, at an event held

by LifeCell, she came out in strong support of the therapy and said, “It is the best gift for the child.” As a patron of LifeCell and Goodwill Ambassador for stem cell banking, Aishwarya Rai said, "It is a

privilege to educate expectant parents on the significance of banking umbilical cord stem cells since it can secure your baby’s future health against many serious medical conditions. Also advancing stem cell research would only increase the benefits”.

She further elaborated, “Choosing to bank our baby's umbilical cord stem cells with LifeCell is a treasured gift that will stay with her for life and is an investment for her healthy future.

LifeCell’s dual storage, comprehensive insurance packages for total security and complete stem cell service solutions including research and therapy gives me confidence that it is the world's most accredited stem cell bank.”

Ray also vouched for LifeCell and said, “LifeCell is one company that keeps up with time and growth in technology thereby bringing only the best of the best for its clients. The company is as versatile as stem cells itself and the fact that they provide comprehensive stem cells

solutions including R&D and menstrual stem cell banking is testimony to it. They now have exciting plans to take the service and the benefits of stem cells out to common people by positioning it at an affordable price. Stem cells saved my life and it is exciting for me to associate with a company that gives so much life and vibrancy to this technology.”

Thus these celebrities have been won over to this cause by their own experience and have chosen to pass on their learnings for the benefits of the masses. Both of them are also involved with several other social causes as well.

Rai Bachchan has been associated with PETA, Smile Train, Aishwarya Rai Foundation and Eye Bank Association of India. Ray also has been campaigning for cancer awareness and Paln Canada's ‘Because I Am A Girl’ initiative, a global movement that supports the rights of girls around the world. Their involvement have been instrumental in bringing crucial issues to the fore and helped to educate the masses at various levels.

69 EXPRESS PHARMA December 16-31, 2013

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The list continues...

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More and more celebrities are coming to the fore and championing various initiatives for health

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GROWING number of stars have been mobilising their popularity and utilising their power over the masses for good causes. Lately some of the famous personalities who were seen promoting health issues include:

Milind Soman Model, actor and national level swimmer, Milind Soman was seen participating in India’s 1st International Women’s 10K – Run competition which was held in New Delhi. The marathon was held to create awareness on breast cancer as well as promote health and fitness among women.

Soman, Marathon Runner and Founder, Pinkathon said, “I’m happy to see so many women coming to lend their support.

Awareness is the key and events such as these go a long way in creating awareness, early diagnosis and helps in the fight against breast cancer.” More than 2500 women from corporates, colleges, nurses, social clubs and doctors participated in the run under various categories. The money raised out of the event, which was flagged of by Gul Panag, actress and social activist, would be used to treat economically challenged cancer patients.

Priya Dutt Politician and daughter of late veteran actor Sunil Dutt, Priya Dutt is another notable personality who has lent her support to several worthy causes.

Lately she was seen at two events that sought to address polio and cancer. She came out in support of the 'End Polio Now' campaign by Rotary International to ensure that India remains polio-free and eradicate the disease from the world. As a Trustee of Nargis

70 EXPRESS PHARMA December 16-31, 2013

Dutt Memorial Charitable Trust, Dutt has also been involved in organising camps and activities for cancer patients and their families. Recently, she was a part of the free hair treatment camp for cancer survivors alongwith BNH HCG and Richfeel, India’s leading Trichology centre. The camp aimed at restoring the self esteem and confidence of cancer patients who have suffered as a result of the disease or chemotherapy's side effects like alopecia or hair loss.

Anil Kapoor Actor Anil Kapoor was recently seen promoting Can India Conclave on social media.

He has been giving out tips for healthy living on their official

facebook page. Some of his recommendations were: ■ Reduce alcohol and meat consumption: In day-to-day life consumption of meat and alcohol should be as low as possible ■ Eat healthy food: A proper diet should have vegetables, fruits in a proper proportion ■ Go for regular doctor checkups: Visit doctors at regular intervals and do routine check ups ■ Exercise regularly: Regular exercise is a must for a fit and healthy life ■ Don't consume tobacco: Avoid tobacco consumption for a long and healthy life

Sonam Kapoor Actress and daughter of Anil

Kapoor has also been involved in spreading cancer awareness. She is the Brand Ambassador of Ogaan Cancer Foundation and is also associated with Can India Conclave. She said that every year in India, we register lakhs of cancer cases and the number of cancer survivors are also on the rise. She advised cancer patients to get away from fear after surviving cancer treatment. She said, “Today there is help available in the society if you seek support from proper groups who can help you during the crucial cancer journey.” Sonam Kapoor spreads the message that cancer is curable if detected on time and normal life is absolutely possible after cancer treatment too. u.sharma@expressindia.com

PHARMA LIFE AWARD

Glenmark Pharmaceuticals wins Thomson Reuters India Innovation Award Wins the Pharma Corporate award while Pharma Academic & Government award went to National Institute of Immunology

THOMSON REUTERS India Innovation Awards 2013 was recently held in New Delhi.

The awards recognised the most innovative academic institutions and commercial enterprises headquartered in India for their spirit of innovation in Research & Development (R&D). Pharma Corporate award went to Glenmark Pharmaceuticals, Pharma Academic & Government award to National Insti-

tute of Immunology, Hi-Tech Corporate award to Reliance Industries and Hi-Tech Academic & Government to Council of Scientific & Industrial Research.

Commenting on their recognition in the Hi-Tech Academic & Government category, Professor Samir K Brahmachari, Director General, Council of Scientific & Industrial Research said, “CSIR today is globally bench-

marked and is recognised as a successful model of post independence India’s innovation system that provides globally competitive, affordable technological solutions to diverse sectors, from leather to generic drugs, pesticides to tractors, glass and ceramics to industrial catalysts, and from minerals and metals to advance materials.”

Winner of the Pharma Academic & Government cat-

egory, Dr Chandrima Shaha, Director, National Institute of Immunology, added, “We would like to make a difference to the nation by developing innovative technologies in the laboratory through discoveries spawned by basic scientific inquiry and developing them for use by the society.

Our aspirations are to solve daunting problems in health emerging in modern times.”

The guest of honour at the

event was Dr T Ramasami, Secretary, Government of India, Department of Science & Technology. The ceremony was attended by more than 150 guests comprising researchers, scientists and heads of pharmaceutical and technology companies, academics, intellectual property (IP) analysts and searchers, and patent examiners.

EP News Bureau - Mumbai

71 EXPRESS PHARMA December 16-31, 2013

PHARMA LIFE APPOINTMENT

Anita Tripathy named president of inVentiv Health India Will be responsible for the management, development and growth of all business units in India across inVentiv’s clinical and commercial segments inVENTIV Health, offering best-in-class clinical, commercial and consulting services to the bio pharmaceutical industry, has named a senior executive in India’s life sciences industry to lead its expanding operations in India.

Anita Tripathy joins inVentiv Health from Capgemini, India, where she served on the leadership team of the global provider of consulting, technology and outsourcing services.

At inVentiv Health, as President, India, she will be responsible for the management, development and growth of all business units in India across inVentiv’s clinical and commercial segments. She will be based in Mumbai and report to inVentiv Health Executive Vice President Ray Hill.

At Capgemini, Anita Tripathy led a strategic cluster of IT products for the European

market. While at Cognizant earlier in her career, she led the strategic business unit for Life Sciences in India. She orchestrated teams based out of India, China and Argentina, delivering services across three continents, North America, Europe and Asia Pacific.

Before transitioning to the life sciences industry, she worked in ERP applications for KPIT Cummins Infosystems, and at Satyam Computer Ser-

vices. She also worked in Pune at Nestle India as a systems analyst, and at ICIM as a senior systems engineer. She holds a Bachelor’s degree in Chemistry from Berhampur University and a Master’s in Computer Applications from the Regional Engineering College, Rourkela, Orissa.

“By enhancing our organisation in India and our service offerings there, inVentiv is prepared to better meet our cus-

tomers’ need for more cost-effective research, data services and strategic outsourcing,” said Paul Meister, Chief Executive Officer, inVentiv Health. “India remains a top choice among global pharma and biotech companies on the skills-to-cost scale, and Anita’s deep understanding of India, IT and the life sciences sector will support our growth.”

EP News Bureau-Mumbai

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