Express Pharma (Vol.10, No.19) August 1-15, 2015 by Indian Express

VOL. 10 NO. 19 PAGES 78

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Market At least 200 new Jan Aushadhi stores to be opened in FY16 Case Study Realising growth through virtualisation 1-15 AUGUST 2015,` 40

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CONTENTS Vol.10 No.19 AUGUST 1-15, 2015 Chairman of the Board Viveck Goenka

HARNESSING DIGITAL INDIA

MARKET

AT LEAST 200 NEW JAN AUSHADHI STORES TO BE OPENED IN FY16

PFIZER INDIA TO SHUT DOWN THANE PLANT FROM SEPTEMBER ’16

FICCI-WORLD BANK JOIN HANDS TO ADVANCE ‘MILLENNIUM ALLIANCE’ INITIATIVE

CIPLA APPROVES INVESTMENT BY FIDELITY GROWTH PARTNERS INDIA

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap

Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P21: PRE EVENT INTERVIEW ‘Pharma industry has a very definite role to play at NCML’

MANAGEMENT

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

P33: INTERVIEW ‘Seven of the ten largest firms are connected to the Life Sciences Identity Hub’

P35: CASE STUDY Realising growth through virtualisation

‘WE MANAGE CASH FLOWS BETTER’

PANCREATIC CANCER TREATMENT PIPELINE DOMINATED BY EARLY-STAGE DEVELOPMENT RESEARCH

P40: CLINICAL UPDATE Merck receives EU-approval to extend Kuvan use to children with PKU below age four

P70: APPOINTMENT Samina Vaziralli joins Cipla’s board of directors

RESEARCH

NOVAVAX’S EBOLA VACCINE SHOWS PROMISE IN EARLYSTAGE TRIAL

BRISTOL-MYERS’ OPDIVO FOUND EFFECTIVE IN KIDNEY CANCER

ALZHEIMER’S RESEARCHERS CONFIDENT OF PRODUCING EFFECTIVE TREATMENT

PHARMA ALLY

PRIME MINISTER INAUGURATES INDIA’S FIRST CONTAINER SCHOOL BY SAFEDUCATE

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. 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 © 2015. The Indian Express (P) 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

Digital India: A new game needs new rules

ith the launch of the Digital India campaign in early July, it is time to relook India Pharma Inc’s engagement with technology. As the cover story in the IT@Pharma segment of Express Pharma August 1-15 issue points out, the use of technology within pharma companies in India has increased manifold, across all functions. (See story Teching up, pages 24-28). The industry is today seen as one of the growth drivers for IT companies, as tech spend in other sectors reaches a plateau. Similarly, pharma companies are gearing up to see how they could leverage the recently launched Digital India campaign to address their challenge areas. (See story Harnessing Digital India, pages 29-32). Most pharma companies would be keen to use the platform to extend their reach into rural markets but physical infrastructure and legal issues need to be first put in place. There is no doubt that the Digital India initiative will create opportunities but will it also widen the divide between India and Bharat? Most of Bharat, i.e. rural India, has little or no access to medicines and doctors, with most pharma companies in India reluctant to invest too much in setting up sales teams for tier-III towns and beyond, or widening their distributor network to cover remote areas. The initiative needs to be modified to address these challenges created by digital technology. For instance, Health and Family Welfare Minister JP Nadda’s response to a starred question in the Lok Sabha on e-pharmacies and

There is no doubt that the Digital India initiative will create opportunities but will it also widen the divide between India and Bharat?

the online sale of drugs, in the ongoing monsoon session of Parliament, left many aspects open to interpretation. Th question is significant as Maharashtra FDA recently took action against online retailer Snapdeal for selling drugs online. The Minister was quite clear that online sale of drugs or e-pharmacy is presently not allowed, and there were currently no plans to issue fresh rules or guidelines to regulate this practice. However, other parts of his response point to the loopholes in India's drug regulation infrastructure which have been exploited in the past and could be used by online retailers as well. For instance, while quoting the laws governing the sale of drugs in the country, the Drugs & Cosmetics Act, 1940, the Minister's statement that 'the sale of drugs in the country is regulated by State Licensing Authorities’ could in fact lead online retailers to try to target softer state governments, while avoiding those where the FDA bodies are known to be tougher and better equipped/staffed to deal with such cases. True, some online pharmacies are at pains to explain that they are putting systems and processes in place to plug the holes but the simple fact is that for every ethical e-pharmacy, there will be many fly-by-night operators. Digital India will surely be a gamechanger, but a new game needs new rules. Policy makers need to give existing laws more teeth and the regulatory arms more muscle (think jail terms instead of fines). Else, the vision will remain just that. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET COMPANY WATCH

At least 200 newJan Aushadhi stores to be opened in FY16 the Indian Drugs & Phamaceuticals Ltd (IDPL) and Hindustan Antibiotics Ltd, (HAL), the Pharma Central Public Sector Enterprises (CPSEs), they will play an important role with regards to providing medicines for the scheme. BPPI has initiated various steps to increase the basket of products and services with a list of 504 medicines and 161 consumables. Rate contract for 314 medicines has already been finalised and the tender for remaining 190 medicines has also been published. 131 medicines have already been identified for PSUs and a list of 173 medicines have already been forwarded to pharma PSUs for exploring the possibility of undertaking the manufacturing of the same.

SPHAERA PHARMA (India), a subsidiary of Sphaera Pharma (Singapore), and the Drug Discovery Research Centre (DDRC) of the Translational Health Science and Technology Institute have received funding from The Wellcome Trust to develop a novel, first-in-class, therapeutic for the treatment of multiple drug resistant (MDR) and extensively drug resistant (XDR) tuberculosis (TB). This is based on a unique approach, first identified at the International Centre for Genetic Engineering and Biotechnology, that targets a host protein. The approach has the potential to be more effective, and is less likely to result in development of drug-resistance. It is also expected to work in conjunction with current therapies. Dr Sundeep Dugar, Chief Executive Officer, Sphaera Pharma Singapore, has indicated that this novel approach through the collaboration between Sphaera Pharma, India, DDRC and Wellcome Trust has the potential to deliver a firstin-class novel therapy for TB.

EP News Bureau- Mumbai

Focus on opening new stores as availability has substantially improved: Hansraj Gangaram Ahir THE MINISTRY Chemicals & Fertilizers will be focusing on opening new Jan Aushadhi Stores (JAS) as availability has substantially improved. According to Hansraj Gangaram Ahir, Minister of State for Chemicals & Fertilizers, all out efforts are made to open at least 200 more JAS during this financial year 2015-16. In response to a question in the Lok Sabha, the Minister said that of the 182 JAS opened across 16 States/UTs, only 111 are operational as of July 13 this year. Steps are also being taken to open JAS in all AIIMS, prominent hospitals, medical colleges under the Ministry of Health & Family Welfare. The Minister also mentioned that remedial measures proposed by the Public Health Foundation of India

182 JAS opened across 16 States/UTs, only 111 are operational as of July 13 this year. Steps are also being taken to open JAS in all AIIMS, prominent hospitals, medical colleges under the Ministry of Health & Family Welfare (PHFI) have also been implemented. For instance, the number of products under the scheme have been increased from 361 to 504 medicines and 161 surgical and consumable items. The supply chain mechanism has been improved through by appointing distributors and

C&F agents in different states while the operating agency i.e., BPPI has been strengthened through augmenting of manpower. Finally, there has been a relaxation in the eligibility criteria of operating agency for JAS. The Minister further mentioned that after the revival of

Sphaera Pharma, THSTI and Wellcome Trust collaborate

Indian Pharma Digital Health Report 2015 released First-of-its-kind study ranks 40 pharma companies in India on their digital health MOST PHARMACEUTICAL companies in India, both multinationals as well as domestic, are still shying away from leveraging the huge opportunities that exist on the digital platforms. This was stated in a report released by D Yellow Elephant recently. Titled ‘Indian Pharma Digital Health Report 2015’, this first-of-its-kind report analysed as many as 40

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August 1-15, 2015

pharma companies in India across 10 key digital parameters, ranging across websites, apps and 10 social media platforms, namely Twitter, Facebook, LinkedIn, YouTube, Google+, Instagram, Pinterest, Vine, Slideshare and Blogger. The report has segregated all firms in key buckets of digital primes, aspirants and onlookers basis analyses of presence, engagement, response,

and consumer followership among few key parameters. According to Aman Gupta, Managing Director, D Yellow Elephant, “The pharma sector in India, whether Indian companies or global players, they are atleast five to seven years lagging behing there global counterparts and if compared to other sectors, the time lag could go upto 10 years and above. Ironically, some of these

same companies abroad are seen to be proactively using digital platforms to engage with health care professionals (HCPs) and patients,” he said, explaining that this report is an attempt to help the pharma sector entities in India catch up on the time gap, identify the loopholes and help them incorporate digital medium in part of the decision making process.

Highlighting the key findings of the report, Chandni Dalal, Lead, Digital Strategy at D Yellow Elephant said, “Out of 40 companies surveyed, only nine companies managed a score above 50 over a scale of 100 points. This shows the reluctance to effectively engage with their stakeholders on the digital platform.” EP News Bureau- Mumbai

MARKET

Pfizer India to shut down Thane plant from September ’16 Sandoz India’s Turbhe plant to down shutters by December 2016

cisions and to ensure a transparent process,” said Vivek Devaraj, Sandoz Country Head in India. He said the company was “committed to managing the

process with the utmost care, sensitivity and respect for all impacted associates at Turbhe, to supporting our customers through the transition and to

LESS THAN a week after Sandoz, the generic division of Novartis, announced that it would discontinue operations at its Turbhe site by end December 2016, another MNC, Pfizer India announced the closure of its manufacturing facility at Thane from September 16, 2015. According to Pfizer India spokesperson, the Thane plant was commissioned in the 1960s, manufacturing medicines for both domestic and international markets but there has been ‘practically been no production activity at this plant since 2013.’ Hence closure of the site would not impact supply of Pfizer India’s medicines. Both plant closures are a consolidation of manufacturing facilities, with the shutting down of older facilities and redirection to more modern facilities, with Pfizer India’s statement attributing the decision to ‘an assessment of its long term viability and its ability to achieve the needed production.’ 132 of the 212 Pfizer India workmen at the Thane plant had already taken up the voluntary retirement scheme (VRS) offered by the company and the statement indicated that the remaining 80 workmen who continued to receive full wages despite plant inactivity, would also receive requisite compensation as mandated by law. While the close down process is in the final stages at Pfizer India’s Thane facility, Sandoz’ July 10 announcement is the beginning of the process at its Turbhe plant, which employs 170 associates and manufactures antibiotics and APIs. “We made the announcement (on July 10) to ensure our associates are informed as soon as possible about our de-

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August 1-15, 2015

meeting patient needs for access to important medicines.” Manufacturing would now focus at its other sites which employ over 1,300 associates and

produce over three billion tablets and 180 tonne of API annually.” EP News Bureau- Mumbai

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FICCI-World Bank join hands to advance ‘Millennium Alliance’initiative To support solutions that provide last mile delivery in healthcare, sanitation, education, clean energy and agriculture to base of the pyramid population THE FEDERATION of Indian Chambers of Commerce and Industry (FICCI) and the World Bank has announced their partnership to advance the Millennium Alliance (MA) initiative. The MA seeks to identify and scale up innovative solutions being developed and tested by social enterprises in India that can improve access to services for poor and underserved populations across India and the world. A Memorandum of Understanding (MoU) was signed by Dr A Didar Singh, Secretary General, FICCI and Onno Ruhl, India Country Director, World Bank. The MoU formalised a shared commitment to support solutions that provide sustainable last mile delivery to populations at the base of the pyramid in healthcare, sanitation, education, clean energy and agriculture. FICCI and the World Bank have come together in a knowledge partnership to promote the replication and scaling up of innovative approaches in service delivery across the South Asia and Africa regions. The partnership will facilitate dialogue between social enterprises and governments so that solutions can be scaled-up to underserved populations under the government’s priority programmes. Besides the Millennium Alliance programme, the agreement also provides for FICCI and the World Bank to work together to enhance private sector engagement in global migration policy and promote the generation and synthesis of knowledge on migration issues. In this, the World Bank’s engagement will be led by the Global Knowledge Partnership on Migration and

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An MoU was signed by Dr A Didar Singh, Secretary General, FICCI and Onno Ruhl, India Country Director, World Bank

Development (KNOMAD). Reportedly, FICCI and the World Bank’s partnership aims to promote the mobility of skilled labour, enhancing safe and legal migration, and ensuring ethical transnational recruitment practices. Potential areas of collaboration include the study of demographic changes and migration; the study of remittances, including access to finance and capital markets; and mobilising the diaspora as agents of social and economic change. In terms of the MoU, both FICCI and the World Bank anticipate that their collaboration will focus on a number of substantive areas, which include, but will not be limited to: ◗ Identifying social enterprise innovations in India through FICCI’s ‘Millennium Alliance’ competition and supporting capacity development activities. ◗ Researching and analysing innovative pilot activities in the

priority areas of health and/or sanitation, and identifying and operationalising mechanisms for replicating/scaling up the benefits of social enterprise at the sectoral level. ◗ Generating and synthesising knowledge on migration issues for the benefits of countries worldwide, including the creation and dissemination of a menu of possible policy choices based on multidisciplinary knowledge and evidence – based research. ◗ Enhancing private sector engagement on migration issues, establishing strategic partnerships, and engaging with Government of India and industry to promote policy cohesion in addressing growth of industry and business through joint initiatives related to international migration and labour mobility. ◗ Framing KNOMAD and FICCI’s efforts to promote portability of skilled labour migration, safe and legal migration, and ethical recruitment initiatives, and to inform policy makers in the interest of industry, business and migrants. “From sectoral cooperation to a flexible framework agreement brings the World Bank and FICCI to a new development opportunity which we are excited about,” said Singh. “The MoU provides a framework to engage private sector in key development initiatives. Collaborations on Swachh Bharat, development of social enterprises, South Asia trade and knowledge exchange with Africa will get immediate focus,” said Onno Ruhl, Country Director India, World Bank.” EP News Bureau- Mumbai

Sanofi Pasteur announces initiative to prevent flu Farhan Akhtar is ‘cause ambassador’ for flu prevention SANOFI PASTEUR, the vaccines division of Sanofi, has announced an initiative to educate parents in India about the seriousness of influenza (also known as flu) and preventing it amongst young children. Film personality, Farhan Akhtar, has chosen to spread awareness about flu prevention. Farhan’s messages will reach people via mass media and in-clinic as well. Speaking about the initiative, Jean-Pierre Baylet, Country Head - Sanofi Pasteur India, said, “Influenza is a serious and contagious disease that often

“It was surprising to learn that flu is not a common cold, but a serious viral infection that carries a high risk especially amongst children below the age of five. It was reassuring to know that flu can be prevented and children can be protected against flu through timely vaccination. This was a revelation to me, and I am sure that there are others too who have misconceptions about the disease, inadvertently risking their children’s lives. Hence, in my capacity as a public figure, I decided to support the initiative to spread the message on flu

According to the WHO, the principal way of reducing influenza burden is by vaccination. However, lack of awareness is a limiting factor in vaccine usage gets mistaken for common cold. As seen during the early part of the year, influenza outbreaks can cause significant morbidity and mortality and strain the healthcare system. According to the WHO, the principal way of reducing influenza burden is by vaccination. However, lack of awareness is a limiting factor in vaccine usage. Sanofi Pasteur, India is therefore embarking on an initiative to educate the masses and improve awareness on influenza and its prevention. We are delighted that Farhan Akhtar is supporting the cause of flu prevention to ignite attitudinal change towards influenza and its prevention.” Regarding his decision to support the cause, Akhtar said,

prevention.” Since 2011, under its corporate initiative, ‘I for Immunisation’, Sanofi Pasteur India has conducted various awareness drives, such as launching a Facebook page called ‘Mothers against flu’; multiple contests to generate ideas for increasing immunization awareness and rural awareness programs in Gujarat and urban schools across the country wherein parents, students, and teachers have been educated about the importance and ways of prevention against diseases such as flu. Both Sanofi Pasteur India and Farhan Akhtar aim to create a behavioural shift from ‘ignorance to awareness to conviction’ about the seriousness of influenza and its prevention. EP News Bureau- Mumbai

MARKET

Cipla approves investment by Fidelity Growth Partners India The business will focus on opportunities arising from the shift from illness to wellness and self-care CIPLA’S BOARD has approved an investment by Fidelity Growth Partners India and USbased Fidelity Biosciences, through FIL Capital Investments (Mauritius) II Limited or its affiliates, in its recently launched consumer healthcare business which is under incorporation. The investment is subject to execution of definitive agreements and regulatory approvals. Through Cipla Consumer Healthcare, the company has entered the rapidly growing overthe-counter (OTC) healthcare market in India. The vision is to improve the lives of Indian consumers, building on Cipla’s strengths in bringing good science to good medicine, while also leveraging its market outreach and equity with the Indian healthcare system. The idea is to leverage Cipla R&D and innovation platform to provide innovative solutions to meet the unmet needs of the Indian consumer. The business will focus on opportunities arising from the shift from illness to wellness and selfcare. Samina Vaziralli, Executive Director, Cipla, who has incubated this business at Cipla New Ventures said, “Partnering with a long-term strategic and financial investor like Fidelity Growth Partners on this journey will help us create a best-in-class consumer healthcare business. In the consumer healthcare business we need a strong FMCG talent pool and the right ecosystem with a ‘pharma in/ FMCG out’ mind-set. We already have great talent on board.” Raj Dugar, Senior Managing Director, Fidelity Growth Partners India, said, “Over-thecounter consumer healthcare is a nascent but rapidly growing market in India, and one we are

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very excited about. This is a unique opportunity for us to partner with Cipla, a company that has long been associated with changing the paradigm of care to build a robust platform

that delivers differentiated, high quality products for the Indian consumer. Using our combined knowledge and resources, we intend to provide OTC products that will bring significant bene-

fits to the consumer.” Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla said, “It is great to see Cipla in consumer healthcare. It has been my aspi-

ration since joining the company that every person in India should have access to Cipla’s healthcare products that are available at a price affordable to them.” EP News Bureau- Mumbai

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Access to affordable medicines in middle-income countries under threat: MSF Criticises moves to base fund allocation in part on income classifications, rather than public health needs AT THE International AIDS Society (IAS) Conference, Doctors Without Borders/Médecins Sans Frontières (MSF) warned that middle-income countries (MICs), which will be home to 70 per cent of people living with HIV by 2020, face increasing threats to their ability to access affordable generic medicines, which are crucial to countries’ ability to reach the global UNAIDS 90/90/90 targets. “No one can deny the pivotal role that affordable antiretrovirals have played in putting 15 million people on HIV treatment, but as we look ahead to the next 15 million, we see that middle-income countries are increasingly constrained in accessing affordable generic medicines, and this spells disaster for the global HIV response,” said Dr Peter Saranchuk, TB/HIV Advisor for MSF. Calling the term ‘middle-income’ an artificial classification that is not linked to public health realities, the release makes the point that more than half of MSF’s medical programmes are in MICs, including India, Kenya,

Myanmar, Republic of Congo and South Sudan. About 70 per cent of the world’s poor live in MICs, and 60 per cent of people with HIV live in these countries today. Leena Menghaney, Head of MSF’s Access Campaign in South Asia said, “Multiple threats on MICs are converging to form an unprecedented assault on access to medicines. Amongst other threats, some of the most acute come from trading partners – like the US and Japan – who seek to impose intellectual property rules that will block access to generic medicines; and from several donor agencies, including the Global Fund to Fight AIDS, tuberculosis and malaria, whose discriminatory policies are moving towards reducing funding for MICs at a time when global HIV targets call for increasing the pace of treatment scale-up.” The association points out that current pharmaceutical industry pricing strategies for antiretrovirals (ARVs) and other medicines, including tiered pricing, voluntary licensing and do-

About 70 per cent of the world’s poor live in MICs, and 60 per cent of people with HIV live in these countries nation programmes, deliberately exclude MIC, and are almost entirely focused on excluding MICs from accessing the lowest global prices available to low-income countries. This is particularly acute for third-line, or salvage regimens, which are priced out of reach for most countries. For example, the raltegravir, etravirine, darunavir and ritonavir salvage regimen is available at the lowest global price for $1,854 per person per year

(PPY), but middle-income countries often pay exponentially more: for example, Myanmar pays $2,929 PPY and Ukraine pays $16,409 PPY. Second-line treatments, and some newer first-line treatments, are also priced out of reach. The MSF release is targetting the negotiators for the Trans-Pacific Partnership (TPP) agreement who met in Hawaii to try to finalise terms for a trade pact that will encompass at least 40 per cent of the world’s GDP. One third of the 12 TPP countries are developing countries classified as middle-income economies who, if the deal is signed in its current form, would be forced to implement a range of new provisions that will lengthen, strengthen and expand patent and regulatory monopolies for medicines. For example, one proposed rule limits governments' ability to restrict pharma companies' efforts to pursue abusive ‘evergreening’ strategies to extend the life of pharma patents well beyond 20 years. The effect is reduced ability to access affordable generic

medicines. The release criticises the ‘new funding model’ of the Global Fund to Fight HIV/AIDS, tuberculosis and malaria as it relies on a funding allocation formula based in part on income classifications, rather than public health needs. As a result, several MICs such as Ukraine and Vietnam have seen their funding reduced in the 2014-2016 funding period compared to previous years, limiting their ability to reach socially excluded groups. Menghaney also refers to pressures India is facing from the US, EU and other governments to roll back the country’s progressive patent laws "in order to restrict generic competition, in favour of supporting the MNC pharma industry’s monopoly- and profit-driven business models. She warns that if these policies are allowed to continue, middle-income countries face nothing short of a calamity that poses a major threat to the global HIV response and other health initiatives. EP News Bureau- Mumbai

Suven secures four patents in China, Mexico and SA The granted claims of the patent include the class of selective H3 ligands discovered by Suven and are being developed as therapeutic agents SUVEN LIFE Sciences have secured patents in China (CN103443093) and South Africa (2013/01143, 2013/06328) to their New Chemical Entities (NCE’s) for CNS therapy through mechanism of action – H3 Inverse agonist. The patents are valid until 2031, 2030 and 2031 respectively. The granted claims of the patent include the class of se-

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lective H3 ligands discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders. Suven also secured a patent for their NCE in Mexico (326651) and the granted claims of this patent include the class of selective alpha-4-beta-2 com-

pounds discovered by Suven and are being developed as therapeutic agents for major depressive disorder (MDD) and the patent is valid through 2030. With these new patents, Suven has a total of 16 granted patents from China, 19 granted patentsWith these new patents, Suven has a total of 16 granted patents from China, 19 granted

patents from Mexico and 22 granted patents from South Africa from Mexico and 22 granted patents from South Africa. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be outlicensed at various phases of clinical development like at

phase-I or phase-II. “We are pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally,” says Venkat Jasti, Chief Executive Officer, Suven. EP News Bureau- Mumbai

MARKET GROWTH TRACKER

IPM clocks ` 7928 crores in June 2015 From regional perspective, 15 regions have outgrown the IPM growth THE INDIAN pharma market clocked ` 7928 crores in June 2015. It has grown at 14.8 per cent in the same month. Amongst the top 10 corporates, Sun grew by 27.9 per cent followed by Pfizer at 20.2 per cent and Abbott at 19 per cent. 23 corporates have crossed the growth of IPM amongst top 50. Wockhardt has the highest growth of 36.2 per cent followed by AstraZeneca at 35.4 per cent and Glenmark at 34.5 per cent. 27 corporate showed growths more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporate, Glenmark has the highest growth of 34.5 per cent followed by Torrent at 28.3 per cent and USV at 27.1 per cent. Amongst the 21-30 ranked corporate, Wockhardt has the highest growth at 36.2 per cent followed by MSD 31.6 per cent and Unichem at 20.5 per cent. Amongst the 31-40 ranked corporates, AstraZeneca has the highest growth at 35.4 per cent followed by Akumentis at 33.4 per cent and JBCPL at 27 per cent. Amongst the 41-50 ranked corporates, Hetero has the highest growth at 21 per cent followed by Fourrts at 17.9 per cent and Allergan at 17.8 per cent. Amongst the 51-60 ranked corporates, Boehringer grew at 79.1 per cent followed by Eli Lilly at 39.9 per cent and Troikaa at 38.4 per cent. Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 38.8 per cent followed by RPG at by 36.1 per cent followed by TTK at 26.3 per cent. AstraZeneca has entered the ` 500 crore-club, Hetero ` 400 crore, Troikaa ` 300 crore, Tablets India ` 200 crores on MAT Basis. Amongst the top 10, Sun Pharma grew by 32.9 per cent followed by Ranbaxy at 20.5 per cent and Pfizer at 20.2 per cent. 25 companies have crossed the growth of IPM for June 2015 amongst top 50. Amongst the 11-20 ranked companies, Glenmark has the highest growth of 34.5 per cent followed by Torrent at 28.3 per cent and USV at 27.1 per cent. Amongst the 21-30 ranked companies, Wockhardt has the highest growth at 36.2 per cent followed by Unichem 20.5 per cent and Novo Nordisk at 18.9

per cent. Indian companies have grown at 14.5 per cent versus 15.7 per cent for MNCs in June 2015. Amongst the top 50 in MNCs, AstraZeneca at 35.4 per cent , MSD grew by 31.6 per cent followed by and Merck at 22.4 per cent. Under the Non-NLEM category Indian companies grew at 4.3 per cent whereas MNCs grew at 9.4 per cent. The DPCO containing molecules market grew at 5.6 per cent whereas the Non DPCO market grew by 16.2 per cent and Non -Sch Para 19 Market at 14.6 per cent resulting in an overall growth of 14.8 per cent for June 2015. NLEM and Non-NLEM Category showed unit growth at -0.1 per cent and 6.2 per cent respectively. The Non-Sch Para 19 market grew at 11.7 per cent from units perspective. The DPCO 2013 portfolio for Pfizer grew at 17.4 per cent, Ranbaxy 31.9 per cent, GSK at -1.8 per cent and Abbott 11.7 per cent. From therapy perspective, 11 therapies have outgrown the IPM growth. The respiratory market grew at 15.4 per cent, gastrointestinal market grew at 15.8 per cent, pain and analgesics market grew at 10.5 per cent whereas antiinfectives grew at 3.2 per cent. The antidiabetic market grew at 27.4 per cent and cardiac at 18.9 per cent in chronic business. The derma market grew by 19.3 per cent and the urology market at 23.5 per cent. From regional perspective, 15 regions have outgrown the IPM growth. The north Andhra Pradesh (AP) market grew the highest at 25.8 per cent followed by Jharkhand market at 25.3 per cent and south AP market at 20.7 per cent. No region had negative growth in June 2015. Amoxycillin + Clavulanic Acid Market grew at 1.3 per cent whereas Glimepiride + Metformin grows at 17.5 per cent at number two. The markets of paracetamol grew at -0.2 per cent, Atorvastatin 12.1 per cent, Probiotic Microbes at 26.3 per cent, Cefixime -2.6 per cent, Pantoprazole 18.7 per cent, Montelukast +

EXPRESS PHARMA

August 1-15, 2015

MARKET Levocetrizine at 23.6 per cent, Glimepiride + Metformin + Pioglitazone at 22.4 per cent, Vitamin-D at 30.6 per cent, Hydroquinone + Mometasone + Tretinoin at 10.3 per cent, Voglibose + Metformin + Glimepiride at 59.3 per cent, Rosuvastatin at 29.2 per cent, protein supplements at 24.1 per cent, Azithromycin at -3.8 per cent. Mixtard leads the pack with ` 40 crore followed by Glycomet-GP at ` 28 crore and Spasmoproxyvon Plus at ` 26 crore for June 2015. Phensedyl Cough grew by 189.6 per cent followed by Janumet at 132.9 per cent, Corex at 38.7 per cent, Mixtard at 33.8 per cent, Lantus at 32.4 per cent and Glycomet-GP at 22.5 per cent amongst the top 10 brands. Few brands who have gained ranks include Chymoral Forte, Phensedyl Cough (+77), Janumet (+76), Betnesol (+75), Eltroxin (+73), Synflorix (+69), Januvia (+49), Pantocid D SR (+41), Shelcal, Jalra M (+39), Panderm Plus (+35),Spasmo Proxyvon Plus (+33), Istamet (+32), Huminsulin , Aztor (+31), Vertin (+29), Budecort (+26), Magnex (+25), Gelusil MPS , Jalra (+21), Zoryl M (+20), Levipil, Omez, Galvus, Glycomet (+18), Rosuvas, Ultracet (+13), Gemcal (+8), amongst top 100 Brands over June 2014. Brands that have moved up ranks fastest into Top 300 brands for the month of June 2015 are Biovac C, Brilinta, Oframax, Monocef SB, Mero, Bevon, Razo D, Renerve Plus amongst others A total of 273 brands and 462 SKUs were launched in June 2015. Top new brands for June 2015 are Rthrombo, Zita Plus and Infimab. Teneligliptin launch under the brand names of Zita Plus an Ziten from Glenmark is seen in the Gliptin space under OAD segment.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind

20 EXPRESS PHARMA August 1-15, 2015

WITH BONUS UNITS AT FULL VALUE Val in Crs

Rank

CORPORATE

MTH

IPM

MAT June-15

June-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

90085

100.00

14.3

7928

100.00

14.8

Sun + Ranbaxy

8058

8.95

15.0

760

9.59

27.9

Abbott + Abbott HC + Novo

5623

6.24

14.6

498

6.28

19.0

Cipla

4528

5.03

17.9

369

4.66

16.6

Zydus + Biochem

3744

4.16

8.7

319

4.03

7.9

Mankind

3227

3.58

16.6

278

3.51

12.3

Alkem + Cachet + Indchemie

3163

3.51

12.5

267

3.37

6.9

Glaxo

3075

3.41

4.9

255

3.21

2.1

Lupin

2960

3.29

12.1

262

3.31

3.0

Pfizer

2699

3.00

18.1

234

2.95

20.2

Macleods

2642

2.93

25.6

216

2.73

7.7

Emcure + Zuventus

2414

2.68

9.8

214

2.70

10.0

Intas

2402

2.67

19.3

228

2.88

26.2

Sanofi India

2265

2.51

16.6

196

2.47

9.6

Aristo

2256

2.50

19.8

193

2.44

15.1

Torrent

2103

2.33

22.1

200

2.52

28.3

Glenmark

2051

2.28

21.4

184

2.32

34.5

Val in Crs

MAT Jun 15

Month Jun-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

90085

14.3

7928

14.8

ANTI-INFECTIVES

14104

10.3

1119

3.2

CARDIAC

11204

14.2

1027

18.9

GASTRO INTESTINAL

10437

16.0

992

15.8

VITAMINS / MINERALS / NUTRIENTS

8136

13.5

755

14.4

ANTI DIABETIC

7092

26.3

657

27.4

RESPIRATORY

7079

14.8

489

15.4

PAIN / ANALGESICS

6262

12.4

552

10.5

NEURO / CNS

5460

12.2

497

19.6

DERMA

5281

17.8

476

19.3

GYNAECOLOGICAL

4470

9.7

410

12.0

HORMONES

1518

9.4

130

15.8

VACCINES

1506

6.3

139

14.5

ANTI-NEOPLASTICS

1460

20.6

129

4.1

OPHTHAL

1318

17.2

118

15.5

BLOOD RELATED

1013

8.8

16.4

OTHERS

1008

23.9

110

51.4

UROLOGY

979

25.6

23.5

ANTI MALARIALS

549

2.9

-15.7

SEX STIMULANTS / REJUVENATORS

488

9.5

14.3

STOMATOLOGICALS

385

12.8

13.2

OPHTHAL / OTOLOGICALS

229

8.0

2.9

OTOLOGICALS

108

11.7

13.5

AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of in-

formation.

Terminologies used MAT – Moving Annual Total

MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage

GR per cent – Growth in percentage. For more information, visit http://www.aiocd.net

MARKET P R E

E V E N T

I N T E R V I E W

â&#x20AC;&#x2DC;Pharma industry has a very definite role to play at NCMLâ&#x20AC;&#x2122; The National Convention on Medicine and Law (NCML) will take place in Mumbai on September 6, 2015. Mahendrakumar Bajpai, Advocate, Supreme Court of India and Director, Institute of Medicine and Law, talks about the benefits that the convention would offer to the participants, in a discussion with Sachin Jagdale

NCML will come out with solutions and recommendations on key legal issues that are a cause of concern to the healthcare providers

What are going to be the key highlights of National Convention on Medicine and Law? This is the first nongovernment effort in India to bring all the stakeholders in the healthcare sector on a single platform to identify, discuss and deliberate on the legal issues affecting medicine. So on one hand, you will have the doctors, hospitals and medical associations and on the other hand, key government officials, regulatory authorities like Medical Council of India and legal professionals. NCML will come out with solutions and recommendations on key legal issues that are a cause of concern to the healthcare providers while ensuring that patientsâ&#x20AC;&#x2122; safety, transparency or accountability that the law expects is not compromised in any way. We understand that this convention will not be able to address all the important issues of concern, but at least it will be a beginning in the right direction, with the right intention and with the right plan of action. The number of general practitioners is significant in the country. Have you tried to include their representatives as well in

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the convention? Yes, in fact, the main sessions as well as the joint sessions will deliberate on issues that usually concern the general practitioners. How significant will be the participation of the pharma industry in NCML? The pharma industry has a very definite and important role to play in this convention as they are very closely involved with both the doctors and the patients. They can act as a bridge between the doctors and the patients and provide valuable help in narrowing the distrust between the two. After the Supreme Court judgment granting compensation of `11 crores in a case of medical negligence, doctors and hospitals are a worried lot. NCML is a platform where medicolegal issues will not only be identified and discussed but legally tenable solutions will also be evolved. These solutions and recommendations will be of much practical help to doctors in their day-to-day practice and assuage their anxiety. The pharma industry could take these issues, concerns, solutions and recommendations to both the healthcare seekers and providers.

Digital India campaign is expected to revolutionise the healthcare campaign in rural India. Will you be discussing this initiative at the convention? We agree that use of digital technology will revolutionise the healthcare space and the greatest beneficiary would be the poorest citizens of this country needing medical service in the remotest parts of our country. But this issue will not be on our agenda as the statutory guidelines on web consulting and tele consulting are being formulated by the Central Government. Should cases of violence against doctors and hospitals be considered as an outcome of the sharp rise in cases of medical negligence? Medical negligence is just the public face of this problem. The real culprits are the underlying factors like distrust between doctors and patients, a soft regulatory framework, unrealistically high expectations of patients, and the peculiar socioeconomic character of the nation. NCML is a sincere endeavour to address these underlying factors in a participative and transparent manner. sachin.jagdale@expressindia.com

EXPRESS PHARMA

August 1-15, 2015

EVENT BRIEF AUGUST-DECEMBER 2015 6

Global Green Nanotechnology Conclave 2015 (GiGaNTiC 2015)

GLOBAL GREEN NANOTECHNOLOGY CONCLAVE 2015 (GIGANTIC 2015) Date: August 6-7, 2015 Venue: Ahmedabad Summary: The conclave will bring together technologists, scientists, academicians, policy makers and end-users of the nanotechnology platform for discussing the various aspects of development and characterisation, exploring the possibilities of Indian industry to take part in nanotechnology research, product development, growth and initiating new ventures through partnerships with foreign players who are leader in the field. Objectives of the conclave are to provide a platform for researchers and industrialists to interact with each other and share knowledge, create awareness among the endusers and consumers on nanotechnology, to facilitate the technology requirement and other related needs of the industry through national and international networking, to interact with the government to establish policy and standards for nanotechnology processes, to facilitate the training needs of the start-up companies in nanotechnology field. Contact details Gaurang Patel Executive Centre of Excellence in Nanotechnology Confederation of Indian Industry, CII House, Gulbai Tekra Road, Near Panchwati Ahmedabad – 380 006 Contact No: 08460464349 Tel. (079) 40279994; Fax. (079) 40279999 Email- Gaurang.patel@cii.in

ASIA LABEX Date: August 25-27, 2015 Venue: Pragati Maidan, New Delhi Summary: Asia Labex is an international exhibition and conference on laboratory,

22 EXPRESS PHARMA August 1-15, 2015

analytical, biotech and diagnostic instruments and consumables. Around 200 plus exhibitors from 15 countries, 1800 brands will take part in the event. 20 seminar topics will be discussed in the expo and seminar. Contact details Fenza Exhibitions Building No. 21, 3rd Floor, Behind Samrat Restaurant, Outram Lines, GTB Nagar Delhi 110009 Email: info@asialabex.com Tel: +91-11-45088781 / 45088782

PHARMALYTICA 2015 Date: September 2-3, 2015 Venue: HITEX Exhibition Centre, Hyderabad Summary: PharmaLytica conference is the knowledge forum where topics in analytical, outsourcing, laboratory, scientific and biotechnology sector will be discussed. The event will see congregation of 200 leading local, regional, and international exhibitors. Country pavilions from China and Korea will be set up. Contact details Jayesh Kanaskar Project Head jayesh.kanaskar@ubm.com T: +91 22 61727162 | M: +91 9819586780 Yogita Panchal Project Manager E: yogita.panchal@ubm.com T: +91 22 61727510 | M: +91 9930027424

6TH ANNUAL SCM PHARMA SUMMIT Date: September 10 - 11, 2015 Venue: Novotel Mumbai Juhu Beach Summary: SCM Confex, the biggest conglomerate of supply chain and logistics professionals from global pharmaceutical and chemical companies, will focus on creating a robust infrastructure for end-to-end supply chain solutions. The organiser for the event is UBM.

POST EVENT 25

Asia Labex

Contact details UBM India E-mail: suvidha.shetty@ubm.com Web: http://globalformulation.com

2ND ANNUAL DATA INTEGRITY & QUALITY METRICS WORKSHOP Date: October 29 - 30, 2015 Venue: The Westin Mumbai Garden CityInternational Business Park, Oberoi Garden City, Mumbai, Summary: CPhI conference’s workshop will focus on the issues related data integrity, reliability and also on quality metrics and pilot programmes in the US. Experts from Lachman Consultants will be conducting the workshop. The organiser for the event is UBM. Contact details UBM India E-mail: suvidha.shetty @ubm.com Web: http://globalformulation.com

ASSOCHAM’s symposium on ‘Nutraceuticals, Herbals and Functional Foods’ held in New Delhi Delhi Government plans to launch 1000 ‘Aam Aadmi Clinics’ by the end of next year

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharmaceutical industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors can meet all major suppliers of pharma ingredients, outsourcing, equipment and bio-solutions in one location. P-MEC, ICSE and BioPh will be co-located with CPhI event. Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

Usha Sharma New Delhi ASSOCIATED CHAMBERS of Commerce and Industry of India (ASSOCHAM) recently organised a national symposium on ‘Nutraceuticals, Herbals and Functional FoodsMarketing, Promotion and Regulatory Framework' in New Delhi. Commenting on the disease burden on the economy and needed action, Satyendar Jain, Minister for Health and Family Welfare, Government of

National Capital Territory of Delhi informed that the state government has come up with various initiatives to improve the healthcare scenario in the state. He said that the government has recently inaugurated its first ‘Aam Aadmi Clinic’ and there are plans to open another 1000 clinics by the end of next calendar year. Jain added, “Delhi government is focusing on how to cure different disease profiles and has allotted 20 per cent of the total budget on health.” He shared an analysed report about the

MARKET The Indian nutraceuticals industry is expected to grow at 20 per cent to $6.1 billion by 2019-2020. At present the industry is pegged at $2.2 billion and is mainly focused in the Southern region followed by the Eastern region

first clinic, where it has been found that the newly opened centre is more frequented by women than men and around 80 per cent of the women have low haemoglobin levels. He said that people often give importance to the calorie intake and forget to pay attention to intake of minerals and proteins. Dr BK Rao, Chairman, ASSOCHAM National Council of Healthcare and Hospitals and Ex-Chairman, Sir Ganga Ram Hospital said that there are big challenges in the regulatory framework for the nutraceuticals products in India, which needs immediate attention. PK Jain, Chairman and Managing Director, PMV Group and Chairman, ASSOCHAM MSME Council said, “The nutraceuticals industry in India is one of the rapidly growing markets in the Asia Pacific region. Factors, like rising awareness about health and fitness, ageing population, changing lifestyle are fostering this growth.” PK Jain added, “The Indian nutraceuticals industry is expected to grow at 20 per cent to $6.1 billion by 2019-2020. At present the industry is pegged at $2.2 billion and is mainly focused in the Southern region followed by the Eastern region, the three major states being Andhra Pradesh, Tamil Nadu and West Bengal.” He urged the Centre as well as NCT of Delhi to provide special incentives to emerging nutraceuticals companies so that they will be in a position to offer affordable medicines to the needy. Shushmul Maheshwari, Founder and Chief Executive Officer, RNCOS spoke about the trends and developments in global nutraceuticals market. He highlighted that a task force committee has been formulated which has conceptualised the guidelines for the sector and FSSAI is analysing it. Maheshwari suggested introducing soya milk in mid-day meal instead of normal milk, since chances for milk

adulteration will be less, which will result in children having more nutritional benefits. Dr HK Chopra,Co-chairman, ASSOCHAM National Council of Healthcare and Hospitals and Chief Cardiologist, Moolchand Medcity emphasised that there is a need to promote health. He also underlined that today we are just treating the effects not the core cause of the disease. He urged the minister to encourage nutra companies under the government’s 'Make in India’ initiative. Arun Kelkar, Managing Director, Hexagon Nutrition India informed about the differences between nutra and Ayurveda products and how herbs are different from herbal extract. Vani Bhambri Arora, Deputy Director, Quality Council of India (QCI) gave a brief introduction on the international scenario related to the food and pharma sector and issues regarding stringent regulations. She also informed various standards available in the market for food and nutra, like Hazard Analysis Critical Control Points (HCCPs) and the need for third party assessment certificates. Dr Shilpi Sharma, Associate Professor, Department of Biochemical Engineering and Biotechnology, IIT Delhi talked about the safety and efficacy issues in probiotics. The last session of the symposium discussed and analysed issues and solutions related to the Indian nutraceutical sector. Rajesh Kumar, Chief Executive Officer and Director, SAMI Direct said that the nutra industry is facing challenges related to lack of awareness. Anil Joshi, Chief Executive Officer, GCV Life talked about the different strategies required for nutra products in the cutting-edge, technological world.

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u.sharma@expressindia.com

EXPRESS PHARMA

August 1-15, 2015

cover ) IT@PHARMA

24 EXPRESS PHARMA August 1-15, 2015

(

THE MAIN FOCUS

Teching

up With technology spend in the global life sciences industry set to touch $40.8 billion by 2017, IT majors are wooing a more choosy clientele with tailored solutions designed to keep them abreast in a dynamic competitive industry BY SHALINI GUPTA

n 2010, IT analyst firm, Ovum, predicted that the technology spend by the global life sciences industry will grow at a compound annual growth rate (CAGR) of 3.3 per cent over the next five years, touching $33.7 billion in 2015. Big biotech and small pharma/biotech sectors were slated to grow the highest at a CAGR of 6.7 per cent and 7.2 per cent respectively. By the end of 2017, the firm sees this figure at $40.8 billion at a CAGR of 3.6 per cent. “The increase in IT spending will be fuelled largely by the growth in data analysis and related technologies, the acquisition of systems to comply with new regulatory requirements, and increased spending on applications that advance operating efficiency and automation,” the report says.

On a high note Ovum’s findings show that “value chain fragmentation caused by new entities being spun out of big pharma and rapid growth in emerging markets will see strong IT spending growth of 9.4 per cent CAGR in the small pharma/biotech sub sector, totalling $10.5 billion in 2017.” A report by Gartner Benchmark Analytics titled “IT Metrics Data 2014”

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August 1-15, 2015

cover ) “ In the March-ended quarter of 2015, our Healthcare segment, which consists primarily of our payer, pharma, biotech, medical device clients and now our TriZetto business, grew 13.8 per cent sequentially and 42.7 per cent year-over-year” R Meenakshisundaram, Vice President, Life Sciences, Cognizant

“The desire by Indian pharma to export indigenous drugs and make them commercially available in international markets mandates their need to follow international regulatory norms” Ram Yeleswarapu, President and CEO, TAKE Solutions

26 EXPRESS PHARMA August 1-15, 2015

also indicates that pharmaceuticals, life sciences and medical products companies spend 3.2 per cent of revenues on their IT infrastructure — a level higher than industrial electronics and electrical equipment (2.5 per cent), industrial manufacturing (1.7 per cent), and interestingly enough, chemicals at 1.3 per cent. So clearly pharma is coming out of its conservative approach to information technology. Cognizant serves 28 of the top 30 global pharma companies, four of the top five pharmacy benefit management companies in the US, nine of the top 10 biotech companies, and 12 of the top 15 medical device companies and has a growing healthcare and life sciences practice that provides domain-aligned consulting, IT, business process and analytics solutions globally. “In the March-ended quarter of 2015, our healthcare segment, which consists primarily of our payer, pharma, biotech, medical device clients and now our TriZetto business, grew 13.8 per cent sequentially and 42.7 per cent year-over-year. Within the pharma segment, we saw a trend towards multi-service deals across infrastructure and IT services, leveraging cloud technologies and platforms. Additionally, we saw steady demand driven by vendor consolidation and cost optimisation across many existing and new clients,” informs

R Meenakshisundaram, Vice President, Life Sciences, Cognizant. He goes on to add that the acquisition of Cadient Group, a full-service digital marketing agency that serves a broad spectrum of life sciences companies in the pharma, biotechnology, consumer health, and medical device industries, is helping drive Cognizant's digital agenda with its pharma clients. Elaborating on the growth of the business, he says, “We are quite pleased with the traction we are seeing from this acquisition, where we have added nine new logos since closing the acquisition late last year. Recently, Otsuka Pharmaceutical, a US pharma research and development company, publicly highlighted the work Cadient delivered in helping it develop and deploy a highly innovative approach to communicating with clinical trial investigators using iPads and large-format touch screen technology.” He attributes this to companies coming out of pipeline challenges with 2014 witnessing the highest number of drug approvals, and a transformation in the how businesses are run and managed. Ram Yeleswarapu, President and CEO, TAKE Solutions reiterates Meenakshisundaram’s sentiment. “There is a demand in the global pharma/life sciences market for regulatory

compliance and customised solutions to meet business needs. Customers are increasingly looking for value and subject matter knowledge in a true partnership model where they can engage by leveraging the best products, solutions, and services available and couple them with best practices and industry knowledge to gain competitive advantage,” he says. As of the quarter ended September 30, 2014, 61 per cent of TAKE Solutions’ revenue came from life sciences. While the US and Europe are the major markets driving growth, the company plans to expand into Japan by FY 17. Utkarsh Palnitkar, Partner, Head of Advisory, Head, Life Sciences practice at KPMG offers a perspective. “In the last decade, life science has emerged as an important target segment for IT companies. Highly regulated pharma and lifescience industry requires significant expenditure to manage the value chain skillfully and tackle issues such as dwindling research and development pipeline, rising costs of research, patent expirations and increasing compliance issues. The services are aimed at the whole width of drug life cycle starting from R&D to marketing the product,” he says. These include solutions such as R&D data management, bringing innovative products quicker, genome mapping, supply chain opti-

misation and efficiency, manufacturing operations management to boost productivity, quality control, customer relationship management and sales force automation, he adds.

The differentiating factor The trends within the industry also merit close coordination with IT. From a scientific standpoint, genomics and precision medicine are changing the way drugs are discovered, developed and marketed. By 2016, over 60 per cent of the top 10 drug sales are expected to be specialty drugs. “In marketing, the key trend continues to be around the “value-versus-volume” debate. There is an increasing focus on real-world analytics to establish product and pricing differentiation and delivery in the context of population health. Market access is also a key focus. Disruptive technologies have passed the chasm and are now becoming mainstream. The (Social, Mobile, Analytics and Cloud) SMAC stack is now a common requirement and evaluated across multiple opportunities and business use cases. There is a strong push towards digital innovation as devices are becoming more a norm than an exception. This is bringing about a dramatic change in process delivery and efficiency,” observes Meenakshisundaram. He

“Combining the hybrid cloud with an as-a-Service delivery model may well be the answer. With this approach, life science and healthcare companies can build collaborative teams of partners more quickly, reduce the cost of connecting everyone together, minimise the burden on their IT organisations, and relieve themselves of operations, maintenance, and support responsibilities. ” Vijay Takanti, Vice President of Security and Collaboration Solutions at Exostar

( adds that the industry is also witnessing significant portfolio consolidation and increased mergers and acquisitions. The operating model has evolved and is highly collaborative—between peer companies and with academia. Most of these changes are being seen in North America and are rapidly catching on in the rest of the world. Pitches in Palnitkar, “North America( followed by EMEA) is the top destinations for IT services companies driving 55 to 60 per cent of the revenues of Indian IT companies. Europe is the second largest market for Indian players contributing close to quarter of their revenue. Eastern Europe, China and South America are gradually emerging on the radar of Indian IT players for their next growth wave. APAC is moderately attractive to the sector due to growing pharma industry in China and India which is the major consumer for IT services followed by medical devices and biotechnology. Major IT companies in India are on the top of the pyramid capturing close to 75 per centile both in delivery capacity and transaction activity.” Stringent FDA regulations and export rejections in this space have urged Indian pharma companies to seek the help of technology. This has led to investments in technology solutions and best practices to enable risk mitigation, quality, and compliance measures. “The desire by Indian pharma to export indigenous drugs and make them commercially available in international markets mandates their need to follow international regulatory norms. M&A activity as well as trading partner relationships with international partners along with more frequent and adhoc audits by the regulators is compelling them to make these investments. Moreover, India pharma companies are looking at technology support to help them in patent filing

THE MAIN FOCUS

Stringent FDA regulations and export rejections in this space have urged Indian pharma companies to seek the help of technology. This has led to investments in technology solutions and best practices to enable risk mitigation, quality, and compliance measures process,” says Yeleswarapu. Companies in the US and Europe, which are higher up the maturity curve, are looking for cost advantages along with better quality outsourced services such as patent management, clinical trial and quality control. The branded/New Chemical Entities (NCE) research that these companies undertake necessitates innovation and adoption of cutting edge technologies to stay ahead of the curve. That said, Indian companies are also catching up. “Currently, a bulk of the Indian market is focused on generics as opposed to the US and Europe, which are more innovation-driven. The services focus is therefore very different, albeit with some common touch-points. Services in the Indian market are driven more by automation, quality benchmarks, and increased compliance needs. The process focus extends to manufacturing, quality assurance, and regulatory compliance. We are seeing an increased focus on research and development with investments in developing novel entities. We do believe that the trend will translate into some companies going after the end-to-end innovator business,” says Meenakshisundaram optimistically. He informs that Cognizant is witnessing a spurt in requirements from the Indian market with companies benchmarking themselves against global standards to meet growing quality and regulatory demands. China,

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Singapore, Australia, Malaysia, New Zealand and Korea are other emerging markets for the company, a few of which are emerging as research and clinical hubs for global pharma companies. Significant investment push from governments to provide universal healthcare is providing the pharma sector with new growth opportunities and markets such as China, he adds. Globalisation and collaboration are becoming a core part of the operating model and service delivery and hence companies not just want to improve performance efficiency and effectiveness, but also drive innovation and transformation. The focus of IT companies is thus is on transforming the client’s business process and underlying technology with a global operating model.

Getting on the cloud bandwagon Today’s leading pharma companies are breaking down internal and external barriers to explore truly novel, collaboration-based approaches to streamline processes, standardise clinical data and accelerate new therapies to the patients they serve. And they are teaming up with providers who can help them achieve the same. Exostar, a global leader in cloud based based solutions launched its life sciences identity hub two years ago. The launch followed a year of working closely with Merck to develop and test the solution and demonstrate it was a viable

approach. Today 700 organisations and 15,000 individuals in 50 countries including manufacturers, contract research organisations, academic institutions, laboratories,participate in the on-line life science community . “Organisations increasingly need to collaborate outside of their enterprise boundaries, especially in life science and healthcare. That makes the cloud a more attractive technology for them. At the same time, they must comply with regulations like 21 CFR Part 11 and HIPPA to protect the integrity of sensitive information. And they desperately want to avoid data leakages triggered by the rising number and complexity of cyber security threats. Our cloud-based, Softwareas-a-Service delivery model, organisations no longer have to deal with the time, cost, and complexity of implementing these capabilities themselves,” explains Vijay Takanti, Vice President of Security and Collaboration Solutions at Exostar. Cloud-based technology platforms help pharma companies to innovate in a more open, collaborative, cost effective and timely manner; demonstrate efficacy and outcomes for patients, with the goal of achieving appropriate pricing of and reimbursement from governments and payers for their products; Promote products by leveraging multiple channels and the digital world and run global supply chains and global operations. And this could be the

“ Eastern Europe, China and South America are gradually emerging on the radar of Indian IT players for their next growth wave. APAC is moderately attractive to the sector due to growing pharma industry in China and India” Utkarsh Palnitkar, Head of Advisory, Head, Life Sciences practice at KPMG

“Over the next few years, as R&D accelerates into the cloud, life sciences companies will layer service components onto their products that will provide value and build loyalty along the entire value chain, from patients to payers” Sriram Srinivasan, MD, Life Sciences, Accenture India

EXPRESS PHARMA

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cover ) future predicts Sriram Srinivasan, Managing Director, Life Sciences, Accenture India. “Over the next few years, as R&D accelerates into the cloud, life sciences companies will layer service components onto their products that will provide value and build loyalty along the entire value chain, from patients to payers. New medicines and services will be developed using an entirely new paradigm, drawing on external innovation and data from multiple sources,” he says. No wonder then that in April this year Cipla, Ranbaxy and Biocon adopted the Cirrius PharmaCRM Digital Platform that runs on Microsoft Azure(in the cloud) for enabling multi-channel digitisation of medical engagements. Pharma companies need to develop a robust pipeline to counteract the revenue squeeze they are feeling. With the window between product launch and patent cliff being too small, time-to-market is crucial. “This has led companies to the realisation that the most efficient way to develop new drugs is to tap into the brainpower outside their four walls while accounting for enterprise security and regulatory compliance require-

THE CLOUD DECODED

Software as a Service (SaaS) is the highest level of the cloud stack and includes actual cloud applications. This segment is the largest segment in the overall cloud computing market and is being adopted by large, medium and small businesses and organisations. This segment is the largest segment in the overall cloud computing market and is being adopted by large, medium and small businesses and

ments. As the number of partner organisations and individuals grows, the challenge of implementing a secure collaboration environment inhouse becomes an immovable obstacle. It simply takes too long, costs too much, and requires too many resources to establish and maintain a secure platform that must accommodate a highly dynamic and diverse set of partici-

organisations. The other key sub segments are Customer Relationship Management (CRM), Content, Communications and Collaboration (CCC) market and Enterprise Resource Planning (ERP) revenue.Adoption of SaaS is being driven by availability of demand software, understanding of the model, increasing interest and pressure on IT managers to reduce costs. North America, followed by Europe are the key markets for it.

pants,” notes Takanti. Unlike other industries, life science and healthcare companies are in the midst of a transition to a business model that relies on external partners. Cross-enterprise collaboration with on-premises solutions introduces complexity and a wealth of security concerns with respect to access by external partners. Cloudbased services are facilitating,

and accelerating, this transition by providing a central gathering place that lies outside of enterprise boundaries. However, the cloud itself is not a panacea. Public clouds may be too vulnerable, especially when personally identifiable information or intellectual property is involved. Private clouds may be too restrictive for productive collaboration amongst a diverse,

large group of partners. Hybrid clouds offer the best of both worlds, but the question remains - who will be responsible for tasks such as onboarding, authentication, and support? “Combining the hybrid cloud with an as-a-Service delivery model may well be the answer. With this approach, life science and healthcare companies can build collaborative teams of partners more quickly, reduce the cost of connecting everyone together, minimise the burden on their IT organisations, and relieve themselves of operations, maintenance, and support responsibilities. In addition, they can shift capital expenditures to operating expenditures, and only pay for what they need, when they need it, ”concludes Takanti. The convergence of mobility, big data, advanced analytics, and social media, all underpinned by the cloud, presents a very attractive opportunity for life sciences companies to operate in a more nimble, collaborative, customer-centric and cost-effective manner than in the past. It is where the future lies. shalini.g@expressindia.com

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28 EXPRESS PHARMA August 1-15, 2015

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THE MAIN FOCUS

HARNESSING DIGITAL INDIA After successfully launching the ‘Make in India’ campaign, PM Narendra Modi launched the ‘Digital India’ project’ in early July. While the government is trying to connect remote areas/villages via high-speed Internet services, most of these locations often do not have functioning primary healthcare centres or chemist shops where patients can buy routine or life saving drugs. Experts from the pharma fraternity give their views on how Indian Pharma Inc can translate the Digital India initiative into better patient access BY USHA SHARMA To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

August 1-15, 2015

cover ) TS JAISHANKAR, Managing Director, Quest Life Sciences

If infrastructure and connectivity are available, companies particularly in the pharma sector would develop industries in rural areas

Implement Digital India project without hesitation

igital India project is a remarkable concept and is achievable considering India’s strength in the software industry. This will definitely become a success. Almost all large software companies in India have already come forward to invest heavily in the Digital India project. Normally any industry would like its factory either close to availability of raw material or skilled manpower or the market. For pharma industry skilled manpower is crucial. It is for this reason the pharma industry

has come up in and around big cities. However, we cannot really say that the pharma industry is restricted to large towns. In fact there are large pharma industries in Dewas, Madhya Pradesh, Baddi in Himachal Pradesh and now in Sikkim and many other backward areas. However, these developments in smaller towns as above are mainly due to incentives given such as excise free zones. It is not always required to give such incentives. If infrastructure and connectivity are available, companies particularly in the pharma sector would de-

velop industries in rural areas. Pharma companies would definitely be interested in the Digital India project as it would help them expand product availability and reach to the remotest villages, as over 60 per cent of our population is in rural areas. The concept of telemedicine is an area where hospitals and pharma companies can work together for the benefit of patients in rural areas. Currently, most rural India patients are serviced by barefoot doctors. This would dramatically change with the implementation of the Digital India

DR MILIND ANTANI, Partner Pharma and Healthcare Practice, Nishith Desai Associates

project. If the government aims to make a success of the newly launched programme then it needs to implement the Digital India project without hesitation. The medical fraternity and the pharma industry together will automatically step in to provide patient care and availability of medicines across India. Currently, the pharma industry is heavily burdened with heavy cost of medical representatives, non availability of professional medical representatives on the one side and price

control order by the Government of India is virtually stifling the industry growth. The Digital India project coupled with the ease of networking would enable the pharma industry to reach out to doctors with innovative cost effective marketing and would probably even connect doctors through Skype and other web related technical inputs of their products. The companies may even organise and support the hospitals for telemedicine. To conclude, the Digital India project will open up several avenues.

Digital India has a bright future in healthcare space. However, certain concerns regarding data privacy, online selling of medicines need to be taken care of

Success depends on creating infra,literacy

igital India project is an excellent initiative which possibly is the need of the hour when we are seeing significant technology advancement. There is a need to connect rural and semi urban areas. Success of this project is very vital to serve the purpose. But success of the project would de-

30 EXPRESS PHARMA August 1-15, 2015

pend on creating infrastructure and literacy. I don’t think pharma companies have neglected rural areas and small towns. But possibly the penetration of pharmacies is less. What can be done is to initiate steps to increase number of pharmacies as well as implement the Jan Aushadhi programme very rig-

orously. Patients will be benefited with the easy access to doctors, government healthcare institution and restrict their excessive movements between hospitals/clinics as data would be available. This would also simplify record keeping.

Steps for improving access to medicines

◗ Developing necessary and adequate technical infrastructure ◗ Creating awareness by various programmes ◗ Training to operate and use technology optimally ◗ Ease of regulations to suit online models ◗ To have one tele - healthcare centre in each village The Digital India project

would have a huge impact on healthcare domain first with telemedicine bringing patients and doctor more closer. Digital India project has a bright future in healthcare space. However, certain concerns regarding data privacy, online selling of medicines need to be taken care of.

( DR AJIT DANGI,

THE MAIN FOCUS

‘Digital future is possible only on top of good physical infrastructure’

President and CEO, Danssen Consulting

Digital India can transform the waywe do business

he vision for Digital India as proclaimed by the Government of India (GoI) is to transform India into a digitally empowered society and knowledge economy. Since pharma industry is a science and knowledge based industry, the GoI vision fits quite well with industry’s own vision. Following are some of the areas where Digital India can transform the way we do business. Access to medicines: Inspite of India having achieved the distinction of being a reliable source of quality medicines at affordable prices, access to essential medicines is less than 40 per cent of the population. The reason for low access is poor health infrastructure. In the interiors where 70 per cent of the

population lives, there is lack of diagnostic facilities, doctors , pharmacies as well as hospitals. With the result, pharma industry has also not penetrated well in to the interiors. This can be corrected by providing Wi-fi connections in villages where patients can access medicines through' e- pharmacy by getting e - prescription from district hospitals on their mobile phones. Sales force effectiveness: This is increasingly becoming a challenge for the pharma industry. The traditional method of detailing has lost its significance as the medical profession has little time and patience to listen to the spiel of medical reps. The doctor coverage of over ` 6 lakhs healthcare professionals (HCPs) and also hospitals and retail

chemists is also increasingly becoming area of low ROI. Many companies like Cipla, Ranbaxy, Biocon etc. have adopted digital platform of Cirrius Pharma CRM model on Microsoft Azure which integrates the company with patients, HCPs and supply chain through this platform increasing the sales productivity and patient access substantially. The mobile health market: It is estimated that the mobile healthcare market is set to cross $27 billion by 2017. Apple iTunes today have more than 20,000 health-related mobile apps. Remote patient monitoring devices are one of the fastest growing markets. Many patients suffering from chronic diseases like diabetes, hypertension, CVD, arthritis etc. have to take medicines life long. They find it

RANJANA SMETACEK, Director General, Organisation of Pharmaceutical Producers of India (OPPI)

difficult to make frequent trips to the local pharmacies to replenish their medicines stock. Online pharmacies with doctors giving e -prescriptions can help these patients get home deliveries. The model is particularly suitable for OTC medicines as most minor ailments like headache, cough & cold, diarrhoea, skin infections etc. are self limiting and can be addressed without intervention of HCPs, ordering OTCs online is quite feasible. Responsible self medication is an important aspect of healthcare in many developed countries. While many of the above suggestions for digital future are doable, their success will depend on some basic requirements. Digital future is possible only on top of good physical in-

frastructure. This means that old issues like good roads, good connectivity, literacy, electricity etc. would still be required to makeDigital India a success. The regulatory issues also need to be addressed for platforms such as e -pharmacy, e prescription etc. Attention to environmental issues are also important. For instance, it is reported that unscrupulous competition among cell phone operators in Chennai who have installed too many towers in proximity of each other has resulted in radiation emanating from such towers making small birds like sparrows and also squirrels virtually extinct. Finally, the contentious issue of net neutrality needs to be resolved to make Digital India a success.

E-healthcare forms part of the Digital India initiative, but able execution in the healthcare sector will require an enabling infrastructure to maximise the benefits

Multiple stakeholders need to be onboard

eechnology is a great enabler and we have experienced its positive intervention across sectors.

This is no different for healthcare delivery; telemedicine, electronic health records, online consultations are all transforming the ways pa-

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tients are treated. E-healthcare forms part of the Digital India initiative, but able execution in the healthcare sector will require an enabling in-

frastructure to maximise the benefits. Multiple stakeholders will need to be onboard and connected, to ensure the success of Digital

India in relation to healthcare. Over all this is a welcome step that can contribute to delivering better healthcare in our country.

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cover ) DR GOPAKUMAR G. NAIR, Chief Executive Officer, Gopakumar Nair Associates

'Large network of Indian post offices all over India can be made a partner in a ‘Digital India'

‘Shooting the messenger’does not kill the ‘message’or the problem

egal drafting or redrafting of technical statutes is not just a matter of law but a blend of arts, science & law. The (Indian) Drugs & Cosmetics Act is a 1940 Act left-over from the British times with “patchwork” and touch up amendments from time to time. A new Act, 2020 or before, may be welcome, if drafted to meet the emerging needs and challenges. The word “exports” has been virtually missing for two reasons. The ‘wise’ argues that Drugs & Cosmetics Act is for India not for overseas and hence no “exports” in the statute. The other being lack of adequate exposure to Indian pharma regulators to international markets and developments, so much so, the need for giving (Indian) Drugs & Cosmetics Act, an International favour, when everyone including the Government of India, is loud and clear in their demand for international approval for Indian pharmacopoeia. All these days India has attracted global attention on “affordability and accessibility” issues vis-à-vis TRIPs, Doha Round and Intellectual Property based regime. However, too little too late (never late) has been done or attempted adequately to address rural penetration and to improve affordable access to life saving masses in interiors and far flung villages. It is often seen

32 EXPRESS PHARMA August 1-15, 2015

that rural patients come to nearest cities like Patna, Allahabad etc. and camp with spot cooking and families in overnight queues to get medical consultation with reputed specialists referred by rural doctors. While India is “empowering and financing” more and more middlemen in its new skill development initiative and are relying on data being dished out by them, very little skills are in fact being developed in locations and pockets where they are badly needed. The skill development benefits must reach the common man which is often not the case. Similarly, Digital India will be a success provided the benefits filter down to reach the public mostly located in rural pockets. Recently one of the popular “e-retailors” has been targeted and sued by the Government for offering medicines through the web to the needy. ‘Shooting the messenger’ does not kill the ‘message’ or the problem. India is declared as the Digital India today. Much is being achieved and more is being promised. From “land records” to all data on tax and direct taxes, banking, insurance, identity modes are all getting digitalised. Much have been achieved and is being achieved, which we are proud of. Can the nation be labelled (proudly) as Digital India, without using the “digital”

India should not miss the Digital India bus to address the “affordabilityaccessibility” issues without letting in the “patient passengers” on board

means to address the health needs of the poor and downtrodden, a population in majority in India? India should not miss the Digital India bus to address the “affordability-accessibility” issues without letting in the “patient passengers” on board. Instead of prosecuting those who make medicines available to the needy through the web, India should amend its Drugs & Cosmetics Act, 1940 (?) or have a new Drugs & Cosmetics Act, 2016 or thereabout by facilitating and empowering webbased solutions to address “medicines for the masses on demand”. Web, being global,

needless to say that, intellectual property violations and “patent and trademark” infringements must be strictly prevented or avoided on the web. The ‘web operator’ should be allowed to tie up with a registered medicine wholesaler or retailer (or even the manufacturers themselves) who should take all legal and regulatory responsibility for meeting the obligations under (to be amended) Drugs & Cosmetics Act. All medical prescriptions issued by qualified medical practitioners, must be digitally uploaded or made available to dispense scheduled and restricted medicines. OTC and non-scheduled (non-IP violative) medicines, ayush and nutraceuticals must be freely available on the web/net to the needy. Those who abuse the system or provide spurious or non-quality medicines including misbranded (not originating from the IP address holder or genuine manufacturer) must be strictly monitored and punished. Above all, the ancient or antique Drugs & Cosmetics Act should be made “web-enabled” and “internationally usable” by incorporating appropriate amendments with all ‘safeguards’ to make the dream of affordable access to rural masses and to make “Health for all by 2020” not just a slogan but a realisable goal. As suggested by me earlier, the large network of Indian post

offices all over India can be made a partner in a Digital India enabled “e-medicine” portal which may as well, be promoted by the Government with high degree of transparency, without enriching the middlemen to eat away the ‘cream’ and leave the poor still “patiently suffering”. If there is an e-will, without an evil, we can fight the menace of non-accessibility of medicines to the poor in far-flung India, the e-way. Digital India can be a success for pharma industry to penetrate all over India including neglected rural India, small towns and remote areas, provided legal and regulatory support is provided with supporting network of hardware and personnel. Indian pharma companies can avail the Digital India platform to establish contact with the patient population, get diagnosis done online, extend expert medical help including from specialist consultants, online. Mobile application-based innovations are getting commercialised currently for diagnosis, examination online and advanced consultations, monitoring and treatment. Digital India can be a success in the medical and pharma domain if the regulatory framework in India is also updated to support ‘web-enabled’ services including diagnosis, prescription, distribution and eventual door delivery of goods and services to patients.

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I N T E R V I E W

‘Seven of the ten largest firms are connected to the Life Sciences Identity Hub’ Exostar’s Life Sciences Identity Hub, a cloud-based, connect-once solution delivered as-aService is increasing collaboration with other partners to deliver value to pharmaceutical companies as it reaches new milestones. Vijay Takanti, Vice President of Security and Collaboration Solutions, Exostar, shares more in an interview with Shalini Gupta

What market position do you enjoy in the cloud based solutions for life sciences sector? We believe we have a leading market position for cloudbased solutions in the life sciences. Not only were we on the scene over three years ago as industry organisations were just starting to seriously consider the cloud, but we bring extensive relevant cloud experience to the table. We have offered cloud-based solutions since we were formed in 2000, before the cloud was cool. These solutions served the aerospace and defense markets, which are similar to life science in terms of ‘coopetition,’ compliance requirements, and the need to protect intellectual property and highly-sensitive information. Our aerospace and defense community includes over 100,000 organisations and nearly 400,000 individuals in 150 countries on all seven continents. We know what it takes to get the job done. Why did you decide to

expand into the medical devices, healthcare sector? We have moved into healthcare and now medical devices because they are adjacent industries with similar security, collaboration, and compliance needs. The demand for solutions like ours is strong and the pain organisations and individuals are suffering is acute. We think our relevant bonafides and success position us to alleviate the pain and take advantage of the market opportunity. What services did you start with? What services do you offer currently? What prompted you to add more services under the umbrella? The engine behind the Life Sciences Identity Hub is our Secure Access Manager (SAM). SAM enforces the policies, procedures, and permissions that connected organisations assign to the assets they own. These organisations connect once to the Identity Hub, which lets them make their applications, portals, and other assets available to external partners

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The demand for solutions like ours is strong and the pain organisations and individuals are suffering is acute

and their employees. Through delegated administration, asset owners assign the privileges, so they retain control. SAM authenticates individuals who present credentials for access, and enables access per the assigned rules. We also are an Identity Provider, so we can issue credentials to individuals for authentication, or we can accept credentials issued either by an asset owner or a trusted third-party. Organisations can accept our credentials with confidence, because the SAFEBioPharma Association has named us a fully-certified Credential Service Provider. Initially, we added value to the community by connecting our SharePoint-based multitenant collaboration solution, Secure Share, to the Life Sciences Identity Hub. With Secure Share, organisations can create dynamic team sites that cross corporate boundaries, control access with multiple levels of security, and exchange documents and data through encryption at-rest and intransit. To enhance the utility

of our cloud-based community, we have continued to add third-party applications, which led to the partner programme launch. The interest from connected organisations and solution providers to participate is fuelling the service expansion. How are cloud based solutions for life sciences industry different from those for other industries? What details need to be kept in mind while designing these solutions? These days, businesses in all industries have made cyber security a top priority. Above and beyond corporate policies, the life science and healthcare industries must account for regulations defined by Government agencies like the FDA and DEA in the US. The need for protection must be balanced against the need to work with external parties. So, while the public cloud may be an option for some vertical markets, it is too open for life science and healthcare. Conversely, a private cloud delivers on security, but it can’t keep up with the continued migration to the

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cover ) external partner model companies in life science and healthcare are adopting. That’s why we chose to deliver our solution with a hybrid cloud. It combines the openness of the public cloud with the security of the private cloud. By offering multiple levels of access with different strengths of credentials, we provide the upgraded security and compliance life science and healthcare organisations demand. What is the USP of the Lifesciences Identity Hub? When companies try to implement a solution on their own, they end up creating a series of point-to-point relationships and connections that are redundant and don’t scale. With the Exostar Life Sciences Identity Hub, organisations connect once and have pathways to all other connected organisations. Onboarding and provisioning times have proven to drop from weeks or months to days. Individuals enjoy a single signon user experience that allows them to get to work faster, without encumbering them with multiple credentials that raise the security risk. Keeping track of individual participants, their permissions, and their credential requirements is an

34 EXPRESS PHARMA August 1-15, 2015

onerous task for life science and healthcare companies. So is conducting the identity proofing process prior to issuing a credential to an individual. We take care of all of those activities, along with on-boarding and customer support, through our as-aservice delivery model. An unexpected area of growth for the company is... One area where we are seeing increasing interest is in electronic prescribing of controlled substances (EPCS). To keep powerful narcotics from falling into the wrong hands or being abused, here in the US, the DEA has instituted strict regulations. Healthcare providers today are writing and filling prescriptions through a paper-based, manual process that is costly and time consuming. By taking advantage of Exostar’s identity proofing and issuance/authentication of strong credentials, health IT vendors are able to augment their solutions to include EPCS capabilities. With EPCS, providers can spend more time with patients and less on paperwork, prescriptions are more secure, and the entire process is captured for audit and proof of compliance. This is an exciting application that is

Our primary goal looking forward is to continue to deliver a valuable service to our customers in life science, healthcare, medical devices, and beyond

bringing more healthcare vendors and providers into our community every day. Tell us something about your new partner programme. How many MNC pharma firms are a part of it and how many are yet to sign up? We formally launched our partner programme this year to enhance the value of belonging to our life science and healthcare community and to respond to the demand

from technology, application, and reseller solution vendors to join the community. The MNC pharma firms aren’t part of the partner programme per se; they are the organisations and users of the solution we offer. Seven of the ten largest firms have connected to the Life Sciences Identity Hub to date, with two of them using it as their dedicated global R&D platform. TransCelerate, the consortium of 19 global pharma leaders, is also connecting to our Identity Hub so their members get the security and access assurance they demand as they look to define standard processes and procedures that will streamline industry operations. Enumerate your goals and plans for the coming few years. What solutions do you aim to offer to healthcare providers and medical device companies? Our primary goal looking forward is to continue to deliver a valuable service to our customers in life science, healthcare, medical devices, and beyond. We want to be the go-to solution for organisations and individuals to securely, productively, and cost-effectively conduct business with one another –

whether that business is new drug R&D; delivery of healthcare involving patients, providers, and payers; enabling collaboration across the supply chain, or emerging technologies and opportunities. In other words, we have to deliver a solution that is scalable; performs impeccably; supports wireless, social, and the Internet of Everything; and provides an unparalleled user experience that gives individuals precisely what they want and need. That means connecting more organisations, identity providers, and applications to the Life Sciences Identity Hub. At this time, we feel we have barely scratched the surface in the life science, healthcare, and medical device sectors. All have tremendous potential for growth, so we expect to expand horizontally, vertically, and geographically. It’s simply too soon to know which will grow fastest, but the key is that we have a cloud-based solution with proven scalability and a dedicated team that understands we have to be flexible as markets, technologies, and business models evolve. shalini.g@expressindia.com

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CASE STUDY

Realising growth through virtualisation Anthem Biosciences has deployed Citrix server and desktop virtualisation for secured remote access, enhanced productivity for employees and better business outcomes BY JASMINE DESAI

he healthcare industry is in a transformative phase with several new innovations being implemented on a regular basis for improving the quality of healthcare and meeting stricter compliances. As these business changes have made the reduction of costs a top priority, IT is being deployed for bringing efficiency and enhancing the productivity of the workforce. The Anthem Group, which is the holding company comprising Anthem BioSciences, Anthem Collations and Anthem BioPharma, is a start-up on fast track growth path. The company’s applications reside in their in-house data centre. Whenever there is a need, the desktops are delivered to the end user. The Dell SAN connects users to the data centre. “We have end-to-end security including port blocking, firewalls, routers, monitoring tools, web filters, and anti-virus at the gateway level. We manage the critical infrastructure that supports all our operations,” says Ravi Kalla, Senior Manager - IT at Anthem BioSciences.

Meeting the challenge of expansion The company was in the process of doubling its capacity at the ex-

isting facility and there was also an expansion plan for a remote location. The recruitment process was in full swing to bring more talent into the organisation. It was becoming a big challenge for IT to provision enough new desktops every month to keep up with the growing numbers of new employees. “We had to provision 25-50 desktops/laptops every month, and it was very time consuming for IT,” explains Kalla. He further explains, “Being a start-up, there was no way we could afford to have clustering and patch management software. So while looking for clustering solutions, we thought that server virtualisation and desktop virtualisation could help us address the challenges.” Recently, Anthem deployed four different server applications. In a traditional model, they would have needed four physical servers for support, because some of them are Linux based and some are Windows based. The IT department would have needed to make substantial investment, if they went for the n+1 concept. Instead they chose the efficient way of virtualisation to address this. “Since we went for server virtualisation, we just created a virtual environment and hosted the servers. The cost

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of doing this was zero. This was a major business advantage of the Citrix XenServer virtualisation solution for Anthem,” mentions Kalla. The company has now implemented complete virtualisation, from server to hosted shared desktop service all provided by Citrix. On the other side, Anthem wanted to extend a remote working opportunity to some of its employees but data and information security concerns had prevented them from taking any steps in that direction. The business requires them to send regular updates to their customers, so workflow breakdowns is not an option at all. “We wanted to get better control of data-flow because there was always the fear of security breaches. Whenever we sign a non-disclosure agreement with companies, security is a non-negotiable issue,” said Kalla. “For example, if we are sending an update to the customer and the desktop suddenly crashes, the email client and applications have to be reconfigured in a different location. This would result in a loss of productivity and delay of at least 2-4 hours. This will defi-

nitely affect our business continuity,” says Kalla. Given such diverse business needs and the technology challenges, Anthem BioSciences decided to deploy a Virtual Desktop Infrastructure (VDI) apart from server virtualisation. Before selecting any product, Anthem did a full due diligence on every worthwhile option. They evaluated various options including VMware. “Of all the options, Citrix came closest to fulfilling our needs. It was cost effective and it had features like hosted shared desktop services. Citrix XenDesktop was also able to provide a much better ROI than VMware,” says Kalla on opting for Citrix. Anthem BioSciences has purchased 200 licenses of Citrix XenDesktop and is planning further expansion. “VDI is slightly expensive, because you have to buy Microsoft licenses and an annual subscription for VDI infrastructure, Citrix still made the most sense as compared to other products,” says Kalla. Anthem BioSciences opted for a Hosted Shared Desktop (HSD), as it is a lightweight component, and most of the users require

only browser and Java.

Benefits of virtualisation With the implementation, the company has achieved the benefit of reduced costs, secure remote access and business continuity. “Citrix can run on any device. We do not require any WAN optimisation tools to achieve better access speed. We feel virtualisation is the best way of addressing our secured remote access concerns. Now users can access their office desktops from remote locations. Whatever they need to do, will be at the data centre and not on the desktop,” says Kalla. The entire desktop is encrypted and delivered to the user, therefore leaving no room for any internal and external security breaches. With Anthem being a startup, keeping cost under control is of immense importance. A well configured desktop costs a minimum ` 25,000. Plus the cost of Microsoft Windows 7 professional license costs ` 9,000. So the total cost of the desktop becomes ` 34,000 before adding the cost of other software like anti-virus, port blocking etc. “In the thin client model, the

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cover ) hardware cost is just ` 14,000. Even with the cost of licenses, the cost will not be more than ` 2200. This is an immediate saving of ` 12,000,” says Kalla. Since Citrix XenDesktop was deployed the IT team does not have to worry about business continuity. Even in the case of a system crash, the user can log in and start work from where they left. “We have created roaming profiles, so a user can go to any computer and access the applications that are tagged to their ID, including the mailing solution and printer access,” says Kalla. Lifecycle of a normal desktop is usually three to four years, whereas a thin client can work for as long as seven years. The power consumption of a desktop is 100-140 watts, whereas thin client consumption is only about 40 to 50 watts. “There is a significant saving on power. If 200

36 EXPRESS PHARMA August 1-15, 2015

conventional desktops run for 12 hours, the cost of power comes at ` 30 lakh per annum, as opposed to thin clients, which may only cost about ` 10-15 lakh,” Kalla says. With the Citrix XenDesktop in place, deployment

can happen on the same day. “With Citrix HSD, one physical server with 128 GB RAM and Xeon processor can support 200 users in a lightweight environment. We were initially apprehensive about

putting so many users on to the server but after seeing the performance in the last four months, we are confident that it can support more than 200 users,” he states. In the past around 150 com-

puters were never shut down, which meant that the company had to incur huge electricity bills. In the virtualisation model, the power cost is much lower as the systems are shut down everyday. Other hidden costs are also being discovered and reduced. With the huge expansion plans now underway, the company has recruited 100 scientists in the last few months. Another advantage is that the Hosted Shared Desktop (HSD) does not consume extra bandwidth, Kalla can now access his desktop with the use of a TATA Photon data card. “I am able to access my entire desktop from a remote location. That is the biggest advantage,” says Kalla. (This article appeared in Express Computer, July 2015 issue) jasmine.desai@expressindia.com

MANAGEMENT I N T E R V I E W

‘We manage cash flows better’ MyCFO helps companies to manage their cashflow process and also helps in operating cycle of distributor/ dealer linkages, negotiating terms on behalf of the distributor’s/ dealers. Deepak Narayanan, Co-founder and Director, MyCFO talks about the requirement of such services in the pharma sector with Usha Sharma

Tell us about the core business strategies of MyCFO? MyCFO is a services brand in the implementation space working with companies across sectors, sizes and ownership types to help CEO's, founders, CFO's and venture capital/ private equity funds (for their portfolio companies) build best in class or improve the quality of the existing Finance systems. MyCFO's core is to stay true to the 'implementation' theme and focusing on delivering 'results' or outcomes as opposed to being measured on time/ number of people involved. MyCFO is also embarking on a 'productisation' strategy where it plans to bundle a product along with its existing services. This is being tried out on a pilot basis for a couple of services across a few clients. The plan is then to launch this across all clients in the next six months. What are the different services that you offer and how do they help companies in managing their cash-flow system? MyCFO offers two services (a) CFO and (b) Finance Effectiveness services. CFO service is aimed at assisting start ups and mid-sized companies as their CFO. The role involves what a CFO typically does in a professionally managed company. Services include business plans including scenario planning, sensitivity

analysis, defining metrics and MIS preparation, budgeting, cash flow forecasting, working capital management, dealing with banks, compliance and regulatory aspects, setting up processes, implementation of an ERP system, setting up of advisory boards, leading and managing investor relations amongst others. This is done through a 'unique' delivery model which entails looking at the CFO's job as a role rather than a 'resource' which institutionalises the CFO function. The service is therefore not recruitment, neither merely placing on client locations nor temping. The other service includes Finance Effectiveness which is delivered to mid to large Indian and multinational companies including the top 1000 corporates in India. Under the Finance Effectiveness service, we work with company's CFO's and the CFO's office to improve the effectiveness of the finance function or transform the finance functions in certain cases. Services include setting up an enterprise risk management system, IFC including CEO/CFO certification, implementation of internal audit findings, linking the distributors/ dealers in a FMCG company including pharma into the ERP, implementation/ reimplementation of an ERP/BI, improvement in performance management systems/ framework amongst others. In recent times, cash flow has

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Indian companies need to spend a lot more on R&D and innovation become one of the most critical metrics to measure in any company given that working capital cycles are getting tighter. One of the ways in which we manage cashflows better is by helping companies to manage their distributor/ dealer linkages better, negotiating terms better on behalf of the distributors/ dealers. Organisations which have a complex supply chain

mechanism particularly those in pharma, FMCG, and chemicals which sell through a distributor/dealer network require market related data to be able to do their production planning and manage their inventory levels. Market information relating to the regions, product type, SKU’s, discount schemes etc is used to predict customer behaviour. Most of the times this information is not available to the company at the level of the end consumer as the tracking stops at the level of the distributor. The other issue is the lack of linkages between the distributors’ data to the data available with the company resulting in loss of time in reconciliations. This makes it difficult to set credit limits for distributors, track inventory and receivable levels, track the benefit of the discount schemes thereby putting strain on working capital levels in the business. Some large companies and CFO’s have realised the importance of this exercise and have integrated the distributor systems to their ERP’s or rolled out the S&D module of their ERP’s to the distributors to allow them real time tracking. The other area where CFO’s play a vital role is in being able to play a part in on boarding new distributors or evaluating existing ones particularly in assessment of Return on Investment (ROI) of the distributor, working closely with them to ensure that their stock turns to the end

customers are quick (improves ROI) and thereby encouraging them to pay quickly to the company (improves company’s cash flow). CFO’s have also partnered with the distributors and helped them negotiate with banks to extend ‘Channel Finance’ which allows them to leverage the company’s ‘balance sheet’ to avail working capital facility with banks thereby allowing companies to get paid immediately on raising an invoice (through bill discounting/factoring) and allowing the distributors to buy more from the company. The company offers implementation services to pharma domain as well, which is highly regulated and monitored, in such scenario, why do you think that companies need to have budgeting Operating in a regulated environment especially in a market like India which is price sensitive and prices of certain drugs being fixed by the government makes it imperative for companies to budget since companies need to keep their costs under check. Secondly, budgeting also allows companies to chart out their growth plans a lot more clearly and establish a business case for new product introduction, foray into different geographies, ascertain RoI in case of setting up production facilities, budget for spends on R&D and its impact on pricing amongst others.

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MANAGEMENT

Besides pharma, which are the other sectors you are offering these services? We are sector agnostic. We do a good mix of both manufacturing and services. We are excited about sectors like healthcare (healthcare delivery, diagnostic chains, and healthcare education), education, E- commerce, IT products, logistics etc where there is a lot of interest amongst investors With the introduction of DPCO 2013 and constant changes in the prices of the essential medicines under the price control regime, what are the challenges you foresee for the pharma industry and what are your recommendations to overcome them? The sector is regulated as far as prices of essential commodities are concerned.

Social security in the form of insurance may also help companies get a share of the revenues that it currently does not have access to

Essential commodities are going to be under the scanner all the time. Most multinational companies for this reason do not get some of the essential drugs to India until this is off patent which means they have recovered their investments and they believe it is safer to get it here given the propensity of such drugs being copied. This continues to be a worry as some of the best medicines may not be available. Indian companies need to spend a lot more on R&D and innovation. Social security in the form of insurance may also help

companies get a share of the revenues that it currently does not have access to. A majority of Indian pharma companies is into generic business and invest negligible amount on their R&D activities. According to you, why should pharma companies focus more on R&D and how it will benefit them in the long run? The 'value' addition that companies may derive through discovery or through improvement is significantly

higher than merely producing 'generics' that are either 'off patent' or a block buster which already exists. The price differential between a drug which is 'discovered' and a mere copy cat could be significant. Investment in R&D will not happen automatically as companies may not have enough to invest given the fact that traditionally most companies have taken the easier route. Availability of talent in India is another area of concern. Most of the talent required for innovation, research moves out of the

country. Large companies are better positioned to access this talent. R&D and investment in world class facilities (approved by global regulators) also opens up a chance to export into developed markets where price realisations and receivable cycles are better. Banks and financial institutions need to come forward to assist companies which have a clear plan and demonstrate payback on the investments that they make. Maybe there is a need for the government to identify the areas where we need more essential drugs and extend tax benefits/ grants which then helps existing companies to develop new drugs. This will also allow them to create something 'world class' without having to worry about profitability/cash flows etc. u.sharma@expressindia.com

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MANAGEMENT REPORTS

Pancreatic cancer treatment pipeline dominated by early-stage development Research The high level of first-in-class development in pancreatic cancer therapeutics is a promising sign of the industry seeking innovative treatment solutions WHILE THE treatment pipeline for pancreatic cancer shows a high level of innovation, with 52 per cent of the products categorised as first-in-class, most development is in the early stages, meaning a significant proportion of therapies are unlikely to reach the market in the near future, says business intelligence provider GBI Research. The report states that while the pancreatic cancer treatment pipeline contains 447 therapeutics in active development across all phases, compared to 209 currently-marketed products, almost 75 per cent of therapies are in Phase I or earlier. According to Joshua Libberton, analyst for GBI Research, 58 per cent of drugs in the pancreatic cancer treatment pipeline are in the discovery or preclini-

report also states that while the current global treatment market for pancreatic cancer consists of 91 per cent small molecules and nine per cent biologics, some 41 per cent of the pipeline is formed from biologic therapies cal stages, 17 per cent are in phase I and 21 per cent are in phase II, leaving just four per cent of products in phase III of development. Libberton said, “While the phase III portion of the pipeline is comparatively small, it is followed by a relatively large phase II, indicating that there will be a sustained stream of products moving through the later devel-

opment stages.” “Despite the majority of pancreatic cancer therapy development occurring in very early stages, many of the assessed targets showed promising preclinical results and a strong alignment to known disease-causing pathways, which could translate to clinical and commercial success,” said Libberton. The analyst adds that the

high level of first-in-class development in pancreatic cancer therapeutics is a promising sign of the industry seeking innovative treatment solutions. GBI Research’s report also states that while the current global treatment market for pancreatic cancer consists of 91 per cent small molecules and nine per cent biologics, some 41 per cent of the pipeline is formed

from biologic therapies. Libberton elaborated, “This considerable difference is in line with the industry trend of increasing biologic development, following the escalating success of biologics in other therapy areas, such as Herceptin (trastuzumab) and Avastin (bevacizumab). Despite this growth in the biologics sector, small molecules remain dominant in the pancreatic cancer pipeline thanks to their versatility and ease of manufacture, as well as a more established understanding of their clinical properties. However, it is clear that drug developers are seeking novel approaches to pancreatic cancer treatment that differ from the present market,” the analyst concludes. EP News Bureau-Mumbai

Anti-hypertensive therapeutics market in APAC to touch $20 bn by 2021: GBI Research Modest growth will be primarily due to lack of hypertension awareness, leading to low diagnosis and treatment rates THE ANTI-HYPERTENSIVE therapeutics market in the Asia-Pacific (APAC) countries of Australia, India, China and Japan will expand in value from $15.7 billion in 2014 to reach $19.9 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 3.4 per cent, according to GBI Research. The company’s latest report states that this modest market growth rate will be primarily

due to the lack of hypertension awareness, which leads to low diagnosis and treatment rates. Aswini Nath, Analyst, GBI Research, said that Japan is the largest anti-hypertensive therapy market among the four APAC countries, valued at $8.1 billion in 2014 and representing 52 per cent of the region’s antihypertensive treatment space. Nath explained, “While Japan has a smaller prevalent population than China and In-

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dia, it has a significantly higher Annual Cost of Therapy (ACoT) than those two countries. “However, the Japanese market is projected to grow at the slowest CAGR in the APAC region, increasing at just one per cent to reach $8.7 billion by 2021. This is partly attributable to the early patent expirations of Rasilez (aliskiren) in 2015 and Ometec (olmesartan medoxomil) in 2016,” said Nath.

GBI Research’s report also states that India’s anti-hypertensive therapeutics market value will expand at the fastest CAGR of 12.6 per cent, more than doubling from $0.8 billion in 2014 to $1.9 billion by 2021. Nath continues, “India is the second smallest anti-hypertensive therapy market among the four APAC countries, primarily due to the low ACoT, which is currently less than a tenth of that in Japan.

“An aging population, as well as other risk factors such as obesity, physical inactivity, and alcohol consumption, will all increase during the forecast period in India, leading to rising disease prevalence. In turn, this will boost demand for pharmacological treatment and drive anti-hypertensive treatment market growth,” the analyst concluded. EP News Bureau- Mumbai

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August 1-15, 2015

RESEARCH CLINICAL UPDATE

Merck receives EU-approval to extend Kuvan use to children with PKU below age four European Commission decision confirms earlier CHMP recommendation for change to product information THE EUROPEAN Commission (EC) has authorised a change to the European marketing authorisation for Merck’s product Kuvan (sapropterin dihydrochloride), to allow its use in children with phenylketonuria (PKU) below four years of age who have been shown to be responsive to such treatment. The EC decision follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in May 2015, which was based on a review of data from SPARK, a Phase IIIb clinical study. The EC decision is applicable to all 28 EU member states and the basis for corresponding decisions issued by Norway, Iceland and Liechtenstein. “PKU is a rare disease with significant consequences — but if managed appropriately, it doesn’t have to impair child development or quality of life for children and adults. We are committed to helping patients with PKU, both at adult age and during childhood. The positive EC decision allows physicians to use Kuvan also in children right from diagnosis, who have shown to be responsive to the medication,” said Luciano Rossetti, Head of Global Research & Development at Merck’s biopharmaceutical business, Merck Serono. Commenting on the news, Professor Dr Ania Carolina Muntau of the University Hospital Hamburg-Eppendorf, Hospital for Children and Youth Medicine, lead investigator of the SPARK study said, “It is a very positive de-

40 EXPRESS PHARMA August 1-15, 2015

In many countries, implementation of national newborn screening programmes has allowed identification of children with PKU at birth, enabling the management of the disease to begin as early as possible in order to prevent potentially severe neurological damage velopment for children with PKU under the age of four who are suitable for the therapy. Managing PKU in young children through the maintenance of a phenylalanine-restricted diet alone is very challenging, and parents will welcome this approval, which could make the treatment easier. The evidence shows that Kuvan significantly improves tolerance to phenylalanine, allowing more flexibility in the management of the very restrictive diet in PKU patients.” Detailed 26-week data from the SPARK study were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium in September 2014. Results showed that the addition of Kuvan to a phenylalanine-restricted diet significantly increased phenylalanine tolerance by 30.5 mg/kg/day in children with PKU below four years of age

and responsive to Kuvan, when compared with phenylalanine tolerance in children following a phenylalanine-restricted diet alone (p<0.001). In the group treated with phenylalanine-restricted diet plus Kuvan phenylalanine tolerance was increased from 37.1 mg/kg/day at baseline to 80.6 mg/kg/day after 26 weeks, and in the phenylalanine-restricted diet alone from 35.8 mg/kg/day at baseline to 50.1 mg/kg/day after 26 weeks, respectively. PKU is an inborn metabolic disorder that causes the toxic accumulation of phenylalanine, an essential amino acid contained in all proteinrich foods, in the brain and blood. 1,2 Untreated, PKU can lead to intellectual disability, seizures and other serious medical problems. 1,2 In many countries, implementation of national newborn screening programmes has allowed identification of children with

PKU at birth, enabling the management of the disease to begin as early as possible in order to prevent potentially severe neurological damage.3 However, in Europe there has not been, to date, a licensed medication for the treatment of PKU in children who are below four years of age. Following EC approval, the Summary of Product Characteristics (SmPC) will be updated to include details about the use of Kuvan in this younger population. It affects approximately 1/10,000 newborns in Europe. The original European marketing authorisation for Kuvan was granted in 2008. In Europe, Kuvan was the first, and remains the only medication in combination with phenylalanine-restricted diet designed to reduce the concentration of phenylalanine in the blood and brain in those patients who are responsive to Kuvan to prevent

the debilitating effects of PKU.4 Kuvan is already indicated in patients of all ages with tetrahydrobiopterin (BH4) deficiency, and in those aged four years and above with PKU (due to phenylalanine hydroxylase enzyme deficiency) who are responsive to Kuvan.

References 1. Blau N: Phenylketonuria and BH4 deficiencies. Bremen: UniMed; 2010 2. Blau N, van Spronsen FJ, Levy HL: Phenylketonuria. Lancet 2010,376:1417–1427 3. Loeber JG. Neonatal screening in Europe: the situation in 2004. J Inherit Metab Dis 2007;30:30–38 4. http://www.ema.europa.eu/ ema/index.jsp?curl=pages/medicines/human/medicines/000943/human_med_000 880.jsp&mid=WC0b01ac058001 d124, Accessed 15.06.2015 EP News Bureau-Mumbai

RESEARCH UPDATES

Novavax’s Ebola vaccine shows promise in early-stage trial Elicits very high Ebola antibody responses at all dose levels NOVAVAX'S EXPERIMENTAL Ebola vaccine induced a substantial immune response to the deadly infection in an early-stage trial involving 230 healthy adults. The Ebola GP Vaccine was well tolerated and elicited very high Ebola antibody responses at all dose levels, the company said. Novavax has the means to make millions of doses per week, and is in ‘fairly advanced’ talks over possible tie-ups with governmental and non-governmental entities to develop the vaccine further, executives said. Potential partners include the Biomedical Advanced Research and Development Authority (BARDA), a division of US Department of Health and Human Services, which Novavax is already working with to develop influenza vaccines. The Ebola epidemic in West Africa is the largest on record and has killed more than 11,200 people. But with vaccines from Bavarian Nordic, GlaxoSmithKline Plc and Johnson & Johnson currently in mid-stage studies, analysts such as JP Morgan's Cory Kasimov see only a limited commercial opportunity for Novavax’s version.

“We’re not at the same stage as some of the other developers but what we have is an improvement over what’s already being tested,” said Dr Gregory Glenn, Senior Vice President of R&D, Novavax. Novavax is unsure when it will be able to proceed to the next stage of development, but is aiming for approval under the ‘animal rule’, a comparatively shorter developmental pathway. The US Food and Drug Administration's animal rule allows developers to combine safety and immune system response data in humans with data from experiments on animals in exceptional circumstances. If all goes well, the vaccine could be market ready in two to three years, Glenn said. Mid-stage data on company’s lead experimental vaccine, which targets respiratory syncytial virus (RSV), the most common cause of lower respiratory tract infections in young American children, is expected later this quarter. The Ebola vaccine data builds confidence in other areas of Novavax's pipeline, particularly the RSV programme, which uses the same technology, Kasimov said. Reuters

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RESEARCH

Bristol-Myers’Opdivo found effective in kidney cancer Opdivo provided a survival advantage over the cancer drug, everolimus, among patients with advanced or metastatic renal cell carcinoma BRISTOL-MYERS Squibb’s late-stage trial of its drug, Opdivo, was stopped early after the immunotherapy was found to be effective in patients with the most common form of kidney cancer. The US drugmaker the study, Checkmate-025, was stopped early after an independent data monitoring committee concluded that Opdivo provided a survival advantage over the cancer drug, everolimus, among patients with advanced or metastatic renal cell carcinoma. Expectations that the trial would be stopped early were high, Evercore ISI Mark Schoenebaum said, given the effectiveness of Opdivo in midstage studies, the limited bene-

fit of everolimus, and that renal cell cancer has historically responded well to immunologic therapies. The trial was expected to be completed by February 2016, according to clinicaltrials.gov. Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths annually. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced kidney cancer, is 12.1 per cent, according to BristolMyers. In April, a large trial testing Opdivo was stopped early after the drug was found effective against the most common form of lung cancer. Opdivo, already in use to

treat advanced melanoma and forms of lung cancer, belongs to a highly promising new class of medicines called PD-1 inhibitors that block a mechanism tumours use to hide from the immune system. The drug competes with Merck & Co’s Keytruda. AstraZeneca, Pfizer and other drugmakers are also developing PD-1 inhibitors, or similar drugs known as PD-L1 inhibitors. Separately, smaller drugmaker Exelixis said latestage data showed that its cancer drug, Cometriq, was more effective than everolimus in improving survival without the disease progressing in patients with advanced kidney cancer. Reuters

Scientists use ‘therapeutic cloning’to fix mitochondrial genes Study showcases the latest advance in the use of somatic-cell nuclear transfer to make patientspecific stem cells that could be used to treat genetic diseases US RESEARCHERS have used a controversial cloning technique to make new, healthy, perfectly matched stem cells from the skin of patients with mitochondrial diseases in a first step toward treatment for these incurable, life-threatening conditions. A study on the technique, published in the journal Nature, showcases the latest advance in the use of somaticcell nuclear transfer to make patient-specific stem cells that could be used to treat genetic diseases. “This work enables the generation of an unlimited – and mutation-free – supply of replacement cells for patients with mitochondrial disease,” said Dr Robert

42 EXPRESS PHARMA August 1-15, 2015

Nuclear transfer is typically the first step in reproductive cloning - using adult cells to make a genetic copy of an individual

Lanza, Chief Scientific Officer at Advanced Cell Technology, who was not involved in the research. Nuclear transfer is typically the first step in reproductive cloning - using adult cells to make a genetic copy of

an individual. Since the technique was first used in 1996 to create the cloned sheep Dolly, the United Nations has urged countries to ban it on ethical and moral grounds. In 2013, Shoukhrat Mitalipov of Oregon Health and

Science University was the first to succeed using the method to make human embryonic stem cells from a patient's skin cells. The cells are prized because they are ‘pluripotent’, meaning they have the ability to transform into any type of cell in the body. In his latest study, Mitalipov and colleagues used the method to make replacement cells for patients with mutations in mitochondrial genes, which are critical for producing energy in cells. Mitochondrial genes have evaded scientists' efforts to correct such mutations, Mitalipov said. For the study, the team removed the nucleus of patients'

cells and implanted them into unfertilised human eggs in which the mitochondria remained, but the rest of the DNA was removed. They then coaxed the eggs into dividing, producing embryonic stem cells which could be used to make healthy heart or nerve stem cells to replace the patient's diseased cells. The researchers also showed that they could produce healthy embryonic-like stem cells using another method in which they reprogram adult skin cells through the introduction of several genes, a method that does not involve the use of eggs. Reuters

RESEARCH

Alzheimer’s researchers confident of producing effective treatment New experimental drugs from Eli Lilly and Co and Biogen have shown promise in slowing down the progression of the mind-wasting disease AFTER DECADES of Alzheimer’s research that led to dead ends, including 123 drugs that failed, top researchers in the field say they are far more confident now of producing an effective treatment. Their optimism has been building ahead of the Alzheimer's Association International Conference (AAIC), which starts in Washington, DC. New experimental drugs from Eli Lilly and Co and Biogen have shown promise in slowing down the progression of the mindwasting disease, attracting the attention of investors and patients. Those drugs are still very early in their development and could still join the scrap heap. But the field has gained a major understanding of how the brain changes with Alzheimer’s and better insight on how and when to intervene medically. “The recurring platitude, which has been going on forever is ‘gee we’re about five years away from a really effective treatment,’” said Steven Ferris, who directs the Alzheimer's clinical trials programme at NYU Langone Medical Center in New York. "It would be premature to say we've turned the corner but there's a lot going on in the pipeline that is quite promising,” said Ferris, who has been involved in trials for over 40 years. The Lilly and Biogen drugs block beta amyloid, a protein which causes toxic brain plaques considered a hallmark of the progressive brain disease. Lilly’s solanezumab showed signs of benefiting patients with a mild form of the disease in 2012. In March, Biogen’s aducanumab became the first experimental drug to significantly reduce beta amyloid in the brain and slow impairment in patients with mild disease. Both companies will present new data next week.

Amgen reports positive preliminary results on leukemia drug The drug helps the immune system to fight cancer

“This year is different because multiple mechanisms are being explored and there's a tremendous revival of faith in the anti-amyloid approach,” said Dr Reisa Sperling, Director of the Center for Alzheimer's Research at Harvard Medical School. Sperling's hope is that several drugs that work differently will prove effective and can be used together for 'a 1-2-3 punch' to Alzheimer's, as combination treatments now control cancer and heart disease. An estimated five million people have the disease in the US. The Alzheimer’s Association estimates that as many as 28 million Americans will develop the disease by mid-century and account for 25 per cent of US Medicare spending on the elderly in 2040. Biogen will present data on a six milligram dose of aducanumab, and researchers hope it will provide the right combination of effectiveness, with less of a brain-swelling side effect, than observed with other doses. If the 6 mg dose fails to show a significant improvement over placebo, the result could hurt

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Biogen shares. Researchers say they have improved the selection of patients for Alzheimer’s trials, making sure they are not suffering from another form of dementia by checking for beta amyloid, and by testing treatments before the disease becomes too advanced to have an impact. George Scangos, Chief Executive Officer, Biogen said that until recently, over one-third of patients referred to trials of its drugs didn’t have Alzheimer’s, “We're at a stage now where we understand the appropriate patient populations,” Scangos said. Lilly estimates about 25 per cent of patients in its previous phase III trials were likely inappropriate candidates. An ongoing phase III programme will use brain imaging technology to ensure all patients have the amyloid plaque. Lilly will present follow-up data from its earlier studies, showing whether those mildly affected patients who continued to take solanezumab for the last two years fared better than those who had initially taken a

placebo for 18 months but then switched over to the actual drug. The Alzheimer’s meeting will also highlight an anti-inflammation drug called azeliragon abandoned years ago by Pfizer when it proved ineffective after 12 months of study. Pfizer's tiny partner, privately held TransTech Pharma, continued to follow patients who had taken the drug and discovered their cognition had improved after 18 months - the primary goal of the study. The smaller company, which recently changed its name to vTv Therapeutics and aims to soon become public, began a latestage study of azeliragon in April. Dr Ronald Petersen, Director of the Mayo Clinic’s Alzheimer’s Disease Research Center, agrees with Sperling that a multi-prong approach will be required to keep the disease at bay. “Another five to eight years down the road, even before symptoms appear, we will be treating with a cocktail of therapies,” he said. Reuters

AMGEN SAID some patients with a deadly form of leukemia experienced complete remission after being treated with its Blincyto drug in a midstage clinical trial, results that could eventually lead to an expanded approval of the pricy cancer medicine. While providing few details, the world’s largest biotechnology company said the drug, which helps the immune system to fight cancer, induced complete remission or complete remission with partial haematological recovery in a ‘clinically meaningful number of patients’ with relapsed or refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (ALL). Complete remission means no sign of cancer and return of normal blood cell counts. Complete remission with partial haematological recovery signifies that the cancer appears to be gone, but blood cell counts are not yet back to normal healthy levels. Blincyto was approved in December for the Philadelphia chromosome-negative form of relapsed ALL. At about $178,000 for two courses of treatment, Blincyto is one of the world's most expensive cancer treatments. The company plans to present more detailed results from the trial at a future medical meeting. Reuters

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PHARMA ALLY VENDOR NEWS

Prime Minister inaugurates India’s first container school by Safeducate Safeducate will create chain of container schools all over India PRIME MINISTER Narendra Modi recently inaugurated India’s first Container School created by Safeducate at Vigyan Bhawan in New Delhi, while unveiling his Skill India Program. Under this programme, the Government intends to skill 40.2 crore people by 2022. The Prime Minister visited the Safeducate container school set up at Vigyan Bhawan premises and congratulated Safeducate on its innovation. Safeducate, the education and training arm of supply chain and logistics industry leader Safexpress, has created an extremely innovative model for skilling people, which can be very easily and quickly replicated to any location in India. This community outreach initiative by Safeducate could help the Government provide high quality skill training at even the remotest areas in the country. Inaugurating the Safeducate container school, Rajiv Pratap Rudy, Minister of State for Skill Development and Entrepreneurship, Government of India said, “Safeducate has introduced an innovation which will revolutionise the way skill training is imparted in the country. By launching India’s first Container School, Safeducate has set an example in the field of skilling. It is difficult to provide training to the youth in the rural areas of the country, where there is minimum availability of infrastructure and resources. By bringing down the cost and effort involved in developing infrastructure to meet education and skilling needs of people in India, this unique training platform will aid in providing quality education to

44 EXPRESS PHARMA August 1-15, 2015

the youth present in the remotest location of the country. This will definitely make a significant difference at the grassroot level.” Showcasing the Container School, Divya Jain, Founder and Chief Executive Officer, Safeducate said, “We have created the Safeducate container schools with a very high visual appeal so as to attract people even in remote areas. They have a very professional look-

and-feel, and are equipped with all amenities present in a regular school, if not more. These schools will provide Safeducate the ability to conduct trainings at any location across India where skilling is needed. This school can be set up anywhere in a short time, with just the availability of land and electricity connection. The educational format and structure of these schools is such that each district in the country will have the

same level of access to quality education. Safeducate container schools will help in creating job opportunities across the country, while creating skilled workforce for the industry.” Explaining the highlights of the Safeducate container school, Jain said, “Safeducate container school has been created by joining four containers together. These are refurbished containers which were earlier being used for the purpose of

logistics. We have recycled those containers and used them for developing our school structure. Not only is this in line with our Go Green initiative, but also it helps in bringing down the development cost of our school. Our first school has a training capacity of 189 students per month, with residential facility for 23 students. The school facility includes three classrooms, computer lab, activity area, recreation area, library, staff offices, etc. Moreover, these containers are like lego bricks, allowing this institution to have a truly flexible and scalable model. Firms like CONCOR and SCI scrap over 5000 containers every year. So there is a huge potential for scaling up our model in the future across all 680 districts of India.” The other dignitaries present during the inauguration included Sunil Arora, Secretary, Ministry of Skill Development and Entrepreneurship (MSDE), Pawan Agarwal, Joint Secretary (MSDE), Rajesh Agrawal, Joint Secretary (MSDE) and Dilip Chenoy, Managing Director and Chief Executive Officer, National Skill Development Corporation (NSDC). Congratulating Safeducate on launching India’s first container school, Chenoy said, “There are massive skill gaps prevalent in the industry today. The chain of container schools launched by Safeducate will help in bridging these skill gaps. These schools will hugely help in increasing the employment opportunities for the rural youth of the country.” EP News Bureau-Mumbai

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PHARMA LIFE RECOGNITION

Kiran Mazumdar-Shaw in Scientific American’s 100 Biotech Visionaries List Only Person from India in prestigious ranking of global life sciences influencers KIRAN MAZUMDAR-SHAW, Chairman and Managing Director, Biocon has received another global recognition. She has featured in ‘The World view 100’ of the prestigious USbased Scientific American magazine, which has drawn a spot light on the visionaries who continue to reshape biotechnology—and the world. Mazumdar-Shaw is the only person from India on this list. Mazumdar-Shaw appears on the list alongside scientists, business leaders, entrepreneurs, legislators, administra-

tors and key media figures. Scientific American says the ‘The World view 100’ list is a ‘collection of extraordinarily talented and effective people’ and describes them as ‘seminal figures’ who are ‘as complementary to the emergence of the field (of biotechnology) as two parents are to a child.’ The magazine quotes Kiran Mazumdar Shaw, “My philosophy has been one of differentiation. Look at what’s there and keep challenging yourself to be different: If everyone is after generic products, how can you

Mazumdar-Shaw appears on the list alongside scientists, business leaders, entrepreneurs, legislators, administrators and key media figures get into novel programmes? If you can do that, then you stand apart and you can do things more effectively.” The list was compiled from

nominations by dozens of leaders in biotechnology and biosciences globally. The nominators were encouraged to select living experts currently working

in the sector from a range of contributing areas, including industry, academia, public policy, finance, law and beyond. The top 10 on this exclusive list include Bill and Melinda Gates, Francis Collins, Bob Langer and Craig Venter. The list also includes seven Indian Americans, however Kiran is the only one from India; Sangeeta Bhatia, Atul Butte, Anita Goel, Ganesh Kishore, Raju Kucherlapati, Ram Sasisekharan and Rajiv Shah are the Indian Americans. EP News Bureau-Mumbai

AWARD

GSK and Save the Children launch third annual $1 m healthcare innovation award Seeks entries that demonstrate new approaches to increasing people’s access to health services in developing countries GSK AND Save the Children have launched their third annual $1 million healthcare innovation award that rewards innovations in healthcare that have helped to reduce child deaths in developing countries. Organisations from across developing countries can nominate examples of innovative health approaches they have implemented till September 7, 2015. These approaches must have resulted in tangible improvements to under five child survival rates, be sustainable and have the potential to be

scaled-up and replicated. With millions of people still lacking access to basic healthcare, this year, there will be a special focus on innovations that aim to strengthen developing country health systems and have proven to help increase access to public healthcare for pregnant women, mothers and children under five. Strengthening health systems for everyone in developing countries is an integral element of GSK and Save the Children partnership, which champions universal health coverage to help ensure

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equitable, accessible healthcare for all. Last year’s Ebola epidemic was one example of the need for new solutions and approaches to address the systemic challenges that weaken healthcare systems. Ramil Burden, Vice-President for Africa and Developing Countries, GSK said, “Through this year’s award, we hope to identify and support those innovations that are most effectively helping to strengthen health systems so that mothers and children are better able to access the care they need, when

they need it.” Mavis Owusu-Gyamfi, Director of Programme Policy and Quality at Save the Children said, “By making good health systems the norm in poor countries rather than the exception, millions of lives will be saved. Ambitious ideas are needed to solve this challenge and we hope this year to find proven ideas that we can help take to scale.” Co-chaired by Sir Andrew Witty, Chief Executive Officer, GSK and Justin Forsyth, Chief Executive Officer of Save the

Children, a judging panel, made up of experts from the fields of public health, science and academia, will award all or part of the funds to one or more of the best healthcare innovations. As well as providing funding, this year’s Healthcare Innovation Award will provide a platform to review and evaluate new approaches to health system challenges, to recognise those that are having an impact, and share their learnings with the wider global health community. EP News Bureau- Mumbai

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PHARMA LIFE APPOINTMENTS

Samina Vaziralli joins Cipla’s board of directors Vaziralli brings diverse experience of working in the US, the UK, and more recently India CIPLA HAS appointed Samina Vaziralli as Executive Director on its board. Vaziralli is the daughter of MK Hamied, Vice Chairman of the Board of Cipla. She is part of the core leadership team and has been with the company since 2011. Vaziralli brings diverse experience of working in the US, the UK, and more recently India. She has been responsible for successfully incubating and shaping Cipla’s consumer healthcare business as part of Cipla new ventures. She has also recently taken on an expanded role leading global strategic alliances and enabling Cipla’s people strategy and leadership development. Welcoming her appointment as a Director, Adil Zainulbhai, Independent Director and Chairman of the Nomination and Remuneration Committee, Cipla said, “I am delighted to welcome Vaziralli to the board. She will reinforce the commitment and continuity of the Hamied family’s involvement in Cipla. She will help drive Cipla to achieving its strategic vision.” On her appointment to the Board, Vaziralli said, “I am happy to be in position to contribute to steering Cipla as a member of the board at this exciting moment. Cipla has made huge strides in the last couple of years in taking the business and the brand into new areas and I look forward to working with our leadership team on executing our strategy.” The board of directors of the company also approved

70 EXPRESS PHARMA August 1-15, 2015

She has also recently taken on an expanded role leading global strategic alliances and enabling Cipla’s people strategy and leadership development the divestment of its consumer healthcare business to a wholly-owned subsidiary that is proposed to be incorporated. This development gives scope to develop the division as a strong, customer focussed business with operational independence and the ability to attract and develop expertise which is more FMCG-oriented. The vision is to improve the lives of Indian consumers, making full use of Cipla’s strengths in bringing good science to good medicine, while also leveraging its market outreach and equity with the Indian healthcare system. The business will focus on opportunities arising from the shift towards wellness and self-care. Commenting on these de-

velopments Subhanu Saxena, Managing Director and Global CEO, Cipla said, “I am personally delighted at having Vaziralli on the board as she will contribute greatly to the strategic direction of the company. I am pleased that the company is making such a positive move into the consumer healthcare space. There is a very good opportunity for Cipla, a company which has contributed immensely to patient health, to also contribute to patient wellness. The over-thecounter business means that we can speak to the patient directly and help them to foster good health and illness prevention.” EP News Bureau- Mumbai

Dr PG Yeole appointed as Pro Vicechancellor of RTM Nagpur University He started his teaching career from September 1, 1982 at IPER, Wardha DR PG YEOLE, Principal, IPER Wardha and former President of APTI has been appointed as the Pro Vicechancellor of Rashtrasant Tukdoji Maharaj Nagpur University by the Chancellor and Governor of Maharashtra. Yeole completed his B Pharm from Mumbai University, M Pharm from Pune University and PhD from Nagpur University. He was awarded Mahindra Talent Search Scholarship for securing first position in M Pharm. Yeole started his teaching career from September 1, 1982 at Institute of Pharmaceutical Education and Research (IPER), Wardha, Maharashtra. In 1985, he was appointed as principal of same institute. Since then he holds the same position at IPER, which conducts diploma, degree, post graduate and doctorate programmes in pharmaceutical sciences. Yeole has been emphatically working for the cause of up-liftment of pharmacy profession in India by being the President of Association of Pharmaceutical Teachers of India, Working President of Association of Unaided Private Pharmacy Colleges, Vice President of Indian society of pharma-

cognosy and member of Indian Pharmaceutical Congress Association and life member of different national and international professional societies. Yeole was the dean of faculty of medicine of RTM Nagpur University. He was a member of Management Council and senate of Rastrasant Tukdoji Maharaj Nagpur University and the Chairman of Board of Studies of Pharmaceutical Sciences of Nagpur University and also member of Board of Studies in Pharmaceutics, Pune University, Member of Board of studies (PG Program), Birla Institute of Technology, Ranchi, and other five different universities of India. EP News Bureau- Mumbai

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