Express Pharma May 1-15, 2014

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Cover Story Maharashtra Day Special Management In the line of fire Pharma Life N Rajaram joins Sanofi India

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CONTENTS MARKET Vol 9 No.13 MAY 1-15, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

13

‘PHARMAS CONTRIBUTE 30 PER CENT TO IRELAND’S EXPORTS’

IN THE LINE OF FIRE

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BOEHRINGER INGELHEIM SEES INCREASE IN OPERATING INCOME AND RETURN ON NET SALES

India’s IP laws have been in the eye of a storm since it issued its first ever Compulsory Licence. Will they land us into the list of a priority foreign country this year as we await the special 301 report? | P30

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NOVARTIS IN AGREEMENT WITH GSK, TO EXCHANGE CERTAIN ASSETS

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma

PHARMA LIFE

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr. Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal G.M. Khaja Ali Ambuj Kumar E.Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P22: PRE EVENT SPDS to conduct DISSO ASIA 2014 convention in Mumbai

P29: INTERVIEW ‘Maharashtra is the hub of quality medicines’

MANAGEMENT

34 36

THOMSON REUTERS NAMES 2014 LEADING DRUGS TO WATCH

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PATENT PROTECTION LOSSES WILL HINDER HIV TREATMENT MARKET GROWTH WITHIN SEVEN YEARS: GBI RESEARCH

P37: CLINICAL UPDATES Biogen’s blood disorder drug succeeds in late-stage trial

P37: RESEARCH UPDATES Scientists find protein that lets egg and sperm hook up

WHY ARE INDIAN GENERICS UNDER ATTACK? ONE VIEW FROM AMERICA

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N RAJARAM JOINS SANOFI INDIA AS COUNTRY HEAD AND GENERAL MANAGER PHARMACEUTICAL OPERATIONS

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DELOITTE REPORT PROJECTS 12.4 % AVERAGE SALARY INCREMENT IN PHARMA SECTOR

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

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

EDITOR’S NOTE

US, India face off on IP yet again

A

s we await the US Trade Representative's annual Special 301 Report, stakeholders on both sides of the fence seem to be hardening their stance.

Even as a senior representative from Pfizer shot off yet another complaint, this time to India's ambassador to the US, officials in India might just be ready to take the matter to the World Trade Organisation (WTO).

Reports of a high level meeting called by Cabinet Secretary, Ajit Seth on April 21 (http://www.financialexpress.com/news/india-may-drag-us-to-wto-incase-of-unilateral-ipr-action/1242726) hint at a tough stance by officials like Amitabh Kant, Secretary, Department of Industrial Policy and Promotion (DIPP) and Lov Kumar Verma, Health Secretary.

Though the Indian Ambassador to the US, S Jaishankar had suggested that the Indian government engage with US pharma firms on this matter, these officials are against such a stance and stressed that the country's IP laws were in compliance with global laws, including the WTO. The rationale is that it is time to settle the dispute once and for all, taking recourse to the dispute resolution mechanism of the WTO. The Special 301 Report has three categories for country identification: the Watch List, the Priority Watch List and the Priority Country Watch list, with the most stringent action being reserved for the last. According to information culled from yearwise reports, (http://www.keionline.org/ustr/special301), from 1989 onwards, India has been in the priority watch list. However, from 1991 to 1994, India was in the priority foreign country list. If India is placed in the last category of the 2014 listing, it will mean withdrawal of certain privileges like the Generalised System of Preferences (GSP), under which Indian goods entering the US markets benefit from reduced tariffs.

While it remains to be seen which side will blink first in this face off, Dun & Bradstreet's India Outlook Report, 2014-15 for the pharmaceutical sector gives a clear picture of what's at stake. Though sales growth of domestic pharma companies have been in single digits since Q4 FY13 to Q3 FY14, the sector's CAGR over the past five years was a robust 14 per cent.

With a growing ageing population and low healthcare penetration, India continues to be an attractive market, according to the report. Global pharma companies, while protesting India's IPR regime, seem to be anticipating a return to double digit growth even while matured markets continue to stagnate in the lower single digits, if not dipping below.

As of March 2013, India has 323 US FDA

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Even as a senior representative from Pfizer shot off yet another complaint, this time to India’s ambassador to the US,officials in India might just be ready to take the matter to the World Trade Organisation (WTO)

approved facilities, the highest outside of the US and while the recent spate of import alerts and bans has been a downer, regulators from both sides are working to increase industry awareness of and compliance with quality norms. On the anvil are a series of training workshops, jointly organised by the US FDA and its Indian counterpart, the Central Drugs Standards Control Organization (CDSCO). The first such one is scheduled on May 5 at Hyderabad to be held in association with the Indian Pharmaceutical Alliance (IPA).

Besides the IPR plank, global pharma is revamping its own model to ward off future threats.

While diversification was a revenue bridge to cope with patent cliff issues, today's mantra seems to be a return to core competencies, which are being further sharpened. Alliances too are being used to maximise reach as well as share risks and rewards.

Pharma MNCs continue to stake out their turf, choosing their battles and allies very carefully.

The portfolio swap between Novartis, GlaxoSmithKline and Eli Lilly is a prime example of the latest strategy reboot. Novartis will sell its vaccine business (except its flu portfolio) to GSK for $7.1 billion, buy GSK's oncology products for $14.5 billion. In addition, it will sell its animal health arm, to Eli Lilly for around $5.4 billion, in a further bid to focus on the high margin/value categories like oncology and exit lower margin/value products like vaccines and animal healthcare.

The deal catapults all three companies to improved global rankings in these chosen segments.

Novartis will move to second place in the oncology market, while Eli Lilly becomes the second largest animal healthcare company. Likewise, GSK gets to builds up its vaccine portfolio. Novartis takes the revamp further with the creation of a joint venture with GSK, for the consumer healthcare division.

GSK will have controlling stakes in the JV. We are sure to see many more such alliances, especially in the OTC and consumer healthcare segments where IPR does not have as much play.

Mirroring these global shifts, we see domestic majors revving up for a stronger play. Sun Pharma's acquisition of Ranbaxy in early April could be a precursor to further consolidation in the pharma space within the country. In the generics space, building scale and capabilities is crucial because it will lead to increasing credibility within the global landscape. Will this consolidation bulk up major domestic players so that they can challenge big global generic majors? That's another face off in the pipeline.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Pharmaceuticals contribute 30 per cent to Ireland’s exports’ Ireland holds a formidable position on the global pharmaceutical map not only being home to nine out of ten pharma companies but also producing seven out of ten blockbuster drugs.

Barry Heavey, Head of Life Sciences, IDA Ireland, tells us more in an interview with Shalini Gupta

How much is the Ireland pharma market worth?

What are the topmost domestic companies? What are the major therapeutic areas? How much of the revenues come from exports? What are the topmost nations the country exports to?

Ireland exports over €50 billion in pharmaceuticals in almost all therapeutic areas, from oncology, cardiovascular, neuroscience, autoimmunity to anti-infectives. Major export destinations include the US, EU and Japan. Nine of the top ten companies have strategic manufacturing operations in Ireland with a total replacement value of the investment exceeding €40 billion. Over €7 billion has been invested in the last ten years, primarily in new Biotech manufacturing facilities.

How much FDI does the country attract currently?

Has this increased over the past few years? How much does the pharma sector contribute to the GDP of the country? How has the M&A scene been in the life sciences sector? Do you see scope for consolidation?

Ireland has been extremely successful in attracting FDI in the pharma sector with several companies such as J&J, Merck & Co (MSD) and Pfizer having multiple sites in Ireland. The sector contributes close to 30 per

cent of total exports and makes a very significant contribution to GDP through net exports, payroll and capital investment.

M&A in the pharma industry has had an impact in recent years, in particular with Pfizer’s acquisition of Wyeth and Merck & Co.’s acquisition of Schering Plough.

This resulted in a number of manufacturing sites being divested by the merged entities. To date, however, these divested sites have helped in attracting new companies to Ireland with Biomarin and Amgen acquiring biopharma and sterile manufacturing sites respectively from Pfizer. There are currently three additional pharma sites being divested in Ireland and IDA is working with the companies to identify potential buyers for these sites. The pharma chemical sector contributed an estimated 12 per cent to Irish GVA in 2012.

GVA (Gross value added) is conceptually similar to GDP but examines production on a sectoral level rather than final expenditure type. Gross value added excludes product taxes and subsidies, although these are largely irrelevant for the pharma-chem sector.

By how much has the life sciences or pharma sector been growing? What have been the drivers of growth?

The life science sector has seen some counter currents

in recent years. Three factors have had a negative impact on growth in the sector: the expiration of patents on blockbusters such as Lipitor, M&A activity in the sector and the failure of high profile candidate drugs to make it through the pipeline. However, other factors have had a positive impact on growth: the continued success in biopharma drug approval, increased rates of drug approvals in speciality pharma and so called “nichebusters” in areas such as oncology.

Ireland has been impacted by the expiry of patents throughout the 50 year history of the industry, but it has always bounced back with new investment in new technology

How big is the biopharma manufacturing sector in Ireland? By how much has it been growing? What are the growth drivers? What pioneering activities are currently underway under your leadership at the National Institute for Bioprocess Research and Training to further this?

There are currently 17 biopharma manufacturing sites in production or under construction in Ireland. This has been a dramatic increase from only one dedicated biopharmaceutical site 10 years ago. This represents an investment of close to €7 billion in facilities in the last 10 years. Employment in biotech manufacturing has grown during that period from less than 500 to more than 6,000. In response to the forecasted growth in Biotech, IDA invested €60 million in the creation of

NIBRT, a bioprocessing facility which provides “real world” training to current and prospective employees at all levels in the biopharma industry.

The expiry of patents in the pharma sector could pose a risk to Ireland's economic progress. Your comments.

Ireland has been impacted by the expiry of patents throughout the 50 year history of the industry, but the sector has always bounced back with new investment in new technology. The last three years have seen a number of overlapping patent expirations for blockbusters like Lipitor and Zyprexa and these have had an impact on the sector with Pfizer looking to divest drug substance and drug product sites. However, the risk has been mitigated by parallel investment in new biopharma manufacturing facilities and in manufacturing capability for complex products such as high potency compounds and drug-device combinations. While the loss of exclusivity on some drugs may have a near term impact on export growth, these new investments will underpin export growth in future as these sites reach full productivity.

In a dynamic climate that pharma and life sciences industry today represents, with new regulatory guidelines, pricing pressures,

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MARKET IP laws, what do you see as a survival tactic for companies worldwide?

I believe that companies need to develop a balanced approach across multiple aspects of the business to deal with the new realities.

This can be seen in many big pharma companies developing strategies to compete with generics companies, especially in areas such as biosimilars. Similarly, big generics companies like Teva are starting to acquire companies with patented products and pipeline candidates. Big

proved nichebuster drugs are small molecules.

Focus on the drug substance must be balanced with opportunities for innovation in the drug product in areas such as formulation and novel delivery devices, especially for biologics. Focus on geographic markets needs to be balanced, the US, Europe and Japan remain highly attractive despite the regulatory and pricing challenges due to the population demographics of aging and chronic disease, while it is clear that companies need

Focus on development of mass market blockbusters has been proven to be lucrative when successful but also highly risky, driving many companies to pursue so called “nichebusters” which may achieve approval with lower clinical development risk barriers to entry remain in areas such as biosimilars and companies like Samsung biologics have recognised this and made extremely large investments to try to overcome this.

Companies need to manage their cost base as austerity bites into healthcare budgets globally but focusing only on cost reduction can create risks in terms of pipeline productivity and manufacturing compliance in a highly regulated industry. Focus on development of mass market blockbusters has been proven to be lucrative when successful but also highly risky, driving many companies to pursue so called “nichebusters” which may achieve approval with lower clinical development risk. Biopharma are seen as a big growth area but this must be balanced with the fact that many recently ap-

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to further develop strategies for entering growth markets like India, China, ASEAN, Brazil, etc.

IDA believes Ireland is a great location for companies to execute this balanced approach – the country has an exceptionally strong regulatory track record which mitigates risk for companies and has combined this with a strong focus on managing costs/increasing competitiveness and productivity. Ireland has a track record in drug substance and drug product manufacturing in small molecule and biopharma, in drug device combinations, in proprietary and generic drugs and in blockbusters, as well as nichebuster products. Sites in Ireland have a successful history in supplying a diverse set of markets shalini.g@expressindia.com

COMPANY WATCH

Boehringer Ingelheim sees increase in operating income and return on net sales Net sales of around €14.1 billion achieved DESPITE SOME challenges, Boehringer Ingelheim, the research-driven pharmaceutical company, succeeded in increasing its operating income and the return on net sales. The company generated net sales of around €14.1 billion, which represents an increase of 1.4 per cent, currency-adjusted (-4.3 per cent in euro terms). This resulted in a 2.4 percentage point improvement in the return on net sales to 15 per cent.

For the current financial year, the company expects net sales to remain at a comparable level to that of 2013. Boehringer Ingelheim now employs more than 47,400 people worldwide, which is three per cent more than in the previous year.

"2013 was for Boehringer Ingelheim a year marked by many successes and some challenges," said Professor Andreas Barner, Chairman of the Board of Managing, Boehringer Ingelheim, at the recently held Annual Press Conference in Ingelheim. "We concentrated on continuing our work on the long-term development of the company."

With afatinib, for the targeted treatment of a specific form of lung cancer, Boehringer Ingelheim last year successfully entered the oncology market. The compound was launched in the US under the brand name of Giotrif and the launch has in the meantime started in the European Union

under the name of Giotrif. A second new product launch in 2013 was Striverdi Respimat (olodaterol) for chronic obstructive pulmonary disease (COPD).

In the next two years alone, the company is planning more than ten new launches in eight indications: diabetes, COPD, asthma, lung cancer, the rare disease idiopathic pulmonary fibrosis (IPF), a rare form of leukaemia (AML) and the treatment and prevention of deep vein thrombosis and pulmonary embolism. For the last mentioned indication, the company received marketing approval from the US Food and Drug Administration for Pradaxa at the beginning of April. The company is currently working on 90 research and development projects. In the current financial year, Boehringer Ingelheim is planning to take on nine new investigational compounds in phase II clinical studies. "We will strengthen our therapeutic areas immunology and disorders of the central nervous system,” said Barner.

“We can say that Boehringer Ingelheim came through 2013 well, despite extraordinary effects and the negative impact of exchange rate developments," said Hubertus von Baumbach, Member of the Board of Managing Directors with responsibility for Finance. At around €2.7 bil-

lion, the company once again invested substantially in research and development. Expenditure for research and development as a share of net sales rose from 19 per cent in 2012 to 19.5 per cent in 2013.

With a 15 per cent increase in equity to €7.1 billion and an equity ratio up by around three percentage points to 39 per cent, Boehringer Ingelheim is in a sound financial position.

The increase in financial funds to €7.5 billion gives the company the financial flexibility for future sustainable, organic growth.

At €1.8 billion, cash flow from operating activities in 2013 ensured that investments were fully covered. In the financial year just ended, Boehringer Ingelheim invested a total of around €600 million in tangible and intangible assets. Among other things, the company increased its production capacity for the Respimat inhaler at its German facilities in Dortmund and Ingelheim at a cost of €57 million.

Boehringer Ingelheim invested a further €23 million in the extension of the production facilities and the chemical research and development laboratory in Shanghai, China.

Boehringer Ingelheim last year generated net sales of just under €11 billion in prescription medicines, its most important business. This represents an increase of 1.4 per cent,

MARKET currency-adjusted (-4.5 per cent in euro terms), and 77 per cent of total net sales. The oral anticoagulant Pradaxa once again proved to be the growth driver, with net sales increasing by more than 16 per cent, currency-adjusted (+8.8 per cent in euro terms), to €1.2 billion. Spiriva for the treatment of COPD remained the most successful medicine. Net sales were up 3.8 per cent, currencyadjusted (-0.3 per cent in euro terms), to around €3.5 billion.

In over-the-counter medicines the company achieved a 6.3 per cent increase in net sales, currency-adjusted (-2.1 per cent in euro terms). Net sales generated in 2013 thus amounted to around €1.5 billion. This represents 11 per cent of total net sales. The international core brands — Buscopan, Dulcolax, Mucosolvan and

The three most important markets — the US, Japan and Germany — accounted for around 60 per cent of Boehringer Ingelheim's total net sales in 2013. In Germany, the company generated net sales of around €1 billion, but the German share of the company’s global business in prescription medicines amounted to only five per cent Pharmaton — were again the most successful consumer healthcare medicines.

In its animal health business, Boehringer Ingelheim in 2013 exceeded the €1 billion mark in net sales. This represents an increase of 4.5 per cent, currency-adjusted (+0.8 per cent in euro terms), and eight per cent of total net sales.

The best-selling product, with

net sales of €260 million, was the swine vaccine Ingelvac Circoflex, as in the previous year.

With an increase of 20.9 per cent, currency-adjusted (+16.2 per cent in euro terms), Ingelvac PRRS, for the active immunisation of pigs against an infectious respiratory disease, achieved the greatest growth.

In biopharmaceuticals, Boehringer Ingelheim gener-

ated net sales in 2013 amounting to €449 million.

The three most important markets — the US, Japan and Germany — accounted for around 60 per cent of Boehringer Ingelheim's total net sales in 2013. In Germany, the company generated net sales of around €1 billion, but the German share of Boehringer Ingelheim's global

business in prescription medicines amounted to only five per cent. In Japan, the company generated net sales of over €1.8 billion and in the US around €5.2 billion. Net sales were last year severely impacted by exchange rate effects in the US and Japan.

In view of the many challenges, no particular signs of growth will emerge in the pharma industry in the course of the next few years. “The market environment for innovative medicines is not going to get any easier in the current financial year,” said Barner. "In view of this and the impact from the expiry of patents, we expect to achieve net sales for our company in 2014 that are comparable to those in the previous year.”

EP News Bureau - Mumbai

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EXPRESS PHARMA

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MARKET

Novartis in agreement with GSK, to exchange certain assets Acquires GSK oncology products NOVARTIS HAS reached a definitive agreement with GlaxoSmithKline (GSK) to exchange certain assets, building global leadership in key segments and focusing the company’s portfolio. Under the agreement, Novartis would strengthen the company’s innovative pharmaceuticals business by acquiring GSK oncology products, and would divest vaccines (excluding flu) to them. The two companies would also create a joint venture, combining their consumer divisions to create a world-leading consumer healthcare business. Separately, the company announced a definitive agreement with Eli Lilly and Company (Lilly) to divest the Animal Health Division, further focusing its portfolio on the leading businesses of innovative pharma, eye care and generics.

“The transactions mark a

transformational moment for Novartis. They focus the company on leading businesses with innovation power and global scale. They also improve our financial strength, and are expected to add to our growth rates and margins immediately,” said Joseph Jimenez, Chief Executive Officer, Novartis. “We have also created a world-leading consumer healthcare business in our joint venture with GSK. We believe the divestment of our smaller Vaccines and Animal Health Divisions will enable us to realise immediate value from these businesses for our shareholders, and those divisions will benefit from being part of large, global businesses that are also leaders in their segments. Patients will benefit from even higher levels of innovation that this focus may afford. Looking

ahead, this positions Novartis well for future healthcare industry dynamics.”

Novartis has agreed to acquire GSK oncology products for a $14.5 billion payment and up to $1.5 billion contingent on a development milestone. Under the terms of the transaction, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.

Novartis has agreed to divest its vaccines business to GSK, currently excluding its flu business, for $7.1 billion plus royalties. The $7.1 billion consists of $5.25 billion upfront and up to $1.8 billion in milestones. As a part of a value-maximisation strategy in the context of the portfolio review, Novartis has initiated a separate sales process for its flu business.

Novartis and GSK have agreed to create a world-leading

consumer healthcare business through a joint venture between Novartis OTC and GSK Consumer Healthcare. Upon completion, Novartis will own a 36.5 per cent share of the joint venture and will have four of eleven seats on the joint venture’s Board. Furthermore, Novartis will have customary minority rights and exit rights at a predefined, market-based pricing mechanism. In a separate transaction, Novartis has agreed to divest its Animal Health Division to Lilly for approximately $5.4 billion. This transaction is the result of a competitive process, which upon completion would create a leading animal health business under Lilly’s ownership and would optimise the value of the asset in the interest of Novartis shareholders.

are excited about the joint venture with Yoshindo, a partner who shares our commitment to bringing biosimilars to market in Japan. YLB is a reflection of Lupin’s long-term commitment to the Japanese market and is an important first step forward to establishing Lupin’s global Biosimilar portfolio.”

Kenzo Shimomura, President, Yoshindo said, “YL Biologics is our bridgehead to expand Yoshindo’s activities to the Biosimilar market in Japan and highlight on the strategic representation of company.”

SUVEN LIFE Sciences has received two patents, one product patent from Hong Kong (HK 1133002) and one product patent from Canada (CA 2737282) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2023 and 2029 respectively.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia.

With these new patents, Suven has a total of 15 granted patents from Canada and 14 product patents from Hong Kong. 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 out-licensed 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

EP News Bureau – Mumbai

EP News Bureau - Mumbai

Lupin inks JVwith Yoshindo New entity YL Biologics to focus on clinical development and commercialisation of biosimilars for Japan LUPIN HAS entered into a strategic joint venture agreement with Toyama-based Japanese pharmaceuticals company, Yoshindo to create a new entity, YL Biologics (YLB).

YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain biosimilars including regulatory filings and obtaining marketing authorisations in Japan.

The new entity YLB will inlicense Monoclonal Antibodies (mAbs) from Lupin and also partner with other companies across the globe for the Japanese market which already has a

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clear cut regulatory regime in place for the development and commercialisation of Biologicals. Lupin’s Etanercept biosimilar, developed by its Biotechnology Research Group in Pune will be the first product to be licensed for clinical development to YLB. Etanercept (Originator Trade name: Enbrel) is a biopharmaceutical product approved globally for treating autoimmune diseases such as Rheumatoid arthritis, Psoriasis and Ankylosing spondylitis. Enbrel is marketed in Japan by Takeda Pharmaceutical and had sales of $ 496 million.

The Japanese biological

market is currently valued at close to $12 billion and growing at two to three per cent annually. mAbs make up $3.5 billion of the overall Japanese biological sales and growing at five per cent (IMS Health).

Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance.

Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks.

Commenting on the joint venture Dr Kamal K Sharma, Vice Chairman, Lupin said, “We

Suven Life secures product patents

MARKET

Piramal Enterprises,Merisant in pact Signs exclusive sales and distribution partnership for Equal in India PIRAMAL ENTERPRISES has partnered Merisant India (Merisant) for an exclusive sales and distribution partnership in India for its artificial table-top sweetener, Equal. The deal enables Merisant to tap into Piramal Enterprises strong distribution network in India, and allows the consumer product division to expand its offerings in the selfcare segment.

Kedar Rajadnye, President and COO, Consumer Products Division, Piramal Enterprises said, “Backed by India’s largest field force (1000+), we are delighted to partner with Merisant to offer seamless distribution of

The deal enables Merisant to tap into Piramal Enterprises strong distribution network in India, and allows the consumer product division to expand its offerings in the self-care segment Equal in India. It brings a brand of international repute to our self-care portfolio. We aim to increase Equal’s reach across the target markets to four times from its current levels within the first year. Equal enjoys a strong brand presence, and this alliance promises to combine strengths of both companies for the sole benefit of our consumers.”

EXPRESS PHARMA

17

May 1-15, 2014

Ayan Ghosh, General Manager for South Asia, Merisant Group said, “This

strategic alliance with Piramal Enterprises is an important step for us to broaden the reach of

Equal across India. We are leveraging Piramal’s excellent infrastructure in sales and distribu-

tion, and are confident of building a strong base for Equal.”

EP News Bureau - Mumbai

YOUR PARTNER FOR PROCESS AND PLANT ENGINEERING Gla (India) Pharma Engineering Pvt. Ltd., member of the Gla Group; is a highly skilled engineering company specializing in the provision of Consul ng & Engineering Services exclusively to the Bio-Pharma & Pharmaceu cal Industries.

Realized projects for:

Solid and Semi-Solid Dosage Forms Produc on of tablets (coated/non-coated), capsules, sachets, oral drops, suppositories, ointments

Bio-Pharma Produc on of vaccines, insulin and products made by frac onaon of blood plasma, e.g. albumin, immuno-globulin, factors VIII and IX

Sterile and Asep c Liquid Dosage Forms Produc on of infusions, pre-filled syringes, lyophilized products, eye drops

Altana Pharma Bakai Helve ca Pharmaceu cals Beximco Boehringer Ingelheim Galenika Leo Pharmaceu clas Novar s Pfizer

Realized projects for: Biomed ROS Plasma

Realized projects for: AB Pharm Faro Pharma Gelfipharma Gematek

Gla (India) Pharma Engineering Pvt. Ltd. Gla is an interna onal company having its headquarters in Germany, with approx. 1500 employees and over 15 subsidiaries & various permanent agencies as points of contact; worldwide. Gla was established in 1954 by Werner Gla and since then the company is not only ac ve in the pharmaceu cal industry but through con nuous innova ons and hard work, has also successfully ventured into the food, feed and fine chemical industries. Gla , for over half a century, has been facilita ng its clients in consultancy, planning and implementa on, using bespoke solu ons and world class services. Our extensive know-how has helped clients incorporate efficient solu ons, to their en re product life cycle, realizing drama c returns on investments and enhancing produc vity.

Plot No. 251, Okhla Industrial Estate Phase III, New Delhi 110020 Phone: +91 11 40 85 85 85 Fax: +91 11 40 85 85 86 eMail: info@gla -india.com

www.gla .com

MARKET

Venus gets marketing nod from Venezuela for meropenem VENUS REMEDIES has extended its footprint in Latin America with marketing authorisation for meropenem from Venezuela.

Pawan Chaudhary, Chairman and Managing Director, Venus Remedies said, “We are planning to launch meropenem in Venezuela in the next couple of months.

The $10-million meropenem market in Venezuela offers a great opportunity to us and we are aiming at capturing a sizeable share in this market in the first year of the launch. Having a presence in important Latin American markets like Columbia, Peru, Guatemala and Mexico, we are constantly strengthening our position in Latin America.”

Meropenem, which accounts for annual global sales of $906 million which are estimated to go up to $1,006 million in the next one year, is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections.

EP News Bureau – Mumbai

18

EXPRESS PHARMA

May 1-15, 2014

US FDAapproves ofatumumab Ofatumumab in combination with chlorambucil is effective for the treatment of previously untreated patients with chronic lymphocytic leukaemia for whom fludarabine-based therapy is considered inappropriate THE US Food and Drug Administration (US FDA) has approved ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

The approval was based on the results of a multicentre, randomised, openlabel trial comparing ofatumumab in combination with chlorambucil to single agent chlorambucil. The trial enrolled 447 patients for whom fludarabine-based therapy was considered to be inappropriate by the investigator for reasons that included advanced age or presence of co-morbidities.

In the overall trial population the median age was 69 years (range: 35 to 92 years).

Around 72 per cent of patients had two or more co-morbidities and 48 per cent of patients had a creatinine clearance of <70 mL/min. Patients received ofatumumab as an intravenous infusion according to

The approval was based on the results of a multi-centre, randomised, open-label trial comparing ofatumumab in combination with chlorambucil to single agent chlorambucil.

The trial enrolled 447 patients for whom fludarabine-based therapy was considered to be inappropriate by the investigator the following schedule: 300 mg administered on cycle 1 day 1, 1000 mg administered on cycle 1 day 8 and 1000 mg administered on day 1 of all subsequent 28 day cycles. In both arms, chlorambucil was given at a dose of 10 mg/m2 orally on days 1 to 7 every 28 days. Prior to each infusion of ofatumumab, patients received pre-medication with acetaminophen, an antihistamine, and a glucocorticoid.

The primary endpoint of the trial was progression free

survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) update of the National Cancer Institute Working Group (NCI-WG) guidelines. Median PFS was 22.4 months (95 per cent CI: 19.0, 25.2 months) for patients receiving Arzerra in combination with chlorambucil compared to 13.1 months (95 per cent CI: 10.6, 13.8 months) for

patients receiving singleagent chlorambucil [hazard ratio 0.57 (95 per cent CI: 0.45, 0.72), stratified log-rank p-value <0.001].

The most common adverse reactions (greater than or equal to five per cent) with ofatumumab in combination with chlorambucil (greater than or equal to two per cent more than in the control arm) were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia and upper abdominal pain.

Overall, 67 per cent of patients who received ofatumumab experienced one or more symptoms of infusion reaction. Ten percent of patients experienced a grade 3 or greater infusion reaction.

The results of this randomised trial were adequate to fulfill the postmarketing requirement for GlaxoSmithKline to verify the clinical benefit of ofatumumab and, therefore, the approval of ofatumumab was converted from accelerated approval to regular approval.

EP News Bureau - Mumbai

MARKET

GAVI Alliance plans drive for access to vaccines Drive to secure a healthy future for children in developing countries AS FIVE African countries prepare to celebrate World Immunization Week (April 24-30) with the impending introduction of new vaccines, the GAVI Alliance is finalising plans to build on its successes with a major drive to increase access to vaccines and the impact of immunisation programmes by 2020.

This week, Angola and the Republic of Congo plan to begin protecting their children against severe diarrhoea with the rotavirus vaccine while Tanzania expects to begin a demonstration project to protect girls from the leading

cause of cervical cancer with the human papillomavirus vaccine. Next week, Madagascar plans to also introduce rotavirus vaccine and Togo expects to undertake a dual launch of rotavirus and pneumococcal conjugate vaccines.

While these launches are taking place, the GAVI Alliance will be preparing for a key meeting to be held next month in Brussels, where the Alliance will set out the significantly increased impact that can be achieved by supporting immunisation programmes in the world’s poorest countries through to 2020.

European Commissioner for Development, Andris Piebalgs, will host the meeting on May 20 where GAVI Alliance will present to its partners the funding requirements needed during the five-year period from the beginning of 2016 to build upon the gains already achieved against the biggest killers of children.

“We are on the eve of a unprecedented expansion of vaccination programmes,” said Dagfinn Høybra°ten, Chair of the GAVI Alliance. “Since 2000, GAVI Alliance partners have vaccinated an additional 440 million children, saving six

million lives. In Brussels, we will present an historical opportunity to go even further and secure a healthy future for a generation of vaccinated children in developing countries, a generation that hold the keys to their countries’ futures.”

Immunisation is widely recognised as one of the most successful and cost-effective health interventions ever introduced, preventing between two to three million deaths every year. Yet each year more than 22 million children - many of them in the poorest and most remote communities have little or no access to a full course of

the most basic vaccines. One in five of all children who die before the age of five lose their lives to vaccine-preventable diseases.

Central to the Alliance’s ongoing drive to immunise more children has been an unprecedented acceleration in the number of new vaccines introduced by the 73 countries that receive GAVI support. Between 2011 and the end of 2013, 93 new vaccine introductions were initiated with GAVI support and a further 50 are projected for 2014.

EP News Bureau – Mumbai

EXPRESS PHARMA

19

May 1-15, 2014

MARKET GROWTH TRACKER

IPM grows 3.9 per cent in March 2014, clocks ` 5948 crores 10 therapies have outgrown the IPM growth and two therapies have double digit growths THE INDIAN Pharmaceutical Market (IPM) clocked `5948 crores in March 2014. It has grown at 3.9 per cent. Amongst the top 10, Lupin grew at 10.7 per cent followed by Alkem at 8.3 per cent and Emcure at six per cent. 32 corporates have crossed the growth of IPM amongst top 50.

Amongst the top 50 corporates, Biocon has the highest growth of 45.8 per cent followed by Ajanta at 28.4 per cent and Apex at 26.2 per cent.

Amongst the 11-20 ranked companies, Ipca has shown high growth at 23.3 per cent followed by Macleods at 17.4 per cent and Torrent at 16 per cent.

Sun as a company has seen 15.4 per cent growth in March 2014. Sun as a corporate now has a MS of 9.49 per cent for March 2014.

Indian companies have grown at 5.5 per cent versus 1.1 per cent for MNCs in March 2014. Amongst the top 50 in MNCs, MSD grew the highest at 13.5 per cent, followed by Allergan at 9.6 per cent and Merck at 9.5 per cent.

The DPCO 2013 containing molecules market was at â&#x20AC;&#x201C;13.9 per cent whereas the nonDPCO market grew by 6.8 per cent resulting in an overall growth of 3.9 per cent for March 2014. The DPCO 2013 portfolio for GSK de-grew at 23.5 per cent and Ranbaxy degrew by 24.2 per cent, whereas Sun Pharma in its DPCO 2013 portfolio de-grew at 10 per cent.

20 EXPRESS PHARMA May 1-15, 2014

With Bonus Units at Full Value Val in Crs

Rank

COMPANY

MAT

MAT Mar -14 MTH

IPM Sun Pharma

1

(Val in Crs)

1

Mar-14

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

75757

100

6.2

5948

100

3.9

4087

5.39

17.2

347

5.83

15.2

Cipla

2

2

3777

4.99

6.1

302

5.08

7.6

Zydus Cadila

3

3

3104

4.10

10.9

247

4.15

3.8

Ranbaxy

4

4

2987

3.94

-1.4

218

3.66

-9.2

Glaxo

5

5

2753

3.63

-15.2

213

3.58

-9.9

Abbott HC

6

7

2711

3.58

0.5

205

3.45

-5.4

Mankind

7

6

2675

3.53

4.7

208

3.49

-0.3

Lupin

8

8

2540

3.35

12.0

204

3.43

10.7

Alkem

9

10

2363

3.12

11.1

177

2.97

8.9

Pfizer

10

9

2207

2.91

3.6

179

3.01

4.0

Macleods

11

11

1980

2.61

9.2

167

2.81

17.4

Sanofi India

12

14

1935

2.55

1.3

141

2.37

-4.9

Intas

13

12

1889

2.49

8.8

152

2.56

4.0

Aristo

14

13

1832

2.42

12.7

142

2.39

14.8

Val in Crs

MAT Mar 14

Month Mar -14

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

75752

6.2

5947

3.9

ANTI-INFECTIVES

12584

0.6

921

-3.3

CARDIAC

9396

9.1

761

6.7

GASTRO INTESTINAL

8518

5.8

661

3.8

VITAMINS / MINERALS / NUTRIENTS

6793

5.6

530

2.7

RESPIRATORY

5925

9.3

488

8.8

PAIN / ANALGESICS

5544

3.5

428

2.5

ANTI DIABETIC

5326

15.2

446

15.8

NEURO / CNS

4729

7.5

381

4.8

GYNAECOLOGICAL

4703

1.4

374

0.1

DERMA

4200

11.2

332

9.2

OPHTHAL / OTOLOGICALS

1375

8.3

112

5.1

HORMONES

1290

5.7

105

6.2

VACCINES

1115

-1.5

81

-15.5

ANTI-NEOPLASTICS

1038

28.2

87

14.5

BLOOD RELATED

915

2.7

69

0.7

OTHERS

909

5.9

74

5.1

ANTI MALARIALS

624

1.5

36

3.6

SEX STIMULANTS / REJUVENATORS

429

5.1

35

3.0

STOMATOLOGICALS

339

8.0

27

6.3

MARKET From therapy perspective 10 therapies have outgrown the IPM growth and two therapies have double digit growths. Respiratory market grew at 8.8 per cent, gastrointestinal market grew at 3.8 per cent whereas the anti-infectives de-grew at -3.3 per cent. The anti-diabetic market grows at 15.8 per cent and cardiac at 6.7 per cent in chronic business. The derma market grew by 9.2 per cent.

From regional perspective 15 regions have outgrown the IPM growth. The Odisha market grew the highest at 15.1 per cent followed by Jharkhand market at 10.4 per cent.

Two regions had negative growths in March 2014.

The biggest molecule Amoxycillin + Clavulanic degrew by 2.7 per cent, whereas Cefixime degrew at 9.1 per

From regional perspective 15 regions have outgrown the IPM growth.

The Odisha market grew the highest at 15.1 per cent followed by Jharkhand market at 10.4 per cent cent. The markets of Glimepiride + Metformin grew at 33.9 per cent, Vitamin- D grew by 26.4 per cent, Levetiracetam by 23.7 per cent, Rosuvastain by 22.7 per cent, Telmisartan by 17.6 per cent and Levocetirizine + Montelukast by 16.9 per cent.

Glycomet-GP grows at 26.3 per cent amongst the top 10 Brands. Amongst the top brands in the IPM, Lantus grew by 30 per cent, Telma by 16.6 per cent, Skinlite by 13.7 per cent, Aciloc by 15 per cent, Dex-

EXPRESS PHARMA

21

May 1-15, 2014

orange 10 per cent amongst top 25 brands. A total of 87 brands were launched in March 2014.

Silodal D, Quinvaxem and Coerip are the top NIs for the month of March 2014.

About PharmaTrac PharmaTrac is a the second-

ary sales data audit conducted

by AIOCD Pharmasofttech AWACS, a pharma 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 AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

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 PRE EVENTS

SPDS to conduct DISSO ASIA2014 convention in Mumbai To promote introduction of new technology, innovation and have deliberations on various issues faced related to dissolution SOCIETY FOR Pharmaceutical Dissolution Science (SPDS) will be conducting its 2nd Annual International Convention DISSO ASIA 2014 on May 5 and 6, 2014 in Mumbai. The event will promote introduction of new technology, innovation and have deliberations on various issues faced related to dissolution.

Around 200-250 eminent professionals are expected to participate in this event. The event will be organised under the Chairmanship of Dr Nandakumar Chodankar, Chief Executive Officer and Promoter (Director on Board) at ASolution Pharmaceuticals and the Organising Secretary, Dr L Ramaswamy, Managing Director, Sotax India. The scientific sessions will be programmed and

executed under the chairmanship of Dr Mangal Nagarsenker, HOD and Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The event will have plenary lectures, poster exhibits, panel discussion and exhibits. Vijay Kshirsagar, Director and Chief Executive Officer, TRAC Consulting, Mumbai will speak on the topic ‘Relevance of Current Batch Centric BE Studies’; Dr Vinod Shah, Ex US FDA, Pharmaceutical Consultant, USA will speak on ‘FDA/USP Perspectives on Dissolution Testing from Regulatory Filing Point of View’; Prof Dr Jean Michel Cardot, Professor, Department of Biopharmaceutics, and Pharmaceutical Technology, Auvergne University, France will

Around 200250 eminent professionals are expected to participate in the event

deliver a lecture on ‘In-Vitro Dissolution as in Vivo Surrogate’; Samir Haddouchi, Managing Director, SPS Pharma Services, Clermont Ferrand – France will speak on ‘Overview of Challenges and Solutions to Dissolu-

tion Testing of Non-Oral Formulations’; Dr Umesh Banakar, Professor and President, Banakar Consultancy Services, USA will speak on 'Biosimilars - The Emerging Frontier for Generics: Role of Dissolution Testing’; Dr Sandip Tiwari, Technical Director: South Asia, Colorcon Asia will speak on ‘Future of Dissolution Testing’; Michel Magnier, Product Manager/Application Specialist, Sotax will speak on ‘Automation for Dissolution Testing’; Bryan Crist, Manager, Scientific Affairs, Agilent technologies, USA will speak on ‘Validation of Components and data of Automated Dissolution Methods’; Prof Dr Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand will speak on

‘Biowaiver of Biopharmaceutics Classification System Class III Drug Products’; Dr Sid Bhoopathy, Chief Operating Officer, Absorption Systems, USA will speak on ‘Strategies for Establishing Equivalence of Complex Drug Products’; Dr Flavian Stefan Radulescu, University of Medicine and Pharmacy ‘Carol Davila’ Bucharest, Romania will speak on ‘Correlation between rheology, in-vitro release and invivo performance of topical dosage forms.’

A panel discussion on ‘Handling dissolution Challenges’ will be held which has been specifically designed for all the professionals from R&D, QA and QC as well as the academia.

EP News Bureau-Mumbai

IDMA to organise conference on ‘Current Challenges & Opportunities in Pharma Marketing’ The theme of the conference is 'Indian Pharmaceuticals for Global Health.'

INDIAN DRUG Manufacturers’ Association (IDMA) will organise pharma marketing conference 'Current Challenges & Opportunities in Pharma Marketing' on May 9, 2014 in Mumbai. The theme of the conference is 'Indian Pharmaceuticals for Global Health.'

Marketing directors, marketing managers, sales managers (All India and regional), group product managers, prod-

22 EXPRESS PHARMA May 1-15, 2014

uct/brand managers, medical professionals, sales and marketing consultants, senior management and owners will take part in the conference.

Discussions will be held on topics like How does one build brands in the age of MCI Guidelines & DPCO pressures?; Understanding recent progressions in Pharma Sales & Marketing; Best practices in KOL Management; How does

one leverage & manage Customers across the company?; What are the key performance parameters for tracking Brand Building?; How can Pharma brands grow using Digital Marketing?; New Opportunities for growth: Nutraceuticals / OTC. Narayan B. Gad, Director, Gadtech will speak on the topic 'How does one build brands in the age of MCI Guidelines &

DPCO pressures?'; Salil Kallianpur, GlaxoSmithKline will speak on 'Understanding recent progressions in Pharma Sales & Marketing'; Athul Hadap, SBU Head, Ranbaxy will speak on 'Best practices in KOL Management'; Dr Sanjoy Gupta, Managing Director, Strategic Marketing Solutions and Research Centre (SMSRC) will speak on 'How does one leverage & manage Cus-

tomers across the company?', Priti Mohile – Managing Director, MediaMedic Communications will speak on 'How can Pharma brands grow using Digital Marketing?' and Dr RK Sanghavi, Clinician & Consultant, Healthcare Neuromarketing will speak on 'New Opportunities for growth: Nutraceuticals / OTC'.

EP News Bureau – Mumbai

MARKET

Cool Chain Strategies Summit to be held in Mumbai Will see 150+ senior level supply chain and logistics professionals THE COOL Chain Strategies Summit will be held in Mumbai on May 29, 2014. The summit will address how supply chain, logistics, QA & packaging professionals in India can enhance temperature control practices that are in-line with international industry standards, but compliant with local and regional regulations. It will feature an impressive list of cold chain experts who contribute in various tracks and would bring together 150+ senior level supply chain and logistics professionals from cold chain industry under one roof.

The key objective of the summit

The summit will address how supply chain, logistics, QA & packaging professionals in India can enhance temperature control practices that are in-line with international industry standards but compliant with local and regional regulations

is to bring all the key stakeholders together to trigger overall cold chain development in the country.

Visitors will be able to discover how to implement the GSP regulations within the supply chain and ensure compliance, limit costs while managing and selecting the right outsourcing partners and vendors to ensure compliance and quality control, learn the challenges and solutions of maintaining temperature/humidity control while distributing to the second-tier cities, major urban towns and internationally and bridge the gaps within your supply chain by keeping continuous data, developing an integrated system and clearing customs.

VPâ&#x20AC;&#x2122;s, directors, heads, general managers from sectors like pharmaceuticals, hospitals, lifesciences, biotechnology, CROâ&#x20AC;&#x2122;s, food, processed food, hotel, large format retailers and wholesalers, government associations and organisations, private equity firms and consultants, refrigeration and cold chain equipment and technology suppliers, packaging service providers, specialised equipment providers, refrigeration solution providers, cold chain logistics players like refrigerated carrier companies, shipping lines, container companies, warehouse and cold storage owners, reefer handling ports, terminals, railways and airlines are likely to attend the event .

The summit will see 25+ subject matter experts, focused tracks and dynamic discussion topics, international cold chain expert conducting workshop and latest cold chain solutions in the exhibition area.

EP News Bureau â&#x20AC;&#x201C; Mumbai

EXPRESS PHARMA

23

May 1-15, 2014

EVENT BRIEF MAY-JULY 2014 9

Conference on 'Current Challenges & Opportunities in Pharma Marketing'

CONFERENCE ON 'CURRENT CHALLENGES & OPPORTUNITIES IN PHARMA MARKETING' Date:May 9, 2014 Venue: Mirage Hotel, Andheri-Kurla Road, Marol, Andheri (East), Mumbai Summary: IDMA’s Marketing & MSME Sub-committees are organising a pharma marketing conference on ‘Current Challenges & Opportunities in Pharma Marketing.’ Marketing directors, marketing managers, sales managers (all India and regional), group

24 EXPRESS PHARMA May 1-15, 2014

16

Seminar on Managing Risks for Quality Compliance 2014

product managers, product/brand managers, medical professionals, sales and marketing consultants, senior management and owners will take part in it.

Discussions will be held on topics such as 'How does one build brands in the age of MCI Guidelines & DPCO pressures?'; 'Understanding recent progressions in Pharma Sales and Marketing; Best practices in KOL Management'; 'How does one leverage & manage Customers across the company?'; 'What are the

11

Contract Manufacturing 2014

key performance parameters for tracking Brand Building?'; 'How can Pharma brands grow using Digital Marketing?'; 'New Opportunities for growth: Nutraceuticals / OTC.' Speakers who will take part in the event are Narayan B Gad, Director, Gadtech, Salil Kallianpur from GlaxoSmithKline, Athul Hadap, SBU Head, Ranbaxy, Dr Sanjoy Gupta - Managing Director, Strategic Marketing Solutions and Research Centre (SMSRC), Priti Mohile - Managing Director, MediaMedic

Communications and Dr RK Sanghavi, Consulting Clinician, Consultant – Healthcare, Neuro Marketing.

Contact details Indian Drug Manufacturers’ Association 102B, A Wing,Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/ 24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Web: www.idma-assn.org

23

Emerging Trends in Drug Discovery: AICADD – 2014

SEMINAR ON MANAGING RISKS FOR QUALITY COMPLIANCE 2014 Date: May 16, 2014 Venue: Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Technical Subcommittee will organise a seminar on Managing Risks for Quality Compliance 2014. Experts in technology, quality assurance, regulatory affairs, engineering, production and packaging spheres from the Indian pharmaceutical industry will converge and interact on various

EVENT BRIEF recent developments.

Dr K Bangarurajan, Deputy Drugs Controller (India), CDSCO West Zone (Mumbai) will give the keynote address on ‘QRM Requirements of WHO’; Bharat Doshi, Pharmaceutical Consultant, will peak on ‘Risk Free Facility Design for efficient QRM’; SM Mudda, Executive Director, Technical & Operations- Micro Labs will speak on Managing Operational Risks for Quality Products; R Raghunandanan, Pharmaceutical Consultant, will speak about ‘Managing Risks in Quality of Aseptic Operations’; RR Tuljapurkar, Vice President, Quality Assurance, Zydus Cadila, will speak on ‘Controlling Risks in Quality Control’; R Dadich, Vice President,Corporate Quality, IPCA Laboratories will speak on 'Quality Materials for Quality ProductsControlling Risks.’

The seminar is designed to cater to all those involved in pharmaceutical industry, bio-pharmaceutical industry, academic institutions; business consulting companies, facility design and materials management.

Contact details Indian Drug Manufacturers’ Association 102B, A Wing,Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/ 24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Web: www.idma-assn.org

CONTRACT MANUFACTURING 2014 Date: July 11, 2014 Venue:Hotel Hilton, Sahar, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the 1st conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’ Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Contact details Indian Drug Manufacturers’ Association 102 - B, 'A' Wing,

Poonam Chambers Dr Annie Besant Road, Worli Mumbai – 400018 Tel: +91-22-24944624/24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Website: www.idma-assn.org

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientistsacademics’ collaboration to meet the major challenges of drug discovery.

The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr P K Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014 Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa VidyapeethamAmrita UniversityAmritanagar, Coimbatore - 641 112 Tel: (0422) 2685000 (Extn: 5592) Email: aicadd_2014 @cb.amrita.edu / aicadd2014 @gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

EXPRESS PHARMA

25

May 1-15, 2014

Presents A Revolu onary Product For Ini al Level R & D Stability Studies Data Collec on

No Electric Supply

21 CFR Part 11 Compliant So ware

Avoids Contamina on

No Water Supply

Accurate Test

Flexible

Compact Design

Environmental Condi ons

Affordable Ideal for ASAP

Wireless Technology

Easy to use

Stability Tes ng & Monitoring System (STAMS)

cover )

We must keep in mind that the industry is a part of the society, so it cannot function in isolation

Difficulties keep on changing as per the situation and department you are dealing with

The process of setting up a plant is simpler in SEZ but difficult in non-SEZ

Shashank Sandu,

Deepali Chile,

Director, Sandu Pharmaceuticals

Chief Executive Officer, Brassica Pharma

General Manager, Biotechnology, Elder Pharmaceuticals

26 EXPRESS PHARMA May 1-15, 2014

Sharad Dahatonde,

(

THE MAIN FOCUS

F

or many decades, Maharashtra has maintained its position as the largest contributor to the pharmaceutical market in India. Many big and small scale pharma companies are operational in the state.

Pro-industry policies of the state government and active support of the state FDA have been instrumental in scripting pharma industry's success story in Maharashtra. However, according to some industry players, government's and FDA's noble intentions have been sometimes punctured by some of its own officials, who for monetary benefits, harass the pharma companies. Though behind the scenes they want things to be rectified, pharma entrepreneurs are very reluctant to come out and discuss this issue fearing a backlash from the government officials.

It's official

The pharma sector in Maharashtra is facing challenges from different quarters, including bureaucratic hurdles, unwarranted political interference and gundaraj at the local level, which are hampering its growth

BY SACHIN JAGDALE

Setting up a manufacturing plant entails a significant amount lot of ground work. As this industry deals with human life, an array of permissions are required from different government offices. This is where the agony begins for pharma players. With a few exceptions, at each stage they would be asked to empty their pockets to get necessary clearances on time even when they have done things as per the rules.

Shashank Sandu, Director, Sandu Pharmaceuticals, says, â&#x20AC;&#x153;Yes, it is true that government officers create hurdles because they know what laws/rules have been framed. In general, no busi-

nessman would like to waste time in clearances since time is money for him. He will want to get his project up and running as cost of the capital, be it interest or opportunity cost, is always biting into the total cost.â&#x20AC;?

Deepali Chile, Chief Executive Officer, Brassica Pharma,

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cover ) reiterates that time is precious for any entrepreneur. She says, “Any entrepreneur, on a monthly/yearly basis, has to deal with government/non government agencies like Maharashtra Industrial Development Corporation (MIDC), factory inspector, Maharashtra Pollution Control Board (MPCB), Maharashtra State Electricity Board (MSEB), Food and Drug Administration (FDA), City and Industrial Development Corporation (CIDCO)/Drug Controller General (India) (DCGI), labour, local gram panchayat, excisestate and central, sales tax, weight and measures, mathadi unions, security board, customs and port, local political parties, transportation local body, income tax and local journalists.

On an average, even if one department takes one week’s time for settling any issue, around 20 weeks out of 52 weeks a year are spent by an entrepreneur in doing liaison work.

How can you expect him to do a productive job?”

Pravin Herlekar, Chairman and Managing Director, Omkar Speciality Chemicals Limited (OSCL), does not feel that government officers are major hurdle creators. He says, “The hurdles are created, on account of the need to deal with various departments which work in isolation. This problem can be solved by adopting a single window system, about which the government has been talking for many years, but has still not implemented the same. The single window system will get rid of all the worries faced by an entrepreneur in seeking necessary consents/clearances from various departments. It will streamline the process of setting-up of new ventures or expansion of existing business.”

Echoing what Sandu and Chile had said, Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals, too points towards delays in getting different approvals or clearances. He says, “Normally the process of setting up a plant is simpler in SEZ but very difficult in non-SEZ.” Speaking about nonSEZ areas, Dahatonde explains,

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“Difficulties are faced in getting no-objection certificates (NOCs) and other clearances from the Pollution Control Board for units and other related activities in non-SEZ zones. Even getting environment clearance from the Ministry of Environment and Forest is a challenge. Permissions are required for adequate water and electricity supply as well. Getting FDA licenses are too difficult in such non-SEZs.” He further says, “The government officers normally do not follow the time-lines for such clearances and delay the process. This indirectly affects the project cost, including potential of the business. Even after beginning the operations, there is no guarantee of support from corresponding authorities, which is not a good omen for the industry's growth.”

Pharma, an easy prey?

Mainly, new start-ups and SMEs are the victims of unlawful activities by some selective government officials.

This section of the industry is not considered cash rich. Their business, which is mostly backed by loans taken from different banks or financiers, suffers a lot as considerable amount of time and money goes into fulfilling demands of corrupt government officers.

“It starts right from the land allotment stage and goes on even after the project is up and running. So it is the entire gamut of departments which are involved in demanding favours.

Government departments consider an industry as the hen that lays golden eggs and so they are in the waiting for the opportune moment to take their pound of flesh,” says Sandu.

Chile says that difficulties keep on changing as per the situation and department you are dealing with. “The pharma companies are mainly required to face FDA administration, frequently. FDA has clear cut guidelines regarding the basic requirements of the plan and documentation of production, quality control, etc. hence if these guidelines are strictly followed or adhered to, there should not be any confrontation

The single window system will get rid of all the worries faced by an entrepreneur in seeking necessary consents /clearances from various departments Pravin Herlekar, Chairman and Managing Director, Omkar Speciality Chemicals Limited (OSCL)

with this department,” says Herlekar.

Ground reality The woes of pharma players don't end with bureaucracy and red tapism. Sometimes an area where a plant is located is full of problems like threats from local goons or political interference.

Government should ensure a safe working environment for the companies, which is perhaps not happening. “When a formulation plant of my company was under construction local goons and politicians used to threaten me or my staff. They would regularly demand money from us.

They were behind us to recruit people of their choice even if they didn't have necessary qualification. I was even asked for tour packages to the US and the UK. Unfortunately, I had to accept most of the demands as all such elements work hand in hand. A loss due to these issues goes into lakhs of rupees,” discloses a the Chairman of a company who does not want to reveal his name. This company deals in speciality chemicals.

“The basic problem is the scant respect that industrialists are given by everyone in the society and this starts from the government itself,” says Sandu.

He adds, “Indians think that an industrialist setting up a facility

has bags of money with him. But, it's his hard earned money.

Anywhere else in the world businessmen are accorded respect due to which no local goons political interference etc. comes in as a major hurdle.

Having said this, we must also keep in mind that the industry is a part of the society, so it cannot function in isolation. Industry follows a capitalist model requiring a totally different political treatment in the entire scheme of things, and this the politicians must bear in mind.”

Chile says, “The Ministry of Labour takes care of labour welfare. There is no entrepreneur welfare programme. It is a general notion that an entrepreneur earn a lot of money easily and it is then the right of other non-entrepreneurs to share it.

Ultimately entrepreneurs are also people aspiring to achieve higher returns on investments done through their own capital or borrowed. Before earning a single rupee, entrepreneurs end up on negative balance by accounting for taxes starting from advance/tax, sales tax, excise tax, service tax and so on.”

Herlekar says, “The state of Mahararashtra has notified industrial areas developed by MIDC. MIDC should take the responsibility of providing basic infrastructural requirements such as good roads, power, process water connection, etc.

Every industry located in the industrial area tries to recruit local manpower for skilled and unskilled labour. It is a fact that the industry faces problems from local goons or political interference. Such problems can be resolved by maintaining proper PR with various local bodies and adopting practices for arriving at amicable solutions, case by case. However, in case of extreme situations, the government should stand by the industry to rule out any violence or unlawful situation.”

Troubles galore Though government departments, goons or politicians top the list of trouble makers, pharma players have to contend with other issues as well. According to Chile, the MIDC lands

are not affordable so private lands are beyond the reach of new entrepreneurs. She says, “There are many MIDCs having sick industries due to various reasons like labour issues, non availability of trained manpower, remote locations resulting in additional transport cost and pressure from local contractors for using their services at higher rates or for poor services. If the land can be acquired or if there is a loan made possible for industrial land it will be advantageous.”

“There are pharma clusters in Thane, Nasik and Aurangabad, more cluster-based projects must be encouraged by providing state-of-the-art common facilities. This will help the SME sector to share costs and enhance quality, productivity and innovative capabilities.

There is an urgent need for dedicated areas/zones to set up the API industry with common effluent treatment plant, generators and other requirements,” suggests Dahatonde.

“Maharashtra, in general, has a congenial atmosphere for industries,” feels Herlekar. However, he also says that the recent policy of moratorium being imposed on chemical and pharma industries in the Western Ghat region are preventing new pharma companies from coming up in these areas. Hence, the policies need to be flexible and clear while protecting the environmental issues at large.

Ayurvedic medicine manufacturer, Sandu points out that Maharashtra government has not done anything for the AYUSH industry while other state governments have declared it as a priority industry.

Tax incentives offered by other states have largely eroded Maharashtra's dominance in the pharma sector. Now, as the incentives have been taken away, pharma companies are again expected to flock to Maharashtra. However, unless the state government ensures a safe and corruption-free working environment, bringing back pharma companies would remain a distant dream. sachin.jagdale@expressindia.com

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THE MAIN FOCUS

I N T E R V I E W

‘Maharashtra is the hub of quality medicines’ Maharashtra still dominates the Indian pharma sector, emphasises Mahesh Zagade, Commissioner, FDA Maharashtra, in conversation with Sachin Jagdale Describe the pharma sector in Maharashtra.

Drugs and Cosmetics Act,1940, The Drugs and Magic Remedies (objectionable advertisements) Act, 1954 and Drugs Price Control Order are the main statures which go in a long way to supply quality medicines and cosmetics as per the requirements of the patients.

Patients should not get spurious medicines and of course the same thing is applicable to cosmetics also. These are the main things for which FDA functions.

FDA also functions as a regulator for manufacture, distribution and sale of medicines and cosmetics. When it comes to the manufacture of medicines, Maharashtra is the major contributor. Earlier, we used to contribute about 70-75 per cent of the total medicines manufactured in the country. Now it has come down to 24-25 per cent.

But the main strength of Maharashtra is that we are very quality conscious. We make the manufacturers follow the Schedule M which is the SOP for GMP to bring out quality product. We need to be quality conscious while supplying medicines in the country and to get international attention. We collect around 6000-7000 drug samples annually from the market in the state, out of which around seven per cent are found not to be of standard quality . If you further analyse this, 14 per cent of these are manufactured outside the state and only three per cent are manufactured in the state.

Quality aspect is much better in Maharashtra compared to other states in the country.

Maharashtra also contributes in a bigger way in the export of the medicines. You will find that US FDA approved plants in the country are more in Maharashtra than any other state. Maharashtra is the hub of quality medicines. We further want to expand our base. As the incentives given by other states are taken away, we believe that pharma companies would again migrate to Maharashtra. We have a good climate, availability of water and electricity and most importantantly quality manpower.

Was the tax incentives the only reason for which pharma companies were migrating towards other states?

Yes, it was. Now, as incentives are over, pharma companies will again look at the places where there is more peace and industry-friendly environment.

In Maharashtra, quality aspects are also looked into, the state is known for it.

What are the unique challenges associated with FDA Maharashtra that other state FDAs may not have to face?

The pharma sector in Maharashtra continues to remain the most productive and quality conscious in the country. For us, challenge is to regain the position where we had 74-75 per cent manufacturing base in the state. We are trying to promote the industry in collaboration with MIDC and other departments.

Now-a-days it is very often said that Maharashtra is losing or has already lost its

approved plants are more in Maharashtra. There are MHRA approved plants in the state. So the statistics show that Maharashtra still has a grip over the pharma industry. Maharashtra hosts 10 per cent of country’s population. Geographically also we are just 10 per cent of the country.

Despite this we manufacture about 24 per cent of country’s pharma output.

The pharma sector in Maharashtra continues to remain the most productive and quality conscious in the country leadership position in the pharma sector. How true is that?

Those who claim so are perhaps ill-informed. There is no data to show that this is happening. In fact, maximum number of WHO-GMP certifications are going from Maharashtra. US FDA

Clinical trial industry is moving out of India. What is your view on this?

This is a wrong perception.

In fact, clinical trial is not a state subject. If you read information available on the Internet, developed countries are losing out on clinical trials.

These trial operators are going to countries like Brazil, China, Argentina and India. So, the clinical trials are moving towards other economies from the economies of developed countries.

What is your take on Indian pharma companies receiving US FDA warning letters?

US FDA's main thrust is on the Quality By Design (QBD) and our main thrust is also on the same. So not just US FDA is quality conscious but we are too. So, wherever there is violation of norms we take actions. If you see the case of Johnson and Johnson where they flouted manufacturing process in a simple product like baby powder, we cancelled their license. So, we are as stringent as US FDA. We don’t differentiate between local companies and MNCs.

The fight between pharmacists and FDA was widely publicised. Are the rules very stringent or have pharmacists taken them lightly?

These rules are meant for the betterment of patients.

Patients should get the services that are described in different acts. A lot of research goes into framing any act. Drugs are concentrated chemicals and cannot be sold like chocolates.

Rules are there and I am just implementing them. This is how I work during my every posting. I have stressed on the presence of pharmacist in the shop, sale of medicines only with bill and no sale of prescription drugs without doctor's prescription. All these factors are important from patient’s perspective. I found that about 34 per cent shops were operating without pharmacists. In the absence of a proper bill, counterfeit medicines would find easy access to the patient.

Moreover, without bill it is difficult to recall the drug and also it cannot be determined whether drug price control order is being followed or not.

Laws that were on holiday for many years, I am just implementing them. Pharmacists should comply with the law or go out of the business.

Associations are not fighting with me, they are fighting with drug price control order. They are pressurising manufacturers to appoint a particular dealer or distributor, or else they threaten to boycott their products. These are backstage things which never come into the picture. sachin.jagdale@expressindia.com

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MANAGEMENT

IN THE LINE OF FIRE India’s IP laws have been in the eye of a storm since it issued its first ever Compulsory Licence. Will they land us into the list of a priority foreign country this year as we await the special 301 report?

BY SHALINI GUPTA

R

eleased recently, the annual report of the USTR (United States Trade Representative) lists ‘treatment of pharmaceutical patents in India’ amongst reasons it cites as a barrier to exports. This comes at a time when rumours are rife that the US Trade Representative might designate India as a ‘priority foreign country’ in its Special 301 Report, due on April 30. Influential pharmaceutical lobbies in the US are thought to have built up the

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momentum on the same and see India's insistence to exercise flexibilities in the existing TRIPS as an infringement of IPR. Should this happen, India would be the only country apart from Ukraine to be placed in this category and the implications could result in trade sanctions including withdrawing tariff preferences for Indian exports.

Unilateral action It is common knowledge that after the Supreme Court decision on Novartis, MNCs have been gingerly and extremely defensive about India's IP laws.

However, differences could have been addressed by challenging

them under WTO's dispute settlement system if the US strongly felt that our IP policy was particularly discriminating against its companies. Argues TC James, President, NIPO, “Such unilateral action is against the principles of WTO. Much hue and cry is being created over India having issued only one compulsory licence so far, when the patent office recently rejected two applications.” He cites a WTO report(December 1999) on United States- Section 301310 of the trade act of 1974 which says: 7.88 When a member imposes unilateral measures in violation of Article 23 in a specific dispute,

serious damage is created both to other Members and the market-place. However, in our view, the creation of damage is not confined to actual conduct in specific cases. A law reserving the right for unilateral measures to be taken contrary to DSU rules and procedures, may – as is the case here – constitute an ongoing threat and produce a 'chilling effect' causing serious damage in a variety of ways.

Further elaborating on the damage caused it says: 7.89 First, there is the damage caused directly to another member. Members faced with a threat of unilateral action, espe-

cially when it emanates from an economically powerful Member, may in effect be forced to give in to the demands imposed by the member exerting the threat, even before DSU procedures have been activated. To put it differently, merely carrying a big stick is, in many cases, as effective a means to having one's way as actually using the stick. The threat alone of conduct prohibited by the WTO would enable the member concerned to exert undue leverage on other members. It would disrupt the very stability and equilibrium which multilateral dispute resolution

Such unilateral action is against the principles of WTO. Much hue and cry is being created over India having issued only one compulsory licence so far, when the patent office recently rejected two applications.

Based on inputs from pharma and IT lobbies, GIPC has adopted a lot of arbitrariness in allocating indices to different parameters. If indexing was done properly, India's rank would be much higher

TC James,

Adviser, Intellectual Property Rights, Former Adviser, Department of Science and Technology

President, NIPO

Raghava Saha,

South Africa and Brazil are looking to the Indian IP system. The former does not have a patent examination system, pre-grant opposition system and is currently handing out patents blindly since 1992 Leena Menghaney, Coordinator (India), Campaign for Access to Essential Medicines, Medecins Sans Frontieres

While older western firms maybe at fault for not doing the same, ultimately the blame lies with the Indian patenting system for not encouraging such voluntary licensing by approving a worthy patent Roger Bates, author of Phake: The Deadly World of Falsified and Substandard Medicines and a scholar at the American Enterprise Institute

The Bayer Nexavar decision is clearly inconsistent with Article 27.1 of the TRIPS Agreement, which prohibits limitations on the enjoyment of the patent right based on whether the products subject to the patent are manufactured locally or imported Krishna Sarma, Managing Partner, Corporate Law Group

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MANAGEMENT was meant to foster and consequently establish, namely equal protection of both large and small, powerful and less powerful members through the consistent application of a set of rules and procedures.

In its submission letter to the USTR, MSF also argues that “Rather than using the Special 301 Review Process as a unilateral tool to impose a heightened intellectual property regime on developing countries, the US Government should use its laws, policies, and financial resources to ensure that developing countries exercise the full flexibilities available to them to ensure access to medicines for all.” “India is on stronger grounds on IP issues than it is on quality, and if it was actually in breach of WTO rules, US or other nations probably would have brought an action/case. A 301 report is US way of pressuring India to reform its IP system – short of WTO action”, pitches in Roger Bates, the author of Phake: The Deadly World of Falsified and Substandard Medicines and a scholar at the American Enterprise Institute.

TRIPS compliant?

The GIPC(Global Intellectual Property Center) report which lists India as the lowest in IPR among list of 25 countries was contested by CII during its deposition before the USITC(United States International Trade Commision. “Based on inputs from pharma and IT lobbies, GIPC has adopted a lot of arbitrariness in allocating indices to different parameters. If indexing was done properly, India's rank would be much higher. For example, on the parameter dealing with legal provisions about IPR, it has given a very low rank perhaps driven by the enforcement aspect only. In my view that is illogical,” says Raghava Saha, Adviser, Intellectual Property Rights, Former Adviser, Department of Science and Technology.

The Indian patent law has remained unchanged after it was amended in 2005 to comply with the requirements of the TRIPS agreement. Despite accounting for its flexibilities, it is far more stricter than that in the US which allows for the granting of secondary patents for very obvi-

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India, meanwhile is closely cautious. This might explain why the recent proposal by the Health Ministry to issue a compulsorily licence for Dasatinib to the Ministry of Industry and Commerce was met with a response by the Department of Industrial Policy and Promotion (DIPP) stating that the kind of data and information provided was insufficient. According to DIPP, the use of Section 92 was impermissible since the provision allowed licensing in the specific circumstances – which were not prevailing in the country presently ous modifications of existing medicines. Termed evergreening, this is something that section 3(d) of the Indian Patents Act desists, by restricting patents for already known drugs unless the new claims are superior in terms of efficacy.

Leena Menghaney, Coordinator (India), Campaign for Access to Essential Medicines, Medecins Sans Frontieres strongly feels that using the stick to make India fall in line might be an example for other countries looking upto India as a role model. “South Africa and Brazil are looking to the Indian IP system. The former does not have a patent examination system, pregrant opposition system and is currently handing out patents blindly since 1992.” It is not difficult to understand then that any action against India would help rein in countries thinking of following into its footsteps.

However, Krishna Sarma, Managing Partner, Corporate Law Group is of the strong opinion that we might be missing the fact that TRIPS was brought about to protect and promote innovation cannot change. She highlights that Article 7 of the TRIPS Agreement which states that “the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to

the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.”

Further, she adds that Article 27.1 of the TRIPS requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.” The patentability criteria of Section 3(d) are in addition to the internationally accepted criteria of novelty, inventive step and utility. “The Bayer Nexavar decision is clearly inconsistent with Article 27.1 of the TRIPS Agreement, which prohibits limitations on the enjoyment of the patent right based on whether the products subject to the patent are manufactured locally or imported,” she exhorts.

Bates cites the case of Gilead, which was denied a patent for VIREAD(Tenofir), at the same time atleast four Indian companies pay them a royalty for having the technology transfer for the product. “While it strikes me that it was a bad decision to deny that patent and businesses are making decisions ignoring the patent issue, I’d argue this is because Gilead doesn’t have the historical baggage of other firms and was prepared to work with Indian firms on this issue re-

gardless of no patent granted,” he says. He is quick to add though, “While older western firms maybe at fault for not doing the same, ultimately the blame lies with the Indian patenting system for not encouraging such voluntary licensing by approving a worthy patent.”

Right or wrong?

It is not only India which is irking Big Pharma. If reports are to believed, PhRMA , has made a case for putting the EU on a priority watch list, accusing European Union of ineffective patent enforcement, taking generics into account when setting medicine prices and EMA's data disclosure policy. On the latter, it is of the view that “providing virtually unrestricted access to and publication of biopharmaceutical companies' clinical trial regulatory submissions and data will substantially harm patient privacy, the integrity of the regulatory system, and incentives for pharmaceutical research and development.” It further adds, “Failing to protect confidential commercial information contained in regulatory submissions is inconsistent with the EU's treaty obligations contained in the WTO Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS) and primarily benefits competitors who wish to free-ride off of the investments of innovators.”

India, meanwhile is closely

cautious. This might explain why the recent proposal by the Health Ministry to issue a compulsorily licence for Dasatinib to the Ministry of Industry and Commerce was met with a response by the Department of Industrial Policy and Promotion (DIPP) stating that the kind of data and information provided was insufficient.

According to DIPP, the use of Section 92 was impermissible since the provision allowed licensing in the specific circumstances – which were not prevailing in the country presently.

It was added that Indian Patent Office(and not the government) has the power vested to wielding Section 84 on grounds of non-affordability of the drug and grant a licence upon receiving an application.

Saha strongly feels that there needs to be a more transparent, competent and broad based mechanism for arriving at a decision about granting CL, perhaps a bench. As far the US stand goes, he feels, “US might put us on a watch list. They will have to keep the interest of Boeing and other engineering industries in mind which have a big market in India. Considering India's stand in respect of what is happening in Ukraine, USA may adopt arms twisting technique.” Even as India takes a measured approach to compulsory licensing, it doesn't stop the western world from a view that the system is protectionist and flawed. Bates argues further, “If the patents were granted, and India then wanted to try and negotiate voluntary licenses at “fair prices” and failed and then issued compulsory licenses for those products, then it has the right to do so. Western companies may complain about that, but India would be following a more obviously correct protocol. Whether, this is right for long run of Indian development is of course another issue”. Even as the special 301 report is being penned down, NATCO pharma has approached India's patent office to deny Gilead Sciences protection on its brand new Hepatitis C drug. The hornet's nest has been stirred again, we can only wait and watch. shalini.g@expressindia.com

MANAGEMENT REPORTS

Why are Indian generics under attack? One view from America

ROGER BATE, Adjunct Scholar at the American Enterprise Institute

Giving a view from America, Roger Bate shares his impressions on the quality of generic drugs in India and opines that the CDSCO, the main regulator should be given more status, funding and power to curb the growing of incidences of pharma manufacturers being pulled up for not maintaining the required quality standards INDIAN GENERIC drugs have helped millions access medicines around the world.

Those suffering from diseases like malaria and tuberculosis, and increasingly non-infectious diseases like diabetes, have been able to afford treatment because of Indian companies. It has not been out of benevolence but considered self-interest that this has occurred. Western interests have admired Indian value for money and penetration of emerging markets, and decried India’s perceived lack of protection of intellectual property rights.

While it is debatable whether India should enforce IP rights more rigorously, IP debates have obviously consumed most of the interest of both Western companies and Western governments in Indian pharma issues. No doubt there have been poor IP decisions out of India; denying certain patents because drugs were expensive - an initial reason given in several cases (notably Glivec) - provides evidence to western interests that protectionism is at work (price is not an issue of law for patent decision making).

But ultimately cases that made their way to higher courts (such as Glivec) probably have been correctly decided in terms of Indian law. In short, westerners may not like Indian decisions, but on the whole those decisions are defendable under World Trade Organization rules – if they weren’t by now some nation would have brought an action

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While India can be confident about its IP decisions, it is on far weaker ground over the quality of its products. But any foreigner, such as myself, pointing out such problems, is assumed to have a malign interest with the intent to destroy Indian generic sales. Regardless of my intent, it is vital for India to look inwardly or it risks losing the advantage it has worked hard to develop against India.

Western fixation on India’s IP rulings has led to massive distrust, lowered attention and undermined action in other critical areas of the pharma business. That is at least until last year’s US FDA felony conviction against Ranbaxy. Since then, and with FDA head Margaret Hamburg’s visit to India, Indian drug quality has been a centre of focus. Such focus was not driven by Western corporations who have paid little attention to the issue, but due to major Indian failings.

While India can be confident about its IP decisions, it is on far weaker ground over the quality of its products. But any foreigner, such as myself, pointing out such problems, is assumed to have a malign interest with the intent to destroy Indian generic sales. Regardless of my intent, it is vital for India to look inwardly or it risks losing the advantage it has worked hard to develop.

First, the laws overseeing drug production are not even Indian, they are colonial.

Amendments to the 1940 Drug and Cosmetic Act have been made but oversight is at best fragmented and weak.

The entire law needs to be rewritten to give the main regulator, the CDSCO, more status, funding and power.

CDSCO’s own head acknowledges that the agency needs more resources to effectively regulate. CDSCO currently oversees ‘new’ products only, and after four years of market approval of a new product, it passes oversight to state regulators. In essence, the generic drugs for which India is famous have almost no federal oversight.

Additionally, the Indian Parliamentary Standing Committee on Health claims CDSCO is corrupt and colludes with local companies. Until CDSCO is better funded and run by an expert in drug quality and not a political functionary, it will continue to

be viewed as insignificant, always trumped by commercial pressures.

Second, CDSCO data is highly suspect. When I investigated the problem of drug quality within India in 2008 and 2009, Vijay Karan, former Head of the Police in Delhi regaled me with stories for 90 minutes of corrupt acts at CDSCO and further afield. According to Karan, pharmacists being sampled by CDSCO often know the inspectors are government employees, and hence always give the best samples to them.

This biases any results, and further undermines trust in the organisation.

Third, state regulators are poorly organised and funded.

GL Singhal, Chief Regulator of Haryana, a drugs manufacturing hub, told Reuters recently that he needs double the number of inspectors if he is to properly scrutinise factories there. “We literally have skeletal services. We are struggling in the present

system. Inspectors are so overburdened, and their nature of duty is very serious,” said Singhal.

Fourth, the quality of drugs India exports to Africa and other emerging markets is also coming under scrutiny.

Most of the uterotonic medicines sampled in Ghana from India failed (while those from Switzerland did not). This reinforces the belief that Indian companies produce inferior products for poor markets.

One also wonders if they always export good medicines to advanced nations.

Fifth and perhaps most damning of all, none of the Indian drug regulators, either at the state level or CDSCO, contacted the whistle-blower in the infamous Ranbaxy case to understand what really happened. It is one thing to think US FDA may be overzealous, it is another entirely to not even investigate matters with the key source.

Part of the fault for lack of consistent production lies with Western nations. Western drug agencies focus investigations on new products, and approving practices to assess whether a company can make a good product, not that it always does. For example, US FDA samples only a few hundred medicines from pharmacies every year – with three billion prescriptions filled annually across the country.

It essentially operates on the honour system – trusting that companies which can make a good product always will.

MANAGEMENT Some companies, and not just Indian ones, appear to be taking advantage of this lack of oversight and are selling inferior products. Dr Preston Mason of Harvard Medical School found that 36 versions of atorvastatin (generic Lipitor), the world’s most valuable drug, bought in Asia, Europe and US had impurities that undermined the performance of the product. Quite a lot of the suspect samples were made by Indian firms.

This obviously irked Indian officials, but even US FDA tried to distance itself from the findings. FDA senior official Janet Woodcock issued hurried and illogical denials of Mason’s findings and even his methodology, which is the standard used by all scientists in the US. As one US drug expert put it to me, “FDA is acting like CDSCO, it denies there is a problem without doing a thorough investigation.”

As if to bolster this impression, FDA has still to contact Dr Mason.

Indian concerns that there are vested interests opposing its generics are of course accurate. Western generic companies in particular are threatened by Indian exports and take advantage of any Indian misfortune. But India’s problems are not imaginary, denials do not make them disappear, they just allow them to fester and worsen.

Following ongoing elections, the new Indian government must rewrite the laws, and properly fund a well constituted drug regulator. Indian companies must move away from accepting different standards of medicine production, one for ‘export’ and another for ‘domestic consumption’. It is unfortunate that the recent revision to the Drugs and Cosmetics Act chose to exclude products made for ‘export’ from the remit of the Indian regulator under misguided reasoning (Section 31, Recommendations, http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Healt h%20and%20Family%20Welfare/79.pdf). Actions such as this help to proliferate two different standards of quality in

the Indian industry.

Indian companies must also demonstrate intentions to improve quality of production. India needs to join the

Pharmaceutical Inspection Cooperation Scheme and harmonise its standards with global health authorities.

If it does this it will find

more willing buyers for its products, and provide those Western vested interests it is so ready to moan about, with little room for manoeuvre

(Roger Bate is the author of Phake, and an Adjunct Scholar at the American Enterprise Institute)

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MANAGEMENT REPORTS

Thomson Reuters names 2014 leading drugs to watch Analysis points to three potential blockbusters: Sovaldi,Anoro Ellipta and Idelalisib entering market this year THE INTELLECTUAL Property & Science business of Thomson Reuters has released its annual forecast of the leading drugs to watch in 2014, including three potential blockbuster treatments anticipated to attain more than $1 billion in sales through 2019, after entering the marketplace this year.

The study utilised Cortellis Competitive Intelligence, the pharmaceutical industry’s leading source for drug pipeline, deals, patents, and company content, to create a Market Insight report identifying drugs that will have a significant impact on the marketplace in 2014 and for years to come.

The analysis points to three potential blockbuster drugs.

● Sovaldi:

Gilead’s oral NS5B ploymersase inhibitor for treating hepatitis C virus (HCV) was approved by the FDA in December 2013 and is expected to reach a consensus of $2.4 billion in sales in 2014, rising to its peak in sales in an estimated $9.1 billion in 2017. ● Anoro Ellipta: GlaxoSmithKline/Theravance’s Anoro Ellipta, which contains two bronchodilators for the long-term, once-daily maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), which is predicted to outsell its developers’ 2013 potential blockbuster Relovair in the COPD field, with forecasted sales of $3 billion through 2019. ● Idelalisib: Gilead filed this

oral P13K p110-delta subunit inhibitor for US approval for indolent non-Hodgkin’s lymphoma in September 2013 and for European approval for chronic lymphocytic leukemia (CLL) and INHL in October 2013. A US filing for CLL is also planned. This treatment demonstrated significant efficacy in a phase III CLL trial; however, idelalisib faces stiff competition in the CLL marketplace.

“These treatments are expected to be the highest performing from our list of drugs to watch in 2014,” said Charlotte Jago, from the Thomson Reuters Life Science business, and author of the Market Insight report. “That is not to say, however, that these are the only drugs of high poten-

tial this year. To the contrary, there are several other therapies we’ve identified and which are also worth keeping an eye on.”

Among those worthy of additional attention are Eli Lilly’s long-acting GLP-1 analogue dulaglutide for diabetes and its anti-VEGFR2 mAb Cyramza for gastric cancer, as well as MannKind’s inhaled insulin product Afrezza. This will be the third filing for Afrezza since 2009, after the FDA twice requested further information.

“It is interesting to watch the transformation from yesterday’s blockbuster drug era to that of the current environment, where precision medicine and drug repositioning are on centre stage,” said Jon

Brett-Harris, Managing Director, Thomson Reuters Life Sciences. “That said, we see three strong potentials of blockbuster caliber this year.

As the pharmaceutical industry searches for replacement revenue streams, our Drugs to Watch report is a valuable tool for identifying therapies that have blockbuster potential, as well as other drugs with strong revenue indicators.”

The Thomson Reuters Market Insight report also includes an update on the 2013 Drugs to Watch, including Vascepa (Amarin), Pomalyst (Celgene), Kadcyla (Roche), and Relovair (GlaxoSmithKline, Thervance).

EP News Bureau-Mumbai

Patent protection losses will hinder HIVtreatment market growth within seven years: GBI Research The first-line antiretroviral therapies Atripla and Truvada will lose patent protection during the forecast period, which will hurt their markets in Europe and Canada THANKS TO patent expirations of several key therapies, the Human Immunodeficiency Virus (HIV) treatment market value will increase at a slow pace in the coming years, from $14.3 billion in 2012 to $16.3 billion by 2019, at a Compound Annual Growth Rate (CAGR) of 1.9 per cent, says business intelligence provider GBI Research.

According to the company’s latest report, the first-line anti-

36 EXPRESS PHARMA May 1-15, 2014

retroviral therapies Atripla and Truvada will lose patent protection during the forecast period, which will hurt their markets in Europe and Canada.

Angel Wong, Analyst for GBI Research, says, “Despite such patent losses, a number of drugs will enter the HIV market by 2019. Among these new entrants, 572-Trii is expected to perform the strongest commercially and will compete with

Atripla following its approval.

However, these drugs will not offset the impact of generic erosion.”

Currently, the HIV pipeline is strong and displays a high degree of novelty and diversity, according to GBI Research. The pipeline also consists of therapies that address the unmet needs of drug resistance and toxicity. These drugs are Nucleoside Reverse Transcriptase In-

hibitor (NRTI) apricitabine, censavudine and elvucitabine, which deal with the issue of NRTI resistance.

Another candidate in the HIV pipeline, which is a new prodrug of tenofovir, called tenofovir alafenamide, has also demonstrated a more favourable toxicity profile than its predecessor Viread.

Wong says, “Despite the promising outlook, the HIV

pipeline has suffered from high attrition rates in recent years, particularly with vaccines. None of these have been approved for the treatment of HIV.” “These failures reflect an urgent need for a more thorough understanding of immune response against HIV and more streamlined clinical trial designs,” the analyst concludes.

EP News Bureau-Mumbai

RESEARCH

Galapagos,GSK Biogen’s blood disorder drug concludes phase succeeds in late-stage trial 2a study of skin disease drug CLINICAL UPDATES

BIOGEN IDEC and Swedish Orphan Biovitrum said their experimental blood disorder drug was effective in treating children with hemophilia in a late-stage trial. The drug, Eloctate, was able to maintain low bleeding rates in children with hemophilia A - a rare genetic disorder in which a person's blood does not clot properly due to missing or reduced levels of a protein called factor VIII. The late-stage trial tested Eloctate in previously treated children under 12 years with severe hemophilia A. The main goal of the study was to

evaluate the frequency of antibody development that can interfere with the therapy and none were detected.

Eloctate is a long-acting he-

mophilia treatment that was given to patients as twice-weekly preventive injections. Hemophilia drugs generally need to be infused every two or three days to prevent bleeding episodes.

Biogen and Swedish Orphan Biovitrum have also developed another hemophilia drug, Alprolix, that was approved by the US Food and Drug Administration last month for treating hemophilia B. Hemophilia B is caused by the absence of the factor IX protein.

Reuters

Brussels BELGIAN BIOTECH group Galapagos NV said it has successfully concluded the phase 2a study of a skin disease drug it is developing with Britain's GlaxoSmithKline PLC. Galapagos tested drug GSK2586184 on 66 patients with chronic psoriasis and observed a 75 per cent improvement in significantly more patients than in the placebo

group. GSK, which owns the drug's commercial rights, will decide whether to proceed with clinical trials, Galapagos said in a statement.

Galapagos said it could receive a milestone payment of up to 34 million euros ($46.94 million) as well as doubledigit royalties as the program proceeds towards commercialisation.

Reuters

RESEARCH UPDATES

Scientists find protein that lets egg and sperm hook up Researchers have identified a protein on the egg cell’s surface that interacts with another protein on the surface of a sperm cell, allowing the two cells to join Washington RESEARCHERS SAID they have identified a protein on the egg cell’s surface that interacts with another protein on the surface of a sperm cell, allowing the two cells to join.

This protein, dubbed Juno in honour of the ancient Roman goddess of fertility and marriage, and its counterpart in sperm, named Izumo after a Japanese marriage shrine, are essential for reproduction in mammals including people, they said. This new understanding of

the role of these two proteins could help improve the treatment of infertility and guide the development of new contraceptives, the researchers said. “By identifying this interaction between Juno and Izumo, we now know the identity of the receptor proteins found on the surface of our father’s sperm and our mother’s egg that must interact at the moment at which we were conceived,” said Gavin Wright of the Welcome Trust Sanger Institute in Britain, one of the researchers in the study published in the journal Nature.

The researchers are now screening infertile women to try to determine whether problems with the Juno receptor are to blame. “It is remarkable that about 20 per cent of infertility cases have an unexplained cause,” said Enrica Bianchi of the Sanger Institute, another of the researchers.

“We are now asking whether Juno is involved in these cases of unexplained infertility,” Bianchi added. Wright said that if defects in the Juno receptor are in fact implicated in human infertility, a simple, non-invasive

genetic screening test could be developed to identify affected women.

Japanese researchers identified the sperm cell’s Izumo protein in 2005, but the identity of its counterpart on the egg cell had remained elusive. The Sanger Institute researchers made an artificial version of Izumo to try to find an answer, and found that it interacted with Juno to initiate fertilisation.

They then developed mice that lacked Juno. The females of these mice were infertile because their egg cells did not

fuse with sperm. The Japanese researchers earlier had shown that male mice lacking the Izumo sperm protein were also infertile.

In the new study, the researchers detected a quick loss of the Juno protein from the egg's surface after fertilisation.

They said this may account for how a fertilised egg blocks out additional sperm cells, preventing formation of embryos with more than one sperm cell that would not be viable.

Reuters

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RESEARCH

Intercept’s liver disease drug proves highly effective in study Nearly half the patients suffering from primary biliary cirrhosis who received the drug, obeticholic acid, achieved the primary goals of the study A DRUG being developed by Intercept Pharmaceuticals led to significant improvement in signs of a rare liver disease that primarily affects middle-aged women, likely reducing the risk of need for liver transplant and of death, according to results of a late-stage clinical trial.

Nearly half the patients suffering from primary biliary cirrhosis who received the drug, obeticholic acid, achieved the primary goals of the study, compared with 10 per cent for those who received a placebo, researchers said. The composite main goal of the study was to achieve at least a 15 per cent reduction in levels of alkaline phosphatase, a biomarker for severity of the liver disease, serum alkaline phosphatase activity of less than 1.67 times the upper limit of normal and bilirubin within normal limits.

“Reduction in alkaline phosphatase is really the best prognostic factor for survival,” Dr Frederik Nevens, the study’s

lead investigator and chairman of the department of hepatology at the University of Leuven, in Belgium, said. He called results “highly, highly significant.”

Results of the 217-patient phase III study, called Poise, were presented at the annual meeting of the European Association for the Study of the Liver (EASL) in London. Primary biliary cirrhosis (PBC) is caused by autoimmune destruction of the ducts that transport bile acids out of the liver, resulting in toxic buildup of bile acids. The dis-

ease causes progressive liver damage and often leads to need for a liver transplant or to death.

Obeticholic acid, a first-in-class drug, is being studied for those who have an inadequate response to, or cannot tolerate, standard treatment with an older generic medicine called ursodeoxycholic acid. Intercept said it plans to apply for approval later this year in the US and Europe for the medicine, which has received orphan drug designation. In the US orphan drug status, given to drugs that

treat rare diseases, comes with seven years of marketing exclusivity if approved.

Patients in the year-long study had a moderate form of the disease, and most on average had been taking the older medicine for about 10 years.

They received either 5 milligrams or 10 mg of obeticholic acid or a placebo. Those in the 5 mg group who had not had an adequate response after six months were increased up to 10 mg for the final six months.

Forty-six percent in the 5 mg group and those who switched to the higher dose and 47 per cent in the original 10 mg group achieved the primary goal of the study, researchers said. Liver tests on those who achieved the primary goal fell to levels that correlate to improvement in the outcome of these patients, said Nevens. In contrast, "there was a tendency of worsening of liver disease in the placebo group," he said.

Reuters

a potential US market of nearly three million patients that will eventually be worth $1 billion in annual sales for these types of drugs. Merck's pollen treatment received regulatory approval in Canada in February and has been available in Europe since 2006 under the name Grazax.

THE US Food and Drug Administration approved GlaxoSmithKline’s Tanzeum injection for treating adults with type II diabetes, in combination with diet and exercise. Tanzeum will carry a warning on its label that tumors of the thyroid gland were observed in rodent studies with some drugs belonging to the same class.

However, it is unknown whether Tanzeum causes thyroid C-cell tumours, the FDA said on its website. The regulator also asked for post-marketing studies to test the drug's dosing, efficacy and safety in children, and to check for heart-related risks.

It also asked the company to identify any increase in medullary thyroid cancer cases related to Tanzeum.

The once-weekly drug, generically known as albiglutide, was approved last month in Europe, where it will be marketed as Eperzan.

Analysts expect the drug to hit $430 million in sales by 2018, according to Thomson Reuters data. Tanzeum belongs to the same class of injectable GLP-1 drugs as Victoza from Novo Nordisk and Byetta and Bydureon from AstraZeneca.

Type 2 diabetes affects about 24 million people and accounts for more than 90 per cent of diabetes cases diagnosed in the US, the FDA said.

Reuters

Reuters

Merck’s grass pollen allergy drug wins US approval MERCK & CO said the US Food and Drug Administration approved its grass pollen allergy drug Grastek, becoming the second such immunotherapy treatment to be given the go-ahead in recent weeks. The company, which developed the tablet with Denmark's ALK Abello, said it expects to launch the drug, approved for patients age 5 to 65,

38 EXPRESS PHARMA May 1-15, 2014

in the US by late April.

Immunotherapies work by boosting the body's immune system and making it less sensitive to allergens. Grastek contains extracts of the timothy grass allergen. The tablet is placed under the tongue and dissolves. An advisory committee to the FDA unanimously recommended approval of the drug

in December. Panelists also called for post-approval studies to test the product's safety in children, citing side effects such as lip swelling, throat irritation and oral blistering.

Earlier this month, the FDA approved Stallergenes' immunotherapy treatment for five types of grass pollen. The French company has said it sees

FDA approves GSK's Tanzeum to treat type II diabetes

RESEARCH

FDAhalts Halozyme’s pancreatic cancer study

Scientists growviable vaginas from girls’own cells Follow-up tests show the new vaginas are indistinguishable from the women’s own tissue FOUR YOUNG women born with abnormal or missing vaginas were implanted with labgrown versions made from their own cells, the latest success in creating replacement organs that have so far included tracheas, bladders and urethras. Follow-up tests show the new vaginas are indistinguishable from the women’s own tissue and have grown in size as the young women, who got the implants as teens, matured.

All four women are now sexually active and report normal vaginal function. Two of the four, who were born with a working uterus but no vagina, now menstruate normally. It is not yet clear whether these women can bear children, but because they are menstruating, it suggests their ovaries are working, so it may be possible, said Dr Anthony Atala, Director of Wake Forest Baptist Medical Center’s Institute for Regenerative Medicine in North Carolina. The feat, which Atala and colleagues in Mexico describe in the journal the Lancet, is the latest demonstration from the growing field of regenerative medicine, a discipline in which

The researchers started off by collecting a small amount of cells from genital tissue and grew two types of cells in the lab: muscle cells and epithelial cells, a type of cell that lines body cavities doctors take advantage of the body's power to regrow and replace cells. In prior studies, Atala's team has used the approach to make replacement bladders and urine tubes or urethras in young boys. Atala said the pilot study is the first to show that vaginal organs custom-built in the lab using patients' own cells can be successfully used in humans, offering a new option for women who need reconstructive surgeries.

All four of the women in the study were born with MayerRokitansky-Küster-Hauser (MRKH) syndrome, a rare genetic condition in which the vagina and uterus are underdeveloped or absent. Conventional

treatment generally involves the use of grafts made from intestinal tissue or from skin, but both tissues have drawbacks, says Atala, a paediatric urologic surgeon at Wake Forest.

Intestinal tissue produces an excess of mucus, which can cause problems with odor. Conventional skin, meanwhile, can collapse. Atala said women with this condition usually seek treatment as teenagers. "They can't menstruate, especially when they have a severe defect where they don't have an opening," he said. This can cause abdominal pain as menstrual blood collects in the abdomen.

"It has nowhere else to go," he added. Girls in the study were

aged 13 and 18 at the time of the surgeries, which were performed between June 2005 and October 2008. The researchers started off by collecting a small amount of cells from genital tissue and grew two types of cells in the lab: muscle cells and epithelial cells, a type of cell that lines body cavities. About four weeks later, the team started applying layers of the cells onto a scaffold made of collagen, a material that can be absorbed by the body. They then shaped the organ to fit each patient's anatomy, and placed it in an incubator.

A week later, the team created a cavity in the body and surgically attached the vaginal implants to existing reproductive organs. Once implanted, nerves and blood vessels formed to feed the new organ, and new cells eventually replaced the scaffolding as it was absorbed by the body.

"By the six-month time point, you couldn't tell the difference between engineered organ and the normal organ," Atala said.

HALOZYME THERAPEUTICS said the US Food and Drug Administration ordered a halt on a study of its drug delivery system in pancreatic cancer patients, barely a week after the company voluntarily stopped the trial.

Halozyme recently said that it had temporarily stopped the trial after the recommendation of an independent safety board, which was assessing a possible difference in the rate of blood clots found in patients receiving Halozyme's treatment and those receiving approved cancer treatments. The company said that it was gathering information related to the issue and would provide it to the safety monitoring committee and the FDA. The midstage study was testing a more potent form of the company's existing technology to deliver chemotherapy drugs intravenously and to prolong the effectiveness of its synthetic enzyme, Hylenex, in the blood stream.

Reuters

Reuters

US FDAapproves Cyramza for stomach cancer THE US Food and Drug Administration has approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. Ac-

cording to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year.

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumours. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread

(metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

“Patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has

demonstrated an ability to extend patients’ lives and slow tumour growth.”

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. The

trial was designed to measure the length of time participants lived before death (overall survival).

Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo.

EP News Bureau-Mumbai

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RESEARCH

Scientists create stem cells from adults The new study was funded by a foundation and the South Korean government SCIENTISTS HAVE moved a step closer to the goal of creating stem cells perfectly matched to a patient’s DNA in order to treat diseases, creating patient-specific cell lines out of the skin cells of two adult men.

The advance, described online in the journal Cell Stem Cell, is the first time researchers have achieved ‘therapeutic cloning’ of adults. Technically called somatic-cell nuclear transfer, therapeutic cloning means producing embryonic cells genetically identical to a donor, usually for the purpose of using those cells to treat disease.

But nuclear transfer is also the first step in reproductive cloning, or producing a genetic duplicate of someone - a technique that has sparked controversy since the 1997 announcement that it was used to create Dolly, the clone of a ewe. In 2005, the United Nations called on countries to ban it, and the US prohibits the use of federal funds for either reproductive or therapeutic cloning.

The new study was funded by a foundation and the South Korean government.

If confirmed by other labs, it could prove significant because many illnesses that might one day be treated with stem cells, such as heart failure and vision loss, primarily affect adults.

40 EXPRESS PHARMA May 1-15, 2014

Patient-specific stem cells would have to be created from older cells, not infant or foetal ones.

That now looks possible, though far from easy: Out of 39 tries, the scientists created stem cells only once for each donor.

Outside experts had different views of the study, which was led

by Young Gie Chung of the Research Institute for Stem Cell Research at CHA Health Systems in Los Angeles.

Stem cell biologist George Daley of the Harvard Stem Cell Institute called it ‘an incremental advance’ and ‘not earth-shattering.’

Reproductive biologist Shoukhrat Mitalipov of Oregon Health and Science University,

who developed the technique the CHA team adapted, was more positive. “The advance here is showing that (nuclear transfer) looks like it will work with people of all ages,” he said in an interview.

A year ago, Mitalipov led the team that used nuclear transfer of foetal and infant DNA to produce stem cells, the first time that had been accomplished in humans of any age.

In therapeutic cloning, scientists use a zap of electricity to fuse a grown cell, usually a skin cell, with an ovum whose own DNA has been removed. The egg divides and multiplies, and within five or six days it develops into an embryo shaped like a hol-

low sphere.

The interior cells are ‘pluripotent’ stem cells, which have the potential to develop into any kind of human cell.

If the embryo were implanted in a uterus, it could develop into a clone of the DNA donor, which is how Dolly was created. “Without regulations in place, such embryos could also be used for human reproductive cloning, although this would be unsafe and grossly unethical,” said Dr Robert Lanza, Chief Scientist of Massachusetts-based biotech Advanced Cell Technology and a co-author of the new study.

The goal is to grow these embryonic stem cells in lab dishes and coax them to turn into specialised cells for therapeutic use against an illness the DNA donor has, such as Parkinson’s disease, heart disease, multiple sclerosis or type-I diabetes. Because the cells are genetically identical to the donor's, they would not be rejected by the immune system.

Despite more than 15 years of trying, scientists’ single success at producing human stem cells through this cloning technique came a year ago. Mitalipov’s team at Oregon had fused foetal and infant cells with donated eggs whose DNA had been removed and got them to develop into about 150-cell embryos.

One key to Mitalipov’s success was letting the engineered eggs rest for 30 minutes before zapping them to start dividing.

Chung and his colleagues waited two hours before triggering the egg to start dividing, which Lanza believes was a key to their success: “It gives you time for the massive amount of genetic reprogramming required” to turn back the calendar on adult DNA so that it can direct the development of an embryo, he said in an interview.

It worked: They generated two healthy embryos, one from each adult donor, aged 35 and 75.

If each stem-cell line has to be created from scratch for each patient, the low success and expected high costs means that “only a few wealthy old men could do it,” said Lanza. A big barrier to producing patientspecific stem-cell lines for tens of millions of people this way is that few women want to donate eggs, a sometimes painful process.

But it may not be necessary to make a unique cell line for each patient. Many people have genetically similar immune systems, Lanza said, so just “100 human embryonic stem cell lines would generate a complete match for over half the (US) population,” he said.

Reuters

PHARMA ALLY VENDOR NEWS

Quintiles bags recognition in phase II/III research Preferred provider among small, mid-size and large biopharmaceutical customers, named as the industry leader FOR THE second year in a row, Quintiles has been named the industry leader that best differentiates itself on service quality for phase II/III research in Industry Standard Research’s (ISR) 2014 CRO Quality Benchmarking phase II/III Service Providers Report. According to the 148 pharmaceutical and biotechnology decision makers surveyed by ISR in this year’s report, Quintiles is the preferred provider for phase II/III research among small, mid-size and large biopharmaceutical companies.

“At Quintiles, we are focused on leading our customers through an increasingly complex and ever-changing drug development landscape,” said Paula Brown

Quintiles outperformed all other large CROs across all customer loyalty-related measures, which are defined by overall satisfaction, willingness to recommend, and likelihood to use Quintiles again Stafford, President of Clinical Development, Quintiles. “We are delighted once again to be recognised as the industry leader in phase II/III research.

This distinction is a result of the work of our tremendous teams around the world and underscores our unique ability

to connect insights, expertise and capabilities across our organisation to improve the probability of success for our customers.”

In the survey, Quintiles outperformed all other large CROs across all customer loyaltyrelated measures, which are

defined by overall satisfaction, willingness to recommend, and likelihood to use Quintiles again.

Quintiles also rated higher than all large CROs in a number of selection criteria, including: Breadth of services; Therapeutic expertise; Commercial market, local market and regulatory knowledge; Data quality; Technology for real-time data access; Speed of site start-up; Patient recruitment strategy.

Survey respondents were decision-makers with large, mid-size and small biopharma companies who were involved in outsourced clinical study activities and phase II/III clinical trials within the past 18 months.

with GLP and cGMP requirements.”

He further said, “The seminar was an excellent platform to share Intertek’s valuable knowledge and experience as a global leader in testing services. This will allow companies to gather the information and perspective which they need to make a difference in their business.”

THE REGULATORY Affairs Professionals Society (RAPS) has established a new chapter in Taiwan, its first in Asia. The RAPS Taiwan Chapter originated as an affiliate. In making the move to become an official chapter, it will be able to offer additional resources and opportunities to the regulatory community in Taiwan.

“Regulatory professionals from Taiwan can look forward to local training and networking activities while continuing to access RAPS resources for their professional development and career progression,” said Sherry Keramidas, Executive Director, RAPS. The chapter is the latest i step in expanding RAPS’ presence in Asia. Last year, RAPS opened two new offices in Asia, one in Singapore, serving the entire AsiaPacific region, and another in Shanghai, serving the regulatory community in China.

It also began working with the Singapore government to develop and implement a new medical device regulatory affairs training programme there.

Taiwan Chapter membership is open to all who reside in Taiwan and are involved in regulatory affairs, quality or other functions related to healthcare product regulation. The chapter has a web page in Mandarin Chinese as well as a facebook page.

EP News Bureau - Mumbai

EP News Bureau - Mumbai

EP News Bureau - Mumbai

Intertekorganises ELseminar in Mumbai Seminar focuses on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies AN INITIATIVE to expedite thorough extractable/leachables evaluations for patient and product safety, Intertek, a leading quality solutions provider to industries worldwide recently organised and presented a seminar 'Manage your Extractable & Leachables Risk' in Mumbai.

The one-day seminar focused on providing detailed information and practical guidance on the issues associ-

ated with extractables and leachables (E/L) studies. An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals.

During his inaugural address at the seminar, Dr Armin Hauk, Senior Consul-

tant, Head of GLP organisation, GMP responsible person acc. Swiss Pharma law said, “Studies of extractable and leachable components within packaging and closures are required to meet the safety requirements for marketed medicines. Intertek undertakes extractables / leachables studies for a wide range of drug products in a variety of packaging types, conducted in accordance

RAPS launches Taiwan chapter, first one in Asia

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PHARMA ALLY

SCHOTTIndia acquitted of anti-competitive conduct Competition Appellate Tribunal rules in favour of SCHOTT India against the Competition Commission of India and Kapoor Glass THE COMPETITION Appellate Tribunal (CAT) has cleared SCHOTT India from all penalties and charges made under an Order of the Competition Commission of India (CCI) that had been initiated by Kapoor Glass. SCHOTT India was falsely accused of abusing its strong position in the glass tubes market and granting discriminatory pricing and other favourable terms to its affiliated entity, SCHOTT KAISHA as compared to other converters in the market.

In July 2010, Kapoor Glass (Kapoor), a converter and for-

mer manufacturer of glass tubes, filed information with the CCI in which it complained of alleged anti-competitive practices of SCHOTT India which affected the competition in the market for Neutral USP Type I Borosilicate Glass Tubes as well as in the downstream market for the Containers. After the CCI initially decided against SCHOTT India, the case was referred to CAT. In the CAT judgement, it was pointed out that SCHOTT KAISHA was a vertically integrated subsidiary of the

SCHOTT Group and that the quantity purchased by SCHOTT KAISHA by far exceeded the purchases of any other converter company.

Better terms for SCHOTT KAISHA were therefore justified. The tribunal also clarified that there was no negative impact on the downstream market for glass tube containers and that the ultimate consumer did not suffer any damage as alleged in Kapoor’s appeal.

The judges refuted CCI’s argument that favourable prices of SCHOTT India for

SCHOTT KAISHA had resulted in reduced profit margins for the other converters and deprived them of their chance to grow. In addition, they rejected the allegations by Kapoor that SCHOTT’s Standard Trademark License Agreement was unfair and restrictive to the detriment of other converters.

Finally, CAT clearly denied any obligation of SCHOTT India to make deliveries to Kapoor, which had been stopped in 2008. The special Tribunal established that Kapoor had once forged

SCHOTT India’s labels and thus committed a clear and unabashed breach of trademarks. It condemned such act of forging as the relevant products had a direct relation with human lives and serious consequences could ensue on account of usage of inferior quality of glass tubes. The Tribunal stated that it could not imagine the seriousness of the consequences if Kapoor could pass off inferior quality glass with the help of such faked labels.

EP News Bureau - Mumbai

Programme Committee members of COMSOL Conference 2014 call for research papers Selected papers, posters, and presentations will be featured at the 10th annual COMSOL Conference to be held in Boston from October 8-10, 2014 THE PROGRAMME Committee members of COMSOL Conference 2014, a premier event for multiphysics modeling and simulation are inviting engineers and researchers to submit abstracts to this year’s event. Selected papers, posters, and presentations will be featured at the 10th annual COMSOL Conference. This year, the conference will be held in Boston from October 8-10, 2014.

Presenting a poster, paper, or both at the COMSOL Conference is a great opportunity for multiphysics users to achieve widespread recognition within a skilled community of engineers and researchers.

42 EXPRESS PHARMA May 1-15, 2014

“COMSOL users who present at the conference will have their work recognised and shared with more than 165,000 people.

Engineers and scientists will have a unique chance to present in front of colleagues who are working through similar problems,” says Jinlan Huang, Program Chair for the Boston conference. “Attendees can really benefit from sharing new simulation techniques and innovative design strategies.”

The highlights of the conference will be application-specific mini-course sessions taught by COMSOL specialists covering a wide array of disciplines; Keynote talks from industry

The highlights will be applicationspecific mini-course sessions taught by COMSOL specialists

leaders and prominent researchers; An exhibition showcasing products offered by COMSOL Partners; The exciting introduction of the newest version of COMSOL Multiphysics; The chance to interact with peers and explore the simulation work of engineers.

Some of the suggested presentation topics include: AC/DC electromagnetics; acoustics and vibrations; batteries, fuel cells, and electrochemical processes; bioscience and bioengineering; chemical reaction engineering; computational fluid dynamics; electromagnetic heating; geophysics and geomechanics; heat transfer

and phase change; MEMS and Nanotechnology; microfluidics; Multiphysics; optics, photonics, and semiconductors; optimisation and inverse methods; particle tracing; piezoelectric devices; plasma physics; RF and microwave engineering; simulation methods and teaching; structural mechanics and thermal stresses and transport phenomena.

Papers and posters presented at the conference will be published on the COMSOL website where they reach a worldwide audience of engineers.

EP News Bureau – Mumbai

PHARMA ALLY PRODUCTS

Bosch launches AIM 8 series of fully automated inspection machines AT INTERPACK 2014, Bosch Packaging Technology, a leading supplier of process and packaging technology, will reveal a vial inspection machine of the new AIM 8 series. This machine is the first of the new generation of fully automated inspection machines by the Inspection Technology sector of Bosch Packaging Technology, which was founded in the beginning of 2012 following the acquisition of Eisai Machinery.

In the future, the series will be completed by additional models to cover further parenteral liquid container types, such as syringes, cartridges and ampoules. The AIM 8 series is characterised by a modular design, which allows an easy adaptation of the machines to customer-specific requirements.

The basic module of the AIM 8 is equipped with a CMOS camera-based particle inspection system and a table for up to five inspection stations. Each station can in turn be equipped with a wide range of different inspection units. Most of these units combine two inspection types, leading to significant space-savings on the tables. Depending on their requirements, customers can expand this main module by connecting it to a sub-module containing an additional inspection table, as well as to a prespin table to reduce bubbles in the liquid or homogenise suspensions.

In contrast to previous series, a camera system is integrated into the main module as standard particle inspection unit.

The new AIM 8 series is designed to inspect up to 600 containers per minute for product and cosmetic container defects, such as particles inside liquid pharmaceuticals or scratches and spots on the container. The machine model that Bosch will

The ETIM inspection machine, which is presented for the first time outside of Japan, identifies tablet defects such as colouration, breakage and foreign particles at output rates of up to 300 000 per hour

The AIM 8 inspection machine for vials is the first of the new, modular generation of fully automated inspection machines by the Inspection Technology sector of Bosch Packaging Technology

The basic module of the AIM 8 is equipped with a CMOS camerabased particle inspection system and a table for up to five inspection stations. Each station can in turn be equipped with a wide range of different inspection units be presented at Interpack 2014 handles 450 vials per minute.

Depending on product requirements and customer preferences, the proven light

transmission-based SD (Static Division) system for the inspection of moving objects and fill levels is available as an option.

ETIM tablet inspection: a

The AIM 8 inspection machine for vials, presented at Interpack 2014, inspects up to 450 vials per minute for product and cosmetic container defects, such as particles inside liquid pharmaceuticals or scratches and spots on the container

novelty outside of Japan Bosch Packaging Technology will present another novelty at Interpack 2014. The fully automated inspection machine ETIM for tablets was initially developed exclusively for the Japanese market and now makes its first appearance outside of Japan.

The ETIM is designed to flexibly handle different types and shapes of tablets at output rates of up to 300 000 per hour.

The inspection machine identifies tablet defects such as coloration, breakage, and foreign particles as small as 50 micrometers in size. The highly accurate camera-based imaging system ensures a 360 de-

gree inspection of each tablet.

It simultaneously inspects the tablet surface and its peripheral edge with a single camera, presenting the information as five images on the operating screens. The opposite side is inspected with the help of a precise tablet flip-over during transport. This leads to allaround inspection by avoiding blind spots or dead angles.

Contact details Robert Bosch GmbH Postfach 10 60 50 D-70049 Stuttgart E-mail: christin.poenisch @bosch.com Phone +49 711 811-58502 Fax +49 711 811-58509

EXPRESS PHARMA

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May 1-15, 2014

PHARMA ALLY

Eppendorf launches electronic microinjectors,FemtoJet 4i and FemtoJet 4x EPPENDORF HAS introduced its latest electronic microinjectors, the FemtoJet 4i and FemtoJet 4x. The new systems are suited for all research laboratories wishing to inject small to intermediate volumes, from femtoliters to microliters, precisely and reproducibly. Reportedly, with simple operation and a wide range of functionalities, the FemtoJet 4i and FemtoJet 4x make otherwise intensive processes convenient and easy to undertake, with limited amount of input and training.

With a built-in compressor, the FemtoJet 4i is ideal for injecting small volumes of up to ~100pL into adherent and suspension cells. For users wishing to inject larger volumes or longer series at higher pressures, the FemtoJet 4x employs an external pressure supply to deliver the precise

workflows.

A company press release claims that the new FemtoJets have exceptionally low noise emissions and a small footprint and also benefit from Eppendorf ’s premium levels of design, making them ideal for use in busy laboratories. When researchers wish to carry out gentle microinjection procedures, including pronuclear injection and serial injections, the new FemtoJet 4i and FemtoJet 4x provide an ideal solution.

and continuous pressure required. The systems can also be easily coupled with the

existing Eppendorf InjectMan 4 and TransferMan 4r, for rapid and efficient microinjec-

tions into delicate cells. This not only simplifies researchers’ daily tasks, but speeds up

Contact details M Anthoni Jai Kumar Eppendorf India, Chennai Tel: +91 44 421 11 314, Fax: +91 44 421 87 405 email: anthoni.jk@eppendorf.co.in website: www.eppendorf.co.in

Contact details Vinita Singh Cole-Parmer India

Tel: +91-22-67162222 / 2253 vinita.singh@coleparmer.in www.coleparmer.in

NewDigi-Sense line of precision measurement instruments byCole-Parmer COLE-PARMER has introduced a comprehensive new line of test and measurement products to fill the technician’s toolbelt. The Digi-Sense brand offers new technologies that deliver accurate readings while withstanding rigorous use. From environmental testing meters to performance monitoring equipment, many

44 EXPRESS PHARMA May 1-15, 2014

of the items are precalibrated to save time, cost, and effort.

With products individually calibrated before shipment, the measurements provide an unrivaled level of confidence.

The Digi-Sense brand currently includes 25 models of thermometers, infrared devices, humidity meters, anemometers, light meters,

and manometers. Additional products that fill other measurement needs will soon be available. Digi-Sense also features a comprehensive line of temperature probes with customisation available for unique applications.

The new suite of products is designed to meet the ongoing needs of technicians.

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PHARMA LIFE APPOINTMENTS

N Rajaram joins Sanofi India as Country Head and General Manager - Pharmaceutical Operations Rajaram will be responsible for driving the company’s ambitious growth plans in the pharma and consumer healthcare segments SANOFI INDIA has appointed N Rajaram as Country Head and General Manager - Pharmaceutical Operations, India with effect from April 2014.

He reports to Dr Shailesh Ayyangar, Vice President, South Asia, Sanofi and Managing Director, Sanofi.

Rajaram joins Sanofi India with diverse experience of over two decades in the FMCG industry with Hindustan Unilever, and in the telecom industry with Airtel. He will be

responsible for driving the company’s ambitious growth plans in pharma and consumer healthcare segments.

Speaking on the appointment and new organisation structure, Dr Shailesh Ayyangar, Vice President - South Asia, Sanofi and Managing Director - Sanofi India said, “The healthcare industry in India is on the threshold of a major transformation, as we address the problem of increasing access to quality healthcare

and medicines to our large population. Rajaram’s induction reinforces Sanofi’s commitment to deliver innovative solutions to access issues. His vast experience and consumer insights will help drive Sanofi’s growth strategy in India.”

Commenting on his new role, Rajaram said, “This is an exciting opportunity for me. The pharma industry is witnessing a rapid change in different aspects such as innovative healthcare delivery

and patient care. The prospect of playing a responsible role in making a difference in the lives of people is very exciting and fulfilling.”

Rajaram holds a Bachelor’s degree in Electrical and Electronic Engineering from the Birla Institute of Technology & Science, Pilani, India; and an MBA in International Business from the Indian Institute of Foreign Trade, New Delhi.

EP News Bureau-Mumbai

Anuradha Gupta appointed Deputy CEO of Gavi Alliance She will join on June 2, 2014 and will be based at the Alliance’s headquarters in Geneva THE GAVI Alliance has appointed Anuradha Gupta as its new Deputy Chief Executive Officer. With more than 30 years of experience in public health and public policy, Gupta brings with her a wealth of management and leadership expertise, a proven track record of success and a passion for making a profound social impact.

Gupta is currently responsible for managing the world’s largest public health programme, with an annual budget equivalent to $3.5 billion in her role as Additional Secretary, Ministry of Health and Family Welfare and Mission Director of the National Health Mission, Government of India. During this time she has played an integral role in India’s hugely successful polio eradication programme, taking strategic decisions that helped secure a polio-free India – a feat once considered

60 EXPRESS PHARMA May 1-15, 2014

Gupta holds an MBA from Wollongong University in Australia and has read Public Policy at Maxwell School in the US

impossible by many observers.

Gupta will join the GAVI Executive Office on June 2, 2014 and will be based at the Alliance’s headquarters in Geneva, Switzerland.

“We welcome Gupta, who joins us at a critical point in the GAVI Alliance mission,” said Dr Seth Berkley, Chief Executive Officer, GAVI Alliance.

“I am delighted to be joining the Alliance at this exciting time,” said Gupta. “I see GAVI as a strong organisation powered by people with a determined spirit who are spurred

by an insatiable faith in their mission to save lives. I very much look forward to becoming a part of that mission.”

In addition to her position within the Government of India, Gupta was also co-chair of the Partnership for Maternal Neonatal & Child Health (PMNCH), and in 2012, at the invitation of then US Secretary of State, Hilary Clinton, was a member of the steering committee for the watershed ‘Child Survival: Call to Action’.

Gupta holds an MBA from Wollongong University in Australia and has read Public Policy at Maxwell School in the US. She has also received executive education at Stanford Business School and John F Kennedy School, Harvard University. Gupta will succeed current GAVI Alliance Deputy Chief Executive Officer, Helen Evans, who is retiring.

EP News Bureau-Mumbai

REPORT

Deloitte report projects 12.4 % average salary increment in pharma sector The objective of the report is to understand the key compensation and benefits trends across sectors in the Indian market DELOITTE HAS released India Annual Compensation Trends Report FY 2014. The Deloitte Compensation Trends Survey is an annual study conducted by Human Capital Consulting. The objective of the study is to understand the key compensation and benefits trends across sectors in the Indian market.

This is the fourth edition of the annual survey. Online survey was launched for the first time in this edition, and more than 60 per cent of the companies submitted data through the online portal. Companies from more than 18 sectors have participated this year and a detailed consolidated report has been prepared for 13 sectors. The data was collected from January to March 2014.

Scope of the survey ◗ Increment

and variable pay projections for FY 2014 and comparison with FY 2013 ◗ Key human resource challenges faced by organisations ◗ Managing and rewarding critical talent ◗ Attrition rates, key reasons for attrition and mitigation measures ◗ Key benefits given across sectors

ANNUAL INCREMENTS FY 2014 (PROJECTIONS)

Level-wise Increment Percentiles In %

10P

25P

50P

75P

90P

Avg

Clerical

8.2

9.7

11.6

13.2

14.6

11.7

JM

8.4

10.4

11.9

13.8

15.4

11.8

MM

8.5

10.7

12.5

14.4

16.1

12.4

SM

8.7

10.7

12.8

14.9

16.8

12.6

TM

9.3

11.5

13.4

15.5

17.4

13.2

Comparison of Level-wise Average Increments Across Sectors 12.6 11.3

10.5

10.8

11.8

10.8

11.1

10.7

10.3 11.9

10.2

11.7

12.9

10.4 11.5

10.6

10.0

10.2

9.6

9.4

10.0

9.5

Overall Industry

Auto

9.6

10.7

11.7

10.6

10.7

9.3

10.7

10.4

10.5

BFSI

Chem

CB

Eng

9.9

9.8 9.2

11.4

12.4

11.2

11.9

10.7

Energy Hi-Tech

10.5

10.4

9.9

12.6

9.5

12.4

9.3

TM

10.3

10.8

11.3

12.6

In %

13.2

13.3

9.7

9.4

9.5

9.0

10.2

SM MM

9.4

9.2 11.8

9.3

8.7

9.6

11.4

9.2

8.9

9.2

11.7

8.6

ITeS

Infra

Log

Media

Pharma

Retail

8.9

JM CL

© 2014 Deloitte Touche Tohmatsu India Private Limited

KEY HR CHALLENGES AND MANAGING ATTRITION Top three Reasons for Attrition

Developing Potential Leaders

Better Career Prospects

Key Reasons for Attrition

Personal Reasons (Marriage, Health, Family, Relocation etc.)

Pursue Further Studies Top three Measures Taken to Curb Attrition

Measures Taken

M

an Car ag ee em r en t

HR Challenges

to Curb Attrition

Recognition Awards (Monetary/Non-Monetary) Retention Bonus Clearly defined Career Paths & Succession Plans

Interventions to Manage & Reward Critical Talent

Average Age of Employees

Top three Methods to Manage and Reward Critical Talent Higher Salaries Faster Growth Opportunities Skill Enhancement Training Programs

Clerical/

31

JM/

31

MM/

37

SM/

43

TM/

48

EXPRESS PHARMA

61

May 1-15, 2014

PHARMA LIFE AVERAGE ANNUAL INCREMENTS FY 2014 (PROJECTIONS) VIS-À-VIS FY 2013 (ACTUALS)

12.4 % THE AVERAGE SALARY INCREMENT ACROSS THE SECTOR

In %

10P

25P

50P

75P

90P

Average

FY 2013

8.2

10.6

12.7

14.9

17.6

12.6

FY 2014

8.1

10.2

12.4

14.6

17.2

12.4

Average Increments Across Levels

In %

14.0 13.4

13.5 12.9

13.0

13.2

12.6

12.5

12.2

12.6

12.0

12.8 % VOLUNTARY ATTRITION RATE IN FY 2013

12.4

12.0 11.5

11.7

11.8

11.0 10.5 Clerical

JM

MM

FY 2014

SM

TM

FY 2013

© 2014 Deloitte Touche Tohmatsu India Private Limited

ANNUAL VARIABLE PAY FY 2014 (PROJECTIONS)

17 % HIGHER INCREMENT EXPECTED ACROSS THE SECTOR

Annual Variable Pay FY 2014 (Projections) Level-wise Variable Pay Percentiles In %

10P

25P

50P

75P

90P

Avg

Clerical

10.3

11.7

13.5

16.2

19.6

13.6

JM

12.4

14.3

16.2

19.9

23.4

16.4

MM

13.4

15.9

18.5

24.3

29.8

18.6

SM

16.8

20.2

23.2

28.8

34.1

23.4

TM

18.3

22.7

27.3

32.3

36.8

27.1

Comparison of Level-wise Average Variable Pay Across Sectors

29.5 24.2

36 % HIGHER VARIABLE PAY ACROSS THE SECTOR

27.6 25.6

25.3 26.5

22.4

18.9

21.7

21.6 17.4

20.2

18.6

17.9

In % 27.4

27.2 25.2

24.3

19.7

22.9

18.1

16.3

18.2

16.2

16.7

15.7

12.1

12.5

14.2

13.1

14.1

13.4

Overall Industry

Auto

BFSI

Chem

CB

Eng

23.7 20.9 17.3

18.7

26.9

23.2

18.6

23.6

23.2

20.1

20.2

17.3

16.7

25.8

21.3

27.1

26.8

23.4

23.2

SM

17.2

18.6

16.4

18.7

14.7

18.1

16.3

14.1

14.2

15.7

16.4

12.2

12.5

12.1

11.7

11.1

12.4

13.6

12.3

ITeS

Infra

Log

Media

Pharma

Retail

Energy Hi-Tech

TM

MM JM CL

© 2014 Deloitte Touche Tohmatsu India Private Limited

62 EXPRESS PHARMA May 1-15, 2014

PHARMA LIFE AVERAGE ANNUAL VARIABLE PAY FY 2014 (PROJECTIONS) VIS-À-VIS FY 2013 (ACTUALS) SECTORS COVERED In %

10P

25P

50P

75P

90P

Average

FY 2013

9.1

13.7

17.8

27.1

35.8

18.1

FY 2014

10.1

14.1

18.2

28.4

36.4

18.4

Average Variable Pay Across Levels

In %

30.0

27.1

25.0

The sectors covered include pharmaceuticals, life sciences and healthcare, auto and auto components, BFSI, chemical consumer business, engineering and manufacturing, logistics media and advertising, retail, energy and natural resources, hi-Tech, IT-enabled services infrastructure and real estate.

23.4 24.0

18.6

20.0

21.5

16.4 13.6

15.0

THE METHODOLOGY

15.9

14.7

10.0 11.0

5.0 0.0 Clerical

JM

MM

SM

FY 2014

TM

FY 2013

© 2014 Deloitte Touche Tohmatsu India Private Limited

KEY BENEFITS Car Policy – Car Value In % < 3 Lacs

Clerical -

Mobile Policy – Bill Reimburse per Annum JM -

MM -

SM -

TM

In %

Clerical

JM

MM

SM

-

< 5000

-

-

-

-

TM -

-

22.7

40.9

31.8

-

3 - 5 Lacs

-

36.4

31.8

18.2

-

5000 - 10000

5 - 8 Lacs

-

31.8

50.0

18.2

-

10000 - 15000

-

27.3

36.4

36.4

31.8

-

13.6

22.7

18.2

22.7

8 -12 Lacs

-

-

18.2

45.5

4.5

> 15000

> 12 Lacs

-

-

-

18.2

95.5

On Actuals

-

-

-

13.6

45.5

N/A

100.0

31.8

-

-

-

N/A

100.0

36.4

-

-

-

KEY FINDINGS

Medical Insurance – Premium Paid by Employer

Car Policy – Fuel per Month In %

Clerical

JM

MM

SM

TM

< 5000

-

27.3

22.7

13.6

-

5000 - 8000

-

27.3

45.5

27.3

-

8000 -12000

-

-

18.2

27.3

18.2

12000 - 15000

-

-

13.6

18.2

27.3

> 15000

-

-

-

13.6

31.8

On Actuals

-

-

-

-

22.7

N/A

100.0

45.5

-

-

-

13.6% (3)

Employee only Employee & spouse Employee, spouse and dependent children Employee, spouse, dependent children and dependent parents

18.2% (4)

31.8% (7) 36.4% (8)

Leave Encashment Car Policy – Driver Allowance Clerical

JM

MM

SM

TM

Provided by

-

-

36.4%

68.2%

90.9%

Average Amount per Month

-

-

8000-12000 8000-12000 10000-16000

The data received was collated and analysed to get detailed insights on sector wise practices, compensation and benefits trends.The responses received from all participants were validated and checked for accuracy and intended interpretation.A formal invitation e-mail and online questionnaire was sent to the Human Resources in the chosen organisations requesting for participation.

The sectors covered in the study were finalised along with the leading organisations from each sector.The parameters of the study were finalized and a structured questionnaire was designed as a primary data collection tool.

95.5%

companies allow leave encashment

31.8%

companies allow leave encashment during tenure

63.6%

companies allow leave encashment only after separation

© 2014 Deloitte Touche Tohmatsu India Private Limited

The average salary increment across this sector is projected at 12.4% in FY 2014, which is 0.2% points lower than the previous FY 2013 (12.6%).The average variable pay percent across this sector is projected at 18.4% in FY 2014, which is 0.3% points higher than the previous FY 2013 (18.1%).

Voluntary Attrition rate for this sector in FY 2013 on an average is 12.8%.

Organisations attribute better career prospects, personal reasons and pursuing further studies as the main reasons for attrition

EXPRESS PHARMA

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May 1-15, 2014

PHARMA LIFE NAUKRI JOB SPEAK INDEX

Hiring activity in pharma sector grows at 8 per cent in March’14: Naukri Job Speak Index Yearly comparison shows a four per cent increase in March 2014 over March 2013 if compared to the same month of the previous year NAUKRI JOB Speak Index for the month of March 2014 reflects growth for the pharmaceutical sector. A month-overmonth analysis reveals that index has grown by eight per cent in March 2014 over February 2014. Yearly comparison shows a four per cent increase

in March 2014 over March 2013 if compared to same month of previous year.

About Naukri.com Naukri.com, India’s No. 1 job site and the flagship brand of Info Edge introduced the concept of e-recruitment in India. Since its

inception in 1997, Naukri.com has seen continued growth while outperforming its competitors in every sphere. Info Edge was the first Internet Company to be listed in India. The site enjoys a traffic share consistently over 60 per cent as per the Comscore data. Naukri.com is a recruit-

ment platform that provides hiring-related services to corporates/recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products like Resume Database Access, listings and Response Management Tools.

With 230000 jobs live at

any point and over 33 million CV’s, Naukri.com serviced over 48000 corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

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REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.