Express Pharma (Vol.10, No.22) September 16-30, 2015

VOL. 10 NO. 22 PAGES 66

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Market ‘Our aim is to make sure that patient safety is achieved at the end of the day’

16-30 SEPTEMBER 2015,` 40

Sometimes I’m blunt.

But never pointless.

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CONTENTS MARKET Vol.10 No.22 SEPTEMBER 16-30, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

PHARMAMARKETOVERVIEW: THE EXPANDING ROLE OFINDIAAND INDIAN COMPANIES Maneesh Chandra, India Business Consulting Head- ZS Associates, elaborates on how the evolving global and domestic market dynamics are likely to result in significant opportunities and challenges for pharma companies operating in India | P24 P20: COVER STORY Pune: Pharma hub in the making

RESEARCH

P29: INSIGHT

‘OUR AIM IS TO MAKE SURE THAT PATIENT SAFETY IS ACHIEVED AT THE END OF THE DAY’

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INDIA IS FREE OF MATERNAL AND NEONATAL TETANUS: PM

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SUN PHARMA COMPLETES GSK’S OPIATES BIZ ACQUISITION

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INDIA TO INTRODUCE INJECTABLE POLIO VACCINE FROM NOVEMBER

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VALEANT PICKS UP ASTRAZENECA PSORIASIS DRUG AFTER AMGEN EXIT

PHARMA LIFE

Myth vs reality of stem cell-based products

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P33: RESEARCH UPDATE Roche haemophilia drug wins fast-track FDA designation

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‘THE GRANT AWARD PROVIDES AN IMPORTANT LEVEL OF VALIDATION TO OUR WORK’

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PFIZER’S QUITSMOKING DRUG NOT LINKED TO DEPRESSION OR HEART RISKS

P59: APPOINTMENTS

BIOCON ACADEMY OPENS ENROLLMENT FOR BIOSCIENCES PROGRAMME

Cipla appoints new management team

P60: AWARD IPA bags Best Association Award

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

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EDITOR’S NOTE

Playing for high stakes

A

ccording to the latest data from the India Brand Equity Foundation (IBEF), the Indian domestic pharma market ended FY15 with a growth of 12 per cent, touching ` 90,400 crores ($ 15 billion). Given that the IBEF's brief is to 'promote and create international awareness of the Made in India label', it is no surprise that the release makes a strong pitch for the sector's achievements. India accounts for 30.3 per cent (2,911) of 9619 Drug Master Files (DMFs) filed with the US, which is the highest outside of the US. Similarly, India has been accredited with approximately 1187 CEPs, more than 950TGA, and 584 sites approved by US FDA. Further progress along this path will depend on many variables. Will the sector get better support from the government? For example, 2015 is billed as the year of APIs, but we are yet to see the promised policy on API manufacture. Thus, it is up to industry to make the best use of the available resources.

And many proactive companies have been doing just that, by migrating to locations which offer the most viable ecosystem for success. Our cover story in the September 16-30, 2015 issue profiles Pune, the cultural capital of Maharashtra, once overshadowed by Mumbai — the commercial hub, but today a magnate for lifescience businesses in its own right. With world class research institutions like the National Institute of Virology (NIV), National AIDS Research Institute (NARI), National Centre for Cell Sciences (NCCS), Indian Institute of Science Education and Research, and National Chemical Laboratory (NCL), as well as others across sectors, Pune became a campus town.

The talent pool and research acumen attracted companies like Serum Institute of India, which grew into a vaccine behemoth from this city. The marriage of IT with biotechnology only added to the perfect storm. The success of Pune needs to be analysed and replicated across India so that India Pharma Inc can not only Make in India, but Innovate in India, for India. (Read story, Pune: Pharma hub in the making; pages 20-23) But, while the domestic market is important, it is too small to contain the global ambitions. And rightly so. Indian pharma majors have made some bold moves in the US market, clearly eyeing a larger share of the biggest pharma market in the world. Lupin's acquisition of US-based Gavis Pharma came after four consecutive quarters of

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Indian pharma majors have made some bold moves in the US market, clearly eyeing a larger share of the biggest pharma market in the world

muted performance in the US. Reliance Securities' analysis predicted that pressure will continue to build on the company's US base business in 2Q as competition mounts in the branded portfolio and key generic launches will continue to be delayed. Even while Lupin's acquisition of Gavis makes a lot of sense, it remains a high stakes gamble as the acquisition will force the former to take on debt and eat into its cash reserves of $200 million. With a payback period of seven-eight years, the next two-three years will be crucial for Lupin, as new launches in the US are expected to start only in FY17E. But if Lupin succeeds in executing its strategy, the Gavis acquisition will place Lupin among the top six generic companies in the US, with a combined pending ANDA pipeline of more than 160. A Motilal Oswal analysis paints a more positive outlook of Lupin's prospects, highlighting gains like the shoring up of its derma pipeline (with 20+ pending filings), as well as an entry into the lucrative control substance market.

Cipla too is making its play for the US market.

As a latecomer to the US market, the company is playing catch up and its acquisition of Invagen Pharma and Exelan Pharma for $550 million is being seen as measured compared to the $880 million Lupin paid for Gavis. One of the main gains of this M&A for Cipla is an over 350,000 sq ft manufacturing plant and a R&D laboratory from Invagen Pharma, a first for Cipla in the US. Exelan Pharma's major attraction seems to be the entry it offers into the hospital and government tender business, areas where Cipla is already very strong, thanks to its long-term association with the WHO tender business. Production costs are kept to a minimum, enabling better margins on the tender business as both plants are vertical integrated, with Invagen Pharma supplying API to Exelan Pharma.

But has Lupin paid too much for Gavis? That seems to be a valid debate, with a Prabhudas Lilladher analysis pointing out that with 30 pending ANDAs including five first-to-files (FTFs), Cipla’s payment of 2.4x sales and valuation of Invagen and Exelan is much cheaper when compared with Lupin’s acquisition of Gavis at 9.2x of sales. Only time will tell which gameplan will succeed better: the measured approach or the audacious bet.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Our aim is to make sure that patient safety is achieved at the end of the day’ Dr Vatsal Shah has been associated with SIRO Clinpharm since the last three years. He recently took charge as the Chief Operating Officer of the company. Shah, in an interaction with Usha Sharma, talks about the company’s ambitious plans and some of the challenging tasks which he has undertaken to maintain the company’s growth trajectory

What are your learning experience at SIRO Clinpharm?

The biggest learning has been the answer to a very intriguing question: Why do some of the world’s largest biopharma companies turn to SIRO for their drug development needs?

Over the years, SIRO has gained versatility and earned a rank amongst those very few CROs in India that could support end-to-end clinical studies with all services inclusive of clinical trial supplies management. How a culture of innovation has allowed SIRO to raise the bar rather than being cocooned in its comfort zone is a lesson in itself! SIRO has been the only CRO to have set up independent services outside clinical operations in medical writing, clinical data management, biostatistics and statistical programming, clinical trial supplies, data analytics and medical communication. It can boast of sizeable groups for each of these domains, including the largest medical writing group on this side of the world so much so that an equal contribution or more comes from SIRO’s non-Clinops business as it does from Clinops business per se. By virtue of these, SIRO can adapt with ease to FSP-FTEfull scope engagements as is evident from our long standing contracts with top global pharma clients and

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their local regional and Indian affiliates.

In recent times, even while the evolving regulatory situation in India pushed several wanting firms out of business, SIRO’s ‘never say die attitude’ has allowed it to run with its head held high, without any global funding or affiliate, that too with a respectable EBIDTA. Although, SIRO is the oldest name in clinical research industry in India, its young but experienced and enthusiastic professional team teaches you how to age like a veteran and still perform like young blood. SIRO has undergone tremendous change in the last several years, three years in particular, and I am glad to have been a part of it — then and now. In my tenure here, I have seen the industry at its best and its worst. Being part of such a dynamic industry has taught me how to make quick decisions, how to always be proactive in taking the right measures to ensure that we are abreast of competition, and, foremost, how to learn the importance of ensuring proper governance in every segment of the services we offer.

Tell us about your responsibilities as the Chief Operating Officer ?

The responsibilities pretty much remain the same, though the accountability towards several activities,

including the overall sales, delivery and finances has tremendously increased. This however, is an opportunity in itself since nowhere else would a platform like this be made available to maximise integration and crossutilisation, to optimise operational efficiencies and to maintain robust central governance. The metricsdriven culture and analytical dashboards, which have been the hallmark of SIRO and are much sought-after by clients, would now be integrated and implemented with ease across the board. We have been representing SIRO on various national and international forums, and the stakes only increase with a more consolidated and strongly integrated team as in SIRO.

In the next two years, SIRO will aspire to be the perfect strategic partner for any clinical research requirement

Recently, the Indian clinical research industry has gone through tough times. Tell us how difficult it is to remain in the business and survive.

The change in the regulatory framework is an evolving process across the globe and it is always aimed at improving the conduct of clinical trials.

So is the current regulatory scenario in India. However, often these changes pose challenges in actual execution of the projects and those CROs found wanting fell off the radar. SIRO, however, in its journey in the clinical research industry for nearly two decades, have had the opportunity of interacting

with the top pharma companies across the globe.

Such a level of exposure has taught us to provide the industry with just the right solutions, allowing us to remain afloat even when a number of other CROs have gone under. While continuing our focus on the ‘CRO core competency’ of clinical operations and strengthening our flourishing medical writing and data services business, we have consciously had a paradigm shift in business operations. There is a renewed and sustained focus on newer areas of growth like medical communication, data analytics, clinical trial supplies, transparency initiatives including redaction, TA alignment involving dedicated vaccines and devices experts, Clinops as an FTE-FSP business, FMCG as an independent sector and so on.

Reiterating my earlier stand, the evolving regulatory situation in India may have pushed several CROs found wanting out of business, but SIRO’s ‘never say die attitude’ and ‘innovative business models’ have allowed it run seamlessly, without any global funding or affiliate, and with an appreciable profitability.

India lags in maintaining research data which is becoming a severe compliance issue in the industry. What needs to be done to tackle this issue?

I would not like to generalise on this. India still retains its respect on the global clinical research map as a major research hub and drug development partner. While I would admit it has been challenging for many to meet the stringent, but necessary global research requirements, it is largely the company’s quality culture, domain expertise and executive governance that determine its adherence to compliance.

Being a part of the global drug discovery process is one of the key factors that motivate our company to continue its pursuits to transcend new heights, the regulatory restrictions notwithstanding.

And the reputation we have built over the years while globally delivering successfully for renowned clients only enhances this motivation.

As a company, our aim is to make sure that patient safety is achieved at the end of the day and the data generated from the trials handled by us is acceptable across the globe.

A testimony to this fact is the number of successful regulatory inspections and audits, including US FDA inspections, handled by us as a company without a single critical finding.

any clinical research requirement. SIRO’s transformation to a customercentric organisation with a

new brand identity couple of years back, and enhancement of Clinops execution capabilities in the APAC

region will provide a perfect platform to achieve this.

All in all, we will continue to work towards providing a

differentiated customer experience through simple, novel solutions to every client. u.sharma@expressindia.com

What are your plans for the next two years?

This industry calls for an organisation to always be on the change. My focus will be on enhancing the share of integrated service offerings across the clinical development spectrum. While there will be significant thrust on medical writing and data services that enjoy steady revenue streams, there will be undivided focus on competency building and quality delivery in newer and niche segments like MedComm, Analytics, Regulatory Consulting and Devices/FMCG sector, which will contribute significantly to the next phase of SIRO’s growth. In the next two years, SIRO will aspire to be the perfect strategic partner for

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MARKET COMPANY WATCH

India is free of maternal and neonatal tetanus: PM The country has achieved under-five mortality rate decline at an accelerated pace compared to the global rate of decline and India is likely to reach close to achieving the MDG target, says the PM

THE PRIME Minister of India, Narendra Modi recently inaugurated the two-day “Call to Action Summit-2015-ending preventable child and maternal deaths” in New Delhi. The event was organised by the Ministry of Health and Family Welfare, Government of India and the Ministry of Health, Government of Ethiopia.

According to a PIB release, the Prime Minister in his inaugural address said that India has made several notable achievements in the healthcare sector especially in maternal and child health in the recent years. He said, “The country has achieved underfive mortality rate decline at an accelerated pace compared to the global rate of decline and India is likely to reach close to achieving the MDG target, if the current trend of annual decline is sustained.

After the victory over polio, India has achieved another major milestone recently.

India has eliminated maternal and neonatal tetanus.”

Speaking at the occasion, JP Nadda, Union Minister for Health and Family Welfare drew attention to the impressive practices India can share with other countries. He renewed India’s pledge and commitment to ending preventable mother and child deaths.

Dr Kesetebirhan Admasu, Minister of Health, Ethiopia,

co-host of the summit mentioned that factors such as health systems, ensuring universal access to primary healthcare, leveraging on international support and funding, robust community ownership, and sharing of knowledge and experience have helped to reach a large population. Ethiopia has set

out ambitious goals for equity and goals for transformation of health sector, the Minister stated. There has been remarkable expansion of health facilities and services to address inequalities and inequity, he added.

BP Sharma, Secretary, MohFW, in his address highlighted the impressive achievements India has made in the area of maternal and child healthcare. He stated that the rate of decline that India has pursued in reducing IMR and MMR, is faster than the global pace of decline. He noted that these achievements strongly reflect a strong political will, sound strategies, focused polices, rigorous implementation framework, sturdy structures of monitoring and evaluation, and focus on health systems strengthening for effective health outcomes.

The speakers present during the inaugural session were Mark Suzman, President, Global Policy and Advocacy and Country programmes,

The Bill and Melinda Gates Foundation, Dr Geeta Rao Gupta, Deputy Executive Director, UNICEF, Alfonso E Lenhardt, Acting Administrator, USAID, Dr Poonam Khetrapal Singh, Regional Director General, WHOSEARO, Dr Jagdish Prasad, DGHS, Ministry of Health and Family Welfare, CK Mishra, Additional Secretary and Mission Director (National Health Mission), Ministry of Health and Family Welfare.

The 3rd Global Call to Action 2015 was hosted for the first time in India, and outside the US. As many as 24 high priority countries participated during the two-day summit. These were Afghanistan, Bangladesh, Democratic Republic of Congo, Ethiopia, Ghana, Haiti, Indonesia, India, Kenya, Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Nigeria, Pakistan, Rwanda, Senegal, South Sudan, Tanzania, Uganda, Yemen and Zambia.

EP News Bureau-Mumbai

Fermenta Biotech ties up with Vitamin Angels Fermenta Biotech and Vitamin Angels are determined to solve the fundamental problem of undernutrition, a widespread challenge, especially in rural areas FERMENTA BIOTECH joined forces with Vitamin Angels, a non-profit organisation that works to save and improve lives across the world, by providing vitamins and

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minerals to pregnant women, new mothers, and children under five. The association synergises with Fermenta Biotech’s vision to ensure that no one is deprived of vital nutrients.

Together Fermenta Biotech and Vitamin Angels, through their partnership, are determined to solve the fundamental problem of undernutrition, a widespread challenge, especially in rural areas. Vita-

mins Angels is working to combat undernutrition through a comprehensive approach that starts with vitamin supplementation and includes support for breastfeeding women,

deworming, and more. Vitamin Angels believes every child deserves the chance to lead a healthy and productive life – something possible through the power of vitamins.

EP News Bureau-Mumbai

MARKET

Sun Pharma completes GSK’s opiates bizacquisition Significantly expands NRM capability through two opiates manufacturing facilities in Australia SUN PHARMACEUTICAL Industries has started the integration of its opiates business in Australia following the successful completion of this acquisition from GSK (announced in March 2015). The acquisition fortifies Sun Pharma’s global position with two opiates manufacturing facilities in Port Fairy & Latrobe (both in Australia) complementing its current API manufacturing footprint globally.

Sun Pharma now offers opiates product line in addition to a large API portfolio and dosage formulations covering a broad range of chronic and acute prescription drugs.

The acquisition also brings a specialised team to drive business growth. The opiates acquisition allows Sun Pharma to significantly expands its narcotics raw material (NRM) market share, enhance opiate alkaloids portfolio and depth in global opiates market and strengthen its strategic position in the global opiates business.

Anil Kumar Jain, Chief Executive Officer – API Business, Sun Pharma said, “The successful completion of this acquisition enables us to leverage our unique position in the global opiates business by capitalising our global footprint and global ranking in the speciality generics market. Sun Pharma stays committed to uncompromised product quality, 100 per cent compliance and innovation.”

Over the last few months, the opiates and Sun Pharma teams put together a transition plan to oversee the implementation of the functional integration of opiates business.

The transition process will emphasise on aligning best functional requirements and leveraging employee talents in this business.

www.merckmillipore.com

EP News Bureau-Mumbai

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MARKET

India to introduce injectable polio vaccine from November From April 2016, the trivalent polio vaccine that is currently administered will be replaced by the bivalent variety to reduce incidence of vaccine-derived polio virus INDIA IS all set to introduce injectable polio vaccine (IPV) in its universal immunisation programme (UIP) in a phased manner from November. This will be over and above the oral vaccine. From April, 2016 the trivalent polio vaccine that is currently administered will be replaced by the bivalent variety to reduce incidence of vaccine-derived polio virus. India eliminated wild polio virus infection in January last year.

In the first phase of IPV introduction, 17 high-risk states and four Union Territories will be covered. These are Bihar, Chandigarh, Delhi, Gujarat, Haryana, Punjab, Rajasthan, Uttar Pradesh, Arunachal Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, Tripura, Assam, Madhya Pradesh, Andaman and Nicobar islands, Lakshadweep, Dadra and Nagar Haveli and Daman and Diu. IPV is one of the three vaccines that were approved by the government for inclusion in the UIP more than a year back on the recommendation of the National Technical Advisory Group on Immunisation. The other two vaccines, measles-rubella and rotavirus are still in the works.

“From November we will introduce IPV in the UIP schedule, in three phases, starting with the high-risk states. The single dose of the vaccine will be administered with the third dose of the DPT vaccine at 14 weeks. This is as per the global endgame strategy and also in preparation for our own switch to bivalent oral polio vaccine next year. For

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now, the administration of the oral vaccine will continue,” said a senior official in the Health Ministry.

Oral polio vaccine is made of live attenuated polio virus of all three strains of polio – P1, P2 and P3. India currently uses the trivalent vaccine. The other variety, the bivalent one that India will introduce next year has only attenuated P1 and P3 strains. India eradicated P2 in1999 — the last case was in Aligarh — but the most number of cases of vaccine-derived polio happen because of P2.

Till date about 44 such cases of polio derived from the vaccine have been reported in the country. That is why the switch to bivalent oral vaccine.

IPV on the other hand is made up of killed polio virus and will give a child immunity from all three strains. There is no risk of vaccine-derived polio either.

In May 2012, The World Health Assembly endorsed the Polio Eradication and Endgame Strategic Plan 201318, calling on countries to strengthen

routine immunisation programmes and introduce at least one dose of IPV in all countries using only oral polio vaccine.

IPV is to be given in addition to the existing oral polio vaccine, in order to boost population immunity.

For the first year GAVI, which is an international vaccine alliance, has given about 28 million vaccine doses to India. This is against India’s original demand for 40 million doses to account for wastage, transportation etc. India’s total annual birth cohort is 27 million.

The first instalment is not sufficient to cover all states but the government is hopeful of further support from GAVI. The target is to cover all states in the next seven-eight months. Continuing IPV without GAVI support will entail a cost of approximately `200250 crores.

(This story has been filed

by Abantika Ghosh from New Delhi)

Novartis in global partnership with Amgen To develop and commercialise pioneering neuroscience treatments NOVARTIS HAS entered into a global collaboration with Amgen to commercialise and develop pioneering neuroscience treatments. The companies will partner in the development and commercialisation of a BACE inhibitor programme in Alzheimer’s Disease (AD). Novartis’ oral therapy CNP520 will be the lead molecule and further compounds from both company’s pre-clinical BACE inhibitor programmes may be considered as follow-on molecules. The collaboration will also focus on new Amgen drugs in the migraine field, including phase III AMG 334 and phase I AMG 301. For the migraine programme, Novartis will have global co-development rights and commercial rights outside the US, Canada and Japan.

“This Novartis collaboration with Amgen highlights our clear commitment to neuroscience and to bring multiple, new targeted therapies to patients living with Alzheimer’s disease and migraine, where the unmet medical need remains high,” said David Epstein, Head, Novartis Pharmaceuticals.

The partnership with Amgen follows two recent developments in the Novartis neuroscience portfolio aimed at complementing Novartis’ neuroscience presence and pipeline in, among others, multiple sclerosis, AD and neuromuscular diseases. In July 2015 Novartis acquired Spinifex Pharmaceuticals, adding phase II compound EMA401 for the treatment of neuropathic pain to the portfolio.

The collaboration will also focus on new Amgen drugs in the migraine field, including phase III AMG 334 and phase I AMG 301 Under the terms of the arrangement, Novartis and Amgen will share responsibilities for development and commercialisation of the BACE inhibitor programme.

Amgen will pay an upfront payment and milestone payments as well as disproportional research and development costs for an agreed upon period followed by a 50/50 cost and profit share arrangement. For the compounds in the migraine field, Novartis receives global co-development rights and commercial rights outside the US, Canada and Japan to the investigative molecules in Amgen’s migraine portfolio. This includes AMG 334 in phase III and AMG 301 in phase I as well as an option to commercialise an additional early-stage Amgen molecule in these territories.

Novartis will fund disproportional global R&D expenses for an agreed period on the migraine programmes and will pay Amgen double-digit royalties on sales.

EP News Bureau-Mumbai

MARKET

Valeant picks up AstraZeneca psoriasis drug after Amgen exit Valeant said that it would make an upfront payment of $100 million to AstraZeneca CANADA’S VALEANT Pharmaceuticals International is buying rights to AstraZeneca’s late-stage experimental psoriasis drug brodalumab after it was dropped by Amgen in May. Amgen pulled out of the project because suicidal thoughts were observed in some patients taking the medicine, casting a shadow over its prospects.

Valeant recently said that it would make an upfront payment of $100 million to AstraZeneca, and additional pre-launch milestone payments of up to $170 million and sales-related milestone payments of up to $175 million following the launch.

Regulatory submissions in the US and Europe for brodalumab in moderate-tosevere psoriasis are planned for the fourth quarter of 2015.

The arrangement excludes Japan and certain other Asian countries where rights to the drug are held by Kyowa Hakko Kirin Co (4151.T).

Brodalumab belongs to a class of drugs called IL-17 inhibitors that work by blocking a signalling pathway that plays a key role in inducing and promoting inflammatory diseases. Psoriasis is a chronic autoimmune disease in which the growth cycle of skin cells is accelerated.

AstraZeneca said the deal, which is expected to complete in the fourth quarter of 2015, would not materially impact its financial forecasts for 2015.

Income from the upfront and milestone payments will be reported as ‘externalisation revenue.’

Reuters

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MARKET

Natco Pharma plans five new products for US market The ` 850 crore company expects to see organic growth of 15-20 per cent NATCO PHARMA is preparing to launch about four to five new products in the US market by the end of next year, through what it terms as a differentiated product pipeline of niche and complex generic products. As a result, the company is upgrading its existing manufacturing facilities in India with new product lines, R&D capabilities, while also expanding its formulation facility in Hyderabad.

“We have a pipeline of niche and complex generics products in the US besides a collaborative research model to grow in the US markets,” Rajiv Nannapaneni, Vice

Chairman and Chief Executive Officer, said. “We will be launching about four to five products in US by next calendar year.”

According to him, the company has to its credit 36 ANDA filings including 15 Para IV filings with US FDA as on August 25. Some of them are First-to-file (FTF) ones targeting a combined market of $15 billion and 14 approved ANDAs including two tentative approvals.

Natco is looking to partner with other global pharma majors to develop and market products for the US. “The US products portfolio is predominantly focused on high

The company is upgrading its existing manufacturing facilities in India with new product lines, R&D capabilities

barrier products that are difficult to formulate, difficult to manufacture or may face complex legal and regulatory challenges; 15 Para IV filings with combined market size of $11.8 billion,” Nannapaneni said.

According to Nannapaneni, the company has entered into de-risked arrangements with marketing partners wherein the partner undertakes the responsibility of lengthy and complex litigation and regulatory issues and securing the ANDA approval.

Some of the key products include Copaxone, Tamiflu, Nexavar, Revlimid, etc. While

the US market contributes to about 15 per cent of its sales revenues and India’s share is 45 per cent. Going forward, the ` 850-crore company expects a organic growth of 15-20 per cent .

The company board has also approved the company’s proposal to issue and allotment of eligible securities to qualified institutional buyers (QIBs) to the tune of `450 crores. In the domestic market, the focus is on oncology and hepatitis segment.

(The story has been filed by BV Mahalakshmi from Hyderabad)

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EVENT BRIEF SEPTEMBER 2015-JANUARY 2016 24

Training on IPR

TRAINING ON IPR Date: September 24, 2015 Venue: Rajiv Gandhi National Institute of Intellectual Property Management, Nagpur Summary: Rajiv Gandhi National Institute of Intellectual Property Management (Rajiv Gandhi NIIPM), a central government organisation under the Ministry of Commerce & Industry engaged in conducting training, awareness programmes on Intellectual Property Rights (IPR) i.e. patents, designs, trademarks and geographical indications, will conduct ‘Training on IPR’ to create awareness of IPRs. The training will be held in Rajiv Gandhi NIIPM, Nagpur.

Contact details Rajiv Gandhi National Institute of Intellectual Property Management 03, Hislop College Road, Civil lines, Near Nagpur University Nagpur, Maharashtra - 440001 Tel: 0712 –2542961 / 2542979 / 2540913 / 2540922 Fax : 0712 - 2542955 / 2540916 rgniipm.ipo@nic.in, niipm.ipo@nic.in www.ipindia.gov.in

SEMINAR ON CHROMATOGRAPHIC TECHNIQUES IN PHARMA API Date: October 7, 2015 Venue: SIES Institute of Chromatography and Spectroscopy, Nerul, Navi Mumbai Summary: Chromatographic Society of India with SIES Institute of Chromatography and Spectroscopy will organise the seminar. The one-day seminar will be beneficial for chemists working with pharma companies, graduates and post graduates who desire to build a career in the pharma industry. The seminar will have lectures on various aspects of active pharmaceutical ingredients chemistry and analysis from experts.

A live demonstration of impor-

7

Seminar on chromatographic techniques in pharma API

tant analytical techniques on GC, GCMS, Head Space (HS) accessory, HPLC and ion chromatography will be conducted.

Contact details Chromatographic Society of India C – 1203 Synchronicity, Nahar Amrit Shakthi Road, Chandivali, Mumbai- 400 072 Email: info@chromsocindia.org

Forum will open up both known and unknown business opportunities to all pharma professionals of the pharma industry, in one central place.

The forum will offer the chance to connect with influential players in the pharma industry.

Contact details UBM India Kumudini Bodha Kumudini.Bodha@ubm.com

APTICON 2015 Date: October 9 – 11, 2015 Venue: Devi Ahilya Vishwavidyalaya Auditorium, Takshashila Campus, Indore, Madhya Pradesh Summary: The 20th Annual National Convention of Association of Pharmaceutical Teachers of India will address the need of changes in pharmacy education in preview of industrial need of skilled professionals. The theme for the convention is strategic approaches to strengthen academic and industrial collaboration. Association of Pharmaceutical Teachers of India along with pharmacy institutes of Madhya Pradesh will organise the event.

Contact details Mob: +91 7354880836 Web: www.apticon2015.com Email: info@apticon2015.com

CPHI WORLDWIDE Date: October 13-15, 2015 Venue: IFEMA, Feria de Madrid, Spain Summary: CPhI Worldwide will host 2,500 plus exhibitors and more than 36,000 plus attendees from 150 plus countries. Visitors will meet international pharma companies, stay informed about the latest industry trends and remain one step ahead of a constantly changing pharma market. The event will be colocated with ICSE, P-MEC and InnoPack.

Through all CPhI channels, and live at CPhI Worldwide 2015 in Madrid, the Pharma

To subscribe: bpd.subscription@expressindia.com

9

Apticon 2015

and also on quality metrics and pilot programmes in the US. Experts from Lachman Consultants will be conducting the workshop. The organiser for the event is UBM. Contact details UBM India E-mail: suvidha.shetty @ubm.com Web: http://globalformulation.com

OTC PE CHARCHA 4TH ANNUAL PHARMA LEGALAND COMPLIANCE SUMMIT Date: October 16, 2015 Venue: The Leela, Mumbai Summary: Lex WITNESS will organise the 4th Annual Pharma Legal and Compliance Summit.

Demystifying compliance will be the key mandate and also the focus at the key note sessions.

The session will encompass various aspects right from the manufacturing hubs to the doorstep of pharmacists. The summit will be an unique platform to get together and share the regulatory and legal developments and challenges in the areas of the industry.

Discussions will also be held on ‘unleashing the sciences of trademarks & copyright’, ‘M&A and FDI rides of the Indian pharma sector’, ‘An insight into the current patent scenario in India’ and ‘The regulatory sagas and the challenges within.’

Contact details Bhupinder Kaur email: Bhupinder@ WitnessLive.in Tel: +91-9654155065

2ND ANNUAL DATA INTEGRITY & QUALITY METRICS WORKSHOP Date: October 29 - 30, 2015 Venue: The Westin Mumbai Garden City International Business Park, Oberoi Garden City, Mumbai Summary: The workshop at CPhI will focus on the issues related data integrity, reliability

Date: November 27, 2015 Venue: Sofitel, Mumbai Summary: Cube X, a division of Sorento, will organise ‘OTC Pe Charcha.’ Visitors at this year’s OTC conference will come face-to-face with firsthand consumer insights, expert views and successfully executed strategies in the OTC arena.

The key note speaker will be Nicholas Hall, Chairman and Chief Executive Officer, Nicholas Hall Group of Companies. Other speakers are Ambi Parameswaran, Advisor, Ex-Executive Director, FCB Ulka, India, Ajay Macaden Executive Director, Nielsen India, Nandini Dias, Chief Executive Officer, Lodestar UM, India, Dinar Mhatre, Head Integration, Johnson and Johnson Consumer, India, Gerard Fernandes, Consumer Healthcare Head, Boehringer Ingelheim, India, S Raghunandan, Director and CEO, Jyothy Laboratories, India, Ajay Rawal, National Marketing Head, JK Ansell, India, etc.

Contact details Prashansa Bora email: pbora@cubex.co.in, Tel (D): +91 022 4036 2037 (B): +91 022 4036 2000

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharma industry from 92 countries, including

13

CPhI Worldwide

India, China, the US, the UK, France and Italy will participate. Visitors will be able meet all major suppliers of pharma ingredients, outsourcing, equipment and bio-solutions in one location. PMEC, ICSE and BioPh will be co-located with CPhI event.

Contact details UBM India Times Square th Unit No. 1-2, 5 Floor, ‘B’ Wing, Andheri Kurla Road, Marol, Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016) – the 8th international exhibition on complete pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition.

During APE 2015, 492 exhibiting companies from 28 countries along with 8,500 square meters of floor space and 9,000 trade professionals visited the show.

The exhibitor’s profile includes pharma processing and packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, lab. reagents – chemicals), environment control equipment and services, utility, and maintenance, R&D, biotechnology, CROs, contractors – turnkey, trade associations / trade publications, formulations and contract manufacturing.

Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

EXPRESS PHARMA

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cover )

20 EXPRESS PHARMA September 16-30, 2015

(

THE MAIN FOCUS

Pune’s pharma and life sciences sector has seen a significant growth, abetted by conducive conditions like good connectivity, cosmopolitan populace, skilled human resources and proximity of renowned educational institutes

BY SACHIN JAGDALE

P

une, the cultural capital of Maharashtra, is increasingly becoming a favourite destination among pharmaceutical and life sciences entrepreneurs to set up their manufacturing units. A allied sector players are also located in the city in a significant number. According to experts, Pune will continue to increase its pharma and life sciences strength, as long as it

meets the demands of the sector.

Pune calling There is a famous adage about Pune in Marathi, Pune tithe kay une. It means ‘Pune is abundant with everything that one would require.’ It perhaps rings true for the pharma and life sciences sectors as well. Already present in significant numbers, pharma and life sciences sector in Pune is slated to grow even further.

Dr Suresh Jadhav, Executive Director, Serum Institute of India, informs, “The prime operational needs of pharma

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Biotech companies need large space for installation of manufacturing facilities and this large space is available in Pune Dr Suresh Jadhav Executive Director, Serum Institute of India

biotech companies are world class infrastructure in R&D, manufacturing, healthcare and education. Pune fulfils most of these requirements by offering state-of-the-art natural biotech cluster which is providing the much needed impetus for biotech innovation and growth.

Pune offers an excellent network of world class institutions including National Institute of Virology (NIV), National AIDS Research Institute (NARI), National Centre for Cell Sciences (NCCS), Indian Institute of Science Education and Research (IISER), and National Chemical Laboratory (NCL),

along with reputed and ranked universities such as University of Pune, and Bharati Vidyapeeth University. The other universities such as Sinhagad Technical University, DY Patil University and Symbiosis are also offering graduate and post graduate courses in basic and biotech sciences.

These universities are also involved in research and collaborate with local biotech industry at various levels.”

He adds, “Pune also hosts world class hospitals, medical colleges and clinics which offer excellent opportunities for clinical research and training.

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cover ) Pune harbours not just a wide range of technical educational institutes but also management institutes, thereby offering to industry both technical as well as administrative human resources Sachin Purohit Managing Director, Genome Biotechnologies

Pune hosts reputed medical colleges such as Armed Forces Medical College, BJ Medical College and KEM, Hospital. Such institutes together offer excellent support to the biotech industry in terms of knowledge and skilled manpower to companies located here.”

Serum Institute of India has been a leading representative of Pune’s biotech industry for several decades.

Serum’s vaccines are taking care of the health of millions, not just in India but also globally. According to Jadhav, Serum Institute of India, since its inception, has benefited from the biotech cluster in terms of advanced instrumentation facilities at NCL, University of Pune etc, technical and epidemiology support from NIV in the field of virology, cell lines repository at NCCS, collaborative projects with University of Pune and Government of India on vaccine adjuvants and clinical trial support from BJ Medical College, KEM and Bharati Hospitals.

Strategic synergies

Pune-based IT companies like Persistent, Cognizant, TCS, Vlife Sciences are actively working with pharma companies and life sciences research institutions on R&D front especially in the field of drug discovery, formulation development, diagnostics, clinical trials and public health Dr Abhay Jere Associate VP and HeadPersistent Labs

22 EXPRESS PHARMA September 16-30, 2015

There are many other companies in this sector that have been benefitted due to their strategic location in Pune. Baner-based Genome Biotechnologies, well known for handling genomic research projects, is one such company.

Sachin Purohit, Managing Director, Genome Biotechnologies says, “Pune forms a very good hub for both pharma as well as biotech companies due to several reasons. Being an educational hub for both pharma and biotech streams, industries find sourcing of manpower relatively easy in Pune for their operations. It harbours not just a wide range of technical educations institutes but also management institutes, thereby offering to industry both technical as well as administrative human resources. Pune has been known as a centre for excellence with respect to the re-

search and development activities in both pharma and biotech fields. Presence of multiple central and state government research institutes offers not just R&D opportunities to the industry but also a rich mine of experts and consultants who are essential in taking strategic and development-related decisions.”

Purohit sees Pune’s population as an added asset. Besides pharma and life sciences sectors many other industries are growing in and around the city. This has resulted in a significant rise in Pune’s population. According to Purohit, with a population close to 65 lakhs including the suburbs, Pune also has been known as a very good test marketing ground for launch of pharma as well as biotech products and services. Pune hosts hundreds of hospitals and healthcare centres and thus opens channels of interactions with thousands of doctors and allied healthcare experts who would be willing to take up value added services and products.

Purohit explains his point further, “Pune has a rich heritage of culture, but the areas like PCMC, Hinjewadi and other suburbs are now also home to many nonPune residents. The pharma and biotech industries hence get an opportunity to make their offerings to a cosmopolitan population, and feedback from such population is very useful in scaling operations to a panIndia level. Pune, hence, can function as a statistically significant representative population of India.”

What sets Pune apart?

Comparison between Mumbai and Pune is imminent since the former is still considered a leading pharma hub. Both cities are not far away from each other and many companies have migrated from Mumbai or have offices in the city. One reason for this is that Mumbai is one of the costliest cities in the world and with each passing

year it has become an expensive affair for entrepreneurs.

Purohit identifies areas where Pune scores over Mumbai. He says, “Manpower and administrative expenses for a company are lesser in Pune. Cost of living, and hence attrition rate with respect to manpower, is lesser in Pune. Density of population in Mumbai and Pune is not drastically different; hence ROI for marketing and sales efforts is almost equivalent to Mumbai. Group interactions such as conferences, group meetings, CMEs etc, are both economically and administration-wise easier in Pune as compared to Mumbai. Local travel time in Pune is lesser as compared to Mumbai, increasing the ratio of travel to client meetings.”

Even Jadhav echoes Purohit’s views adding few more points to the above discussion, “Biotech companies need large space for installation of manufacturing facilities and this large space is available in Pune. Moreover, weather is good almost all the months of the year.”

Pune has some of the globally known IT companies that have their interests in pharma and life sciences sector. Persistent Systems is a leading IT company specialising in software product and technology services. Giving the IT perspective of this debate, Dr Abhay Jere, Associate VP and Head-Persistent Labs, says, “Pune-based IT companies like Persistent, Cognizant, TCS, V-life Sciences are actively working with pharma companies and life sciences research institutions on R&D front especially in the field of drug discovery, formulation development, diagnostics, clinical trials and public health. Pune also has a large number of educational institutions offering courses in bioinformatics and biotechnology which have a huge stress on IT. Institutions like CDAC, Pune have dedicated research groups working in the field of life sciences and informatics.

Considering the require-

ments of a matured ecosystem for pharma/ biotech/life sciences companies to thrive, Pune’s human resource in large number can work as an interface between IT and BT.”

Ground for growth Pune is famously known as the vidyanagari of Maharashtra. As mentioned by experts before, availability of top ranked educational institutes was one of the magnets to attract pharma/life sciences companies to the city. Skilled and educated workforce ensures the survival of any industry.

“Pune has multiple options for technical training and research in pharma sciences. It hosts more than four universities, offering pharma education at all levels, from diploma to post graduation upto post-doctoral level. Moreover, most of the universities have been well recognised and hold good national and international ranking endorsed by government bodies such as UGC, India. In fact, research opportunities in pharma sector are much more by the virtue of research institutes, research projects being handled by scientists and publications in Pune. Hence, Pune may in fact prove to be a better location for pharma education standards,” opines Purohit.

In Pune, IT companies, educational institutes and pharma and life sciences companies are working together in a symbiotic way.

For eg; Persistent Systems is collaborating with research institutions like NCCS, Pune, NCL Pune; IISER Pune and Maharashtra University of Health Sciences (Pune Regional Center) for conducting collaborative research in the field of life sciences/ biotech/ bioinformatics/ pharma.

Jere informs, “Pune has premier national institutions like NIV and NARI working in the area of public health and our company has collaboratively designed laboratory in-

The process of pharma manufacturing moving out of Mumbai started quite some time back, possibly 15-20 years ago. The large manufacturing sites were mostly of multinational companies.

They did not find much benefit in continuing to be producing their products in sites in Mumbai Kapil Bhargava Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies in India

formation management systems (LIMS) with these organisations which will be soon deployed across other organisations in India. Similarly, TCS research division which is based out of Pune is also collaborating with multiple research organisations based out of Pune.”

Pune’s gain, others’ envy?

The general perception is that the rising share of Pune in pharma and life sciences sector must have inflicted losses to cities like Mumbai. However, experts believe that this may not be the case. Migration of companies is a commonly observed phenomenon and as far as Mumbai is concerned, it is still the corporate headquarters for many reputed pharma and life sciences companies. However, the loss is in the jobs that these sites may be providing, had manufacturing continued here.

Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies in India, says, “The process of pharma manufacturing moving out of Mumbai started quite some time back, possibly 15-20 years ago. The large manufacturing sites were mostly of multinational companies. They did not find much benefit in continuing to be producing their products in sites in Mumbai.

Mumbai always meant MumbaiThane. They were looking for sites outside Mumbai. Many of the sites were not Schedule M compliant in true sense and were thinking of going to new areas and making new plants instead of up-grading plant. Few have thought of moving to Pune, though not setting up their manufacturing sites, for manufacturing of their products at the sites existing there.”

He adds, “I recall the first-to-use Pune facility to make their products

was probably Burroughs Welcome for their product ‘Ridake’ and later ‘Septran’ and the site selected was Emcure Pharmaceuticals. Soon after, other companies followed this trend and companies like Glaxo, Pfizer, Novartis and Ciba were getting their products manufactured in Pune.”

It is also to be noted that the big Indian companies did not move exactly to Pune, but to areas in the vicinity, such as Jejuri. Cipla set up its plant (formulations and API ) in Kurkumbh, Lupin and Wockhardt moved to to Aurangabad and the trend continued for locations within the vicinity of Mumbai.

Bhargava informs, “The medium sector continued for some time in Mumbai-Thane and set-up newer sites in industrial hubs such as Palghar–Tarapur, Dombivali and Ambernath areas, more so to meet the requirements of Schedule M. Exports were increasing and they wanted to demonstrate at-least good-looking manufacturing sites. Small scale players, which were operating in 'industrial galas' have to compulsorily move out of Mumbai for several commercial and social reasons.”

Besides globally acclaimed pharma and life sciences cities like Hyderabad and Bengaluru, Pune too is fast emerging as a preferred destination for companies in these sectors. Many eminent companies, who have their headquarters in different parts of the country, have set up their manufacturing plants in Pune. Apart from being a good talent pool of human resources from all across India, it is also a sought after location for many foreign professionals. Industry experts predict a very bright future for Pune as a pharma hub in the coming years. sachin.jagdale@expressindia.com

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EXPRESS PHARMA

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MANAGEMENT INSIGHT

Pharma market overview: The expanding role of India and Indian companies

MANEESH CHANDRA, India Business Consulting Head- ZS Associates

Maneesh Chandra, India Business Consulting Head- ZS Associates, elaborates on how the evolving global and domestic market dynamics are likely to result in significant opportunities and challenges for pharma companies operating in India THE GLOBAL pharma market is going through major structural changes with significant implications for India and Indian companies. North America continues to be the largest pharma market in the world contributing to about a third of the $1 trillion in annual global pharma sales in value terms. However, with the rapid pace of growth in pharma sales in Asia over the last five years and the expected growth in the medium-term future, the centre of gravity for the pharma market is slowly shifting toward Asia.

Asia is likely to soon overtake North America in terms of overall pharma sales. This is a trend that is likely to continue for the foreseeable future due to broad macroeconomic drivers such as population and income growth. It is true that Japan and China will continue to dominate pharma sales in Asia. For example, with annual pharma sales of over $80 billion, China is already more than five times the size of the Indian domestic pharma market in terms of value. However, rapid annual market revenue growth rates of over 10–12 per cent in countries such as India are likely to see an expanding interest by global pharma companies in other Asian markets including India.

Another factor affecting the global pharma industry is the increasing pace of branded

24 EXPRESS PHARMA September 16-30, 2015

through a mix of strong local affiliate presence and strong centralised capabilities, often located and/or managed from India.

Even within India, the growing size of the domestic market, the growing scale of Indian pharma companies and the expanding introduction of new products into the market is leading to a significant increase in competitive intensity. Growing scrutiny of promotional tactics by the government is only increasing the pressure for local companies to find out ways to differentiate themselves in the market. Increasingly, companies are focusing on enhancing their internal strategies and capabilities in this hypercompetitive environment.

Emerging needs of the Indian pharma industry

products losing patent exclusivity in developed markets.

Much of this phenomenon has impacted mass market small molecule products. Generic companies around the world including Indian companies have and will continue to reap the benefits of this trend. Another opportunity that is open-

ing up for Indian pharma majors is the beginning of the trend of more complex biologic products losing patent exclusivity in developed markets through competition from biosimilars. This phenomenon is likely to significantly expand the opportunities for many Indian pharma companies with

strong international operations. Today, pharma exports from India are nearly as large as the domestic pharma market. As this international business for India pharma majors grows, companies are gearing up to further strengthen their internal capabilities to manage these international businesses

The evolving global and domestic market dynamics are likely to result in significant opportunities and challenges for pharma companies operating in India, both Indian companies as well as Indian affiliates of MNC companies. Some key issue areas are already starting to capture the attention of leadership teams within the industry.

Growth acceleration with sales and marketing excellence With an increasingly competitive domestic market in India,

Given the evolving market dynamics the traditional sales structure, processes and sales reps skills are not enough to succeed today. Companies are starting to explore ways to assess their current sales capabilities, identify and prioritise gap areas, and invest in ways to systematically upgrade themselves in the prioritised areas

pharma companies are being faced with the challenge of having to work much harder to drive revenue growth.

Companies will need to increasingly develop ways to systematically identify unmet customer opportunities and barriers, identify and prioritise specific promotional strategies to take advantage of the opportunities and execute tactics successfully. Having robust sales and marketing capabilities is going to be critical for pharma companies to differentiate themselves in the market. Developing these capabilities will require people with advanced skills, robust and well-defined processes, and enabling tools and techniques.

Given the evolving market dynamics the traditional sales structure, processes and sales reps skills are not enough to succeed today. Companies are starting to explore ways to assess their current sales capabilities, identify and prioritise gap areas, and invest in ways to systematically upgrade themselves in the prioritised areas through a combination of talent management and enabling tools and processes. Strong investments in CRM and reporting technologies to enable the sales force and sales management are good examples of that.

More and more pharma companies in India are starting to think about the best return from their investments by strengthening their marketing capabilities. Decision-driven analytics to support marketing investment decisions is an area that many companies are taking a serious look at. Evolving customer needs require sharper segmentation, targeting and positioning.

Commercial organisation design The role of different players within

the healthcare space is continuing to evolve in India. Some changes include the expansion of corporate hospitals and pharmacy chains, the increasing importance of medical insurance companies and the growing role of patients in decision making, especially with ready access to information and prevalence of the social media.

All these changes along with increasing competition, trend toward consolidation and likel ihood of more government scrutiny around pharma promotional tactics will require companies to continuously re-evaluate how to most appropriately structure their commercial organisations. More and more companies are also realising that there is a strong need to strengthen roles such as key account management and medical within their sales organisations.

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Opportunity assessment With the continuous growth of the Indian healthcare market, both multinational pharma companies as well as India pharma companies have had the need to evaluate the potential opportunity to introduce new products and services. Companies cannot afford the downstream implications of poor forecasts including sub-optimal investments, guidance to corporate strategy and sales force attrition. The need for robust methodologies is also increasing as companies invest in more specialty areas such as oncology and immunology.

As Indian pharma companies start work to take advantage of the growth opportunities and appropriately address the challenges to come, there will be a growing demand for best in class ideas around marketing and sales issues.

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MANAGEMENT REPORT

Antisense RNAi therapeutics deals value approached $5.6 billion in landmark 2014: GlobalData The figure almost triple that of the previous year,with just over $1.9 billion raised from 62 deals in 2013 THE DEALS market for antisense RNA interference (RNAi) therapeutics witnessed a record year in 2014, with a total value of almost $5.6 billion across 59 transactions, by far the largest deal value ever seen in this space, according to research and consulting firm GlobalData.

The company’s latest report states that this figure is almost triple that of the previous year, with just over $1.9 billion raised from 62 deals in 2013, and almost double the previous high of approximately $2.9 billion from 58 transactions in 2010.

Adam Dion, Senior Industry Analyst, GlobalData, says three mergers and acquisitions worth $1.2 billion, as well as record highs for licensing and

The figure is almost triple that of the previous year, with just over $1.9 billion raised from 62 deals in 2013, and almost double the previous high of approximately $2.9 billion from 58 transactions in 2010 capital raisings, helped to fuel deals in 2014.

Dion explains, “In particular, 2014 witnessed two very significant licensing deals when Celgene and Nogra Pharma struck a $1.5 billion agreement for Nogra’s GED-0301 to treat Crohn’s disease, and Genzyme and Alnylam signed a $775 million pact to co-develop Alny-

lam’s patisiran for transthyretin-mediated amyloidosis patients with familial amyloid polyneuropathy.”

“The number and value of capital raisings in the antisense RNAi therapy field has been steadily increasing, with the past six years averaging about 40 deals at a combined value of just over $1.1 billion per year.

This peaked in 2014, when capital raisings grew considerably by $600 million in 2013 to $1.9 billion last year, highlighted by a $500 million private placement from Isis Pharmaceuticals,” Dion says.

GlobalData believes these developments provided a groundswell of support for future industry advancement

and expects 2015 to register another strong year for capital raisings, given that 15 deals had already been struck by the end of July, for a total value of over $1.4 billion.

Dion continues, “The majority of the capital raised was from investment banks, such as JP Morgan, Deutsche Bank, and JMP Securities, for top RNAi therapeutics vendors, including Alnylam, Isis Pharmaceuticals, Moderna, and BioMarin.

“Projecting forward, these numbers suggest that the deals volume will be in line with historical averages, although deal values will be significantly higher than pre-2014 levels,” the analyst concludes.

EP News Bureau-Mumbai

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regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

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Preferably in colour, postcard size and with a good contrast.

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RESEARCH I N T E R V I E W

‘The grant award provides an important level of validation to our work’ Botanisol, was awarded an NIH/ NCCIM grant to develop a new anti-inflammatory and possible Non-Steroidal Anti-Inflammatory Drug (NSAID) replacement. P Scott Waterhouse, Chief Executive Officer, Botanisol LLC reveals more to Sachin Jagdale

Botanisol has received NIH/NCCIM grant. What is the eligibility criteria for this grant?

The grant is a competitive award under the US Federal Government's STTR (Small Business Technology Transfer) Program. The purpose is stated as: “STTR's most important role is to bridge the gap between performance of basic science and commercialisation of resulting innovations.”

More details about the programme can be found at the following link: https://www.sbir.gov/ about/about-stt All applications go through a comprehensive scientific review by leading scientists and must demonstrate strong commercial viability. In our case, the application was submitted in early December 2014 with notice of the award on August 10. It is a lengthy, detailed and thorough process. Only US citizens, majority-owned business is eligible for an award. At least 30 per cent of the work must be done in a research institution and at least 40 per cent must be done by the company in companycontrolled facilities.

Besides NIH/NCCIM, do you have any other funding options?

At this time, Botanisol is funded by its founders, as well as a small investment by a venture-focused law firm. We

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are currently seeking investment capital and/or strategic partnerships. The grant award provides an important level of validation to our work and plans that will aid in successfully raising funds. According to our plan, less that $1 million will fund the development needed to get a product to human clinical trials. We believe our research plan will lead to variants of the original compound with other, specific anti-inflammatory properties. In this case, our programme will likely expand beyond the initial discovery and require more funding. We are pursuing this as a regulated, ethical, OTC (US FDA approved) drug candidate. However, it probably qualifies as a dietary supplement (nutraceutical) which could reach the market fairly quickly and at relatively low cost.

What benefits would TAILCx offer over NSAIDs? Could you explain its exact mode of action?

One of the three areas that we will explore with the HIH Grant is the various modes of action for our TAI-LCx compound (and promising variants). The original research/discovery showed that it works by mediating TNF-alpha, PGE2 and IL-6 but does not affect COX2. Our scientists believe that it does not affect COX1, however, will be determined in the grant funded research. The

Our business model is to take the discovery along the preclinical development stages and partner with or license to a larger company for clinical trials and final product development

research will assay for other anti-inflammatory activity and should provide a fairly complete picture. We also expect to measure antiinflammatory response against some existing medications. The original research showed TAI-LCx to be equivalent to or more effective than indomethacin but with a better safety profile. All NSAIDs mediate COX 1 and/or COX 2. The interference with COX expression is the cause of the serious adverse affects from NSAID use which include cardiovascular (due to COX 2 mediation) and gastrointestinal, liver and renal due to (COX 1 mediation). The need for a better drug to treat acute pain has been well documented and known at least since about 2001 with the deaths caused by the Coxhibs (Bextra, Vioxx and Celebrex). It is an area of major interest to the global pharmaceuticals industry.

When is TAI-LCx expected to get commercialised?

Our business model is to take the discovery along the preclinical development stages and partner with or license to a larger company for clinical trials and final product development. This should occur soon, certainly within the next 18 months. The timeline for (human) clinical trials and regulatory approval is difficult to forecast and best

addressed by firms that specialise in the process. If someone were to take TAILCx to the market as a nutraceutical or ingredient, I think they could have something substantial on the market within two years or less. US FDA regulations do not allow for drug development of compounds that are sold as dietary supplements so simultaneous development of the same compound for both markets is not possible.

Is anti-inflammatory the only focus area for your company?

Botanisol provides safer, more affordable medicines to the pipelines of large healthcare companies by applying modern science to known bioactive constituents of plants.

Till now, how much investment has gone into developing TAI-LCx? What is the expected investment till this molecule gets commercialised?

I prefer at this time not to publicly disclose the total investment. The original discovery was funded by NIH under a multiple year programme that totalled $6.8 million. It is not our business model to take drugs candidates all the way through regulatory approval and to commercialisation. sachin.jagdale@expressindia.com

RESEARCH INSIGHT

Myth vs reality of stem cellbased products With stem cell therapy set to become an acknowledged treatment alternative globally for unmet medical diseases, BN Manohar, Managing Director and Chief Executive Officer, Stempeutics Research, opines that it has become increasingly crucial to improve the level of knowledge among doctors about the importance of stem cells

THE TRADITIONAL science of medicine has evolved exponentially, today there is a pill for almost everything that could possibly plague a human body. But when it comes to critical and life threatening or debilitating/degenerative diseases like diabetes, arthritis, muscle degeneration or organ disease, are these medicines offering a complete treatment, or just slowing down the progression of the ailment and creating an illusion of improving quality of life? Most often than not, the latter scenario is true.

This is when an innovative arm of medicinal science walks into the picture – Stem Cell Treatments. This non-traditional approach is much more than just an intervention to give patients temporary relief or delay the effects of the condition. Research so far gives hope that in addition to possibly completely halting the progress of specific medical conditions, it may also be possible to actually reverse the degeneration of tissues/organs, giving birth to the term ‘Regenerative Medicine.’ The world over, scientists and researchers are working aggressively towards unlocking the true potential of stem cell therapies and treatments.

Clinical trials are successfully proving

BN MANOHAR, MD & CEO, Stempeutics Research

the efficacy of stem cells in repairing damaged tissue. Regenerative medicine, is a novel multi-disciplinary field that relies on cell therapeutics and bio-engineering techniques to enhance the functionality of organs and tissues. In technical terms, regenerative medicine as defined by the US NIH is the process of creating living, functional tissues to repair or replace tissues or organ function lost due to age, damage or congenital defects.

Stem cell research is continually advancing knowledge on how an organism develops from a single cell and how healthy cells are derived from precursor cells to replace damaged tissue. All this knowledge and data is then used in developing stem cell treatments for diseases that do not have a cure yet, with an aim to replace /regenerate damaged cells with healthy cells.

Stempeutics Research, which is a

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RESEARCH group company of Manipal Education & Medical Group and a joint venture with Cipla Group, has invested in ground breaking research in this space. The company has spent the last nine years developing innovative stem cell products that could provide a cure for chronic and degenerative diseases. Stempeutics’ stem cell based technologies and products, are under various phases of clinical trials which will put India firmly on the global medical innovations map and potentially revolutionise the treatment protocols for a number of unmet medical conditions.

The most significant breakthrough has been the successful completion of phase II clinical trial of Stempeucel – a novel stem cells based medicinal product, designed to treat Critical Limb Ischemia (CLI) due to Buerger’s disease. Buerger’s Disease is a rare and severe disease affecting the blood vessels of the limbs. It is characterised by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe rest pain and ulcers or necrosis, which finally leads to amputation of the limbs.

Buerger’s Disease is a major unmet medical need in India and globally. Stempeucel treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving blood flow to the affected limbs.

The phase II trial conducted by Stempeutics is the largest ever phase II trial in no-option patients with Buerger’s disease in the world. In the trial Stempeucel demonstrated statistically significant results in ulcer healing, rest pain reduction, increased ankle brachial pressure index (indicator of increased blood flow due to neoangiogenesis) and improvement in quality of life.

Stempeucel is developed from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary

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COMMON MYTHS ABOUT STEM CELL TREATMENTS Myth

All stem cells are from embryos

Reality

Stem cells can be derived from the different tissues including bone marrow, umbilical cord, umbilical blood and dental pulp.The cells are often more effective in developing treatments for major unmet medical conditions

Myth

Stem cell research is illegal and unethical

Reality

This is not true. All research and treatments using stem cells are legal and are always authorized by governing bodies. There were number of controversies revolving around embryonic research earlier, but nowadays research in these areas have been made legal and few clinical trials using Embyronic stem cells are approved by US regulators and are ongoing

Myth

Stem cells are a magic cure for every disease

Reality

Researchers believe that stem cell therapy has the potential to radically change the treatment of human disease. But the practical application of this technology has only just begun and is in a very nascent stage, especially in India. We are hopeful that one day we might be able to cure any disease. However, initial clinical trials are focusing on specific conditions which are major unmet medical needs of the community like Critical limb Ischemia, liver cirrhosis and different heart diseases. Globally, testing in the areas of treatment for macular degeneration, neurological diseases and heart disease are promising, but stem cell companies refrain from making claims until they have hundred percent results

Myth

Stem cells automatically migrate to injuries

Reality

This myth revolves primarily around the homing of stem cells by any route of injection in regenerative medicine to the site of injury.While research and clinical trials do suggest regenerative properties, but homing of stem cells to specific injury site is believed to be very limited due to the environmental cues that exist within the body. Hence, to be more effective, it is ideal to inject stem cells as close to the site of injury as possible.

Today, in cases of critical conditions of organ defect or degeneration, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells offer the possibility of a renewable source of replacement cells and tissues to treat diseases which has no treatment by standard existing therapy.

donors. The drug works by increasing blood flow which is the root cause of diseases and just does not give symptomatic relief, thus proving to be much more effective agent of treatment. Stempeutics’s proprietary pooling technology allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. Stempeucel has a strong patent protection with 18 patent applications filed across the globe. The core patent has been granted in the US, Australia, New Zealand, Singapore, South Africa, China and Japan. In addition, Stempeucel has been given the Advanced Therapeutic Medicinal Product designation by the European FDA and Buerger’s disease has been granted the Orphan Drug Designation (ODD) by the same agency.

Challenges Stem cell related research is in its infancy in India, similar to the IT/ITES industry two decades ago. Stempeutics has faced several challenges including having to convince policy makers about the importance of aggressive R&D including clinical research in this area, ensuring that the company is self-regulated and works to the highest global standards and to invest in a technology that is not even understood well by most people.

As with any new or innovative treatment method, there are a number of myths and misconceptions surrounding stem cell research and treatment. These are mainly due to lack of knowledge among professional doctors as well as end consumers. With stem cell therapy set to become an acknowledged treatment alternative globally for unmet medical diseases, it has become increasingly crucial to improve the level of knowledge among doctors about the importance of stem cells. This in turn will help doctors guide their patients better, give them complete and accurate information and secure a patient right to informed decision making.

RESEARCH RESEARCH UPDATES

Pfizer’s quit-smoking drug not linked to depression or heart risks Chantix reduces both the craving for and pleasurable effects of cigarettes PFIZER’S STOP-SMOKING drug Chantix does not raise risks of heart attack or depression, contrary to previous reports, and should be recommended to more smokers wanting to quit, scientists said.

In a study tracking 150,000 smokers in England for six months, researchers found that patients who took Chantix, known generically as varenicline and marketed as Champix in Europe, were no more likely to suffer a heart attack than those using nicotine replacement therapy or another quit-smoking drug. They were also not at higher risk of depression or self-harm, the study found. Describing

Britain, and generated $647 million in revenue in 2014. Investors had high hopes for the drug when Pfizer first launched it in 2006, but reports of mental health problems in users led FDA officials to order a ‘black box’ warning on the drug’s label in 2009. Two years later, the FDA changed the Chantix label further to add a warning of increased heart risks for people who already have cardiovascular disease.

The latest research, published in The Lancet Respiratory Medicine journal, studied patients who had been prescribed either varenicline or Zyban, an anti-smoking drug fromGlaxoSmithKline known

the study as an ‘extensive analysis’ of the potential risks of Chantix, Aziz Sheikh, Co-director, University of Edinburgh’s Center for Medical Informatics, said he considered it ‘highly unlikely that varenicline has any significant adverse effects on cardiac or mental health.’

“Regulators such as the United States Food and Drug Administration (FDA) should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid,” he said.

Chantix reduces both the craving for and pleasurable effects of cigarettes and is used by heavy smokers who find it difficult to quit. It is one of the biggest-selling stop-smoking drugs in the US and

generically as bupropion, to help them quit, or had used nicotine therapies such as patches, gum or lozenges. Daniel Kotz, a professor at Germany’s Heinrich-HeineUniversity Dusseldorf who also worked on the study, said the findings suggested the risks were low so the benefits of Chantix should be made more widely available.

“Smokers typically lose three months of life expectancy for every year of continued smoking,” he said. “Our research supports the use of varenicline as an effective and safe tool to help people quit.” Smoking kills up to half of those who do it and is predicted to claim up to eight million lives a year worldwide by 2030 if current trends persist.

Reuters

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RESEARCH

Novavax’s vaccine first to protect against common respiratory virus An RSV vaccine represents a $1 billion opportunity in the US and potentially double that worldwide

A VACCINE developed by Novavax was shown to prevent a common respiratory viral infection in a mid-stage study, taking it one step closer to becoming the first vaccine for the virus that affects almost all American children. A vaccine to protect against the respiratory syncytial virus, or RSV, has long eluded developers as deficits in the understanding of the virus' molecular structure and multiple trial failures have come in the way.

An RSV vaccine represents a $1 billion opportunity in the US and potentially double that worldwide, Wedbush analyst Heather Behanna estimated. For most older healthy children and adults, the seasonal infection causes little more than a common cold, but in high-risk groups - including those with weak immune systems,

young infants and the elderly - it can lead to more serious lung and airway infections.

Novavax’s vaccine was similar to or better than a number of respiratory vaccines tested in the elderly, data presented showed.

Armed with this data, Novavax hopes to begin a latestage 8,000-10,000 patient study in the elderly later this year, coinciding with the RSV season in the US. Meanwhile, Novavax is also immunising pregnant women in a separate midstage trial in an attempt to jumpstart infant immunity.

Data from this trial is expected later this quarter. The biotech is aiming for the regulator's fast-track and/or breakthrough therapy pathway, potentially shortening its path towards approval.

Even though vaccine developers have been frus-

trated since the virus’ identification nearly 60 years ago, MedImmune, now part of AstraZeneca, developed a drug that prevents lung infections caused by RSV, but not the RSV infection itself. “If you look at the principle involved in this monoclonal antibody working, you knew if you could replicate that, your vaccine should work ... that's been our big breakthrough," Gregory Glenn, Senior Vice President of R&D, Novavax.

According to researcher Dr Pedro Piedra of the Baylor College of Medicine, who also serves on Novavax’s scientific advisory board, RSV kills fewer people than influenza.

Piedra said between 10,000 and 15,000 elderly Americans a year on average die from RSV, while 20,000-50,000 older adults succumb to the flu.

For the flu we know how antibodies relate to stopping the infection, for RSV we haven’t drawn those correlations yet, Behanna said. “Part of what Novavax is doing for the first time is getting us data to help understand that relationship.”

Reuters

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Scientists use bioengineered yeast instead of poppies to make opioids The new method if more efficient could significantly change the multibillion-dollar pain medication manufacturing business SCIENTISTS HAVE invented a speedy method to make potent painkilling opioids using bioengineered baker’s yeast instead of poppies, but need to fine-tune the process to make it commercially viable, according to a study. The new method, if it can be made more efficient, could significantly change the multibillion-dollar pain medication manufacturing business, but raises concerns about aggravating the growing problem of opioid abuse.

This same type of approach potentially also could be used to make other currently plantbased medicines for fighting cancer, infectious diseases and chronic illnesses. The scientists said they altered the yeast’s genetic make-up in a way that coaxed the cells to convert sugar into two opioids - hydrocodone and thebaine in three to five days.

Hydrocodone, which shuts down pain receptors in the brain, and related chemicals like morphine and oxycodone are part of a group of painkilling drugs called opioids produced from the opium poppy. Making opioids from opium poppies can take more than a year.

“This is important because, with further development, it may provide an alternative supply for these essential medicines and allow greater access for most of the global population that currently has insufficient access to pain medication,” said Stanford University bioengineering pro-

fessor Christina Smolke, who led the research published in the journal Science.

The researchers said they recognised their findings on a quicker process to make opioids could generate concern about worsening the growing abuse of these painkillers.

Smolke’s team inserted DNA into the yeast that encodes instructions for the cells to make the enzymes necessary to perform the sugar conversion steps.

The baker’s yeast was engineered with 23 genes from six different organisms: the brown rat, the goldthread herb, the California poppy, the Iranian poppy, the opium poppy and a soil bacterium called Pseudomonas putida.

The process unveiled by Smolke's team represents ‘proof of principle experiments’ showing that the bioengineered yeast can produce small amounts of opioid painkillers from scratch, Smolke said. Currently, about 4,400 gallons of bioengineered yeast would be needed to yield a single dose of the medication.

Smolke said the process needs to be improved to make it efficient enough for commercial production, saying this could take several years.

Stanford University holds the patents on the technology described by the researchers, who have formed a company to pursue the commercial applications.

Reuters

RESEARCH

FDAapproves longer-term use Roche haemophilia of AstraZeneca blood thinner drug wins fast-track ASTRAZENECA said the US Food and Drug Administration approved a new dose of its blood thinner Brilinta intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome. The FDA approved Brilinta tablets at a new 60 milligram dose that would be taken along with aspirin beyond a year after a heart attack. The drug, which is used to prevent blood clots that can cause heart attacks, strokes and deaths, had previously been approved at a higher dose for use during the first year after a heart attack.

crease sales of the heart drug as patients would be taking it for considerably longer periods than they are now. It would also greatly increase the numbers of patients eligible for the medicine to include those who had a heart attack more than a year ago.

Growing Brilinta is a high priority for the British drugmaker, which has forecast that annual sales of the drug could reach $3.5 billion by 2023. Large clinical studies have shown a clear benefit in reducing heart risk from use of dual blood thinners beyond the first year after an attack.

The expanded approval could help to significantly in-

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Reuters

FDA designation

ROCHE SAID it had won breakthrough therapy designation from the US Food and Drug Administration for an experimental hemophilia medicine, aiming for a piece of the $11 billion haemophilia drug market. The Swiss drugmaker said its USbased Genentech unit’s ACE910 secured the fast-track designation as the company prepares separate phase III trials in 2015 and 2016, the first in patients with haemophilia A with factor VIII inhibitors and the second for patients without inhibitors.

It represents a threat to more traditional treatments from Novo Nordisk and Baxalta, the

target of a $30 billion takeover attempt by Shire. Haemophilia A is a rare genetic disorder that prevents blood clotting. Patients receive lifesaving infusions of clotting factors, but development of inhibitors in many of those being treated interferes with efforts to control their bleeding. Roche’s ACE910 drug is closely watched because it could change the way the disease is treated.

“FDA has granted breakthrough therapy designation for ACE910” Sandra Hornung, Chief Medical Officer, Roche said in a statement.

Reuters

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RESEARCH

First trial targeting mutation,not cancer type,gives mixed results In the new study, researchers focused on a mutation known as BRAF V600, which is a defect in a genetic instruction that tells a cell when to die A POWERFUL skin cancer drug may also be effective against lung cancer and other types of malignancies, according to a novel study that focused on a gene mutation seen in many kinds of tumours. This sort of study is 'the new wave,' said Dr Otis Brawley, Chief Medical Officer, American Cancer Society, who wasn’t involved in the research. “This is the new molecular medicine," he said.

Most cancer drug studies focus on a particular type of malignancy. But projects in recent years to analyse the DNA of various cancer types have found that certain gene mutations appear in many kinds of tumour, and appear to play a role in driving the disease. In the new study, researchers focused on a mutation known as BRAF V600, which is a defect in a genetic instruction that tells a cell when to die. It is most common in metastatic melanoma, but other tumours harbour it as well.

The goal was to see if the drug vemurafenib, already approved for metastatic melanoma cases with the BRAF mutation, would work in other tumours with the same mutation. Among 20 patients with non-small-cell lung cancer, the most common form of lung cancer, 42 per cent of patients showed signs of responding to the drug and average progression-free survival time was 7.3 months, researchers reported in The New England Journal of Medicine.

The response rate was 43 per cent among 18 people with either Erdheim-Chester disease or Langerhans'-cell histiocytosis, both rare cancer-like condi-

34 EXPRESS PHARMA September 16-30, 2015

Different parts of the same primary tumour may have very different groups of mutations tions. Other cancers with the BRAF V600 mutation showed a far more tepid response to the drug, sold in tablet form under the brand name Zelboraf by F Hoffmann-La Roche and Genentech. The companies paid for the trial. Similar studies are in the pipeline and could change the way cancer is treated, Brawley said. “It’s not whether you have pancreatic cancer, or colon cancer or lung cancer that’s going to be important to the treating clinician,” he said. “What’s going to be important to the treating clinician is what's wrong with your tumor at a molecular level.”

The new research is ‘a proofof-concept kind of study,’ he said. “We are going to see more and more things like this someone with colon cancer who didn't do well with the normal treatment may get their tumour analysed and (one) of these small molecule drugs the FDA has approved for some other cancer might be tried,” because it shares a similar genetic defect. Despite the new trial’s encouraging results in lung cancer and two other tu-

mours, much smaller effects, or no effects, were seen in patients with colorectal cancer, brain tumours, multiple myeloma, anaplastic thyroid cancer or bile duct cancer.

“It’s a starting point,” said the study’s lead author Dr David Hyman, Acting Director of Developmental Therapeutics, Memorial Sloan Kettering Cancer Center in New York.

“It’s harder to draw firm conclusions about the effectiveness of vemurafenib in these patients.”

In the cancer types with less response, Hyman noted, the BRAF V600 mutation is typically present in fewer than five per cent of tumours that have resisted conventional therapy and spread, so only those patients would be candidates for the drug. The treatment costs about $11,000 to $12,000 per month.

In a commentary in the Journal, Dr David Hunter of the Harvard TH Chan School of Public Health and Dr Ralph D'Agostino Sr of Boston University caution that newer sequencing studies have found that individual tumours can be very heterogeneous. Different parts of the same primary tumour may have very different groups of mutations, which would further complicate treatment with targeted drugs. Such drugs may block one chemical pathway used by cancer cells to grow and spread, but “if you block one route, (a tumour) can always detour around it,” which is why the benefits of vemurafenib didn’t always last, Brawley said.

Reuters

Hetlioz pill may ease sleep disorder for some blind people The pill won clearance in the US and Europe HETLIOZ, A prescription pill designed to help blind people sleep at night and stay awake during the day, helped some achieve normal sleep rhythms in two company-funded studies. Vanda Pharmaceuticals won US marketing approval for Hetlioz (tasimelteon) last year as a treatment for what’s known as non-24-hour sleepwake disorder, or ‘non-24,’ a chronic circadian rhythm problem that’s common among blind people who don’t have the benefit of light to synchronise their body clocks to the outside world.

drugs that treat serious, rare conditions with limited treatment options. In the two studies Vanda used to seek marketing approval for Hetlioz, Lockley and colleagues examined the effectiveness of the drug in 104 totally blind patients at 27 clinical trial centres in the US and Germany. In the first experiment, researchers asked 84 blind people with non24 to take a pill roughly one hour before bedtime, giving half of them Hetlioz and half a placebo, or dummy pill. Among 40 patients who remained on the drug throughout the study,

“The treatment needs to be taken every 24 hours, at a fixed clock time each day, in order to provide the replacement daily time cue usually provided by the 24-hour light-dark cycle,” lead author of the studies, Dr Steven Lockley of Harvard Medical School, said. European regulators approved the pill last month for totally blind people with non-24. According to the US Food and Drug Administration, the drug stimulates the same cellular receptor as the popular supplement melatonin. The pill won clearance in the US and Europe under accelerated review processes allowed for so-called orphan

eight achieved normal sleep patterns, compared with one out of 38 people on placebo. For the second test, researchers selected 20 blind people with non-24 who achieved normal sleep rhythms with the drug and compared what happened when half of them stayed on the pill while the other half had it replaced with a placebo. During the two studies, both published in The Lancet, the most common side effects of Hetlioz were headaches, elevated liver enzymes, nightmares or abnormal dreams and infections of the upper respiratory and urinary tracts.

Reuters

PHARMA ALLY POST EVENTS

Innovation takes centrestage at PharmaLytica 2015 The innovation gallery was the key highlight of the show THE SECOND edition of PharmaLytica2015, hosted by UBM India, recently concluded at the HITEX exhibition centre. This year's event saw an increase in the number of participating exhibitors, delegates and visitors as compared to last year's edition. The two-day event saw participation from analytical, contracting, biotech and quality control sectors.

The innovation gallery was the key highlight of the show.

Gandhi Automations, Sigma

Scientific Glass, Mack PharmaTech, Caliber Technologies, Biolinx Lab systems and Jofrax showcased their innovative product offerings as part of the gallery. The products were evaluated both by an esteemed panel of jury as well as by popular choice, voted by the visiting participants. AMETEK Test & Calibration Instruments received the Jury’s Choice Award and SRICO Innovative Laboratory Technology received the Visitor's Choice Award.

Yogesh Mudras, Acting Managing Director, UBM India said, “Unveiling and show casing of innovative product offerings at PharmaLytica 2015 by the participating pharma companies further validates the industry need for such a platform to present and parade technological innovations and sector breakthroughs, to both the Indian as well the global markets.”

AMETEK Test & Calibration Instruments has received the jury’s choice award

EP News Bureau-Mumbai

SPDS conducts 3rd Annual International Convention Disso India 2015 Event promotes introduction of new technology, innovation, deliberates on various issues related to dissolution SOCIETY FOR Pharmaceutical Dissolution Science (SPDS) recently conducted its 3rd Annual International Convention Disso India 2015 in Goa. The event aimed to promote introduction of new technology, innovation.

The event also saw deliberations on various issues related to dissolution. It saw the presence of eminent professionals from the pharma industry.

The event was organised under the chairmanship of Salim A Veljee, Director - Food and Drugs Administration, Goa and the Organising Secretary, Anant Naik, Deputy General Manager-Quality, Unichem Laboratories, Goa. The scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD and Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The event comprised plenary lectures, panel discussion and exhibits. Around 150 delegates participated in this mega sympo-

36 EXPRESS PHARMA September 16-30, 2015

Delegates at the event

sium focussing on dissolution.

Dr Prakash Amrut Mody, Chairman and Managing Director, Unichem Laboratories was the Chief Guest of the symposium. Salim Velji, Chairman of the symposium released the scientific abstract book during the inauguration.

Dr Vinod P Shah, Ex US FDA, Pharmaceutical Consultant, US spoke on dissolution data in new and generic drug regulatory submissions: USFDA Perspective; Dr Suresh Venkatram, Chief Scientific Officer, Semler Research,

Bengaluru, India spoke on bio-relevant and discriminating dissolution test methods, Samir Haddouchi, Managing Director, SPS Pharma Services, Clermont Ferrand, France elaborated on dissolution studies for novel drug delivery systems, Dr A Atilla Hincal, Founder and General Manager, IDE Pharmaceutical Registration Biopharmaceutics Consultancy, Ankara, Turkey gave insights on regulatory aspects related to dissolution studies: European perspective, Dr Nevin Çelebi, Gazi University, Faculty of Pharmacy,

Department of Pharmaceutical Technology, Ankara, Turkey spoke on fed and fasted condition dissolution studies, Vijay Kshirsagar, Director and CEO, TRAC Pharma Consulting, Mumbai elucidated on Qbd approach in dissolution studies, Vatsala Naageshwaran, Director of Operations, Absorption Systems, US talked on advancing methods for equivalence of ophthalmic and topical drug products – A new vision for the future, Prof Imre Klebovich, Semmelweis University Department of Pharmaceutics, Bu-

dapest, Hungary spoke on predicting drug interactions from dissolution studies, Dr Sandip Tiwari, Actavis Laboratories FL, Florida, US informed on recent innovations in dissolution testing, Dr Constantin Mircioiu, President, Pharmaceutical Dept.

Academy of Medical Sciences, Bucharest, Romania discussed on statistical sampling and dissolution data analysis, Makarand Avachat, Sr Vice President, R&D - Formulations, Lupin Laboratories gave insights on linking CQA and CPP to clinically relevant dissolution method, and Umesh Banakar, Professor and President, Banakar Consulting Services, US talked on beyond guidances: Convincing regulatory authorities of data interpretation and data integrity.

During the event, a deskbook of pharmaceutical dissolution science and applications was also released at the hands of Mody.

EP News Bureau-Mumbai

PHARMA ALLY VALUE ADD

Changing production strategies: New challenges in sterile filling Sieghard Schuchmann, Managing Director — OPTIMA pharma, elaborates on the new system concepts for dosing and packaging processes, which have been developed to meet current market requirements INCREASED FLEXIBILITY represents nothing less than a paradigm shift in the pharmaceuticals industry. As part of this transition, complete production facilities for new drugs are being realised or redesigned for maximum flexibility. What isn’t changing, however, are the high standards for product quality and patient safety, which must continue to be achieved as (cost-) efficiently as possible.

New system concepts for dosing and packaging processes have been developed to meet the new market requirements.

Modular machine engineering There is a fundamental difference between producing blockbuster drugs and small batches of niche products, as is typical for biopharmaceuticals. Of key importance in this scenario are the filling and packaging processes, which also play an important role in successful flexibilisation strategies. But it takes a diverse range of updated technologies and new system types to achieve something as “simple” as flexibility.

Most system concepts have not been developed with frequent format and product changes in mind. The filling and packaging equipment in facilities of the future need to be able to convert to new products in a simple, fast and reliable manner, especially considering that machine downtime is a critical factor in cost-effective manufacturing.

Making pharma machinery

more modular and flexible is essential to a multi-product manufacturing strategy. Modularisation is the answer for projects where it is initially not clear what formulation will be used for a pharma or what quantities will be produced.

Even more time and cost savings can be achieved if custom solutions do not need to be developed. Modular machine engineering is possible in numerous applications, making faster and more inexpensive production possible.

Optima pharma’s INOVA SV 125 machine model has recently been refined into a modular machine platform. It is compatible with the four most common filling systems: rotary piston pumps, peristaltic pumps, mass flow and time pressure systems. Furthermore, the SV machine type has been optimised for processing vials, prefilled syringes and cartridges Modular systems can be easily extended and added to enhance functionality and increase output. This means the INOVA SV 125 can first be set up with two filling points and then later expanded to 10, which corresponds to an out-

Variable functions and output

put of max. 20,000 containers/hour. The same holds true for functionality, which can be modified or extended depending on the pharma classes and container types to be processed.

The new OPTIMA H4-10 presented this year at Interphex in the US and Achema in Frankfurt goes a step further.

Its design is as flexible as the INOVA SV and it can accommodate the same filling systems.

The OPTIMA H4-10, however, is also able to integrate a standardised, space- saving robot in the filling machine section to remove the tyvek wrappers from the tubs. The standardised machine base also makes it much easier to set up any kind of containment device type, including isolators, CRABs and ORABs. Project execution is considerably simplified thanks to predefined connections and preproduction of standardised components.

The transport system in the OPTIMA H4-10 originates from a high- output machine.

It has been mechanically simplified yet boasts the same gentle handling without containers coming into contact with one another. The output range is higher than that of the INOVA SV125, 24,000 containers/hour are processed at 10 positions, but can be in-

The filling and packaging equipment in facilities of the future need to be able to convert to new products in a simple, fast and reliable manner, especially considering that machine downtime is a critical factor in cost-effective manufacturing

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creased to 36,000 containers/hour. Filling formats range from 0.5 to 50 ml.

Overall, this means the OPTIMA H4-10 combines the technology and design of highperformance machines in a modular, cost-effective model.

The high-performance INOVA H6-10 and H10-16 machines likewise come with flexible options.

The INOVA 125 and OPTIMA H4-10 feature the following options: ◗ Manual, semi-automatic or automatic unpacking ◗ Manual, semi-automatic or robot removal of tyvek wrappers ◗ Filling and closing with or without vacuum ◗ Syringe assembly, including if needed insertion of plungers, attachment of finger flanges, backstop locks and safety devices ◗ Optical and sensor inspection systems ◗ Labeler for identification and track and trace systems ◗ In-process control ◗ Barrier systems: isolators, O-RABSs and C-RABS can be used

The next step: Multiuse fillers Optima pharma is pleased to expand its range of modular machine platforms with the new multiuse filler series. The focus is on three areas of application with a high demand for flexibility: ◗ Clinical studies, laboratory filling ◗ Production Lines

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PHARMA ALLY ◗ Personalised medicine Superior flexibility is a fundamental feature of all multiuse fillers. The series includes base versions designed for either processing of nested containers or bulk processing.

They take into consideration key aspects such as maximum utilisation of available product quantities, fast format changeovers and production scalability.

controlled by special algorithms that today are an integral part of the company’s extensive wealth of expertise.

Maximisation of product yield, new isolator technology and new approaches to freeze drying also reflect the new demands on system equipment.

As a turnkey supplier, OPTIMA pharma can supply all of the above mentioned solutions.

Single-use technologies

Quick product changeover

A major advance in multiproduct manufacturing has been the introduction of single-use technologies. Peristaltic pumps and single-use product supply lines for filling and dosing are indispensable in many modern biopharma applications.

For frequent format and product changeovers, they help reduce costs and minimise cross-contamination risks.

Optima pharma recognised the importance of this development early on and developed its own peristaltic pumps for the product portfolio. Filling accuracy is of key importance in this area and is

It is often tiny details in a system that makes the difference between cost-effective and uneconomical production.

An example of intelligent integration of a disposable product path. To allow for quick format changes, the hose pumps in an isolator-equipped system were located outside the protected area. Sterility when changing disposable materials is maintained thanks to the RTP port and the beta bag. Format changeovers of all parts in contact with product in this complex filling and closing system can be completed in just 15 minutes.

PRODUCT

MeasureTest Corporation launches advanced 100 LPM airborne particle counter MEASURETEST Corporation has launched Lighthouse USA Model 3350, which can measure down To 0.3 Micron @ 100 Lpm flow rate.

Lighthouse model 3350’s most sensitive threshold for 100 lpm flow rate is 0.3 microns. Lighthouse counting efficiency for 0.3 microns is 50 per cent and for 0.5 microns it is

38 EXPRESS PHARMA September 16-30, 2015

100 per cent. Lighthouse sensors have the industry’s longest laser diode life of 20+ years MTTF based on continuous 24/7 operation. So maintenance costs are low. An attractive feature of the Lighthouse portable counters is selective printing where just two channels can be printed say 0.5 and 5 microns out of the six chan-

nels if desired. Sampling can be done in terms of time or volume.

Contact details MeasureTest Instruments 94, Atlanta Nariman Point Mumbai 400 021 Phone: 022-2202 7982 Email: sheesh@mtnl.net.in

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PHARMA PLANT AVAILABLE FOR SALE (ON “AS IS WHERE IS BASIS”) A fully integrated formulation plant, suitable for production of tablets, capsules and oral liquids, is available for sale near Village Kachivani Singaram, Ghatkesar Mandal, Ranga Reddy District, Hyderabad. Spread over 1½ acres land, the built up area of the plant is around 28,500 sq. ft. The plant can produce up to 10 crores of tablet/capsules per annum and 75 lakhs bottles of oral liquids per annum.

We are ready to sell the land & building and plant & machinery separately.

If Interested,

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Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

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PHARMA LIFE APPOINTMENTS

Cipla appoints new management team Vohra will be the global chief financial and strategy officer and Jha will take over as global chief people officer CIPLA HAS appointed Umang Vohra as global chief financial and strategy officer and Prabir Jha as global chief people officer effective October 1, 2015.

In addition to the finance role, Vohra will be responsible for strategy, portfolio, business development, mergers and acquisitions and business technology. Until recently, Vohra was the Head of the North America business for Dr

Reddy’s. Prior to this, Vohra was the global CFO of Dr Reddy’s for four years. He also worked with PepsiCo and Eicher Motors.

In addition to providing leadership to the human resources function globally for the company, Jha will lead the corporate communications and Administration functions as well. After a decade long tenure as a civil servant, he has

pursued a corporate career in human resources.

As the Chief HR Officer at some of the country’s leading corporations like Dr Reddy’s, Tata Motors and most recently, Reliance Industries, Jha has built a good reputation as an organisation transformation strategist and a very progressive HR practitioner.

Umang Vohra

Prabir Jha

EP News Bureau-Mumbai

Bosch Rexroth appoints Hans Bangert as MD He joined Bosch in 1982 and has since then successfully established and led many innovative projects HANS BANGERT has been appointed as the managing director of Ahmedabad-headquartered Bosch Rexroth.

Bangert comes from Bosch Rexroth Denmark- the regional subsidiary Nordic where he was managing director. He will concentrate on driving growth for Bosch Rexroth in India by focusing on different market

segments relevant to the company.

Bangert holds a master’s degree in mechanical engineering from the University of Ruhr, Bochum. He joined Bosch in 1982 and has since then successfully established and led many innovative projects. He has held several positions at both Bosch and Rexroth and

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has abroad experience in leading product development, technology development, production and manufacturing processes at various divisions of Bosch.

During a career span of over 33 years, he has served as managing director, worldwide in various Bosch Group Companies. Bosch Rexroth in India

provides complete Drive and Control solutions, serves customer through manufacturing facility at Ahmedabad and customised unit in Bangalore with wide spread sales and service offices, dealer’s network all over India.

EP News Bureau-Mumbai

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PHARMA LIFE AWARD

IPAbags Best Association Award The award was conferred to IPA in the first year of its inception INDIAN Pharmaceutical Association (IPA) has bagged the maiden Best Association Award at the 5th India Association Congress, which was held recently in Bangalore. Dr Rao VSV Vadlamudi, President – IPA, TB Nair and Kaushik Desai, Honorary General Secretary – IPA received the award.

IPA was conferred with the award in the first year of its inception.

India Association Congress (IAC) is organised by CIMGLOBAL every year with participation from association lead-

ers and stalwarts representing various associations of engineering, health, construction, plastic, machinery, information technology etc. The two-day event covered various topics and challenges through interactive panel discussion and participative workshop stressing on areas like membership strategy for recruitment and retention, global practices, marketing skills to generate member participation and resource mobilisation, corporate social responsibility initiatives and other subjects like successful

organisation of meetings and importance of leadership.

The inaugural address was given by Prof Rajeev Gowda, Member of Rajya Sabha and professor of economics with Indian Institute of Management, Bangalore. Prof AK Sood, Professor, Indian Institute of Science, Bangalore was the keynote speaker on nano technology. The congress was attended by more than 200 participants from various associations.

TB Nair, Kaushik Desai and Dr Rao VSV Vadlamudi receiving the Best Association award during the congress

EP News Bureau-Mumbai

CAMPUS BEAT

Biocon Academy opens enrollment for biosciences programme The admission process for Batch 6 will be on till October 31, 2015 and classes will commence on January 11, 2016 BIOCON ACADEMY, a Centre of Excellence for Advanced Learning in Applied Biosciences set up by Biocon in 2013, has opened enrollment for Batch 6 of its flagship ‘Biocon-KGI Certificate Program in Biosciences.’

The admission process for Batch 6 will be on till October 31, 2015 and classes will commence on January 11, 2016.

Biocon Academy leverages the technical expertise and industrial leadership of Biocon along with the strong academic excellence of its international education partner Keck Graduate Institute (KGI) in California, US, to make biotech students industry-ready. The academy’s ‘Biocon-KGI Certificate Program in Biosciences’ is a 16-week, full-

60 EXPRESS PHARMA September 16-30, 2015

time certificate programme that offers a broad-based international curriculum encompassing industrial processes, production, quality assurance, regulatory affairs and product development.

Both freshers and biotechnologists with some initial experience can enroll for this programme to sharpen their skills and advance their learning. Interested candidates can apply online through the Biocon Academy website (www.bioconacademy.com). Students with a BE / B Tech in Biotechnology or Industrial Biotechnology; M Sc in Biotechnology / Microbiology / Biochemistry / Biology; and B Pharm with a CGPA of 7.5 on a scale of 10 (71 percentage) and above are eligible to apply

Both freshers and biotechnologis ts with some initial experience can enroll for this programme to sharpen their skills and advance their learning

for the course.

Online applications will be screened by academic experts and shortlisted candidates will have to successfully clear the interview stage to be selected for the course. Biocon offers a scholarship that covers up to 75 per cent of the course fee for selected candidates.

SS Easwaran, Academic Director, Biocon Academy, said, “The biosciences programme is a bridge from academia to the biotechnology industry for biosciences students as it enhances education outcomes through experiential learning methods. Till date, 120 young biotech professionals have benefited from the intensive 16-week course and have readily found employment

with reputed global biotech/ pharma companies. The feedback from employers is also extremely positive. ” Dr Meghana Joshi, Program Director, Keck Graduate Institute (KGI), said, “The BioconKGI programme is an extension of the programmes conducted

by KGI in the US and offers a good opportunity for biosciences students in India to develop a deeper understanding of the biotech industry and the overall business of science. Early in their career, students benefit both from the varied background and experiences of the faculty as well as the mentorship of subject matter experts from Biocon.”

EP News Bureau-Mumbai

pharmaceuticalconferences.com

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Wishing you all a Healthy and Happy Living !!!!!

OMICS

Promoting Pharmaceutical Research through OMICS International Open Access Journals and Global Pharma Events

International:

W

e work on a larger and far bigger canvas and paint only healthy and cheerful pictures. We capture those joyful and active moments of the children, youth, and aged free from physical and mental disabilities and disorders. Our motto is to transform the fundamental research from the pharmaceutical laboratories into medical and healthcare strategies that reach people efficiently and effectively. OMICS International put extra efforts in making these dreams a reality by offering worldwide online open access forums to bring the pharmaceutical innovations through its peer reviewed Open Access Journals, where the aspiring scholars and scientists get valuable information, well researched, yet free from all subscription hurdles. Our worldwide science events are reaching the nook and corner of the globe through conferences, symposia, seminars, workshops, tradeshows and exhibitions where academia, research and corporate world meet on a common platform to share and exchange knowledge.

Accelerating Pharmaceutical

Apart from knowledge sharing, we promote networking, collaborations and entrepreneurial development of small and medium players in this field. Our trade shows and exhibitions are always ahead of others in promoting the latest pharmaceutical discoveries and innovations. Through its 700+ Open Access Journals and over 1000+ Global Events, OMICS International is a global player meeting the local pharmaceutical needs.

With 300+ Pharmaceutical Events annually, OMICS International aims to attract the attention of the leading personalities in this field. Our tradeshows and exhibitions at these conferences are of immense help in promoting their products and services.

OMICS International firmly believes in collaborating with likeminded academic, research and corporate, government and non-government agencies and it has entered a progressive alliance with more than 1000 such bodies worldwide.

300+ Pharmaceutical Journals

Research for a Healthy Living!

300+ Pharmaceutical Conferences 6th Analytical & Bioanalytical Techniques Conference September 01-03, 2015 Valencia, Spain 4th Medicinal Chemistry & Computer Aided Drug Designing Conference November 02-04, 2015 Atlanta, USA 2nd Past and Present Research Systems of Green Chemistry Conference September 14-16, 2015 Florida, USA Biopharmaceutics Conference September 21-22, 2015 Baltimore, USA Pharmaceutical Summit and Expo October 08-10, 2015 New Delhi, India 3rd Pharmacognosy, Phytochemistry & Natural Products Conference October 26-28, 2015 Hyderabad, India 4th GMP, GCP & Quality Control Summit October 26-28, 2015 Hyderabad, India 4th Biologics and Biosimilars Conference October 26-28, 2015 Baltimore, USA Pharma Middle East Congress November 02-04, 2015 Dubai, UAE 3rd Clinical Pharmacy Conference December 07-09, 2015 Atlanta, USA 8th Pharmaceutics & Novel Drug Delivery Systems Conference March 07-09, 2016 Madrid, Spain Industrial Pharmacy Conference April 11-12, 2016 Dubai, UAE Cosmetology, Trichology & Aesthetic Practices Conference April 25-27, 2016 Dubai, UAE

Biochemistry & Pharmacology: Open Access Journal Medicinal & Aromatic Plants Pharmacovigilance Bioequivalence & Bioavailability Pharmaceutical Regulatory Affairs: Open Access Clinical & Experimental Pharmacology Pharmaceutica Analytica Acta Cardiovascular Pharmacology: Open Access Clinical Pharmacology & Biopharmaceutics Pharmacogenomics & Pharmacoproteomics Bioanalysis & Biomedicine Biomolecular Research & Therapeutics Alcoholism & Drug Dependence Drug Metabolism & Toxicology Advances in Pharmacoepidemiology & Drug Safety Developing Drugs Pharmacoeconomics: Open Access Pharmacological Reports Pharmacokinetics & Experimental Therapeutics Pharmacognosy & Natural Products Current Trends in Nutraceuticals International Journal of Drug Development & Research International Journal of Applied Biology and Pharmaceutical Technology Research & Reviews: Journal of Pharmacy and Pharmaceutical Sciences Research & Reviews: Journal of Pharmacognosy and Phytochemistry Research & Reviews: Journal of Pharmaceutics and Nanotechnology Research & Reviews: Journal of Pharmaceutical Quality Assurance Research & Reviews: Journal of Pharmaceutical Analysis Research & Reviews: Journal of Hospital and Clinical Pharmacy Molecular Pharmaceutics & Organic Process Research Pharmaceutical Care & Health Systems Drug Designing Neuropsychopharmacology & Mental Health Applied Pharmacy International Journal of Research & Development in Pharmacy & Life Sciences Biochemistry & Pharmacology: Open Access Journal Biochemistry & Pharmacology: Open Access Journal

OMICS International Conferences in India 6th World Congress on Biotechnology October 05-07, 2015 New Delhi, India 7th Indo- Global Summit and Expo on Food & Beverages October 08-10, 2015 New Delhi, India Pharmaceutical Summit and Expo October 08-10, 2015 New Delhi, India 6th Indo Congress and Expo on Dental & Oral Health October 19-21, 2015 Bengaluru, India 7th Indo-Global Diabetes Summit and Medicare Expo October 19-21, 2015 Bengaluru, India 4th International Summit on GMP, GCP & Quality Control October 26-28, 2015 Hyderabad, India 2nd Indo-Global Summit & Expo on Veterinary October 26-28, 2015 Hyderabad, India 3rd International Conference and Exhibition on Pharmacognosy October 26-28, 2015 Hyderabad, India 9th Indo-Global Summit on Cancer Therapy November 02-04, 2015 Hyderabad, India 8th Indo-Global Summit and Expo on Vaccines & Vaccination November 02-04, 2015 Hyderabad, India

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