Wednesday, July 4, 2012

AMRI further expands discovery capabilities in India

RECRUITMENTS:

 

As part of a long-term strategic plan to further discovery capabilities in India, Albany Molecular Research, Inc. (AMRI), a global contract research and manufacturing organization offering customers fully integrated drug discovery, development and manufacturing services, has announced the hiring of two experts in medicinal and computational chemistry at its research center located in Hyderabad (HRC).

 

Simultaneously, the company announced the completion of the relocation of custom library synthesis resources and capabilities to HRC from the company's Budapest (Hungary) operations.

 

"The new hires and relocation of resources provide additional flexibility to enhance productivity and client service for AMRI's global drug discovery operations, which draw upon a broad spectrum of service capabilities from multiple sites," the company stated in a press release.

 

Dr. Srinivas Nanduri, Ph.D., has been hired as Director of Medicinal Chemistry in India, reporting to Mr. Subramanyam Maddala, President of India Operations. In addition, Dr. Suneel Kumar Bommisetty, Ph.D., was hired as Senior Research Associate of Computational Chemistry, reporting to Dr. Nanduri.

 

These newly created positions are expected to further strengthen AMRI's capabilities in problem-solving medicinal chemistry and complement its current strength in custom synthesis at HRC.

 

"Dr. Nanduri and Dr. Bommisetty bring a high level of medicinal chemistry expertise, a strong track record of industry experience and additional drug discovery project management experience to the Hyderabad site," Mr. Maddala said. "AMRI is committed to providing best-of-class services to our customers, and servicing the entire value chain of contract research services. These additions enhance our capabilities to move towards that target."

 

LOOKING AHEAD

Favourable outlook forecast for Indian pharma industry

 

The outlook on the Indian pharmaceutical industry remains favourable, according to a new report by ICRA & Moody. Domestic formulation market grew by 13-16% per annum in last five years and is valued at Rs. 58,300-crore. It is ranked third in terms of volume and tenth in terms of value, globally. The domestic growth was driven mainly by expansion in volumes and new introductions. Lifestyle-related disorders are driving growth at faster pace in chronic segments along with increasing healthcare spending, the report said.

 

Product patent regime was not seen as a major constraint; companies have not been affected as existing products continue to exhibit extended life cycle and companies continue to launch novel combinations to support growth. Moreover, a limited number of products have been launched under patent protection in India.

 

The report expects domestic companies to face challenges and competition from regulatory driven price cuts, smaller players' aggression and MNC generic majors coming in to tap the $12-13-bn market growing at 14-15% per annum.

 

MNCs have stepped up their focus on the Indian market as they are pursuing a comprehensive strategy. They are focusing on chronics, branded generics and launching patented products from portfolio of parent companies, expanding their field force and focusing on Tier-II as well as Tier-IV towns. Even as the domestic market grew at 15%, MNC pharma revenue grew at 18.7%, the report indicated.

 

SETBACK

Natco Pharma loses US patent suit filed by Teva

 

Natco Pharma has lost a patent infringement suit in the US filed by Israeli pharma major Teva over sale of generic version of 'Copaxone', a drug used to treat multiple sclerosis.

 

In a ruling delivered on June 22, 2012, the US District Court, New York, upheld the contention of Teva Pharmaceuticals that Natco's abbreviated new drug application (ANDA) for Copaxone infringed all asserted claims of Teva. The Hyderabad-based company had filed an ANDA for Copaxone with its partner, Mylan Inc, in June 2008 and obtained a Para IV certification, which challenged the existing patents held by Teva.

 

The ruling might have repercussions on Natco's court case at Delhi High Court, where it is locked in a patent infringement suit with Teva over the same drug. Natco said it will appeal once the court's full order is available.

 


SEEKING FUNDS

Higher allocation sought for biotech sector in 12th Plan period

 

The Department of Biotechnology (DBT) is pressing for a three-fold increase in allocation for the 12th Five Year Plan. "Considering the maximal utilisation of allocations and implementation trends of the Department, increasing needs of bio-industrial development and clearly focused programmes for 12th Plan, the working group of the Planning Commission has recommended an investment of Rs. 17,887.81 crores for 2012-2017 at the rate of three-fold fold increase over 11th Plan allocation," a senior official of the DBT said.

 

Higher budgetary allocations (Rs. 6,389-crore) for the 11th Plan as compared to 10th Plan (Rs. 1,653-crore) had aided major expansion of programmes for the biotech sector. The achievements included seven new autonomous R&D institutions, 10 translational research centres and platforms, grand challenge mission mode programmes, 50 centres of excellence, more than 2,400 R&D projects in priority areas involving more than 3,000 investigators and 6,000 research personnel, 100 public private partnership projects and key global partnerships involving high investments. These major government initiatives helped biotech industry revenues increase from Rs. 8,541-crore in 2006-07 to Rs. 17,249-crore during 2010-11.

 

The main emphasis of 12th Plan is scaling up of existing successful schemes by at least three folds and starting of several new initiatives in human resource development; expansion and establishment of new generation research resources, facilities and services; major support to universities and institutions for interdisciplinary research in medical sciences and biopharmaceuticals; mega national projects on mission mode in specific areas of chronic diseases, agriculture productivity, climate change, bioengineering and bio-fuels; sustained support to newly established autonomous institutions and expansion of existing institutions for setting up innovation and translational centres.

 

SUPPORT FOR START-UPS

New scheme launched to drive early stage innovation in biotech sector

 

The 'Biotechnology Industry Research Assistance Council' (BIRAC), recently set up by the Department of Biotechnology (DBT) to stimulate research and innovation capabilities of the Indian biotech industry, has launched the Biotechnology Ignition Grant (BIG) scheme for igniting new ideas in biotechnology. The scheme is for potential entrepreneurs from academia, start-ups or an incubatee (researchers, PhDs, medical degree holders, biomedical engineering graduates) who have an exciting idea, which may be in the nascent and planning stage, and there is an unmet need for mentorship and initial funding. The scheme will help to support and nurture these high-risk early starters and their concepts.

 

The main aim of the scheme is to establish and validate proof-of-concept and also to enable creation of spin-offs. The scheme supports only up-to proof-of-concept stage.

 

BIRAC will issue a national call for BIG scheme at least twice each year. The scheme would be implemented through partners called the BIG Partners, across the country. Centre for Cellular and Molecular Platforms (C-CAMP), Bangalore; Foundation for Innovation and Technology Transfer (FITT), New Delhi; and IKP Knowledge Park, Hyderabad are the current BIG Partners. Established recently as a 'Not-for-Profit' Section 25 company, BIRAC is the DBT's inter-face agency for supporting industry-academia interaction, and will serve as a single window for the emerging biotech industry in the country.

 

Daiichi Sankyo to market Ranbaxy products in Venezuela

 

Daiichi Sankyo's subsidiary, Daiichi Sankyo Venezuela SA, will commence marketing of Ranbaxy products in Venezuela – the third largest market in Latin America – as part of the hybrid business model. Till now, Ranbaxy has been marketing the products in Venezuela through a local distributor.

 

Daiichi Sankyo has started its business in Venezuela prior to the other Japanese pharmaceutical companies and has built its presence with innovative pharmaceuticals such as the hypertension medicine 'Benicar' (olmesartan medoxomil). Daiichi Sankyo will now also focus on expanding Ranbaxy's portfolio of medicines to promote the hybrid business model, encompassing both innovative and established pharmaceuticals to expand and strengthen its presence in Venezuela.

 

DIFFERING VIEWS

India, Brazil and China defend generic drugs at WTO

 

India, Brazil and China have defended the right of poor countries to access cheap generic medicines at the World Trade Organisation (WTO), resisting attempts by the US, Japan and some other developed countries to club counterfeits or copies of patented drugs with fake or spurious ones. "The cases of seizure of high quality generic or off-patent drugs by third countries that hold patents for these could gain legitimacy if counterfeits are confused with fakes," an Indian official said.

 

In a recent meeting of the WTO's Trips Council, developed countries such as Canada, Switzerland and the EU said they considered counterfeiting to be one of the most serious problems to be discussed by the council. These countries said counterfeit medicines not only cause economic loss, but also put the lives of patients at risk as they could be "dangerously sub-standard".

 

India, Brazil and China, however, argued that infringing intellectual property rights should not be confused with sub-standard products and the issue of fake drugs should be discussed at other forums and not the WTO.

Changing definitions

Interestingly, many developed countries, led by the US and the EU, had earlier tried to convince WHO to include fake drugs in the definition of counterfeits. India, with the support of countries like Thailand and Indonesia, managed to convince the WHO that merging of definitions was not only unwarranted, but could also be counterproductive in terms of supply of cheap medicines to the poor.

 

Counterfeits are copies of patented drugs that may have infringed intellectual property rights of patent holding companies. However, a product that is considered a counterfeit in one country may not necessarily be so in another as it may be off-patent there. Therefore, if counterfeits are considered as fake, countries that hold patents to particular drugs could destroy consignment of copycat version of those drugs that pass through their ports on health grounds without fear of retribution.

 

FEE-BASED SYSTEM

Indian drug firms amenable to US law on enhanced inspection

 

The Indian generic drug industry is generally receptive to the proposed US law on medicine even though it seeks to enhance US-FDA inspection of the manufacturing facilities globally for a fee. Industry players and analysts feel that while the level of inspection by the US-FDA will increase, the clearances will be faster to enable expeditious exports of the generics to the world's biggest and most lucrative market.

 

The 'FDA user fee reauthorisation bill', which has been cleared by US House of Representatives, now goes to the US Senate for voting. By taking a fee for new drug filings and for foreign inspections, the US-FDA will build resources it needs to complete inspections fast.

 

According to estimates, the FDA could collect around US$6.4-bn in fees from companies all over the world over the next five years. According to industry estimates, the FDA currently has a backlog of roughly 2,700 generic drugs awaiting review.

 

FRAMING RULES

Technology transfer might not be mandatory for FDI in existing pharma firms

 

An inter-ministerial group set up to frame rules on FDI (foreign direct investment) for brownfield proposals in the pharma sector has decided to do away with the mandatory transfer of technology by the foreign investor to the target company. A brownfield investment means acquiring or buying stake in an existing company.

 

The group has said the clause mandating the requirement proposed by the health ministry would restrict foreign investors and compliance would be difficult to monitor. However, the group has imposed riders on the quantity of generic drugs a foreign company must produce for the domestic market and the enhanced investment in research and development it must make.

 

The group was formed after there were major delays in the clearing of FDI proposals due to differences between the health ministry, which favoured stiff riders, and other departments keen on a liberal regime.

 

In November last year, the government had made FDI in brownfield pharma companies stricter by putting it under FIPB (Foreign Investment Promotion Board) scrutiny and moving it out of the automatic approval route. However, amid growing inter-ministerial differences, the Commerce Ministry decided to set up the said group with representatives from the health ministry, the Department of Industrial Policy & Promotion (DIPP), the Department of Pharmaceuticals and others.