2010 Business Agenda : Roadmap for R& D

2010 Business Agenda : Roadmap for R& D

Indian pharma has to innovate for long term sustenance

So we should capitalize on natural resources in India, balance NCE with NBE research and focus on NDDS, advises Dr Veena Agarwal, Senior Vice President, Strategy and Business Development, and Dr Girish Mahajan, Group Head, Department of Natural Products, Piramal Life Sciences

Historically, the focus on “reverse engineering” amongst Indian pharmaceutical companies in order to provide affordable medicine to Indian consumers has restricted the amount of “innovative” R&D. Indian companies had preferred to stay away from the new drug discovery and development business segment, which involve sizeable investment of money and time coupled with very high risk of failure. However, since 2005 the drug discovery efforts for getting NCEs have accelerated. Patent reform has forced Indian pharma to rethink its strategy, which is to innovate for long term sustenance. Indian companies might want to think about following approaches:

In addition to synthetic chemistry and combinatorial chemistry, companies should try to capitalize on natural resources in India in order to find NCEs. For example Piramal Life Sciences limited (PLSL) is fishing microbial and plant products for NCEs other than using synthetic molecules. PLSL has demonstrated that natural resources can give a competitive edge in finding new leads. As far as New Biological Entity (NBE) research is concerned, some companies are focusing in this area. Shantha Biotech’s success in the area made it an attractive target to be acquired by large pharma Sanofi-Aventis. There are few companies like Biocon and Lupin which are very active in this area. Many of the companies are in the process of capability building, front-end for marketing, back-end for technology. Right balance between NCE and NBE research is probably needed.

Drug delivery system and drug development are two parallel streams but depend intrinsically on one another. Successful development of Novel Drug Delivery System (NDDS) can rejuvenate even the shelved drugs. For example, persistence of amphotericine B (toxic and poorly soluble antifungal) through various delivery systems from simple bile salt complex to cochleates through liposomes is an ideal example of role of NDDS in pharma business. Therefore, the efforts on NDDS should be continued.

From the Pharma Summit 2009 held by the Confederation of Indian Industry (CII) in Mumbai, it has become apparent that the Indian pharma sector has demonstrated the potential to emerge as one of the world’s leading and fastest growing markets and formed an integral part of drug development, manufacturing and supply chain. Indian companies are looking at products with high technological barriers and limited competition to generate steady cash-flows. We expect companies with higher proportion of chronic and lifestyle product sales, better supply chain management and higher revenue per sales force to lead the pack. Chronic therapeutic segments like anti-diabetic, CVS, CNS and lifestyle diseases like gastro-intestinal are expected to drive growth of the domestic markets. Moreover anti-infectives (anti-MRSA, anti-TB and anti-malaria etc.) are likely to maintain their prevailing position in the market. Importantly, Indian pharma has also been working on cancer, a therapeutic segment of high unmet medical need, and poorly diagnosed in India. For example 200,000 out of 500,000 worldwide new cases of head and neck cancer are diagnosed annually in India. Company like PLSL’s primary focus is on cancer, and its lead molecule is in four Phase II trials for different cancer indications in different countries.

India’s pharma industry needs to ensure that ongoing “rapid and cost effective” value proposition is sustainable and scalable. For the same reasons, in the recent years many multinational companies have entered into alliances with Indian companies such as PLSL and Lilly for clinical development in the therapeutic area of metabolic disorders; PLSL and Merck for R&D collaboration for cancer, Torrent and AstraZeneca for discovery collaboration for novel drug candidate for the treatment of hypertension; Advinus and Merck for developing drug candidates for metabolic disorders, Zydus Cadila and Lilly for the development of novel molecules for cardiovascular diseases, Jubilant and Lilly to discover molecules for cancer and metabolic disorders. In 2010 Indian companies should try to set up more R&D collaborations, and strengthen their capabilities in drug discovery and development. The collaborative model can mitigate the risks of failure and bring in the required investment.

In conclusion, it will be prudent for Indian pharma to have a diversified pipeline focusing on unmet medical needs for diseases such as cancer, TB, malaria, diabetes, and tropical diseases etc. for both developing and developed countries. The success of Indian pharma will depend on innovative thinking, good management, and close partnerships with the government and academic institutions.