The process of drug discovery is fraught with uncertainties, but that doesn't deter drugmakers from diving deeper into it. Coming up with novel therapies is the most crucial aspect in the drugmaking business, and that’s why big pharma firms were historically reluctant to gnaw deep into their R&D spends, despite drastic cuts in other areas of the workforce, forced by flagging sales in these trying times.
Maybe the inevitability of innovation is one good reason for Indian companies to get more aggressive in the drug discovery arena these days. Although they have earned quite a reputation as masters in producing look-alikes by successfully replicating established formulas, drug firms here are yet to come out with a self-made, all-new drug product in the market. The prohibitive cost and risk involved in bringing a molecule from lab to the chemist's rack is often cited as the impeding factor. A limited R&D budget does not allow them to undertake such a risky proposition to its logical conclusion.
Now India's generic chieftains are rolling up their sleeves for the high-risk, high-reward drug discovery game, albeit in their own manner, if the sudden spurt in R&D investment by certain companies is any indication. Piramal Healthcare makes a striking example. After selling off its entire formulations business to Abbott Laboratories in 2010, this Mumbai-based firm has steadily been raising the outlay for drug discovery research. For the financial year 2012-13, the company has planned an R&D budget hike of as much as $39 million (from about $24 million last year) to fund studies on three prospective oncology candidates. Two of the molecules, including one that seeks to beat resistance against the breakthrough chronic myeloid leukemia treatment imatinib, are currently in early phase clinical trials.
In Search of Newer Paradigms
This leading custom manufacturer hopes to commercialize the new drugs in short timelines of three to four years. “Our work in this area reaffirms our commitment to changing the paradigm of drug discovery by using Indian drug discovery capabilities to build a diversified and strong pipeline of products to address unmet medical needs,” according to Dr. Swati Piramal, director, Piramal Healthcare.
Piramal, which acquired florbetaben and other imaging agents portfolio from Bayer last month, has more than a dozen lead compounds spanning the therapeutic areas of cancer, diabetes, inflammation and infectious diseases in the drug discovery pipeline. It also has drug discovery and development agreements with Eli Lilly and Merck.
Pursuit of new models seems to be theme behind the very recently opened Biocon Research Centre (BRC), Bengaluru, in southern India. Considered the first of its kind in southeast Asia, the $40 million centre has a team of over 300 scientists aiming at ‘pathbreaking’ research in biologics, according to a statement from Biocon, India's leading biotech firm. The company plans to expand the facility by adding 300 more scientists from India and abroad. The focus of discovery research will be diabetes, cancer and auto-immune diseases. The very purpose of BRC is to search out “an innovation-led effort to develop advanced yet affordable solutions for several debilitating diseases,” stated Kiran Mazumdar-Shaw, chairman and managing director of Biocon Group, at the launch event.
Biology Skills Far-Off?
Even as Piramal and Biocon revisit the discovery research in a big way, India's predominantly outsourcing-oriented drug makers continue to bolster own discovery pipelines.
The Daiichi-owned Ranbaxy has reportedly completed the development of an indigenous antimalarial and is working up to launch. Once in market, Ranbaxy’s combo pill will be the first indigenously developed drug by an Indian firm. Similarly, Dr. Reddy's, Sun Pharma, Glenmark, Zydus Cadila, Wockhardt all have impressive line-ups of NCEs at various stages of discovery and development.
Quite a few mid caps and even small-time players are also engaged in efforts to find new therapies. Suven Life Sciences has won patents in several markets for a class of selective 5-HT compounds, which are being developed as therapeutic agents in the treatment of cognitive impairment associated with neurodegenerative disorders. A CRAMS player from Hyderabad, Suven offers a range of discovery services from medicinal chemistry to bioanalysis and spends 18% of its annual revenues for R&D.
Indian companies usually follow a strategy that involves either partnering with a deep-pocketed multinational or developing potential molecules to a certain stage and licensing out. Most of them have working alliances with innovators and a few, like Glenmark, have successfully licensed the rights of potential molecules for upfront and milestone payments out to bigger companies.
CROs such as GVK Bio and ITG Life Science have already crossed certain critical milestones in alliances with Wyeth (pre-Pfizer) and Pfizer for preclinical and clinical development. Critics, however, feel that India is yet to hone skills in biology as the current contributions are mostly in the area of research chemistry, which is essential to become an attractive location for outsourcing discovery research.
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at firstname.lastname@example.org.