For many Indian pharmaceutical companies, generics might still be a key focus segment, but the research and development (R&D) divisions of some of them are making the transition from reverse engineering to discovery and development of new drug molecules. The urge to innovate rather than replicate is being led by Glenmark Pharmaceuticals, which has successfully completed phase III trials for Crofelemer, an anti-diarrhoeal drug for HIV-associated diarrhoea. The company is gearing up for the launch of Crofelemer in 140 countries globally and this could potentially be the first novel drug launched by the organisation. It anticipates approval of Crofelemer in India in 2012.
In August this year, Glenmark announced the discovery of a drug molecule called GRC 17536 for pain and respiratory disorders. Glenmark plans to file the phase I application in January 2011. The company has a pipeline of 7 molecules?5 new chemical entities and 2 new biological entities?in various stages of preclinical and clinical development. Most molecules have potential sales opportunity ranging from $1 billion to $3 billion.
Glenmark Pharmaceuticals CEO & MD Glenn Saldanha says, ?It is important that India begins to get recognised as a destination where drug discovery is possible. When Glenmark began its discovery R&D efforts several years ago, not many believed that drug discovery is possible from India. Now after having discovered several new molecules for unmet medical needs, concluding five out-licensing deals and now one of the molecules completing phase III trials, we have made significant progress in the area of drug discovery and are now close to becoming the first Indian company to take an NCE to market.?
He adds: ?The potential for drug discovery is immense and while it is a high-risk business there is also huge potential waiting to be tapped.?
In pharmaceuticals discovery, India might be a late entrant and a small player at the moment, but in recent years, home-grown pharmaceutical companies have displayed potential to build their expertise and capabilities and have made inroads in this space.
Take biotech major Biocon for instance, which is steadily raising its profile as a research-led unique business model with a focus on diabetes, oncology and auto-immune dieses. The company plans to take two R&D programmes?IN-105 (oral insulin) and T1h (anti-CD6 monoclonal antibody) through proof-of-concept phase III clinical studies before licensing.
Biocon chairman and managing director Kiran Mazumdar-Shaw says, ?IN-105 is the most advanced programme in global oral insulin space with a US IND filed in December 2009. For T1h, we are on the verge of entering a crucial phase III trial for psoriasis.
Biocon?s strategy for both programmes is to develop them to ?proof of safety and efficacy? in India and only then pursue more expensive global development through licensing partnering. Drug discovery is a high-risk, high-reward business. Our innovation strategy based on collaborative R&D and co-development is enabling us to build high-value assets that are expected to pay back handsome returns.?
Ranbaxy Laboratories president Ramesh Adige believes that companies in India have the scientific capabilities to succeed. However, this requires significant financial investment on a sustained basis. ?To address public health needs, the Indian government is now providing financial grants to promising Indian companies investing in the development of new chemical entities for neglected diseases that are endemic to the Indian subcontinent and the less developed world.?
Ranbaxy is presently conducting phase III clinical trials for its new anti-malaria combination drug, Arterolane Maleate + Piperaquine Phosphate. If all goes well, Ranbaxy will be able to launch this new anti-malaria molecule in 2011, he informs. It may be recalled that Ranbaxy?s New Drug Discovery Research (NDDR) has been transferred to Daiichi Sankyo India Pharma as part of the strategy to strengthen the global R&D structure of the Daiichi Sankyo Group.
Another company in phase III stage is Dr Reddy?s Laboratories, India ?s second biggest drugmaker, and Denmark?s Rheoscience; their Balaglitazone (DRF 2593) diabetes drug met its primary target of blood glucose levels in clinical trials. The first of phase III clinical trials was conducted on 409 patients over 26 weeks. Balaglitazone belongs to the same family of drugs as Takeda Pharmaceutical?s best-selling diabetes pill Actos, which generated $2.1 billion in global sales in the six months ended September 30, 2009. If Dr Reddy?s is successful in bringing Balaglitazone to market, it could become the first Indian company to develop a cost effective drug for diabetes, a disease the World Health Organisation predicts will afflict 366 million people worldwide by 2030.
Healthcare analysts aver that money drains in the drug discovery process and it is pertinent to keep key trends in mind. Loss of patent protection, a decline in the commercialisation of block-buster drugs and spiralling R&D costs are some of the challenges faced by the pharmaceuticals industry today. Drug regulators around the world and more so in the developed world, which also happens to be the largest pharmaceutical markets, are gradually raising the bar for approving new drugs. Applicants are required to demonstrate significant superiority over existing treatments with much lower side effects. As a result, the number of new product approvals has been falling year after year. In such a scenario, companies from India , given their limited experience in drug research and development, face and uphill task.
This raising of bar by the regulators also impacts the investments required for each product. With limited balance sheet size, Indian companies have limited ability to take full risks of such investments. Also, empirical evidence suggests that discovery, innovation and creativity flourish better in smaller, entrepreneurial setups. Sun Pharmaceuticals chairman Dilip Shanghvi says, ?Innovation requires a novel approach to scientific problem solving, higher level of resource commitments over much longer time durations. Projects can take years to exhibit proof-of-concept and a few more years to be converted into commercial realities. Thus, it would not be an overstatement if I say that the nature of product development effort at Sun Pharma Advanced Research Company is qualitatively different than the usual product development that you have been used to witnessing in generic pharmaceutical companies in India .? As part of the company?s drug discovery programme, SUN-1334H is being developed as oral formulation and eye drops. A phase I study is expected to begin shortly.
While the Indian pharmaceutical companies are developing their NCE baskets and gearing up to launch their own patented drug molecules in the future, they are also looking at government support. ?Drug discovery has a long gestation period and requires significant amount of resources and hence government support is very critical for the mushrooming of Indian companies in this area. If the government provides the necessary stimuli for this business, it can create millions of jobs and also change the perception of India to that of a nation where genuine innovation is also possible,? summarises Saldanha.