The next two or three weeks will be crucial for Glenmark Pharmaceuticals’, and India’s, dreams of developing an original blockbuster pharmaceutical drug.
Forest Laboratories of the US, which partnered Glenmark in September 2004 to develop and commercialise Oglemilast (a lead molecule for asthma and bronchitis) will soon decide whether to continue further development work or to drop the drug. The drug, with an estimated market size of $3 billion, was instrumental in making Glenmark an investor favourite at that time.
But Glenmark, like fellow companies in the same pursuit, has had to face many setbacks in the recent past in its drug discovery efforts. Merck, which was developing a diabetes drug, returned the molecule last year, citing its “disinterest” in pursuing diabetes drug research. Also, Eli Lilly, which had in-licensed an osteoarthritis and pain molecule from Glenmark, suspended development in October last year. The company’s efforts to find a new partner for these drugs have not succeeded so far.
Glenmark is in august company. A few years ago, companies like Dr Reddy’s, Lupin, Piramal Healthcare, Ranbaxy were falling over each other, with 50 to 70 drug leads in the pipeline, to become the first Indian drug maker to come out with at least one original molecule in the commercial stage before 2010-11.
After a decade of such attempts, the scorecard is still blank. Look at Dr Reddy’s Laboratories. Its lead molecule and India’s first new chemical entity, Balaglitazone (named after Lord Balaji of Tirupathi), had a roller-coaster ride to reach the final stage of Phase III clinical development. This potential diabetes drug was out-licensed in 1997 to Novo Nordisk, but Novo returned it in 2004. In between, Novo took up the development of another anti-diabetic compound, Ragaglitazar (named after promoter Anji Reddy), but it failed in the final stages of development.
Two years ago, Danish biopharmaceutical company Rheoscience took up further development of Balaglitazone, a class of compounds now under the scanner of regulators for safety issues. Sources said the global financial meltdown had affected the health of Rheoscience, so the fate of this drug was hanging in balance once again.
The company’s attempts to float a unique research and development company — Perlecan Pharma — a few years ago to pursue new drug research, with private equity (PE) funding from Citigroup and ICICI Venture, was also a failure.
The PEs exited the company after two years without large investments and Dr Reddy’s was forced to buy back their stake.
Another frontrunner in new drug research, Piramal Life Science, is also facing hurdles. Piramal Life was demerged from Piramal Healthcare two years ago to attract strategic investors to fund the research programme and insulate the parent company from the risks involved in R&D research, as done by companies such as Orchid Chemicals and Laboratories, Dr Reddy’s and Sun Pharma.
But neither Piramal, nor any of the other players have found a strategic investor yet.
“The planned strategic stake sale of Piramal Life Sciences has been stalled for the time being because of unfavourable market conditions,” said N Santhanam, executive director and chief financial officer of Piramal Healthcare.
So what’s the problem? The challenges specific to Indian companies included, in many cases, limited access to experienced scientific personnel who have a deep understanding of how to efficiently and effectively do drug discovery and development. The global economic meltdown has also affected the outlicensing opportunities as multinational companies are risk-averse and are going through a bad phase.
Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals, however, said it wasn’t fair to write off India’s new drug discovery efforts. “One should understand that new drug development is a time-consuming, high-risk game involving patience and conviction. In that process, some deadlines may change, but I am sure India will be able to develop a new drug in near future” he said.
Saldanha has a point, as even major pharmaceutical companies have challenges discovering and developing a blockbuster drug. For a single product to make it to market, many hundreds or thousands of compounds have to be tested, and the pre-clinical and clinical failure rates are high, in a process involving 10-12 years.
Coupled with this, the regulatory agencies have become far more stringent about safety standards for approval, said an executive with Dr Reddy’s Laboratories, which pioneered new drug research in India in the early 1990s, headed by its scientist- turned-entrepreneur Dr Anji Reddy.
That’s the main reason companies like Lupin are unable to give any timeline. Lupin rejigged its R&D recently to get better results. The company has four drug candidates under clinical trials, including an anti-migrane nasal spray under development named Amigra, which is now in the last lap of clinical trials in India.
Ramesh Swaminathan, president, finance and planning at Lupin, would only say that “our endeavour is to take the drugs forward and then outlicense to other partners.”