Thrill of the magic pill
When Dr Reddy's labs announced last fortnight that its anti-diabetic molecule Balaglitazone had entered phase III clinical trials, it was easily one of the highest points of the Indian pharma sector's research & development (R&D) programme in a long time. This is the first time that an Indian new chemical entity (NCE) has reached this far on its development path. If this molecule, an insulin sensitiser, does sail through this phase, it would be ready to hit the market-a multi-billion one-as an oral anti-diabetic drug by 2010-11.
"Dr Reddy's molecule entering phase III trials is surely a positive for the industry and further reinforces the point about India being a (preferred) research destination,'' says Glenn Saldanha, CEO, Glenmark Pharmaceuticals, another company that has some eight molecules in the pipeline with three in phase II. Saldanha is hopeful that "some of them could move into phase III in the next financial year.''
For Dr Reddy's, the study is the first in a series of planned phase III trials which will investigate the safety and efficacy of Balaglitazone as an oral anti-diabetic drug. So, is Dr Reddy's close to getting that coveted innovator tag? Talk to analysts and while they see reasons to be upbeat about the drug moving thus far, they would rather prefer to wait to hear more announcements, particularly when the company announces its plans to enter into an out-licensing agreement for marketing it in the US/Europe. At the moment, the company is going it alone on marketing it in the US. Balaglitazone is being developed under a co-development agreement between Dr Reddy's and Rheoscience in Denmark. Rheoscience will retain the marketing rights to European Union and China and Dr Reddy's will retain the marketing rights in the territories of United States and rest of the world. Rheoscience shall obtain all necessary regulatory approvals on behalf of Dr Reddy's in the US.
The biggest risk involved in drug R&D is that it can be a case of being so near, yet so far. Dr Reddy's knows what it's like to be there: In 2004, its stock took a pounding when Novo Nordisk suspended clinical development and returned the molecule, which was out-licensed by Dr Reddy's to the Danish firm in 1997. This time around, the company prefers to wait till the 'first headline data' emerges, which could be by end of 2008.
Analysts point out that close to 10 companies (including other companies like Ranbaxy, Wockhardt, Nicholas Piramal and Zydus Cadila) are pursuing serious NCE research and working on about 40 NCE leads; the most aggressive among them are players like Dr Reddy's and Glenmark. Saldanha points out that India having started late on this path has still a lot of catching up to do to get close to the quality of research being generated globally. Dr Reddy's has surely shown the way.
