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PHARMA
The Trials Begin

GINA S. KRISHNAN

Glen Saldanha, managing director of Glenmark Pharmaceuticals, is a relieved man these days. Eli Lilly has inlicensed its molecule GRC 6211 with an upfront payment of $45 million and $90 million in milestone payments. Further, if the molecule enters the market, Glenmark gets another $290 million. GRC 6211 is a next generation pain management molecule for osteoporosis and is undergoing late Phase II clinical trials in Europe. Phase II trials are carried out on a limited number of patients who have that particular disease and no other complication.

The good news comes on the heels of Merck KgAa’s announcement that it would get out of diabetes research. Glenmark had outlicensed its molecule GRC 8200 (for diabetes) to Merck KgAa early last year. Glenmark will now have to either undertake research on the molecule or find another company willing to take on its development.

October has largely been a good month for Indian pharmaceutical companies engaged in research. Of the seven promising molecules licensed hitherto (one each by Ranbaxy and Torrent, and three each by Dr. Reddy’s and Glenmark), two are moving into Phase II and Phase III clinical trials. Dr. Reddy’s Balaglitazone (DRF-2593) has been given the green signal by the US Food and Drug Administration to move into Phase III clinical trials. Phase III is the last stage in clinical trials before the drug hits the market. It is administered to a larger group of patients that may have more than one disease. Glenmark’s GRC 3886, a molecule for asthma and chronic obstructure pulmonary disorder (COPD), outlicensed to US-based Forest Labs and Japan’s Teijin Pharma, will move into Phase II, almost a year later than scheduled.



 
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