Glenmark Pharmaceuticals Ltd has and disclosed details of its third new chemical entity that is expected to be filed for a Phase I trial in May 2006. The molecule, GRC 10389, is the lead candidate in the company''s Cannabinoid (CB-1) receptor antagonist programme.

Glenmark says that this is a highly selective drug candidate targeting obesity and its associated disorders. This long acting compound is presently completing pre-clinical studies for its primary indication, obesity, and is expected to result in a once-daily-dosing regimen in humans.

The in-vitro studies have found GRC 10389 to be highly selective to the target with an IC50 of 14 nM and Ki (Humans) of 11 nM. Additionally, the molecule has produced a significant reduction of food and nutrient intake in animal models of feeding in the in-vivo food intake studies. It was also well absorbed showing good bio availability in rats and dogs consistent with pharmacodynamic activity observed. The toxicity studies are progressing well and have established a clean profile for the compound.

Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals, says, "We believe that GRC 10389 will prove to be an excellent candidate for metabolic disorders in our NCE programme and we are happy with the promise it is showing. CB-1 receptor antagonists are being increasingly looked at for treating obesity and Glenmark is keen on being one of the early players in this category."

The company expects to file the compound for a Phase I trial by May 2006. The Phase II should follow by January 2007 and the product launch for the primary indication in the first geography by 2011 subject to success in all ensuing clinical trials.

Rimonabant, another CB-1 antagonist being developed by Sanofi-Synthelabo, is the leading molecule in this category till date. The compound has been successful in human trials and is due for approval this year.

GRC 10389 is the third candidate from Glenmark portfolio that will enter clinical trials. The first compound was GRC 3886, a PDE-4 inhibitor for the primary indications of Asthma and COPD. GRC 3886 has been named Oglemilast and is currently expected to enter Phase II shortly in the US.

The compound has been licensed to Forest Laboratories for the North American market and Teijin Pharma for the Japanese market in two deals totalling $243 million in upfront fees to Glenmark and milestones. Glenmark says that it has also advanced another compound GRC 8200, a DPP-IV inhibitor for the treatment of Type II diabetes, into clinical trials. The compound is currently completing its Phase I trials in UK. The Company has two other programmes for inflammatory conditions in the pre-clinical stage which includes another PDE-4 inhibitor in the areas of Rheumatoid Arthritis, topical inflammations. These programmes are expected to result in a Phase I candidate in FY 2007.