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Our Bureau

Mumbai , Feb. 13

GLENMARK Pharmaceuticals Ltd expects to file its prospective obesity drug, the third new chemical entity from the company, for phase I trial in May. Phase I trials involve the exposure of the drug on 50-100 healthy human volunteers to evaluate the drug's safety profile and safe dosage range.

Glenmark's molecule, GRC 10389, is a highly selective drug candidate targeting obesity and associated disorders. Pre-clinical studies are being done on this long acting compound for its primary indication, obesity; this is expected to result in a once-daily dose regimen in humans, the company told the Bombay Stock Exchange.

Glenmark expects to file the compound for a phase I trial by May. This will be followed by phase II trials by January 2007. Glenmark expects to launch the product for primary indication in the first geography by 2011, provided the clinical trials go through, the company added.

Rimonabant, a similar product 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. The other two new chemical entities from the Glenmark stable undergoing human trials include prospective molecules for asthma and diabetes.

The prospective asthma drug GRC 3886 has been named Oglemilast and is 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 and milestone payments.

Another compound, GRC 8200, targeting type II diabetes, is completing its phase I trials in the UK.

Glenmark has two other prospective molecules for inflammatory conditions in the pre-clinical stage - for rheumatoid arthritis and topical inflammations. These programmes are expected to result in a phase I candidate in the financial year 2007, the company said.

Glenmark's shares closed at Rs 334.65, up 2.43 per cent, on the BSE.

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