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Our Bureau

Mumbai , Jan. 25

GLENMARK Pharmaceuticals has completed the first phase of its clinical study on a prospective asthma and chronic obstructive pulmonary disorder (COPD) drug, GRC 3886.

The second level of the trial is set to commence on the molecule by early 2006 in North America, even as Glenmark scouts for partners to develop the same molecule for the European and Japanese markets.

Phase II studies on GRC 3886 will be initiated in early 2006 and the studies will be conducted by Forest Laboratories Inc, Glenmark's development partner for the molecule in North America. But the Phase II trials on the molecule in Europe and Japan will also look at alternate indications, in this case, rheumatoid arthritis.

Glenmark's wholly-owned subsidiary, Glenmark Pharmaceuticals, SA [Switzerland], has successfully completed Phase I single and multiple dosing studies on its novel oral GRC 3886, said a company communiqué issued here on Monday. The Phase I studies were conducted in the UK.

Early results of Phase I studies have demonstrated that GRC 3886 is well-tolerated by human volunteers. The drug also exhibited a long half-life, suggesting a once-daily-dosing regimen may be possible in future studies of patients, the note said.

Mr Glenn Saldanha, Managing Director and Chief Executive Officer of Glenmark Pharmaceuticals, said, "While the efficacy of a drug candidate in clinical trials is generally first established in Phase II-a trials, GRC 3886's inhibitory effect on TNF-Alpha suggests that we have reached dosages in these Phase I studies, which are both well-tolerated and biologically active based on this surrogate endpoint."

On the Phase II trials, company officials said that Glenmark would provide the active pharmaceutical ingredients (API), but the development of the molecule would be done by Forest. Glenmark Switzerland had entered into a $190-million deal with Forest in September 2004.

Under the agreement, post-Phase I, Forest will be responsible for the development and commercialisation of GRC 3886 in North America. Forest has paid Glenmark an up-front amount of $10 million upon the initiation of the agreement, and future milestones are linked to several steps in the successful development and commercialisation of the product in the North American market. If all goes well, the drug is expected to be ready for launch by 2009.

Glenmark will earn royalties in the "mid-teens" from Forest on net sales of the product in North America. Glenmark will also earn further revenues on the exclusive supply of API for the formulation and sales by Forest.

Glenmark is evaluating similar potential partners to take GRC 3886 forward in the European and the Japanese markets for asthma, COPD and the additional indication of rheumatoid arthritis.

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