The Hindu Business Line : Glenmark's asthma drug gets nod for further trials

GLENMARK Pharmaceuticals has received the green signal from regulatory authorities in the US for further development of its prospective asthma drug, GRC 3886.

The drug is now on course to enter the second phase of testing on human beings, or Phase II clinical trials, by early 2006 in the US.

The molecule, GRC 3886, has also been granted its International Non-proprietary Name Oglemilast by a World Health Organisation body that controls the grant of `generic' names to new experimental drugs.

Glenmark's wholly owned subsidiary, Glenmark Pharmaceuticals S A, said that the lead PDE-4 inhibitor GRC 3886 has received US Food and Drug Administration approval to proceed further in clinical testing within the US.

Oglemilast is being tested for asthma and COPD and had successfully completed Phase I single and multiple dosing studies in the UK in March 2005.

Forest Laboratories, Glenmark's development and marketing partner for the drug in North America, had submitted an Investigational New Drug (IND) filing early this year to the FDA.

The filing incorporated both pre-clinical as well as safety data in human volunteers generated during the Phase I trials, the company said in its statement to the Bombay Stock Exchange.

The FDA has now approved the IND filing, allowing Oglemilast to be evaluated in further clinical trials in human volunteers.

Phase II studies in the US would be conducted by Forest Laboratories,

Glenmark's development partner for Oglemilast in North America.

Glenmark Switzerland had entered into a collaborative agreement with Forest in September 2004.

A similar collaboration agreement with Teijin Pharma Ltd for the territory of Japan was formalised in April 2005.

Glenmark is now evaluating similar partners to take Oglemilast forward in the European market and expects to finalise a partner by March 2006.

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