Glenmark gets FDA nod in US

Glenmark Pharmaceuticals' molecule GRC 3886 today received the US Food and Drug Administration (FDA) approval to proceed further in clinical testing within the United States.

The molecule is being developed by Glenmark Pharmaceuticals SA, the company's US-based wholly owned subsidiary. The molecule has also been granted its international non-proprietary name (INN) "Oglemilast" by a WHO body, based on an expert advisory panel's recommendations.

Oglemilast (GRC 3886), Glenmark's novel, oral, long-acting PDE4 inhibitor being tested for the indications of asthma and chronic obstructive pulmonary disorder (COPD), 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 the territory of North America, had submitted an investigational new drug (IND) filing early this year to the FDA.

The filing incorporated both preclinical data as well as safety data in human volunteers generated during the Phase I trials. The FDA has now approved the IND filing thereby allowing Oglemilast to be evaluated in further clinical trials in human volunteers. As indicated earlier, the drug is on course to enter Phase II clinical trials by early 2006 in the US.

"The clinical development of GRC 3886 is on schedule, spurred by this recent approval of Forest's IND filing by the US FDA. We are very excited by the performance of this molecule in Phase I trials and the recent IND approval and are working with our collaboration partners on accelerating the development program for the molecule," said Glenn Saldanha, managing director and CEO Glenmark Pharma.

The Phase II studies of the molecule in the US would be conducted by Forest Laboratories, Inc. (Forest), Glenmark's development partner for "Oglemilast" in North America.

Glenmark Switzerland had entered into a collaborative agreement with Forest in September 2004. This was followed by a similar collaboration agreement with Teijin Pharma Ltd for the territory of Japan 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.