Glenmark Pharmaceuticals Ltd has informed BSE that the Company’s wholly owned subsidiary Glenmark Pharmaceuticals SA, Switzerland has completed preclinical development for initiating Phase I trials for GBR 500 - a monoclonal antibody for inflammation.

Press Release :

“Glenmark Pharmaceuticals SA (Switzerland) a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd, on April 10, 2008 announced that its monoclonal antibody GBR 500 has completed crucial IND-enabling preclinical studies. Glenmark intends to file an IND application with the US FDA by August 2008 for initiation of Phase I trials. The Company expects to complete Phase I in this fiscal year immediately followed by a Proof of Concept Phase IIa study. Glenmark has already manufactured sufficient antibody for conducting Phase I and Phase IIa clinical studies.

Glenmark intends to develop GBR 500 for indications such as MS (Multiple Sclerosis), COPD (Chronic Obstructive Pulmonary Disease) and IBD (Inflammatory Bowel Disease).

Glenmark would be among the first companies to target VLA-2 GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (o2B1) integrin. VLA-2 mediates interactions of cells with the extra cellular matrix Integrin-mediated cell migration is required for the recruitment of immune cells to sites of inflammation, and Glenmark intends to develop GBR 500 as a modulator of inflammation.

The broad mechanism of GBR 500, a VLA-2 integrin antagonist is validated by marketed drugs ReoPro (Centocor / Lilly), Raptiva (Genentech / Xoma) and Tysabri (Biogen / Elan) are marketed monoclonal antibodies which target integrins.

Speaking on this development, Mr. Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd , said, “We are happy to take our biologics program forward with GBR 500 moving into Phase I trials. This is Glenmark’s first NBE to enter the clinics from our pipeline of 11 NCEs and NBEs, and demonstrates our steady progress in the drug discovery space.”