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Glenmark Pharmaceuticals SA 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
MUMBAI, India | April 10, 2008 | Glenmark Pharmaceuticals SA (Switzerland) a wholly owned subsidiary of Glenmark Pharmaceuticals Limited, today 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 (α2ß1) integrin. VLA-2 mediates interactions of cells with the extracellular 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.
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-driven, global, fully integrated pharmaceutical company headquartered at Mumbai, India. Its shares are listed on India’s two large stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5000 people across its global operations across 80 countries.
The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.] and metabolic disorders [Diabetes, Obesity, etc.]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark‘s speciality business alone is guided to generate US$ 306 mn in net sales in FY 08 and US$ 352 mn in FY 09. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, undergoing Phase II clinical trials in Europe, has recently been out-licensed to Eli Lilly & company. Glenmark’s API and generics business interests span over the highly regulated markets of USA, Latin America and Europe, and are managed by its subsidiary Glenmark Generics Limited.
SOURCE: Glenmark Pharmaceuticals SA
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