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Posts Tagged ‘Glenmark Pharmaceuticals’

Glenmark Pharmaceuticals - Outcome of Operations Committee Meeting

Tuesday, June 10th, 2008

Glenmark Pharmaceuticals Ltd has informed BSE that the meeting of the Operations Committee of the Board of Directors held on June 09, 2008, the Committee has approved conversion of Zero Coupon Foreign Currency Convertible Bonds amounting to US$ 7,500,000 into 1,293,706 Equity Shares at a price of Rs 253.11 per share of face value Rs 1/- each out of US$ 50,000,000 Zero Coupon Foreign Currency Convertible Bonds issued in 2005.

Glenmark Pharmaceuticals - Press Release

Friday, April 11th, 2008

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

Press Release :

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, 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.”

Glenmark Pharmaceuticals - Glenmark launches Nabumetone & Hydroxyzine Hydrochloride Tablets

Thursday, March 13th, 2008

Glenmark Pharmaceuticals Ltd has informed BSE that Inc (GPI), the US subsidiary of Ltd (Glenmark), has initiated the marketing and distribution of Nabumetone tablets and Hydroxyzine Hydrochloride tablets in the U.S. market.

Glenmark commenced shipping immediately upon final approval from the U.S. Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for: Nabumetone tablets in 500mg and 750mg strengths and Hydroxyzine Hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (Invagen).

The Company will exclusively market and distribute Nabumetone and Hydroxyzine Hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on Nabumetone and Hydroxyzine hydrichloride tablets’s sale in the US will be shared equally between Glenmark and Invagen.

Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. According to IMS Health data, for the 12 month period ending December 2007, the market size of Nabumetone was USD 97 million.

Hydroxyzine belongs to a group of medicines called sedating antihistamines Hydrbxyzine’s main use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month period ending December 2007, the market size of Hydroxyzine Hydrochloride was USD 60 million.

In FY 06, Glenmark and InvaGen entered into a collaboration agreement for the joint development, filing and marketing of seven generic pharmaceutical products for the US market. The product list included a mixture of off-patent and patent-protected molecules with cumulative annual sales in the US of about USD 4.1 billion.

This recent approval expands Glenmark’s portfolio to 28 generic products for the US market. The Company has over 35 ANDAs undergoing review with the US FDA for approval / launch.

Glenmark Pharmaceuticals - Updates

Thursday, February 28th, 2008

Glenmark Pharmaceuticals Ltd has informed BSE that the shareholders at the Deemed Extra Ordinary General Meeting (EGM) of the Company held on February 05, 2008, inter alia, have passed the resolution by way of Postal Ballot, to transfer by way of sale, lease or otherwise its Domestic Active Pharmaceutical Ingredients and Generics Formulations Business together with all land, building, plant and machinery, brands, trademarks and other assets related thereto and pertaining to the operations of the Company at its plants in Goa, Ankleshwar, Kurkumbh and Mohol and all the employees of the said business, as a going concern, to Glenmark Generics Ltd, a subsidiary of the Company for a consideration not less than Rs 698 Crores (Rupees Six hundred ninety eight crores) as may be determined by the Board of Directors with effect from April 01, 2008 and on such terms and conditions as the Board of Directors may think fit, proper and beneficial for the Company, with requisite majority.