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Par to market Glenmark’s ezetimibe (Zetia) generic in US

Thursday, May 6, 2010, 17:20 This news item was posted in Patents category and has 0 Comments so far.

Glenmark has entered into an exclusive licensing agreement with Par Pharmaceutical to market ezetimibe 10 mg tablets in US.

Glenmark’s  ezetimibe 10 mg is the generic version of Merck- Schering Plough’s Zetia.

Zetia is a cholesterol modifying agent with annual U.S. sales of approximately $1.4 billion, according to IMS Health data.

On April 24, 2009, Glenmark was granted tentative approval for its product by the U.S. Food and Drug Administration.Glenmark believes it is the first-to-file an ANDA containing a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity.

Under the terms of the licensing and supply agreement, Par has made a payment to Glenmark for exclusive rights to market, sell and distribute ezetimibe in the U.S. The companies will share in profits from the sales of the product.

Glenmark is currently involved in patent litigation concerning ezetimibe in the U.S. District Court for the District of New Jersey.

Par will share control and costs with Glenmark for ongoing litigation. A trial is scheduled to commence on May 12, 2010.

Recently, Glenmark and Sanofi-Aventis signed a licence agreement to develop agents to treat chronic pain India’s Glenmark Pharmaceuticals has licensed out its pain drug candidate to Sanofi-Aventis for development and commercialization.

Glenmark’s pain drug candidates portfolio consists the new class of agents called vanilloid receptor (TRPV3) antagonist molecules. This includes Glenmark’s first-in-class clinical compound, GRC 15300.

GRC 15300 is currently in phase I clinical development as a potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.

Under the terms of the agreement, Glenmark will receive an upfront payment of US $20 million, as well as development, regulatory and commercial milestone payments. All such payments could reach a total of U.S. $ 325 million. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialized under the license.

Sanofi-aventis will have exclusive marketing rights for North America, European Union and Japan subject to Glenmark’s right to co-promote the products in the United States and five Eastern European countries.

Sanofi- aventis will also have co-marketing rights in 10 other countries including Brazil, Russia, and China, whereas Glenmark will retain exclusive rights in India and other countries of the rest of the world.

Glenmark Pharmaceuticals Ltd is headquartered at Mumbai, India. Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of inflammation (asthma/COPD, rheumatoid arthritis etc.), metabolic disorders (diabetes, obesity, etc.) and pain (neuropathic pain and inflammatory pain]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.

Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company. Through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.

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