Glenmark Generics inks licensing agreement with Par Pharma

Glenmark Generics Ltd. announced that its US subsidiary, Glenmark Generics Inc., has entered into an exclusive licensing agreement with Par Pharmaceutical, the generic division of Par Pharmaceutical Companies, Inc. to market Ezetimibe 10 mg tablets, the generic version of Merck-Schering Plough’s Zetia in the US. Zetia is a cholesterol modifying agent with annual US sales of approximately US$1.4bn, according to IMS Health data. 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. On April 24, 2009, Glenmark was granted tentative approval for its product by the US Food and Drug Administration (FDA).

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 US. The companies will share in profits from the sales of the product. Glenmark is currently involved in patent litigation concerning Ezetimibe in the US 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.

Glenmark Generics Inc., a wholly owned subsidiary of Glenmark Generics Ltd., also announced that it has entered into an exclusive license and supply agreement for a branded product with Taro Pharmaceuticals Inc. (Taro USA), a subsidiary of Taro Pharmaceutical Industries Ltd. Under the agreement, Glenmark will manufacture the FDA approved product exclusively for Taro USA. Taro USA’s branded division, TaroPharma, will be the exclusive US distributor of the product. Glenmark will receive milestone payments and a royalty on sales. Additional terms of the agreement are not being disclosed.