Glenmark signs deal with InvaGen to develop, market seven generics for U.S. market

By E. Janene Geiss

Philadelphia, Dec. 15 - Glenmark Pharmaceuticals Ltd. has announced that it has entered into a collaboration with InvaGen Pharmaceuticals, Inc. for the joint development, filing and marketing of seven generic pharmaceutical products for the U.S. market.

The product list includes a mixture of off-patent and patent-protected molecules with cumulative annual sales in the United States of about $4.1 billion, according to a company news release.

Pursuant to the agreement, InvaGen will develop and license to Glenmark, seven generic products, officials said.

InvaGen also will undertake filing for Abbreviated New Drug Applications, while Glenmark will be responsible for obtaining regulatory approval in the U.S. market.

Upon approval, Glenmark's U.S. subsidiary, Glenmark Pharmaceuticals, Inc., will exclusively market the products while InvaGen will be responsible for their manufacture and supply, officials said.

All development and regulatory costs and profits on sale in the United States will be shared equally between Glenmark and InvaGen.

Of the seven on the list, one ANDA has already been filed and three more are expected to be filed by March, officials said.

"We are happy to take our association with InvaGen even further. The deal is also in line with our multi-pronged approach to strengthen our presence as a serious generics player in the U.S. market," Glenn Saldanha, Glenmark managing director and chief executive officer, said in the release.

Glenmark officials also announced that the company has signed a collaboration agreement with Shasun Chemicals and Drugs Ltd. for the joint development and marketing of 13 generic products in the U.S. market. Shasun is expected to file two of its ANDAs under this agreement by March, officials said.

Additionally, the company said it had planned to file a total of 12 to 14 ANDAs during fiscal year 2006 through its in-house formulation development efforts.

The company said it has completed almost half these filings and is on course to achieving its target by March 2006.

Along with the seven ANDAs to be filed by its partners, the company expects to close fiscal year 2006 with a portfolio of about 20 ANDAs filed during the year.

And the company said it had already filed six ANDAs in fiscal year 2005 and also purchased two ANDAs from Clonmel Healthcare Ltd. in the same period.

The company is marketing these three generic products in the U.S. market and has already locked-in contracts amounting to a market share in excess of 10% to 15% of the U.S. market. The company said it expects to have at least five products on the U.S. market before the end of this year, including Naproxen, Nitroglycerin and Fosinopril Sodium.

Glenmark, based in Mumbai, India, is a pharmaceutical company focused on manufacturing and marketing of formulation products and active pharmaceutical ingredients.

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