Glenmark Pharmaceuticals Ltd has announced that it has entered into a collaboration agreement with InvaGen Pharmaceuticals, Inc for the joint development, filing and marketing of seven generic pharmaceutical products for the US market. The product list includes a mixture of off-patent and patent-protected molecules with cumulative annual sales in the US of about USD 4.1 billion.

Earlier this year, Glenmark had announced its exclusive licensing agreement with InvaGen for marketing its anti-hypertensive agent, Fosinopril Sodium.

InvaGen will develop and license to Glenmark, seven generic products, InvaGen will also undertake filing the ANDAs while the Indian company will be responsible for obtaining regulatory approval in the US market. Upon approval, the company''s US subsidiary, Glenmark Pharmaceuticals, Inc, will market the products exclusively while InvaGen will be responsible for their manufacture and supply.

All development and regulatory costs and profits on sale in the US will be shared equally between Glenmark and InvaGen. Of the list, one ANDA has already been filed till date and three more are expected to be filed by March 2006.

Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals, 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 US market."

Glenmark had also signed a collaboration agreement with another Indian company, Chennai-based Shasun Chemicals and Drugs Ltd, for the joint development and marketing of 13 generic products in the US market. Shasun is expected to file two of its ANDAs under this agreement by March 2006.

Of the dozen ANDAs that Glenmark had planned to file during FY 2006 almost half of them filings are in various stages of filing and Glenmark says that it 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 FY 2006 with a portfolio of about 20 ANDAs filed during the year.

In FY 2005, it had already filed six ANDAs and purchased two from Clonmel Healthcare Ltd. Earlier this year the US FDA inspected and approved Glenmark''s dose formulation manufacturing site at Goa.

The company had licensed two generic products, Naproxen and Nitroglycerin, from two US-based manufacturers Interpharm, Inc and Konec, Inc, which it markets through its front-end in the US market along with InvaGen''s Fosinopril Sodium. Till date it has locked-in contracts valued at between 10 and 15 per cent of the US market for each of the three drugs. It expects to have at least five products in the US market before the end of this financial year.