Glenmark inks marketing pact with US firm

Glenmark Pharmaceuticals (Glenmark) today signed a development and marketing collaboration with the US-based InvaGen Pharmaceuticals Inc for seven generic product for the US market.

The collaboration would involve joint development, filing and marketing of these generic pharmaceutical products "" a mixture of off-patent and patent-protected molecules. These products have total annual sales of about 4.1 billion in the US market.

With the agreement, InvaGen will develop and licence all these seven generic products to Glenmark. InvaGen will also undertake filing the ANDAs (abbreviated new drug applications) while Glenmark will be responsible for obtaining regulatory approval in the US.

Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc, will exclusively market the products in the US while InvaGen will undertake manufacture and supply.

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

Glenmark sources said that one ANDA among the seven products had already been filed with the US FDA and three more were expected to be filed by March 2006.

Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals, said in a release that the Invagen deal was in line with Glenmark's multi-pronged approach to strengthen its presence as a serious generics player in the US market.

Meanwhile, Glenmark had signed a collaboration agreement with the Hyderabad based Shasun Chemicals and Drugs for the joint development and marketing of 13 generic products in the US market.

Shasun is expected to file 2 of its ANDAs under this agreement by March 2006.

Glenmark had licensed two generic products, Naproxen and Nitroglycerin, from two US based manufacturers Interpharm, Inc. and Konec, Inc. respectively.

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

The company is marketing these three generic products through its front-end in the US market and has already locked-in contracts amounting to a market share in excess of 10-15% of the US market.

Glenmark expects to have at least 5 products on the US market before the end of this financial year including these three in-licensed products that are currently being marketed.

Glenmark has generic formulation and API business interests in over 70 countries across the world including the highly regulated markets of USA and Europe. The formulation business of the company spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.