Glenmark Pharmaceuticals Ltd and InvaGen Pharmaceuticals, Inc. have entered into a collaboration agreement 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.
Pursuant to the agreement, InvaGen will develop and license to Glenmark, seven generic products, InvaGen will also undertake filing the ANDAs while the Company will be responsible for obtaining regulatory approval in the US market. Upon approval, the Company's US subsidiary, Glenmark Pharmaceuticals, Inc., will exclusively market the products 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 the company and InvaGen. Of the list, one ANDA has already been filed till date and three more are expected to be filed by March 2006, stated a company release here.
Glenn Saldanha, Managing Director and CEO of the Company stated, "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."
The company had also signed a collaboration agreement with another Indian company, Shasun Chemicals and Drugs Ltd, 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.
Additionally, the company had planned to file a total of 12-14 ANDAs during FY 2006 through its in-house formulation development efforts. The company has completed almost half these filings till date and is on course to achieving its target by March 2006. Along with the 7 ANDAs to be filed by its partners, the company expects to dose FY 2006 with a portfolio of about 20 ANDAs filed during the year. In addition, the Company had already filed 6 ANDAs in FY 2005 and also purchased 2 ANDAs from Clonmel Healthcare Ltd, in the same period. The company's formulation [solid dose] manufacturing site at Goa was inspected earlier this year by the US FDA and was approved.
The company had licensed two generic products, Naproxen and Nitroglycerin, from two US-based manufacturers Interpharm, Inc and Konec, Inc. respectively. Earlier this year, the company 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. The company 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, the release added.