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December 15, 2005: Glenmark Pharmaceuticals Ltd. [Glenmark] and InvaGen Pharmaceuticals, Inc. [InvaGen] 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 million.
Pursuant to the agreement, InvaGen will develop and license to Glenmark, seven generic products. InvaGen will also undertake filing the ANDAs while Glenmark will be responsible for obtaining regulatory approval in the US market. Upon approval, Glenmark'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 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.
Glenmark 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, Glenmark 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 close 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. Glenmark's formulation [solid dose] manufacturing site at Goa was inspected earlier this year by the US FDA and was approved.
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.
Glenn Saldanha, Managing Director and CEO of Glenmark Pharmaceuticals 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."
Terrance Coughlin, President of Glenmark Pharmaceuticals Inc., USA stated, "Our InvaGen alliance enhances our plans for the US market and also complements our pipeline of products."
Dr. Sudhakar R. Vidiyala, President of InvaGen stated, "InvaGen is excited to expand our relationship with Glenmark Pharmaceuticals Inc., USA as our Marketing Partner and believe that this relationship will benefit from the individual complementary strengths of the two companies."
About Glenmark
Glenmark Pharmaceuticals Limited is an emerging global, fully integrated, research-based pharmaceutical company headquartered in Mumbai, India. The Company 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 spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.
The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. It recently announced the licensing of its first Asthma/COPD molecule, GRC 3886 [INN: 'Oglemilast'], to Forest Labs and Teijin Pharma for the North American and Japanese markets, respectively. This compound has subsequently completed Phase I clinical trials successfully and will be entering Phase II clinical trials in the US shortly. The Company has also filed its second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, for Phase I clinical trials in the UK in September 2005. [www.glenmarkpharma.com]
About InvaGen
InvaGen Pharmaceuticals, Inc. is a leading US generic pharmaceutical company based in Long Island, New York. The company is vertically integrated with a leading active pharmaceutical manufacturer based in India. InvaGen has filed seven ANDAs till date with the USFDA and received its first ANDA approval for Fosinopril Sodium Tablets, 10 mg, 20 mg and 40 mg, a generic version of Bristol-Myers Squibb's Monopril Tablets. [www.invagen.com]
For further information, please contact:
Ms. Vaijayanti Karande
Sr. Manager - Corporate Communications
Glenmark Pharmaceuticals Limited
Tel: [91-22] 5654 9999
Fax: [91-22] 2351 9652
Email: vaijayantik@glenmarkpharma.com
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