Glenmark Pharmaceuticals Inc., USA the wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. has signed another supply and marketing agreement with Lehigh Valley Technologies, Inc. (LVT) for the manufacturing and marketing of 7 products for the US market.
The products, with a cumulative market size of USD 2.8 billion (IMS), belong to the C-II (controlled substances) category, which have limited competition. These products, which are for pain management comprise both, Para 3 and Para 4 applications, and are a mix of immediately release and controlled release solid oral dosage formulations.
As per the agreement, LVT will develop and manufacture the products. These products will be filed with the FDA under Glenmark's name and marketed exclusively by Glenmark in the US. The company expects to launch these products starting FY09.
Glenmark currently markets two products, Codeine Sulphate and Morphine Sulphate, from its deal with Aspen USA, Inc. in the beginning of FY2007.
The company is in the process of launching three more C-II products [1 from Aspen and 2 from LVT] that it had in-licensed earlier this year before the end of FY07; with one of the products, Oxycodone HCl capsules, to be launched next week.
Glenn Saldanha, MD and CEO of Glenmark Pharmaceuticals Ltd. stated, "Our second deal with LVT greatly enhances our product basket and takes us closer to establishing our presence as a company selling niche products in the highly competitive US generics market. Presently, we are marketing 10 products in the US and expect to meet our target of ending the year with 18 to 22 generics in the market."
Terrance Coughlin, president of Glenmark Pharmaceuticals Inc., USA remarked, "The LVT collaboration is in line with our strategy of developing our product portfolio with products having greater margins and sustainability. We have already captured significant inroads into this niche market with the launch of the two Aspen products since August 2006."
Jeffrey Moshal, CEO of Lehigh Valley Technologies, Inc. remarked, "This second agreement with Glenmark further enhances LVT's position as a quality cGMP manufacturer of controlled substances and we look forward to expanding our relationship."
Glenmark has filed a total of 35 ANDAs as of October 2006 from its US FDA approved facility at Goa. It had purchased 2 ANDAs from Clonmel Healthcare Ltd. in FY 2005. In addition to filing ANDAs, Glenmark's efforts to accelerate its portfolio build-up have involved in-licensing generics from US based manufacturers, collaboration agreements for joint development with other companies and also acquisition of ANDAs. Its strategic co-development tie-ups with Shasun Chemicals and Drugs Ltd. and InvaGen Pharmaceuticals Inc. together account for 20 additional filings, to which Glenmark has marketing access.
Glenmark had launched its sales and marketing front-end in the US in January 2005 and has 10 generics on market as of October 2006. The company also has 25 ANDAs undergoing the US FDA approval process.