labels: pharmaceuticals, glenmark pharmaceuticals
Glenmark signs an additional deal for seven ANDAs with LVTnews
07 December 2006

Glenmark Pharmaceuticals Inc, USA, (GPI), the wholly owned subsidiary of Indian pharmaceutical company Glenmark Pharmaceuticals Ltd, has signed a new supply and marketing agreement with Lehigh Valley Technologies, Inc (LVT) to manufacture and market seven products for the US market.

The products, with a cumulative market size of $2.8 billion, belong to the controlled substances category which have limited competition. These products, which are for pain management are a mix of immediately release and controlled release solid oral dosage formulations.

According to the agreement, LVT will develop and manufacture the products, which will be filed with the FDA under the Glenmark''s name and marketed exclusively by the Glenmark in the US starting FY09.

The new deal, according to Glenn Saldanha, managing director and CEO, " greatly enhances our product basket and takes us closet 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."

Glenmark currently markets codeine sulphate and morphine sulphate, from its deal with Aspen USA, Inc, signed earlier this year. Glenmark also says that it is in the process of launching three more controlled substance products before the end of FY07of which one is from Aspen and the other two from LVT, which it had in-licensed earlier this year. One of the products, Oxycodone HCI capsules is due to be launched next week.

"The LVT collaboration is in line with our strategy of developing our product portfolio with products having greater margins and sustainability," explained Terrance Coughlin, president of Glenmark''s US subsidiary. "We have already captured significant inroads into this niche market with the launch of the two Aspen products since August 2006," Coughlin added.

Glenmark has filed a total of 35 ANDAs as of October 2006 from its US FDA approved facility at Goa. It had purchased two 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.

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Glenmark signs an additional deal for seven ANDAs with LVT