Glenmark Inc signs deal with LVT for 7 additional ANDAs

New Delhi, Dec 7 (UNI) Glenmark Pharmaceuticals Ltd today announced that its US-based wholly-owned subsidiary, Glenmark Pharmaceuticals Inc (GPI), has signed a supply and marketing agreement with Lehigh Valley Technologies Inc (LVT) for the manufacturing and marketing of seven products for the US market.

The products, with a cumulative market size of 2.8 billion dollars (as per IMS), belong to the controlled substances (C-II) category which have limited competition.

This is the company's second agreement with LVT, under which the latter will develop and manufacture the products. These products will be filed with the FDA under the Glenmark's name and marketed exclusively by the company in the United States.

The company expects to launch these products by the fiscal 2009-2010.

The products, which are for pain management, comprise both Para three and Para four applications, and are a mix of immediately release and controlled release solid oral dosage formulations.

''Our second deal with LVT 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 ten 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 two products, Codeine Sulphate and Morphine Sulphate, in the country under its deal with Aspen Inc, formed in the beginning of FY2007.

It is in the process of launching three more C-II products (one from Aspen and two from LVT) that it had in-licensed earlier this year before the end of FY07; with one of the products, Oxycodone HCI capsules, to be launched next week.

The LVT collaboration is in line with the company's strategy of developing product portfolio with products having greater margins and sustainability. It has already captured significant inroads into this market with the launch of the two Aspen products since August 2006, GPI President Terrance Coughlin said.

Glenmark had filed a total of 35 Abbreviated New Drug Applications (ANDAs) till October 2006 from its United States Food and Drug Authority (US FDA) approved facility at Goa.

It had purchased two ANDAs from Clonmel Healthcare Ltd in FY2005.

In addition to filing ANDAs, it is making efforts to accelerate its portfolio build-up by procuring in-licensing generics from US-based manufacturers, collaboration agreements for joint development with other companies and also acquisition of ANDAs.

Its co-development tie-ups with Shasun Chemicals and Drugs Ltd and US-based InvaGen Pharmaceuticals Inc together account for 20 additional filings, to which the company has marketing access.

UNI CS DS1255