Glenmark USFDA approval

Glenmark Pharmaceuticals Ltd has announced that Glenmark Pharmaceuticals SA (GPSA), the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd (Glenmark), on October 29, 2007, announced that USFDA has provided a favorable partial response to the submission made by Forest, allowing it to initiate an additional Phase II study in COPD for Oglemilast (GRC 3886), Glenmark's lead PDE4 inhibitor molecule. The approval came after Forest satisfactorily addressed FDA's outstanding non-clinical questions.

Glenmark is working closely with Forest Labs, which is Glenmark's North American partner for Oglemilast, to detail out plans for further longer term development, while additional communication is expected from the FDA in the next 2-3 months. Glenmark views this as an important positive step in continuing overall clinical development of Oglemilast.

Speaking on this development, Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals Ltd, said, "The favourable response to Oglemilast from the FDA is an affirmation of Glenmark's research capabilities and our focussed approach towards drug discovery. Today we have a pipeline of 11 lead molecules at various stages of development, with an increasing focus on NBE research along with NCE research. This progress reiterates Glenmark's commitment towards setting benchmarks in speed, efficacy and monetisation of drug discovery & research."

GRC 3886 is a novel, orally available PDE4 inhibitor in development for Chronic Obstructive Pulmonary Disorder (COPD), and may also have utility in other conditions such as Asthma. According to the Centers for Disease Control, COPD affects approximately 24 million people in the United States and Asthma affects approximately 20 million. Combined, these markets are worth over $10 billion and are growing at a significant rate. PDE4 inhibitors target the underlying cause of both COPD and Asthma by blocking inflammation through a non-steroid dependent mechanism.

GPSA had entered into a collaborative agreement with Forest in September 2004, wherein Forest would develop, register and commercialize GRC 3886 for the North American market, while Glenmark will retain commercialization rights for the rest of the world. Forest paid Glenmark an up-front payment upon initiation of the agreement, and Will pay other milestones if the development and commercialization of the product is successfully completed in the North American market, the total value of these payments could be $190 million. Additionally, after commercial launch, Glenmark will earn a royalty from Forest on net sales of the product, and, in addition, will supply all API for sale by Forest.

This was followed by a similar collaboration agreement with Teijin Pharma Ltd for the territory of Japan in April 2005.