Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Aug 19 2009

Forest Laboratories, Inc. (NYSE: FRX) and Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a Phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD. Oglemilast was well tolerated at all doses studied.

“Oglemilast is an orally administered PDE 4 inhibitor, which we believe to be an important and novel therapeutic target for COPD. We are, of course, disappointed that oglemilast has not been successful in this study,” said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. “Oglemilast is still being studied for the treatment of asthma, with results expected during the first calendar quarter of 2010. We are considering together with Glenmark what further action would be useful or appropriate.”

Oglemilast Phase IIb Study Design

This was a twelve-week randomized, double-blind, placebo-controlled, multi-center Phase IIb study that evaluated the efficacy and safety of once-daily oglemilast at doses of 200 mcg, 400 mcg and 800 mcg in patients with moderate to very severe COPD. Patients were at least forty years of age with a history of ten or more pack-years of smoking. During the study period 428 patients were randomized to receive one of three doses of oglemilast>

About Oglemilast

Oglemilast is a potent and selective inhibitor of phosphodiesterase 4 (PDE4). Oglemilast is currently in development for the treatment of COPD and asthma. Forest Laboratories licensed US rights for oglemilast from Glenmark Pharmaceuticals.

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