Forest Laboratories Inc. and Glenmark Pharmaceuticals SA Switzerland, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., 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 CEO 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 is a potent and selective inhibitor of phosphodiesterase 4 (PDE4). Oglemilast is currently in development for the treatment of COPD and asthma. Forest Labs licensed US rights for Oglemilast from Glenmark Pharma.
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