Glenmark Pharmaceuticals S.A. (Switzerland), a subsidiary of Glenmark Pharmaceuticals India (GPL) and Forest Laboratories, Inc have announced that the top-line results from a phase IIb dose range finding study of Oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD) failed to generate positive results and they are taking further action.
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."
This was a twelve week randomized, double-blind, placebo controlled, multi-centre 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 (n=320) or placebo (n=108) and assessed at eight visits. The primary endpoint was defined as change from baseline in pre-bronchodilator (morning/trough) FEV1 at Week 12.
Meanwhile, yesterday the company confirmed that the Smithkline Beecham Corporation, a part of global pharma major Glaxosmithkline (GSK), filed a lawsuit on Glenmark Generics Inc for its intentions to manufacture generic versions of two anti-malarial tablets- Atovaquone and Prog uanil hydrochloride, on which GSK holds a patent right.
With the negative results in phase IIb study of COPD drug Oglemilast and GSK's action regarding the patent infringement lawsuit on the company's subsidiary pushed down the share price of Glenmark on BSE by 13 per cent to Rs.227.85 in the morning session today.