In another setback for its plans to develop a range of new drugs, India's Glenmark Pharmaceuticals and its U.S. partner Forest Laboratories revealed that their experimental COPD drug failed a Phase IIb trial. While well tolerated at all dose levels, researchers said that oglemilast--Glenmark's lead development program--failed to post a statistically significant efficacy outcome.
"This is a big blow for Glenmark as oglemilast was its lead experimental molecule," Ranjit Kapadia, vice president of institutional research at HDFC Securities, told the Wall Street Journal. "The company had pinned a lot of hopes on a positive outcome."
Glenmark has been trying to blaze a trail in India's drug development industry, pushing clinical trial work in alliances with global partners. But it's been hit with a series of crucial failures. Both Eli Lilly and Merck Serono bowed out of development alliances with Glenmark last year. Glenmark's shares plunged 11 percent on the latest setback. It's also bad news for Forest, which has shelled out $35 million so far for the U.S. licensing rights.
The drug is also being studied as a treatment for asthma. "The results are expected during the first calendar quarter of 2010. We are considering together with Glenmark what further action would be useful or appropriate," said Forest CEO Howard Solomon.