Nycomed wins EU approval for COPD therapy

Despite being rebuffed by the FDA and its drug experts, Switzerland's Nycomed has won EU approval for Daxas, its new therapy to treat chronic obstructive pulmonary disorder. The approval will usher in the first new drug for smoker's lung in more than a decade. The OK marks a big step ahead for Merck, which holds European and Canadian marketing rights. The approval by the EU also marks a major advance for Nycomed, which has been working hard to develop a blockbuster market for the drug. Nycomed...

FDA stiff-arms Daxas, demands more info on COPD drug

Forest Laboratories may be second-guessing its decision to provide $100 million upfront to license marketing rights to Nycomed's respiratory drug Daxas. The FDA rejected the COPD drug yesterday, which was not a surprise given the resounding thumbs-down it got from an FDA advisory panel last month. The agency asked for more information on the drug before it could approve it, according to a statement from Forest. Forest also noted, though, that "no additional patient trials have been...

Nycomed scores Merck co-promotion pact for Daxas

Nycomed's COPD drug Daxas may be in deep trouble in the U.S., but a thumb's up from the European Medicines Agency last week set the stage for a new co-promotion deal with Merck covering the continent and Canada. An FDA panel voted not to recommend the therapy for approval a little more than two weeks ago. That was a heavy blow for Switzerland's Nycomed--which has been grooming itself for an IPO--and its U.S. partner Forest Laboratories. The developer, though, gets an undisclosed upfront...

EU recommends Daxas approval following FDA panel rejection

Nycomed is in luck. The European Medicines Agency today recommended approval of Daxas, the company's once-a-day pill for patients with severe COPD. The approval follows an expert FDA panel's decision earlier this month not to recommend the drug for approval. In a 10-5 vote, panelists determined the side effects of Daxas outweighed the limited improvement in lung function. The ruling was a blow to Nycomed's partner Forest Labs, which has U.S. rights to Daxas. A final FDA decision...