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 requested for the continued review of the NDA." The 10-5 vote against recommending approval came after at least one of the experts explained he was unhappy with the "meager" benefits associated with Daxas. Several patients taking the drug either committed or attempted suicide, which raised additional red flags about the drug's safety. But the experts also voted 9-6 that the drug had been shown to be safe and effective.

Just two weeks after the FDA panel vote, the EMA backed the drug. That was a much-needed endorsement for Switzerland's Nycomed, which has been planning on launching an IPO. Nycomed's pact with Forest also included $500 million in milestones. Forest shares were up five percent this morning as investors responded to a new share buyback program.

- here's Forest's press release
- here's the feature from Bloomberg