Cardiome (NASDAQ:CRME) is sitting pretty as the FDA took another step yesterday toward imminent approval of its lead drug, Vernakalant.
Now given the ugly-sounding brand name KYNAPID, Vernakalant was in testing as a treatment for acute atrial fibrillation (essentially irregular heart rhythm). Following two successful phase 3 trials, Cardiome and partner Astellas filed a marketing application with the FDA a year ago.
As the FDA made clear from its briefing documents released Monday, Vernakalant will almost certainly be approved by the agency by its Jan. 19 PDUFA target date (or, at worst, given a short approvable letter concerning labeling changes).
This likely course of FDA action was further reinforced by an advisory committee, which voted 6-2 yesterday in favor of recommending approval for Vernakalant. Like all advisory hearings, this vote is nonbinding.
Now that Vernakalant's regulatory fate has likely been determined, the torch is largely passed onto Astellas, which will be responsible for all marketing of the drug in the U.S. Unlike drugmakers such as Neurocrine Biosciences (NASDAQ:NBIX), Encysive Pharmaceuticals (NASDAQ:ENCY), or CV Therapeutics (NASDAQ:CVTX), Cardiome won't be saddled with an expensive sales force without revenue coming in, and it can sit back while the royalties start to accrue. Cardiome also still owns rights to Vernakalant outside North America.
But even more important than the outcome of the intravenous version of the drug are the coming study results for the oral version of Vernakalant. The market for oral Vernakalant is much larger than the intravenous version: It is being tested as a treatment for chronic atrial fibrillation. Interim phase 2 results from oral Vernakalant are expected in March with final results coming in "mid-2008." Expect the wild times to continue with Cardiome until then.
