FDA ACCEPTS CARDIOME, ASTELLAS' NDA FOR HEART DRUG

Cardiome Pharma and its co-development partner Astellas Pharma announced that the FDA has accepted for review their new drug application (NDA) for the intravenous formulation of vernakalant hydrochloride for the acute conversion of atrial fibrillation.

The companies resubmitted the application in December 2006 after the FDA sent a "refusal to file" in May in response to the original NDA submission. If approved, the drug will be marketed in the U.S. by Astellas. The trade name for the marketed product has not yet been determined.

The application is based on a five-year clinical development program. Positive top-line results from two pivotal Phase III trials, ACT 1 and ACT 3, were released in 2004 and 2005.

In 2003 Cardiome granted Astellas an exclusive license to develop and commercialize vernakalant in North America. The companies have co-developed vernakalant through the submission of the NDA, with Astellas having been responsible for 75 percent of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, the U.S. and Mexico.