CARDIOME, ASTELLAS RESUBMIT NDA FOR VERNAKALANT

Cardiome Pharma and its co-development partner, Astellas Pharma, have announced Astellas' resubmission to the FDA of the new drug application (NDA) for the intravenous formulation of vernakalant hydrochloride, an investigational new drug for the acute conversion of atrial fibrillation.

Cardiome met with the FDA in July after the agency sent a "refusal to file" letter to the company in May in response to its NDA submission.

"This resubmission is the culmination of a comprehensive and thorough review process conducted by Astellas Pharma, Cardiome and outside consultants," Charles Fisher, executive vice president and chief medical officer of Cardiome, said. "With the inclusion of an additional 150 patients in the safety dataset from the ongoing ACT 2 and ACT 4 studies, we are pleased with the NDA Astellas has submitted for the FDA's consideration."

Pursuant to the amended co-development agreement reached in June, a $10 million payment from Astellas to Cardiome has been triggered by the resubmission.

Vernakalant is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation. Positive top-line results from two pivotal Phase III trials, ACT 1 and ACT 3, were released in 2004 and 2005. An additional Phase III study evaluating patients with post-operative atrial arrhythmia, ACT 2, and an open-label safety study evaluating recent-onset atrial fibrillation patients, ACT 4, are ongoing.