Cardiome gains European MA rights for Brinavess from Merck & Co

Canada-based Cardiome Pharma (TSX: COM) has announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorization for Brinavess (vernakalant intravenous) from Merck & Co (NYSE: MRK), which announced last year that it would return rights to the drug (The Pharma Letter September 27, 2012).

The decision marks Cardiome's assumption of responsibilities as the new marketing authorization holder (MAH) for Brinavess, a treatment for chronic atrial fibrillation, in the member states of the European Union. Cardiome and Merck will continue to work together until September 15, 2013 to finalize the organizational arrangement for transfer of all responsibilities, including batch release, and operational management of SPECTRUM, the post-approval safety study.

"The transfer of the European marketing authorization to Cardiome marks an important milestone in the company's history," said William Hunter, Cardiome's president and chief executive, adding: "Cardiome now assumes full control of all key commercialization activities for Brinavess in the European Union and as of July 1, will begin realizing the benefit from worldwide product revenues."