BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD (known in the US and Canada as Merck) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

“We welcome this important milestone in our collaboration with Cardiome and we are planning to make the product available in the EU by the end of the year.”

The full indication is for the rapid conversion of recent onset AF to sinus rhythm in adults: for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.

The new treatment has a unique mechanism of action from other AF medicines and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU.

"BRINAVESS is the first and only agent that acts preferentially in the atria. This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease," said Patrick Magri, senior vice president, general manager, Cardiovascular Franchise, Merck. "We welcome this important milestone in our collaboration with Cardiome and we are planning to make the product available in the EU by the end of the year."

"BRINAVESS is the first pharmacologic innovation for recent onset of AF in over ten years, and European approval is an exciting juncture for Cardiome." said Doug Janzen, president and chief executive officer of Cardiome. This success was made possible through the commitment and hard work of our employees and our partner Merck, the support of our shareholders, and the efforts of many dedicated medical professionals and patients who have taken part in the clinical program."