EU approves Cardiome’s Brinavess for IV

Cardiome Pharma’s (NASDAQ: CRME; TSX:COM) intravenous formulation of Brinavess has received marketing approval in the European Union, Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.

Patrick Magri, senior vice president, general manager, Cardiovascular Franchise, Merck (NYSE:MRK), said “we welcome this important milestone in our collaboration with Cardiome and we look forward to launching Brinavess in the EU beginning in the fourth quarter of 2010.”

Doug Janzen, Cardiome’s CEO, said Merck’s upcoming launch represents an “exciting juncture in Cardiome’s evolution, which will provide us with our first commercial product revenues.”

Versant Partners analyst Doug Loe said European approval triggers a $30 million (U.S.) milestone payment from Merck, augmenting Cardiome’s cash position of $57.7 million at end of the 2010 second quarter.

However, he points out that there is still “some risk” to the pill program of Brinavess going ahead until Merck details its Phase 3 development strategy. “But we believe IV approval in the EU should intensify Merck’s interest in focusing resources on Phase 3 oral program, which we assume will start in the first quarter of 2011.”  If Merck proceeds with a Phase 3 trial for the pill, it would trigger a separate $20 million payment to Cardiome.