|Another step toward Approval for IV Vernakalant:|
7:30AM Merck: Investigational BRINAVESS for Infusion recommended for approval by the CHMP in the EU for the rapid conversion of recent onset atrial fibrillation (MRK) 35.61 : Co and Cardiome Pharma (CRME) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing approval for BRINAVESS, an investigational intravenous formulation for the conversion of recent onset atrial fibrillation to sinus rhythm in adults. The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant
Merck heart rhythm drug endorsed by EU agency
* Vernakalant recommended for some atrial fibrillation cases
* Drug licensed from Cardiome last year
(Adds details on drug, Cardiome deal)
LONDON, June 25 (Reuters) - The European Medicines Agency has
recommended Merck & Co's drug Brinavess, or vernakalant,
as a treatment for acute atrial fibrillation, or irregular heart
beats, the London-based regulator said on Friday.
Recommendations for marketing approval by the European
agency's Committee for Medicinal Products for Human Use (CHMP)
are normally endorsed by the European Commission within a couple
The move is a boost for the U.S. drugmaker and its Canadian
partner Cardiome Pharma . Merck licensed the heart drug
from Cardiome for $60 million and additional milestone payments
in April 2009.
That deal gave Merck global rights to oral vernakalant for
maintenance of normal heart rhythm in patients with atrial
fibrillation. It also gave it rights outside of the United
States, Canada and Mexico to the intravenous formulation of the
drug for rapid conversion of acute atrial fibrillation to normal
heart rhythm -- the indication now being recommended in Europe.
Japan's Astellas Pharma holds North American rights
to the intravenous formulation of vernakalant.
Under terms of the agreement, Merck will pay Cardiome an
initial fee of $60 million and Cardiome is eligible to receive
up to $200 million in payments based on achievement of certain
development and approval milestones. Cardiome will also receive
tiered royalty payments on sales.