EDIT: TORONTO, Sept. 1 /CNW/ - Trading resumes in:
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Issuer Name: Cardiome Pharmaceuticals Corp.
TSX Ticker Symbol: COM
Resumption Time: 16:15pm
Investment Industry Regulatory Organization of Canada - Trading Halt - Cardiome Pharma Corp - COM
Issuer Name: Cardiome Pharma Corp
TSX Ticker Symbol: COM
Time of Halt: 3:25pm ET
Reason for Halt: Pending News
This PR came out about 2 minutes prior to the trading halt notice but the notice was effective about 15 minutes earlier ...
BRINAVESS™ (vernakalant) for Infusion Approved in the European Union for Rapid Conversion of Recent Onset Atrial Fibrillation
bwire
WHITEHOUSE STATION, N.J. & VANCOUVER, British Columbia (Business Wire) -- Merck (known as MSD outside the United States and Canada) (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 rapid conversion of recent onset atrial fibrillation (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.
BRINAVESS acts preferentially in the atria and is the first product in a
new class of pharmacologic agents for cardioversion of AF to launch in
the EU.
"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 look
forward to launching BRINAVESS in the EU beginning in the fourth quarter
of 2010."
"European approval of BRINAVESS and Merck's subsequent launch represent
an exciting juncture in Cardiome's evolution which will provide us with
our first commercial product revenues," 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."
Information on the clinical program for BRINAVESS
The approval of BRINAVESS is based on the results of three randomized,
double-blind, placebo controlled studies (ACT I, ACT II, and ACT III)
and an active comparator trial (AVRO).
In ACT I and III, the efficacy of BRINAVESS at converting patients from
AF to sinus rhythm for a minimum duration of one minute with 90 minutes
of initiating therapy was evaluated in 390 haemodynamically stable adult
patients with short duration AF (3 hours to 7 days) versus placebo. In
ACT I, vernakalant cardioverted 51.0 percent of patients versus 4.0
percent of patients taking placebo (n=74 and 3, respectively; p<0.0001).
In ACT III, vernakalant cardioverted 51.2 percent of patients versus 3.6
percent of patients taking placebo (n=44 and 3, respectively; p<0.0001).
Conversion of AF to sinus rhythm occurred rapidly; in responders, the
median time to conversion was 10 minutes from start of first infusion,
based on pooled results from the ACT I and ACT III studies.
The efficacy of BRINAVESS was also studied in ACT II in 150 patients
with sustained AF (3 hours to 72 hours duration) that occurred between
24 hours and 7 days post coronary artery bypass graft and/or valvular
surgery. Treatment with BRINAVESS effectively converted 47.0 percent of
patients from AF to sinus rhythm versus 14.0 percent placebo (p=0.0001).
In the AVRO, study BRINAVESS was significantly more effective than
amiodarone IV in providing rapid conversion to sinus rhythm within the
first 90 minutes of initiating therapy
In the AVRO (Active-Controlled, Multi-Center Study of Vernakalant
Injection versus Amiodarone in Subjects with Recent Onset Atrial
Fibrillation) study, BRINAVESS was demonstrated to be significantly
faster than amiodarone IV in converting AF patients to sinus rhythm. In
the trial, BRINAVESS was studied in 116 patients with AF (3 hours to 48
hours) versus 116 patients on amiodarone. The amiodarone infusion was
given over two hours (i.e., one hour loading dose of 5 mg/kg, followed
by one hour maintenance infusion of 50 mg) with the objective to compare
rapid conversion to sinus rhythm. The primary endpoint was the
proportion of patients that achieved sinus rhythm for a minimum duration
of one minute within 90 minutes of the first exposure of the study drug.
In this study, treatment with BRINAVESS converted 51.7 percent of
patients to sinus rhythm at 90 minutes versus 5.2 percent with
amiodarone.
Important Safety Information for BRINAVESS
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