Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
17 Dezembro 2009 - 9:00PM
PR Newswire (US)
NASDAQ: CRME TSX: COM VANCOUVER, Dec. 17 /PRNewswire-FirstCall/ --
Cardiome Pharma Corp. (NASDAQ: CRMENASDAQ:/NASDAQ:TSX:NASDAQ:COM)
today announced that the recently-completed Phase 3 European
Comparator Study (the AVRO study) evaluating vernakalant (iv)
versus amiodarone for the acute conversion of atrial fibrillation
met its primary endpoint. The AVRO study achieved statistical
significance in demonstrating the superiority of vernakalant (iv)
over amiodarone in the conversion of atrial fibrillation to sinus
rhythm within 90 minutes of the start of drug administration.
Overall the data suggests that vernakalant (iv) was well-tolerated
in the study population. There were no vernakalant-related deaths
or cases of "Torsades de Pointes", a specific and
well-characterized ventricular arrhythmia. Cardiome expects that
detailed results of this study will be presented at a scientific
conference in 2010. In April 2009, Cardiome and Merck & Co.,
Inc. announced a collaboration and license agreement for the
development and commercialization of vernakalant, an
investigational candidate for the treatment of atrial fibrillation.
The agreement provides a Merck affiliate, Merck Sharp & Dohme
Corp., with exclusive global rights to vernakalant (oral) for the
maintenance of normal heart rhythm in patients with atrial
fibrillation, and provides another Merck affiliate, Merck Sharp
& Dohme (Switzerland) GmbH, with exclusive rights outside of
the United States, Canada and Mexico to vernakalant (iv) for rapid
conversion of acute atrial fibrillation to normal heart rhythm. If
approved by the European regulatory authorities, Merck has
exclusive rights to commercialize vernakalant (iv) in the European
Union. About the AVRO study The AVRO study, titled "A Phase III
Prospective, Randomized, Double-Blind, Active-Controlled,
Multi-Center, Superiority Study of Vernakalant Injection Versus
Amiodarone in Subjects With Recent Onset Atrial Fibrillation",
enrolled a total of 254 patients with symptomatic atrial
fibrillation of 3 to 48 hours duration. Subjects were randomized to
receive vernakalant (iv) or amiodarone in a 1:1 ratio. Safety was
assessed through the monitoring of adverse events, vital signs,
continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead
ECGs, and laboratory tests. About Cardiome Pharma Corp. Cardiome
Pharma Corp. is a product-focused drug development company
dedicated to the advancement and commercialization of novel
treatments for disorders of the heart and circulatory system.
Cardiome is traded on the NASDAQ National Market (CRME) and the
Toronto Stock Exchange (COM). For more information, please visit
our web site at http://www.cardiome.com/. Forward-Looking Statement
Disclaimer Certain statements in this press release contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 or forward-looking
information under applicable Canadian securities legislation that
may not be based on historical fact, including without limitation
statements containing the words "believe", "may", "plan", "will",
"estimate", "continue", "anticipate", "intend", "expect" and
similar expressions. Such forward-looking statements or information
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, events or developments, or
industry results, to be materially different from any future
results, events or developments expressed or implied by such
forward-looking statements or information. Such factors include,
among others, our stage of development, lack of product revenues,
additional capital requirements, risk associated with the
completion of clinical trials and obtaining regulatory approval to
market our products, the ability to protect our intellectual
property, dependence on collaborative partners and the prospects
for negotiating additional corporate collaborations or licensing
arrangements and their timing. Specifically, certain risks and
uncertainties that could cause such actual events or results
expressed or implied by such forward-looking statements and
information to differ materially from any future events or results
expressed or implied by such statements and information include,
but are not limited to, the risks and uncertainties that: we may
not be able to successfully develop and obtain regulatory approval
for vernakalant (iv) or vernakalant (oral) in the treatment of
atrial fibrillation or any other current or future products in our
targeted indications; our future operating results are uncertain
and likely to fluctuate; we may not be able to raise additional
capital; we may not be successful in establishing additional
corporate collaborations or licensing arrangements; we may not be
able to establish marketing and sales capabilities and the costs of
launching our products may be greater than anticipated; we rely on
third parties for the continued supply and manufacture of
vernakalant (iv) and vernakalant (oral) and we have no experience
in commercial manufacturing; we may face unknown risks related to
intellectual property matters; we face increased competition from
pharmaceutical and biotechnology companies; and other factors as
described in detail in our filings with the Securities and Exchange
Commission available at http://www.sec.gov/ and the Canadian
securities regulatory authorities at http://www.sedar.com/. Given
these risks and uncertainties, you are cautioned not to place undue
reliance on such forward-looking statements and information, which
are qualified in their entirety by this cautionary statement. All
forward-looking statements and information made herein are based on
our current expectations and we undertake no obligation to revise
or update such forward-looking statements and information to
reflect subsequent events or circumstances, except as required by
law. DATASOURCE: Cardiome Pharma Corp. CONTACT: Peter K. Hofman,
Senior Director, Investor Relations, (604) 676-6993 or Toll Free:
1-800-330-9928, Email:
Copyright