Merck & Co., Inc. and Cardiome Sign License Agreement for Vernakalant, an Investigational Drug for Treatment of Atrial Fibrillation



    WHITEHOUSE STATION, NJ and VANCOUVER, April 8 /CNW/ - Merck & Co., Inc.
and Cardiome Pharma Corp. (NASDAQ:   CRME / TSX: COM) today 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 Merck with exclusive global rights to the
oral formulation of vernakalant (vernakalant (oral)) for the maintenance of
normal heart rhythm in patients with atrial fibrillation, and provides a Merck
affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights
outside of the United States, Canada and Mexico to the intravenous (IV)
formulation of vernakalant (vernakalant (IV)) for rapid conversion of acute
atrial fibrillation to normal heart rhythm.
    "This agreement underscores Merck's ongoing commitment to the research
and development of new cardiovascular drugs," said Luciano Rossetti M.D.,
senior vice president and franchise head, Atherosclerosis and Cardiovascular,
Merck Research Laboratories. "Vernakalant is an important addition to our
broad portfolio of products and candidates that target multiple aspects of
heart disease."
    "Given Merck's long-established leadership in the cardiovascular space,
we believe there is no company better suited to advance vernakalant," said Bob
Rieder, chairman and chief executive officer of Cardiome. "This collaboration
places Cardiome in a strong financial position as we conclude our strategic
review, and moves the Company closer to providing doctors with an important
tool to address this critical unmet medical need."
    Under terms of the agreement, Merck will pay Cardiome an initial fee of
US$60 million. In addition, Cardiome is eligible to receive up to US$200
million in payments based on achievement of certain milestones associated with
the development and approval of vernakalant products (including a total of
US$35 million for initiation of a planned Phase III program for vernakalant
(oral) and submission for regulatory approval in Europe of vernakalant (IV)),
and up to US$100 million for milestones associated with approvals in other
subsequent indications of both the intravenous and oral formulations. Also,
Cardiome will receive tiered royalty payments on sales of any approved
products and has the potential to receive up to US$340 million in milestone
payments based on achievement of significant sales thresholds.
    Cardiome has retained an option to co-promote vernakalant (oral) with
Merck through a hospital-based sales force in the United States. Merck will be
responsible for all future costs associated with the development,
manufacturing and commercialization of these candidates. Merck has granted
Cardiome a secured, interest-bearing credit facility of up to US$100 million
that Cardiome may access in tranches over several years commencing in 2010.
    Vernakalant (IV) is an investigational candidate being evaluated for its
ability to terminate an atrial fibrillation episode and return the heart to
normal rhythm. Cardiome's co-development partner in North America, Astellas
Pharma U.S., Inc., submitted a New Drug Application with the U.S. Food and
Drug Administration (FDA) for KYNAPID(TM) (vernakalant hydrochloride)
Injection in December 2006 that included results from two pivotal Phase III
clinical trials. In December 2007, the Cardiovascular and Renal Drugs Advisory
Committee recommended that the FDA approve vernakalant (IV) for rapid
conversion of atrial fibrillation. In August 2008, the FDA issued an
Approvable action letter requesting additional information.
    Vernakalant (oral) is being evaluated as an oral maintenance therapy for
the long-term prevention of atrial fibrillation recurrence. A Phase IIb
double-blind, placebo-controlled, randomized, dose-ranging clinical trial in
patients at risk of recurrent atrial fibrillation showed that at the 500 mg
dose, vernakalant (oral) significantly reduced the rate of atrial fibrillation
relapse as compared to placebo.
    The effectiveness of the collaboration agreement is subject to the
expiration or earlier termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act, if applicable, as well as other
customary closing conditions. The agreement between Cardiome and Astellas
Pharma U.S., Inc. for vernakalant (IV) in the United States, Canada and Mexico
is unaffected by this agreement.

    About Atrial Fibrillation

    Atrial fibrillation is the most common cardiac arrhythmia (abnormal heart
rhythm). It has been estimated that 5.5 million patients each year are treated
for atrial fibrillation in the seven leading industrialized nations(1). Atrial
fibrillation is the term used to describe an erratic and often rapid heart
rate where the beat of the heart's two small upper chambers (the atria) is not
coordinated with the two lower chambers (the ventricles). It commonly leads to
symptoms of heart palpitations, shortness of breath and weakness, and blood
clots may form. If a blood clot in the atria leaves the heart and becomes
lodged in an artery in the brain, a stroke results. About 15 percent of
strokes occur in people with atrial fibrillation. The risk of atrial
fibrillation increases with age.

    About Vernakalant

    Vernakalant is a new chemical entity discovered by Cardiome and designed
to treat atrial fibrillation, with the potential to overcome the limitations
of current drugs used to treat the disease. Its mechanism of action involves
the selective blockade of multiple ion channels in the heart that are known to
be active during episodes of atrial fibrillation. The drug is currently being
developed for two potential applications: (1) vernakalant (IV) is being
evaluated as a potential candidate to terminate an atrial fibrillation episode
and return the heart to normal rhythm; and (2) vernakalant (oral) is being
evaluated as an oral maintenance therapy for the long-term prevention of
atrial fibrillation recurrence.

    About Merck & Co., Inc.

    Merck & Co., Inc. is a global research-driven pharmaceutical company
dedicated to putting patients first. Established in 1891, Merck currently
discovers, develops, manufactures and markets vaccines and medicines to
address unmet medical needs. The company devotes extensive efforts to increase
access to medicines through far-reaching programs that not only donate Merck
medicines but help deliver them to the people who need them. Merck also
publishes unbiased health information as a not-for-profit service. For more
information, visit http://www.merck.com.

    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 www.cardiome.com.

    Merck Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the risk factors and cautionary
statements in Item 1A of Merck's Form 10-K for the year ended December 31,
2008, and in its periodic reports on Form 10-Q and Form 8-K, which the Company
incorporates by reference.

    Cardiome Forward-Looking Statement

    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 www.sec.gov and the Canadian securities regulatory authorities at
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.

    
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    (1) Decision Resources
    





For further information:

For further information: Merck & Co., Inc. Contacts, Media: Ian R.
McConnell (U.S.), (908) 423-3046; Vincent Lamoureux (Canada), (514) 428-3456;
Investors: Eva Boratto, (908) 423-5185; Cardiome Contacts, Media: Irma
Gomez-Dib - FD, (212) 850-5761; Investors: Peter K. Hofman, (604) 676-6993


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