FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation



    NASDAQ:   CRME
    TSX: COM

    VANCOUVER and DEERFIELD, IL, Dec. 11 /CNW/ - Cardiome Pharma Corp.
(NASDAQ:   CRME / TSX: COM) and its co-development partner Astellas Pharma US,
Inc. ("Astellas") today announced that the Cardiovascular and Renal Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA) has
recommended that the FDA approve KYNAPID(TM), the intravenous formulation of
vernakalant hydrochloride, an investigational new drug for rapid conversion of
acute atrial fibrillation (AF).
    At the panel review conducted today in Maryland, the members voted 6 to 2
in favour of recommending to the FDA that KYNAPID be approved for the rapid
conversion of acute AF to sinus rhythm. If approved, KYNAPID will be the first
new pharmacologic therapy for the conversion of AF in eight years.
    "We are pleased with the committee's recommendation," said William E.
Fitzsimmons, PharmD, Senior Vice President, Research & Development at
Astellas. "We strongly believe in the therapeutic value of KYNAPID based on
clinical trial data and are confident it will be an important therapy for
people with atrial fibrillation."
    "We welcome the committee's recommendation for approval, and look forward
to the FDA completing their review and acting on the application early in the
new year," stated Bob Rieder, Chief Executive Officer and Chairman of
Cardiome. "People with atrial fibrillation suffer significant disease burden,
and we are pleased to move an important step closer to providing doctors with
an important tool for meeting this critical unmet medical need."
    The Cardiovascular and Renal Drugs Advisory Committee is convened on
request of the FDA, and reviews and evaluates available data concerning the
safety and effectiveness of human drug products for use in the treatment of
cardiovascular and renal disorders. Although the Committee provides
recommendations to the Agency and suggests a course of action, final decisions
are made by the FDA. An action further to the FDA review of KYNAPID is
expected on or before January 19, 2008.
    KYNAPID is the proposed brand name in North America for the intravenous
formulation vernakalant hydrochloride, and has been provisionally accepted by
the FDA. Final approval of provisionally accepted names is granted upon
approval of the investigational drug. The NDA for KYNAPID, based on a
five-year clinical development program, was submitted in December 2006 and
accepted for review by the FDA in February 2007.
    In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive
license to develop and commercialize KYNAPID in North America. Cardiome has
retained all rights to the intravenous formulations outside of Canada, the
U.S. and Mexico. Upon approval, KYNAPID will be marketed in the United States
by Astellas Pharma US, Inc., a U.S. affiliate of Astellas Pharma Inc.

    About Atrial Fibrillation

    AF, the most common cardiac arrhythmia, is an interruption of the normal
sinus rhythm (arrhythmia) of the heart in which the atria, the two uppermost
chambers of the heart, beat irregularly and at an extremely rapid rate. During
AF, rapid and uncoordinated electrical discharges are generated by the heart's
natural pacemaker (sinoatrial node) and other parts of the atria. This causes
ineffective contractions of the atria and reduces the ability of the heart to
pump blood through the body. Symptoms include dizziness, heart palpitations,
weakness, shortness of breath and angina (chest pain). If AF is left
undiagnosed or untreated, life-threatening complications such as stroke can
occur.(1)
    The number of AF patients is expected to increase dramatically over the
next 50 years due to an aging population, and the increased prevalence of risk
factors including hypertension, obesity, diabetes and sleep apnea.(2)

    About Cardiome

    Cardiome Pharma Corp. is a product-focused cardiovascular drug
development company with two late-stage clinical drug programs focused on
atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for
GED-aPC, an engineered analog of recombinant human activated Protein C, and a
pre-clinical program directed at improving cardiovascular function.
    Vernakalant (iv) is the intravenous formulation of an investigational
drug being evaluated for the acute conversion of atrial fibrillation. Positive
top-line results from two pivotal Phase 3 trials for vernakalant (iv), called
ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome's
co-development partner Astellas Pharma US, Inc. submitted a New Drug
Application for vernakalant (iv) in December 2006. Positive top-line results
from an additional Phase 3 study evaluating patients with post-operative
atrial arrhythmia, called ACT 2, were released in June 2007. An open-label
safety study evaluating recent-onset AF patients, called ACT 4, has completed.
    Vernakalant (oral) is being investigated as a chronic-use oral drug for
the maintenance of normal heart rhythm following termination of AF. Cardiome
announced positive results from a Phase 2a pilot study for vernakalant (oral)
in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
    In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC
for all indications. Cardiome intends to initially develop GED-aPC in
cardiogenic shock, a life-threatening form of acute circulatory failure due to
cardiac dysfunction, which is a leading cause of death for patients
hospitalized following a heart attack.
    Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ
National Market (CRME).

    About Astellas

    Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S.
affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceutical products. The
organization is committed to becoming a global category leader in focused
areas by combining outstanding R&D and marketing capabilities.
    In the US, Astellas markets products in the areas of Immunology, Urology,
Anti-Infectives, Cardiovascular and Dermatology. For more information about
Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.

    References

    
    1.  Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC guidelines for the
        management of patients with atrial fibrillation. Journal of the
        American College of Cardiology. 2006;48(4):854-906.
    2.  Miyasaka Y, Barnes ME, Gersh BJ, et al. Secular Trends in Incidence
        of Atrial Fibrillation in Olmsted County, Minnesota, 1980 to 2000,
        and Implications on the Projections for Future Prevalence.
        Circulation 2006;114:119-125.
    

    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 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.





For further information:

For further information: Peter K. Hofman, Senior Director, Investor
Relations, Cardiome Pharma Corp., (604) 676-6993 or Toll Free: 1-800-330-9928,
Email: phofman@cardiome.com; Maribeth Landwehr, Astellas US LLC, (847)
317-8988; Ulysee Huling For Astellas Pharma US, Inc., (312) 397-6614


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