Cardiome And Astellas Announce Receipt Of FDA Approvable Letter For KYNAPID(TM)


    VANCOUVER and DEERFIELD, IL, Aug. 11 /CNW/ - Cardiome Pharma Corp.
(NASDAQ:   CRME/TSX: COM) and its co-development partner Astellas Pharma US,
Inc. ("Astellas") today announced that they have received an action letter
dated August 8, 2008 from the U.S. Food and Drug Administration (FDA) for
KYNAPID(TM) (vernakalant hydrochloride) Injection for the treatment of atrial
fibrillation (AF) - a potentially life-threatening condition that occurs when
electrical signals in the heart malfunction. KYNAPID is under review for the
rapid conversion of AF to sinus rhythm.
    In the action letter, the FDA informed the sponsor (Astellas) that it has
completed its review of the KYNAPID NDA and that the application is
approvable. Prior to considering approval, FDA requires additional information
associated with the risk of previously identified events experienced by a
subset of patients during the clinical trials in order to assure an acceptable
risk benefit profile compared to electrical cardioversion. FDA has also
requested a safety update from ongoing or completed studies of vernakalant,
regardless of indication, dosage form, or dose level. Cardiome and Astellas
will work closely with the FDA to address all issues raised in the approvable
    "Astellas will be in contact with the FDA within the next few days to
discuss next steps, and we expect that several months may be required to
assemble a complete and appropriate response," stated Bob Rieder, Chief
Executive Officer and Chairman of Cardiome. "While this action letter could
result in the need for an additional clinical study, Cardiome is optimistic
that the questions raised can be satisfactorily addressed from currently
available data."
    "Astellas and Cardiome strongly believe in the therapeutic value of
KYNAPID based on clinical trial data and are confident it will be an important
therapy in the treatment of atrial fibrillation," said William E. Fitzsimmons,
PharmD, Senior Vice President, Research & Development at Astellas.
    In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive
license to develop and commercialize KYNAPID in North America. Cardiome
retains worldwide rights to vernakalant (oral) for the prevention of AF
recurrence and all rights to the intravenous formulations outside of Canada,
U.S. and Mexico. The NDA for KYNAPID, based on a five-year clinical
development program, was submitted in December 2006.

    About Cardiome

    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

    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

    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 and the Canadian securities regulatory authorities at
    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:; Maribeth Landwehr, Astellas US LLC, (847)

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