Cardiome Provides Regulatory Update


    VANCOUVER, Oct. 9 /CNW/ - Cardiome Pharma Corp. (NASDAQ:   CRME / TSX: COM)
today announced that it has been informed by its co-development partner,
Astellas Pharma US, Inc., that an End of Review meeting with the U.S. Food &
Drug Administration (FDA) has been scheduled for November 14th, 2008 regarding
the New Drug Application (NDA) for KYNAPID(TM) (vernakalant hydrochloride)
Injection for rapid conversion of atrial fibrillation to sinus rhythm. At the
conclusion of FDA's review of an application and the issuance of an action
letter, FDA provides applicants with an opportunity to meet with agency
reviewing officials to discuss what further steps need to be taken by the
applicant before the application can be approved.
    Cardiome has also been informed by Astellas that, in an effort to align
the North American regulatory strategy, Astellas has elected to withdraw the
New Drug Submission (NDS) for KYNAPID with the Therapeutic Products
Directorate (TPD) of Health Canada, originally submitted in May 2007. Cardiome
and Astellas intend to revisit the Canadian regulatory strategy following
resolution of the FDA process.
    "Since receiving the FDA Approvable Letter in August, Cardiome and
Astellas have been working diligently to collate information and analyses
relevant to the issues raised in the action letter, and this meeting is
intended to provide us with clear guidance so that we can focus our efforts on
providing a robust response and attain U.S. approval for KYNAPID," said Bob
Rieder, Chief Executive Officer of Cardiome. "We look forward to working with
the FDA with the goal of having KYNAPID available to appropriate patients as
soon as possible."

    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

    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, (604) 676-6993 or Toll Free: 1-800-330-9928, Email:

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