Additional Clinical Trial to be Conducted for KYNAPID Under FDA Special Protocol Agreement



    
    NASDAQ:   CRME   TSX: COM
    

    VANCOUVER and DEERFIELD, IL, Aug. 10 /CNW/ - Cardiome Pharma Corp.
(NASDAQ:   CRME/TSX: COM) and its co-development partner Astellas Pharma US,
Inc. ("Astellas") announced today that Astellas will undertake a single
confirmatory additional Phase 3 clinical trial of KYNAPID(TM) (vernakalant
hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus
rhythm. The trial, to be called ACT 5, is expected to begin enrolling patients
by the end of 2009, with completion expected in the first half of 2011.
    The decision to conduct another trial was reached following extended
discussions with the FDA to define the best regulatory path forward for
KYNAPID. Under the Special Protocol Assessment (SPA) process, the FDA has
agreed that the design and planned analysis of the study adequately address
objectives in support of the KYNAPID New Drug Application (NDA). The
prospectively-defined trial will enroll recent-onset atrial fibrillation
patients without a history of heart failure. Cardiome and Astellas believe
that this study, coupled with the overall clinical development program, should
in principle meet the FDA standards for approval.
    "In addition to receiving a positive recommendation for approval from the
FDA Cardiovascular and Renal Drugs Advisory Committee, KYNAPID has
demonstrated consistent results across all of the four completed Phase 3
clinical trials," said William E. Fitzsimmons, PharmD, Senior Vice President,
Development at Astellas. "We are confident that the ACT 5 trial will confirm
these prior results and further demonstrate the therapeutic value of this
exciting drug candidate."
    "We support the decision to conduct the ACT 5 trial, and we will assist
our partner Astellas in every way to expedite the launch and successful
completion of this study," said Doug Janzen, President and Chief Executive
Officer of Cardiome. "We estimate that Cardiome's allocation of costs from
this trial will be on the order of US$6 million, and while the additional time
and expense of conducting another trial is unfortunate, we believe that
Astellas will ultimately be successful in gaining approval for KYNAPID in this
important indication."

    The ACT 5 Trial

    The ACT 5 trial, "A Phase 3b Randomized, Double-Blind, Placebo
Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of
Vernakalant Hydrochloride Injection in Patients with Recent Onset Symptomatic
Atrial Fibrillation," will enroll approximately 450 patients across
approximately 100 centres focused in North America. The study is designed to
measure the safety and efficacy of KYNAPID Injection in patients with
recent-onset atrial fibrillation (more than 3 hours but less than 7 days). The
study excludes patients with evidence or history of congestive heart failure
(CHF). Further, the study will evaluate the influence of CYP2D6 genotype
status on the pharmacokinetics and pharmacodynamics of vernakalant (and its
metabolites), and also allows for an exploratory analysis of safety and
healthcare resource utilization between vernakalant and electrocardioversion
(ECV).

    Conference Call Notification

    Cardiome will hold a teleconference and webcast on Tuesday, August 11,
2009 at 9:00am Eastern (6:00am Pacific). To access the conference call, please
dial 416-340-2217 or 866-696-5910 and reference conference 2345242. There will
be a separate dial-in line for analysts on which we will respond to questions
at the end of the call. The webcast can be accessed through Cardiome's website
at www.cardiome.com.
    Webcast and telephone replays of the conference call will be available
approximately two hours after the completion of the call through September 11,
2009. Please dial 416-695-5800 or 800-408-3053 and enter code 3147267 followed
by the number sign to access the replay.

    About KYNAPID

    KYNAPID (vernakalant hydrochloride) Injection, or vernakalant (iv), is an
investigational new drug for the rapid conversion of acute atrial fibrillation
to sinus rhythm. 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.
    In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive
license to develop and commercialize KYNAPID in North America, with Astellas
responsible for 75% of development costs. Astellas and Cardiome conducted four
successful Phase 3 clinical trials which demonstrated the potential for
KYNAPID as a conversion agent. In December 2004 and September 2005, we
announced positive top-line results for the first and second pivotal Phase 3
atrial fibrillation trials, or ACT 1 and ACT 3, respectively. In addition,
positive top-line results from ACT 2, evaluating KYNAPID for the treatment of
atrial fibrillation following cardiac surgery, were announced in June 2007.
Astellas also conducted an open-label safety study, or ACT 4, in order to
gather additional safety data.
    The NDA for KYNAPID was submitted in December 2006. In December 2007, the
FDA Cardiovascular and Renal Drugs Advisory Committee recommended to the FDA
that KYNAPID be approved for rapid conversion of acute atrial fibrillation to
sinus rhythm. In August 2008, Astellas received an Approvable letter from the
FDA.

    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 www.cardiome.com.

    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.us.astellas.com.

    Cardiome 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


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