�Cardiome
Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner
Astellas Pharma US, Inc. ("Astellas") 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 realised its review of the KYNAPID NDA and that the covering is
approvable. Prior to considering blessing, FDA requires additional
information associated with the peril of antecedently identified events
experienced by a subset of patients during the clinical trials in order to
reassure an acceptable risk benefit profile compared to electrical
cardioversion. FDA has likewise requested a safety update from ongoing or
completed studies of vernakalant, regardless of reading, dosage form, or
battery-acid level. Cardiome and Astellas will work closely with the FDA to address
all issues raised in the approvable letter.
"Astellas will be in contact with the FDA inside the future few days to
hash out next stairs, 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 varsity letter could
result in the need for an additional clinical cogitation, Cardiome is optimistic
that the questions raised butt be satisfactorily addressed from currently
available data."
"Astellas and Cardiome strongly believe in the therapeutic value of
KYNAPID based on clinical run data and are confident it volition 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
return and all rights to the endovenous formulations external of
Canada, U.S. and Mexico. The NDA for KYNAPID, based on a five-year clinical
development programme, 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 scheme. Cardiome is traded on the
NASDAQ National Market (CRME) and the Toronto Stock Exchange (COM). For
more information, please bring down our world Wide Web site at http://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
ship's 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 combination 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., delight visit our website at
http://www.astellas.com/us.
Forward-Looking Statement Disclaimer
Certain statements in this press release turn back forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995 or advanced 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", "estimation", "continue", "anticipate", "intend", "expect"
and like expressions. Such forward-looking statements or information
involve known and unknown risks, uncertainties and former factors that may
effort our actual results, events or developments, or manufacture results, to
be materially different from any future results, events or developments
expressed or implied by such innovative statements or information.
Such factors include, among others, our stage of development, lack of
product revenues, additional capital requirements, risk associated with the
closing of clinical trials and obtaining regulative approval to market
our products, the ability to protect our intellectual property, dependence
on collaborative partners and the prospects for negotiating extra
corporate collaborations or licensing arrangements and their timing.
Specifically, sure risks and uncertainties that could reason such actual
events or results verbalised or implied by such forward-looking statements
and information to disagree materially from any future events or results
verbalized 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 originate 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 non be capable
to grow additional capital; we crataegus oxycantha not be successful in establishing
additional corporate collaborations or licensing arrangements; we may non
be able to establish marketing and sales capabilities and the costs of
launching our products may be greater than hoped-for; we trust on third
parties for the continued supply and manufacture of vernakalant (iv) and
vernakalant (oral) and we have no feel in commercial manufacturing;
we may cheek unknown risks related to intellectual attribute 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 http://www.sec.gov and the Canadian securities
regulatory regime at hypertext transfer protocol://www.sedar.com.
Given these risks and uncertainties, you are cautioned non to spot
undue reliance on such forward-looking statements and information, which
ar qualified in their entireness by this cautionary statement. All
modern statements and information made herein ar based on our
stream expectations and we set about no obligation to revise or update
such modern statements and information to reflect subsequent
events or circumstances, take out as requisite by jurisprudence.
Cardiome Pharma Corp
http://www.cardiome.com
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