VANCOUVER and DEERFIELD, IL, Jan. 21 /CNW/ - Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM) and its co-development partner Astellas Pharma US,
Inc. ("Astellas") today announced that they have been informed by the U.S.
Food and Drug Administration (FDA) that a decision has not yet been made
regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalant
hydrochloride). The FDA did not provide an action letter prior to the PDUFA
date of January 19, 2008.
"While we look forward to the FDA reaching a decision, we respect their
need for additional time to review the KYNAPID NDA," said William E.
Fitzsimmons, PharmD, Senior Vice President, Research & Development at
Astellas. "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."
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. The NDA for KYNAPID, based on a five-year clinical
development program, was submitted in December 2006. In December 2007, the FDA
Cardiovascular and Renal Drugs Advisory Committee voted 6-2 in favour of
recommending to the FDA that KYNAPID be approved for the rapid conversion of
acute AF to sinus rhythm.
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).
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.
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
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: email@example.com; Maribeth Landwehr, Astellas US LLC, (847)
317-8988; Ulysee Huling For Astellas Pharma US, Inc., (312) 397-6614