Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of New Drug Application for Vernakalant (iv)
19 Dezember 2006 - 2:08AM
PR Newswire (US)
NASDAQ: CRME TSX: COM VANCOUVER and DEERFIELD, IL Dec. 18
/PRNewswire-FirstCall/ -- Cardiome Pharma Corp.
(NASDAQ:CRME/TSX:NASDAQ:COM) and its co-development partner,
Astellas Pharma US, Inc., today announced Astellas' re-submission
of the New Drug Application (NDA) to the United States Food &
Drug Administration (FDA) seeking approval to market the
intravenous formulation of vernakalant hydrochloride, an
investigational new drug for the acute conversion of atrial
fibrillation. "This re-submission is the culmination of a
comprehensive and thorough review process conducted by Astellas
Pharma US, Inc., Cardiome and outside consultants," stated Dr.
Charles Fisher, Executive Vice President and Chief Medical Officer
of Cardiome. "With the inclusion of an additional 150 patients in
the safety dataset from the ongoing ACT 2 and ACT 4 studies, we are
pleased with the NDA Astellas has submitted for the FDA's
consideration." "With this NDA, we have taken an important step
forward in the development process of this therapeutic candidate,"
stated William E. Fitzsimmons, Pharm.D., Senior Vice President,
Business Development at Astellas Pharma US, Inc. "The collaborative
effort between Cardiome and Astellas Pharma US, Inc. has been
emblematic of our successful development partnership and mutual
commitment to success." Pursuant to the amended (July 2006)
co-development agreement between Cardiome and Astellas Pharma US,
Inc., a US$10 million milestone payable to Cardiome has been
triggered on re-submission of the NDA. In October 2003, Cardiome
granted Astellas Pharma US, Inc. an exclusive license to develop
and commercialize vernakalant (iv) in North America. The companies
have co-developed vernakalant (iv) to NDA, with Astellas
responsible for 75% of development costs. Cardiome has retained all
rights to the intravenous formulations outside of Canada, U.S. and
Mexico. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a
product-focused cardiovascular drug development company with two
clinical drug programs focused on atrial arrhythmia (intravenous
and oral dosing), 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 (AF). 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. An additional Phase 3 study evaluating patients
with post-operative atrial arrhythmia, called ACT 2, and an
open-label safety study evaluating recent-onset AF patients, called
ACT 4, are ongoing. Cardiome's co-development partner Astellas
Pharma US, Inc. submitted a New Drug Application for vernakalant
(iv) in December 2006. 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. Cardiome is traded on the Toronto Stock Exchange (COM) and
the NASDAQ National Market (CRME). About Astellas Pharma US, Inc.
Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US
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 pharmaceutical company by combining outstanding R&D
and marketing capabilities and continuing to grow in the world
pharmaceutical market. For more information about Astellas Pharma
US, Inc., please visit our website at http://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 http://www.sec.gov/ and the Canadian
securities regulatory authorities at http://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. CONTACT: Peter K. Hofman, Senior Director, Investor Relations,
(604) 676-6993 or Toll Free: 1-800-330-9928, Email: ; Maribeth
Landwehr, Assistant Director, Corporate Communications, Astellas
Pharma US, Inc., (847) 317-8988 DATASOURCE: Cardiome Pharma Corp.
CONTACT: Peter K. Hofman, Senior Director, Investor Relations,
(604) 676-6993 or Toll Free: 1-800-330-9928, Email: ; Maribeth
Landwehr, Assistant Director, Corporate Communications, Astellas
Pharma US, Inc., (847) 317-8988
Copyright