CV Therapeutics Submits New Drug Application For Regadenoson
May 14 2007 - 5:01PM
PR Newswire (US)
PALO ALTO, Calif. and DEERFIELD, Ill., May 14
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) and
Astellas Pharma US, Inc. announced today that CV Therapeutics has
submitted a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) seeking approval of regadenoson for use in
myocardial perfusion imaging (MPI) studies. The NDA submission
triggers a $7 million milestone payment from Astellas to CV
Therapeutics. Regadenoson is a selective A2A-adenosine receptor
agonist under development for use as a pharmacologic stress agent
in MPI studies. Regadenoson has been designed to be delivered as a
rapid bolus with no dose adjustment required by weight, and to
selectively stimulate the A2A-adenosine receptor, the receptor
responsible for coronary vasodilation. "We are very pleased to have
submitted an NDA for regadenoson, which, if approved in 2008, would
represent the second innovative cardiovascular product CV
Therapeutics will have brought to market in a two year period,"
said Louis G. Lange, M.D., Ph.D., chairman and chief executive
officer of CV Therapeutics. "As the market leader in pharmacologic
stress testing, we look forward to the market introduction of
regadenoson. We are seeing a continued increase in demand for
myocardial perfusion imaging tests in the United States and, upon
approval, we believe both patients and physicians will benefit from
the clinical profile of regadenoson," said Yoshihiko Hatanaka,
president and chief executive officer of Astellas Pharma US, Inc.
If regadenoson is approved by the FDA, Astellas Pharma US, Inc.
will be responsible for all commercial activities for regadenoson
in the United States. CV Therapeutics retains all rights to
regadenoson outside of North America. The NDA contains data from
two identically designed Phase 3 clinical trials. In both Phase 3
trials, regadenoson met the primary endpoint by showing with 95
percent confidence that MPI studies conducted with regadenoson were
comparable to MPI studies conducted with Adenoscan(R) (adenosine
injection). Regadenoson was generally well tolerated in both Phase
3 studies. The most common adverse events reported in patients who
received regadenoson were shortness of breath, headache, flushing,
chest discomfort and dizziness. Phase 3 Design Patients 18 years or
older with the clinical need for an MPI study were eligible to
participate in the Phase 3 clinical trials. Individuals who had an
acute myocardial infarction or unstable angina within three months,
or coronary revascularization within six months, were not permitted
to participate in the study. All study participants received a
clinically indicated baseline MPI study using Adenoscan(R)
(adenosine injection). Participants then were randomized to receive
either regadenoson or Adenoscan(R) (adenosine injection) in a
double blinded fashion during a second MPI study. Each patient's
scans were classified as indicating normal, moderate or severe
ischemia. Baseline and blinded scans then were evaluated to
determine if the scans were comparable. Myocardial perfusion
imaging studies MPI studies help detect and characterize coronary
artery disease by identifying areas of poor blood flow in the
heart. In 2005, approximately 9.3 million patients in the United
States underwent MPI studies. Astellas Pharma US, Inc. / CV
Therapeutics Inc. Collaboration Under a license and collaboration
agreement providing Astellas with exclusive North American rights
to regadenoson, CV Therapeutics manages the development program and
Astellas is responsible for all commercial activities for
regadenoson in North America, if the product is approved for
marketing. Under the arrangement, Astellas owes CV Therapeutics a
$7 million milestone upon NDA submission and a $12 million
milestone upon FDA approval, and reimburses CV Therapeutics for 75
percent of development costs. CV Therapeutics will receive a
royalty on product sales of regadenoson, if approved, and may
receive a royalty on another product. CV Therapeutics owns the
rights for regadenoson outside of North America. About Astellas
Pharma US, Inc. 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
U.S., 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 http://www.astellas.com/us. Astellas currently markets
Adenoscan(R) (adenosine injection), the leading agent for MPI
studies in the United States. Adenoscan is indicated as an adjunct
to thallium-201 myocardial perfusion scintigraphy in patients
unable to exercise adequately. The most common side effects include
flushing, chest discomfort, and dyspnea. Less frequent side effects
reported in patients administered Adenoscan include second and
third degree AV block, fatal cardiac arrest, ventricular
tachycardia, and nonfatal myocardial infarction. For full
prescribing information, please visit http://www.adenoscan.com/.
About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo
Alto, California, is a biopharmaceutical company focused on
applying molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics' approved product,
Ranexa(R) (ranolazine extended-release tablets) is indicated for
the treatment of chronic angina in patients who have not achieved
an adequate response with other antianginal drugs, and should be
used in combination with amlodipine, beta-blockers or nitrates. CV
Therapeutics also has other clinical and preclinical drug
development candidates and programs, including regadenoson, which
is being developed for potential use as a pharmacologic stress
agent in myocardial perfusion imaging studies and CVT-6883, which
is being developed as a potential treatment for asthma and other
conditions. Regadenoson and CVT-6883 have not been determined by
any regulatory authorities to be safe or effective in humans for
any use. Trademarks listed belong to their respective owners.
Except for the historical information contained herein, the matters
set forth in this press release are forward-looking statements
within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially, including; the conduct and
timing of studies; timing of regulatory submissions; timing of
regulatory review and approval; commercialization of products;
market acceptance of products; dependence on collaborative
partners; intellectual property protection and disputes; and other
risks detailed from time to time in CV Therapeutics' SEC reports,
including its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2007. CV Therapeutics disclaims any intent or obligation
to update these forward-looking statements. DATASOURCE: CV
Therapeutics, Inc. CONTACT: Investor and Media: John Bluth, Senior
Director, Corporate Communications and Investor Relations, CV
Therapeutics, Inc., +1-650-384-8850; Astellas Media: Maribeth
Landwehr, Assistant Director, Corporate Communications, Astellas
Pharma US, Inc., +1-847-317-8988 Web site: http://www.cvt.com/
http://www.adenoscan.com/
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