Regadenoson Meets Primary Endpoint in Second Phase 3 Clinical Trial
December 04 2006 - 7:00AM
PR Newswire (US)
- New drug application planned for mid-2007 - PALO ALTO, Calif. and
DEERFIELD, Ill., Dec. 4 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) and Astellas Pharma US, Inc. announced today
that the second of two Phase 3 clinical studies of regadenoson met
its primary endpoint. A prior identically designed Phase 3 study,
completed in 2005, also met its primary endpoint. Based on the
results of these two Phase 3 clinical trials, CV Therapeutics plans
to submit a new drug application to the U.S. Food and Drug
Administration (FDA) in mid-2007. 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. Regadenoson is a selective A2A-adenosine receptor agonist
for potential use as a pharmacologic stress agent in myocardial
perfusion imaging (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. In this study,
regadenoson met its 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). This multinational, randomized, double-blind Phase 3
study of 1231 patients undergoing MPI studies was designed to
evaluate the comparability of MPI studies conducted with
regadenoson and Adenoscan(R) (adenosine injection). Regadenoson was
generally well tolerated. In the study, the most common adverse
events reported in patients who received regadenoson were shortness
of breath, chest pain, headache, flushing and gastrointestinal
discomfort. "With two identically designed Phase 3 studies having
hit their primary endpoints, we are excited about the opportunity
to pursue approval of regadenoson. We are also pleased that
regadenoson once again demonstrated safety and tolerability." said
Louis G. Lange, M.D., Ph.D., chairman and chief executive officer
of CV Therapeutics. "The need for myocardial perfusion imaging
tests as a diagnostic aid continues to increase in the United
States. Our expertise as a leader in this category will help
maximize our ability to offer regadenoson, once approved, as a
viable option for patients and physicians," said Yoshihiko
Hatanaka, president and chief executive officer of Astellas Pharma
US, Inc. 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 in a
double blinded fashion to receive either regadenoson or
Adenoscan(R) (adenosine injection) in 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. Many patients exercise on a treadmill
to generate the increase in coronary blood flow necessary to
perform an MPI study. However, more than 45 percent of the patients
undergoing an MPI study are unable to exercise adequately because
of medical conditions such as peripheral vascular disease,
arthritis or other limiting medical conditions which prevent them
from exercising on the treadmill. For these patients, a
pharmacologic agent that temporarily increases coronary blood flow
is used to mimic the increase in coronary blood flow caused by
exercise. Regadenoson is being studied for potential use as a
pharmacologic agent under these circumstances. Astellas Pharma US,
Inc. / CV Therapeutics Inc. Collaboration Under a collaboration
agreement providing Astellas with exclusive North American rights
to regadenoson, CV Therapeutics manages the clinical 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 reimburses CV
Therapeutics for 75 percent of development costs and 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 Regadenoson Regadenoson is a selective
A2A-adenosine receptor agonist for potential use as a pharmacologic
stress agent in MPI studies. Regadenoson has been designed to be
delivered rapidly as a bolus and to selectively stimulate the
A2A-adenosine receptor, the receptor responsible for coronary
vasodilation. About Astellas Pharma US, Inc. Astellas Pharma US,
Inc., a US subsidiary of Tokyo-based Astellas Pharma Inc., is a
research-based pharmaceutical company dedicated to improving the
health of people around the world through the provision of
innovative and reliable pharmaceutical products. Established on
April 1, 2005, the company was formed through a merger that
combined the outstanding research, development and marketing
capabilities of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi
Pharmaceutical Co., Ltd. Astellas ranks among the top 20
pharmaceutical companies in the world and will continue to grow as
a competitive company in the world pharmaceutical market. For more
information on Astellas Pharma US, Inc., go to
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. 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; 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 September 30, 2006. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: Investor and
Media Contact, John Bluth, Senior Director, Corporate
Communications and Investor Relations of CV Therapeutics, Inc.,
+1-650-384-8850; or Media Contact, Maribeth Landwehr, Assistant
Director, Corporate Communications of Astellas Pharma US, Inc.,
+1-847-317-8988 Web site: http://www.astellas.com/us Web site:
http://www.cvt.com/
Copyright
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Aug 2024 to Sep 2024
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Sep 2023 to Sep 2024