CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection
April 10 2008 - 7:18PM
PR Newswire (US)
-First A2A Adenosine Receptor Agonist Approved for Use as
Pharmacologic Stress Agent in Myocardial Perfusion Imaging- PALO
ALTO, Calif. and DEERFIELD, Ill., April 10 /PRNewswire-FirstCall/
-- CV Therapeutics, Inc. (NASDAQ:CVTX) and Astellas Pharma US, Inc.
today announced that the U.S. Food and Drug Administration (FDA)
has approved Lexiscan(TM) (regadenoson) injection, an A2A adenosine
receptor agonist, for use as a pharmacologic stress agent in
radionuclide myocardial perfusion imaging (MPI) -- a test that
detects and characterizes coronary artery disease -- in patients
unable to undergo adequate exercise stress. Lexiscan is the first
A2A adenosine receptor agonist shown to be safe and effective as a
pharmacologic stress agent in MPI studies. Lexiscan is delivered as
a rapid bolus (approximately 10 seconds) with no dose adjustment
required for body weight. The A2A adenosine receptor is the
adenosine receptor subtype responsible for coronary vasodilation.
MPI tests, commonly called cardiac stress tests, identify areas of
poor blood flow in the heart to help detect and characterize
coronary artery disease, the most common type of heart disease.
Many patients exercise on a treadmill to generate the increase in
coronary blood flow necessary to perform an MPI study. However,
almost half of the patients undergoing the 7.5 to 9.3 million
cardiac stress tests each year are unable to exercise adequately
because of medical conditions. For these patients, a pharmacologic
stress agent that temporarily increases blood flow through the
coronary arteries is used to mimic the increase in coronary blood
flow caused by exercise. "Lexiscan represents the second novel
chemical entity in cardiovascular medicine that CV Therapeutics has
received approval for in just over two years," stated Louis G.
Lange, M.D., Ph.D., chairman and chief executive officer of CV
Therapeutics. "We are very excited to have Astellas -- the clear
market leader in pharmacologic stress for MPI -- commercializing
Lexiscan." "We are extremely pleased that the FDA has approved
Lexiscan, an exciting new option for diagnosing coronary artery
disease in patients who cannot undergo an exercise stress test,"
said Yoshihiko Hatanaka, president and chief executive officer of
Astellas Pharma US, Inc. "We are preparing to launch Lexiscan soon
after this approval in order to provide clinicians with this
important new option for patients who need pharmacologic stress
agents for MPI studies." Lexiscan Clinical Trials In two
identically designed Phase III clinical trials, Lexiscan met
primary endpoints for scan agreement rates by showing with 95
percent confidence that MPI studies conducted with Lexiscan were
similar to MPI studies conducted with Adenoscan(R) (adenosine
injection). Lexiscan was generally well-tolerated in both Phase III
studies. The most common adverse events reported in patients who
received Lexiscan were shortness of breath, headache, flushing,
chest discomfort, dizziness and nausea. About Lexiscan Lexiscan is
an A2A adenosine receptor agonist approved for use as a
pharmacologic stress agent in radionuclide MPI studies in patients
unable to undergo adequate exercise stress. Lexiscan was designed
to produce coronary vasodilation and increase coronary blood flow
by activation of the A2A adenosine receptor. Lexiscan is
administered as a rapid bolus (approximately 10 seconds) with no
dose adjustment required for body weight. Lexiscan should not be
administered to patients with second- or third-degree AV block or
sinus node dysfunction who do not have a functioning artificial
pacemaker. Adenosine receptor agonists, including Lexiscan, induce
arterial vasodilation and hypotension. The risk of serious
hypotension may be higher in patients with cardiac or
cerebrovascular insufficiency. Complete prescribing information for
Lexiscan is available at http://www.lexiscan.com/. Astellas Pharma
US, Inc. / CV Therapeutics Inc. Collaboration Under a license and
collaboration agreement providing Astellas with exclusive North
American rights to Lexiscan, CV Therapeutics manages the
development program and Astellas is responsible for all commercial
activities for Lexiscan in North America. Under the arrangement,
Astellas paid 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 Lexiscan,
and may receive a royalty on another Astellas 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 Web site at http://www.astellas.com/us. Astellas
currently markets Adenoscan(R) (adenosine injection), the leading
pharmacologic stress 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 primarily 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 products include Ranexa(R)
(ranolazine extended- release tablets), indicated for the treatment
of chronic angina in patients who have not achieved an adequate
response with other antianginal drugs, and Lexiscan(TM)
(regadenoson) injection for use as a pharmacologic stress agent in
radionuclide myocardial perfusion imaging. CV Therapeutics also has
other clinical and preclinical drug development candidates and
programs. CV Therapeutics Conference Call Company management will
webcast a conference call on Friday, April 11, 2008 at 8:30 a.m.
EDT, 5:30 a.m. PDT, on the company's website. To access the live
webcast and corresponding slides, please log on to the Company's
website at http://www.cvt.com/ and go to the Investor Information
section. Alternatively, domestic callers may participate in the
conference call by dialing (866) 524-6241, and international
callers may participate in the conference call by dialing (706)
679-3061. Webcast and telephone replays of the conference call will
be available approximately two hours after the completion of the
call through Friday, April 18, 2008. Domestic callers can access
the replay by dialing (800) 642-1687, and international callers can
access the replay by dialing (706) 645-9291; the PIN access number
is 42825384. 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 strategic collaborative partners; intellectual
property protection and disputes; and other risks detailed from
time to time in CV Therapeutics' SEC reports, including its Annual
Report on Form 10-K for the year ended December 31, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: Astellas Pharma US, Inc.
CONTACT: CV Therapeutics Investors and Media, John Bluth of CV
Therapeutics, Inc., +1-650-384-8850; or Astellas Media, Maribeth
Landwehr of Astellas US LLC, +1-847-317-8988; or Katherine
Williams, +1-312-397-6613, for Astellas Pharma US, Inc. Web site:
http://www.lexiscan.com/ http://www.astellas.com/us
http://www.cvt.com/
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