CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson)...

CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM)
(regadenoson) Injection
-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.
SOURCE Astellas Pharma US, Inc.

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.