FDA Approves Ranexa
January 27 2006 - 5:14PM
PR Newswire (US)
Conference Call on Sunday, January 29, 2006 PALO ALTO, Calif., Jan.
27 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX)
announced today that the U.S. Food and Drug Administration (FDA)
has approved Ranexa(TM) (ranolazine extended-release tablets). The
approved indication is as follows: Ranexa is indicated for the
treatment of chronic angina. Because Ranexa prolongs the QT
interval, it should be reserved for patients who have not achieved
an adequate response with other anti-anginal drugs. Ranexa should
be used in combination with amlodipine, beta blockers or nitrates.
The effect on angina rate or exercise tolerance appeared to be
smaller in women than men. Complete prescribing information for
Ranexa, including detailed safety and dosage information, will be
available soon at http://www.cvt.com/. The approval of Ranexa marks
the first new pharmaceutical approach to treat angina in more than
20 years in the United States. CV Therapeutics anticipates that
Ranexa will be available in pharmacies in late March. "Patients
will now have access to a new angina therapy for the first time in
decades," said Louis G. Lange, M.D., Ph.D., CV Therapeutics
chairman and chief executive officer. "CV Therapeutics is very
proud to have succeeded in bringing this innovative new product to
the market, and we look forward to educating cardiology specialists
about Ranexa." Conference Call Company management will webcast a
conference call on Sunday, January 29, 2006, at 4:00 p.m. EST, 1:00
p.m. PST, on the company's website. To access the live webcast,
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
888-370-6121, and international callers may participate in the
conference call by dialing 706-679-7163. Webcast and telephone
replays of the conference call will be available approximately two
hours after the completion of the call through Sunday, February 5,
2006. 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 4913253. 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 products
include Ranexa(TM) (ranolazine extended-release tablets) and
ACEON(R) (perindopril erbumine) Tablets. Ranexa is indicated for
the treatment of chronic angina. Because Ranexa prolongs the QT
interval, it should be reserved for patients who have not achieved
an adequate response with other anti-anginal drugs. Ranexa should
be used in combination with amlodipine, beta blockers or nitrates.
The effect on angina rate or exercise tolerance appeared to be
smaller in women than men. In addition, CV Therapeutics co-promotes
ACEON, an ACE inhibitor, for reduction of the risk of
cardiovascular mortality or non-fatal myocardial infarction in
patients with stable coronary artery disease and treatment of
essential hypertension. 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.
Regadenoson has not been approved for marketing by any regulatory
authorities. Except for the historical information contained
herein, the matters set forth in this press release, including
statements as to development, clinical studies, regulatory review
and approval, and commercialization of products, 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, early stage of development; regulatory review and
approval of our products; the conduct and timing of clinical
trials; the dependence on collaborative and licensing agreements;
commercialization of products; market acceptance of products;
product labeling; 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, 2005. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. FCMN Contact: andrea.campbell@cvt.com DATASOURCE: CV
Therapeutics, Inc. CONTACT: investors, Christopher Chai, Vice
President, Treasury and Investor Relations, +1-650-384-8560, or
media, John Bluth, Senior Director, Corporate Communications,
+1-650-384-8850, both of CV Therapeutics, Inc.; or Emily Wilson of
Fleishman-Hillard, +1-212-453-2459, for CV Therapeutics, Inc. Web
site: http://www.cvt.com/
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