CV Therapeutics Files Application for European Marketing Approval of Ranolazine for Treatment of Chronic Angina
December 20 2006 - 4:01PM
PR Newswire (US)
PALO ALTO, Calif., Dec. 20 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that a Marketing
Authorization Application (MAA) seeking approval of ranolazine for
the treatment of chronic angina has been filed with the European
Medicines Agency (EMEA). The MAA includes additional data and
results from studies conducted after March 2004. The MAA for
ranolazine, a new chemical entity, has been filed for review under
the EMEA centralized procedure by the company's European
subsidiary, CV Therapeutics Europe, Ltd. "A new anti-ischemic
option like ranolazine could meet a significant unmet medical need
in Europe," said Louis G. Lange, M.D., Ph.D., chairman and chief
executive officer of CV Therapeutics. "With ranolazine now on the
market in the U.S., we look forward to bringing the benefits of
ranolazine to patients around the world." Chronic angina is a
serious and debilitating heart condition, usually associated with
coronary artery disease and marked by repeated and sometimes
unpredictable attacks of chest pain. 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; dependence on lead product; dependence on performance of
commercialization 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 September 30, 2006. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: John Bluth,
Senior Director, Corporate Communications & Investor Relations,
+1-650-384-8850, or Investors, Dahlia Bailey, Senior Investor
Relations Manager, +1-650-384-8585, or Media, Brendan Doherty,
Manager, Public Relations, +1-650-384-8372, all of CV Therapeutics,
Inc. Web site: http://www.cvt.com/
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