CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
PALO ALTO, Calif., Aug. 14 /PRNewswire-FirstCall/ — CV Therapeutics, Inc. announced today that it has received approval from the European Medicines Agency (EMEA) for the brand name Ranexa(R) (ranolazine).
On July 10, 2008, the Company announced that the EMEA had granted marketing authorization for ranolazine in all 27 European Union (EU) member states under the brand name Latixa.
“Securing approval for the Ranexa brand name in Europe provides important brand synergy in the world’s two largest cardiovascular markets, the U.S. and the EU,” said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.
Ranexa is approved for use in Europe as an add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies. The product is approved for use in 375 mg, 500 mg and 750 mg doses, administered twice daily.
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 Ltd. is the company’s European subsidiary based in the United Kingdom.
CV Therapeutics’ approved products in the United States 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 in patients unable to undergo adequate exercise stress. Ranexa is also approved for use in the European Union as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies.
Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development 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 operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of our products; special protocol assessment agreement; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property 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 June 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.
CV Therapeutics, Inc.
CONTACT: John Bluth, Executive Director, Corporate Communications &Investor Relations, CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/