PALO ALTO, Calif., Aug. 14 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc.
(Nasdaq: CVTX) 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.
SOURCE CV Therapeutics, Inc.