CV Therapeutics Receives European Marketing Authorization for Ranolazine for the Treatment of Patients With Chronic Angina
July 10 2008 - 4:01PM
PR Newswire (US)
PALO ALTO, Calif., July 10 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that it has
received marketing authorization from the European Medicines Agency
(EMEA) for ranolazine for the treatment of patients with chronic
angina in all 27 European Union (EU) member states. This approval
follows a positive opinion from the EMEA Committee for Medicinal
Products for Human Use (CHMP) on April 24, 2008. Ranolazine is
approved for use in Europe 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. Ranolazine is approved for use in 375 mg, 500 mg and 750
mg doses, administered twice daily. The approved European labeling
reflects data from the MERLIN TIMI-36 and other recently reported
studies, including data showing statistically significant
reductions in ventricular arrhythmias with ranolazine. The labeling
also notes that the ability of ranolazine to reduce cellular
calcium overload is expected to improve myocardial relaxation and
decrease left ventricular diastolic stiffness. "We expect
ranolazine could be available to patients and physicians across
Europe beginning in the first part of 2009, as we continue to see
very strong interest from potential commercial partners," said
Louis G. Lange, M.D., Ph.D., chairman and chief executive officer
of CV Therapeutics. "Revenues from European sales of ranolazine
would represent a fourth product-related revenue stream for CV
Therapeutics." There are currently 48-50 million angina
prescriptions written annually in the largest five EU member
countries (UK, Germany, France, Spain and Italy). "Considering the
well-established need for medical treatment of angina across the EU
and the unique product labeling, we believe that ranolazine may
become a leading therapy for the millions of angina patients across
Europe," said Robin Bhattacherjee, executive director of CV
Therapeutics Europe Ltd. About Ranolazine In the United Sates,
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. In the U.S., CV
Therapeutics is seeking changes to the approved product labeling
for Ranexa to include a first line angina indication, a significant
reduction in cautionary language, and the potential addition of
promotable claims for the reduction of hemoglobin A1c and
ventricular arrhythmias in patients with coronary artery disease.
The Prescription Drug User Fee Act (PDUFA) action date for these
requested labeling changes is July 27, 2008. In Europe, ranolazine
is indicated 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. The
approved labeling reflects data from the MERLIN TIMI-36 and other
recently reported studies, including data showing statistically
significant reductions in ventricular arrhythmias with ranolazine.
The labeling also notes that the ability of ranolazine to reduce
calcium overload is expected to improve myocardial relaxation and
decrease left ventricular diastolic stiffness. 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. 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
March 31, 2008. CV Therapeutics disclaims any intent or obligation
to update these forward-looking statements. DATASOURCE: CV
Therapeutics, Inc. CONTACT: John Bluth, Executive Director,
Corporate Communications & Investor Relations, of CV
Therapeutics, Inc., +1-650-384-8850 Web site: http://www.cvt.com/
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