European Medicines Agency Adopts Positive Opinion for Ranolazine for Treatment of Chronic Angina
April 24 2008 - 2:51PM
PR Newswire (US)
PALO ALTO, Calif., April 24 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMEA) has adopted a positive opinion recommending
approval of ranolazine in the European Union (EU) for the treatment
of chronic angina. Following this positive recommendation from the
CHMP, CV Therapeutics expects the European Commission to issue full
marketing authorization for ranolazine by the end of June. The
brand name for ranolazine in the product labeling is Latixa(TM).
The approved indication states that 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 (such as
beta-blockers and/or calcium antagonists)." The 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. The doses of the product in the EU
will be 375 mg, 500 mg and 750 mg twice daily. "This positive
opinion from the CHMP brings ranolazine significantly closer to
physicians and patients in Europe for the treatment of chronic
angina," said Louis G. Lange, M.D., Ph.D., chairman and chief
executive officer of CV Therapeutics. "The strong first-in-class
product labeling should position ranolazine very favorably with
potential partners and allow for broad patient acceptance and
premium pricing in the European market." "Europe represents a
larger potential market for medical treatment of angina than the
United States," said Robin Bhattacherjee, executive director of CV
Therapeutics Europe Ltd. "With lower rates of intervention and a
tremendous unmet need for novel medical approaches to angina across
the EU, we believe ranolazine could become a significant therapy in
routine clinical practice." 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 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: ability of CV
Therapeutics to achieve profitability; 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; reliance on strategic collaborative partners;
reliance on contract manufacturers; intellectual property; and
other risks detailed from time to time in CV Therapeutics' SEC
reports, including its Annual Report on Form 10-K for the year
ended December 31, 2007. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements. DATASOURCE:
CV Therapeutics, Inc. CONTACT: Investor and Media 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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