CV Therapeutics Withdraws European Marketing Application for Ranolazine
October 25 2005 - 5:07PM
PR Newswire (US)
PALO ALTO, Calif., Oct. 25 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the European
Medicines Agency (EMEA) has indicated that additional clinical
pharmacokinetic information would be needed prior to potential
approval of ranolazine in Europe for the treatment of chronic
angina. At this point in the process, the European centralized
regulatory procedure does not provide a mechanism for obtaining and
adding new information to a marketing authorization application
(MAA). Accordingly, the company has withdrawn its MAA for
ranolazine in Europe, and anticipates resubmitting it at a later
date. Based on dialogue to date with the EMEA, the company expects
one or more additional clinical pharmacokinetic studies will be
required prior to any approval, but does not expect that a large or
lengthy clinical trial would be required. The company plans to
continue working with the EMEA to further clarify the next steps to
support the potential resubmission and approval of ranolazine in
Europe and has not determined a target date for resubmission of an
MAA. In the United States, an amended new drug application (NDA)
for ranolazine for the treatment of chronic angina in a restricted
patient population is currently under review by the U.S. Food and
Drug Administration (FDA). This amended NDA includes the results of
the ERICA study, which was conducted under the FDA's special
protocol assessment (SPA) process. The NDA amendment was submitted
as a complete response to an October 2003 approvable letter, and
the Prescription Drug User Fee Act date for FDA action on the NDA
is January 27, 2006. The SPA agreement is an agreement between CV
Therapeutics and the FDA and does not apply to European regulatory
authorities. 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
currently has three programs in commercial or late-stage
development: ACEON(R) (perindopril erbumine) Tablets, Ranexa(TM)
(ranolazine) and regadenoson. CV Therapeutics also has other
clinical and preclinical drug development candidates and programs.
The company co-promotes ACEON(R), an ACE inhibitor, for the
treatment of essential hypertension and reduction of the risk of
cardiovascular mortality or non-fatal myocardial infarction in
patients with stable coronary artery disease. Ranexa is being
developed as a novel potential treatment for chronic angina.
Regadenoson is being developed for potential use as a pharmacologic
stress agent in myocardial perfusion imaging studies. Ranexa and
regadenoson have not been approved for marketing by any regulatory
authorities. Except for the historical information contained
herein, the matters set forth in this press release, including
statements as to development, clinical studies, regulatory review
and approval, 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, early stage of development; regulatory review and
approval of our products; the conduct and timing of clinical
trials; the dependence on collaborative and licensing agreements;
commercialization of products; market acceptance of products; 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, 2005. CV Therapeutics disclaims any intent
or obligation to update these forward-looking statements.
DATASOURCE: CV Therapeutics, Inc. CONTACT: investors, Christopher
Chai, Vice President, Treasury and Investor Relations,
+1-650-384-8560, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, both of CV Therapeutics, Inc. Web
site: http://www.cvt.com/
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