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EXHIBIT 99.1
PRESS RELEASE
FOR IMMEDIATE RELEASE
Contacts: CV Therapeutics Fleishman-Hillard
Dan Spiegelman Dana Gandsman
SVP & Chief Financial Officer (212) 453-2423
(650) 812-9509
Christopher Chai
Treasurer & Director,
Investor Relations
(650) 812-9560
CV THERAPEUTICS UPDATES CARISA TRIAL ENROLLMENT
PALO ALTO, CA. (January 5, 2001) - CV Therapeutics, Inc. (Nasdaq: CVTX)
today announced that it has completed enrollment of the originally planned 462
patients in the Phase III CARISA (Combination Assessment of Ranolazine In Stable
Angina)
trial, but plans to enroll an additional 186 patients based on a blinded
interim assessment.
The just-completed CARISA interim assessment was performed in order to
minimize the risk of a false negative study. The interim evaluated the
statistical variance of the primary endpoint, treadmill times, but did not
assess the efficacy of ranolazine compared to placebo. Based on the variability
in treadmill times, the protocol-specified interim assessment dictated
enrollment of an additional 186 patients. With the current enrollment rate, the
Company anticipates completing enrollment of the additional patients by the
second quarter of 2001. The CARISA trial is designed to examine the
effectiveness of ranolazine in combination with other anti-anginal medications.
Ranolazine is an investigational drug candidate in a new class of drugs known as
pFOX (partial Fatty Acid Oxidation) inhibitors.
"We are pleased with the current strong enrollment rate in the CARISA
trial, our trial design and our completion of enrollment of the originally
specified patients according to our timetable," said Louis G. Lange, M.D.,
Ph.D., Chairman and Chief Executive Officer of CV Therapeutics. "The interim
variability assessment provides us with an opportunity, prior to unblinding the
trial and without a statistical penalty, to support the power of the trial by
enrolling additional patients."
Ranolazine has not been approved for marketing by the Food and Drug
Administration or other foreign agencies. Ranolazine is presently being
investigated in Phase III clinical trials subject to a United States IND and
applicable foreign authority submissions. CV Therapeutics has not yet submitted
an NDA to the FDA or equivalent application to any other foreign regulatory
authorities for ranolazine and ranolazine has not yet been determined to be safe
or effective in humans for its intended use.
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Statements in this press release concerning the development, potential
application and commercialization of ranolazine are forward-looking statements
that involve risks and uncertainties, including, but not limited to,
uncertainties related to CVT's early stage of development and clinical trials.
Actual results could differ materially. Factors that could cause or contribute
to such differences are more fully discussed in CVT's Annual Report on Form 10-K
for the year ended December 31, 1999.
CV Therapeutics, Inc., headquartered in Palo Alto, CA, 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. CVT currently has three compounds in
clinical trials. Ranolazine, the first in a new class of compounds known as
partial fatty acid oxidation (pFOX) inhibitors, is in Phase III clinical trials
for the potential treatment of chronic angina. CVT-510, an A(1) adenosine
receptor agonist, is in Phase II clinical trials for the potential treatment of
atrial arrhythmias. CVT-3146, an A(2A) adenosine receptor agonist, is in Phase I
clinical trials for the potential use as an adjunctive pharmacologic agent in
cardiac perfusion imaging studies. For more information, please visit CV
Therapeutics' web site at WWW.CVT.COM.
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