For Immediate Release (2004)Full Document 

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FOR IMMEDIATE RELEASE

 

Investor Contacts:   Media Contacts:

Dan Spiegelman

 

John Bluth

SVP & Chief Financial Officer

 

Senior Director, Corporate Communications

(650) 384-8509

 

(650) 384-8850

Christopher Chai

 

Carol Harrison

Treasurer & Executive Director, Investor Relations

 

Fleishman-Hillard

(650) 384-8560

 

(212) 453-2442

 

CV THERAPEUTICS INITIATES APPROVAL-ENABLING TRIAL OF RANEXA

 

PALO ALTO, Calif., August 2, 2004 — CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population. The study is being conducted under the U.S. Food and Drug Administration’s (FDA) special protocol assessment (SPA) process, as announced on June 2, 2004.

 

“We are very excited to have initiated this approval-enabling study. In addition to the SPA agreement we have in place for this study, we also have a second SPA in place for the MERLIN trial, which could support potential approval of Ranexa as first-line therapy in chronic angina, and could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS,” said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics, Inc.

 

If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States.

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