CV Therapeutics Receives European Marketing Authorization for Ranolazine for the Treatment of Patients With Chronic Angina

Friday, July 11, 2008 General News
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PALO ALTO, Calif., July 10 CV Therapeutics, Inc.(Nasdaq: CVTX) announced today that it has received marketing authorizationfrom the European Medicines Agency (EMEA) for ranolazine for the treatment ofpatients with chronic angina in all 27 European Union (EU) member states.This approval follows a positive opinion from the EMEA Committee for MedicinalProducts for Human Use (CHMP) on April 24, 2008.

Ranolazine is approved for use in Europe as add-on therapy for thesymptomatic treatment of patients with stable angina pectoris who areinadequately 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 andother recently reported studies, including data showing statisticallysignificant reductions in ventricular arrhythmias with ranolazine. Thelabeling also notes that the ability of ranolazine to reduce cellular calciumoverload is expected to improve myocardial relaxation and decrease leftventricular diastolic stiffness.

"We expect ranolazine could be available to patients and physicians acrossEurope beginning in the first part of 2009, as we continue to see very stronginterest from potential commercial partners," said Louis G. Lange, M.D.,Ph.D., chairman and chief executive officer of CV Therapeutics. "Revenues fromEuropean sales of ranolazine would represent a fourth product-related revenuestream for CV Therapeutics."

There are currently 48-50 million angina prescriptions written annually inthe largest five EU member countries (UK, Germany, France, Spain and Italy).

"Considering the well-established need for medical treatment of anginaacross the EU and the unique product labeling, we believe that ranolazine maybecome 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) isindicated for the treatment of chronic angina in patients who have notachieved an adequate response with other antianginal drugs. In the U.S.,CV Therapeutics is seeking changes to the approved product labeling for Ranexato include a first line angina indication, a significant reduction incautionary language, and the potential addition of promotable claims for thereduction of hemoglobin A1c and ventricular arrhythmias in patients withcoronary artery disease. The Prescription Drug User Fee Act (PDUFA) actiondate for these requested labeling changes is July 27, 2008.

In Europe, ranolazine is indicated as add-on therapy for the symptomatictreatment of patients with stable angina pectoris who are inadequatelycontrolled or intolerant to first-line antianginal therapies. The approvedlabeling reflects data from the MERLIN TIMI-36 and other recently reportedstudies, including data showing statistically significant reductions inventricular arrhythmias with ranolazine. The labeling also notes that theability of ranolazine to reduce calcium overload is expected to improvemyocardial relaxation and decrease left ventricular diastolic stiffness.

About CV Therapeutics

CV Therapeutics, Inc., headquartered in Palo Alto, California, is abiopharmaceutical company primarily focused on applying molecular cardiologyto the discovery, development and commercialization of novel, small moleculedrugs for the treatment of cardiovascular diseases.

CV Therapeutics Ltd. is the company's European subsidiary based in theUnited Kingdom.

CV Therapeutics' approved products in the United States include Ranexa(R)(ranolazine extended-release tablets), indicated for the treatment of chronicangina in patients who have not achieved an adequate response with otherantianginal drugs, and Lexiscan(TM) (regadenos

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