CV Therapeutics Receives European Marketing Authorization for Ranolazine for the Treatment of Patients With Chro...( PALO ALTO Calif. July 10 /- CV Th...)

PALO ALTO, Calif., July 10 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that it has received marketing authorization from the European Medicines Agency (EMEA) for ranolazine for the treatment of patients with chronic angina in all 27 European Union (EU) member states. This approval follows a positive opinion from the EMEA Committee for Medicinal Products for Human Use (CHMP) on April 24, 2008.

Ranolazine is approved for use in Europe 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. 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 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 cellular calcium overload is expected to improve myocardial relaxation and decrease left ventricular diastolic stiffness.

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

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

"Considering the well-established ne
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