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FDA Grants Priority Review Status for Perindopril in Cardiovascular Mortality

MARIETTA, Ga. and PALO ALTO, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Solvay Pharmaceuticals, Inc. and CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that the U.S. Food and Drug Administration (FDA) has formally notified Solvay Pharmaceuticals that their supplemental new drug application (sNDA) for ACEON(R) (perindopril erbumine) Tablets seeking an expansion to the label will receive a priority review, pending FDA filing of the application.

The proposed label expansion is based on the EUROPA (EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease) study which assessed the ability of perindopril to reduce cardiovascular mortality, nonfatal myocardial infarction and cardiac arrest in a broad population of patients with stable coronary artery disease, but without heart failure or substantial hypertension.

Solvay Pharmaceuticals holds the new drug application for ACEON(R) and submitted the sNDA to the FDA on December 10, 2004.

CV Therapeutics and Solvay Pharmaceuticals recently entered into a co-promotion agreement for ACEON(R), an angiotensin converting enzyme (ACE) inhibitor with tissue activity approved in the United States for the treatment of patients with essential hypertension.

About the EUROPA Study
EUROPA was a multicenter, randomized, double-blind, placebo-controlled trial in 12,218 patients with stable coronary disease and without heart failure for at least three years. The study was designed to assess the ability of perindopril to reduce cardiovascular death, myocardial infarction and cardiac arrest. The results from EUROPA were published in The Lancet on September 6, 2003.

In Europe, perindopril is marketed under the brand name Coversyl(R). Perindopril is one of the leading ACE inhibitors in Europe.

About ACE Inhibitors
ACE inhibitors act to reduce hypertension by interfering with the conversion of angiotensin I to artery-constricting angiotensin II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure.

ACE inhibitors currently are recommended as first-line therapy for hypertension in certain patient populations, because of their safety and efficacy. Most recently, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure has recommended ACE inhibitors as one of the initial therapy choices for compelling indications such as heart failure, postmyocardial infarction, high coronary disease risk, diabetes, chronic kidney disease and recurrent stroke prevention. ACEON(R) is only indicated for the treatment of patients with essential hypertension.

Certain ACE inhibitors, including ACEON(R), which have been shown to have an enhanced affinity for the tissues, are known as tissue-ACEs.

About ACEON(R)
ACEON(R) is an ACE inhibitor indicated for the treatment of essential hypertension. It offers continuous 24-hour blood pressure control with once-daily dosing for hypertensive patients. ACEON(R) may be used alone or with other classes of antihypertensives.

ACEON(R) is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitors and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ACEON(R) should be discontinued as soon as possible.

Source: Solvay Pharmaceuticals, Inc. and CV Therapeutics, Inc.

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