NEW YORK, NY — April 26, 2002 — Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Benicar, a new treatment option for hypertension which is a member of the rapidly growing angiotensin II receptor blocker (ARB) class. Benicar was discovered and developed by Sankyo Pharma and Forest will be its long-term co-promotion partner in the United States. Benicar, which can be administered alone or in combination therapy with other antihypertensive agents, will be available in the U.S. in the first half of 2002.
Studies have shown that Benicar 20 mg once a day, the recommended starting dose, resulted in double-digit blood pressure reduction, lowering systolic blood pressure by an average of 15mm Hg* and diastolic blood pressure by an average of 12mm Hg. In these studies, patients receiving placebo had average reductions in systolic blood pressure of 5.6 mm Hg and in diastolic blood pressure of 6.2mm Hg. In clinical trials the only adverse event that occurred in more than 1 percent of patients treated with Benicar and more frequently than those receiving placebo was dizziness (3% vs 1%).
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