Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension

NEW YORK, December 18, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Mylan Inc. announced today that the novel beta blocker Bystolic(TM) (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range (blood pressure <140/90 mmHg), underscoring the need for additional therapeutic options.

Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 percent Black, 54 percent male, 19 percent elderly and 8 percent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.
"Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patients and its favorable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the U.S. and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the U.S. and will pay Mylan undisclosed royalty payments as part of their collaboration agreement.

Forest expects Bystolic to be available to physicians, patients, and pharmacies in January 2008.