NEW YORK, Dec. 18 Forest Laboratories, Inc.(NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced today that the novel betablocker Bystolic(TM) (nebivolol) was approved by the U.S. Food and DrugAdministration (FDA) for the treatment of hypertension. Bystolic is a oncedaily medication that can be used alone or in combination with otherhypertension treatments. Hypertension affects approximately 72 million adultsin the U.S. and 65 percent of patients diagnosed with hypertension have notreduced their blood pressure to an acceptable range (blood pressure <140/90mmHg), underscoring the need for additional therapeutic options.
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Beta blockers are one of the most widely used classes of drugs in theUnited States. In an extensive clinical trial program involving more than2,000 patients, Bystolic demonstrated significant reductions in sittingdiastolic and systolic blood pressure in a general hypertensive population,which included 26 percent Black, 54 percent male, 19 percent elderly and 8percent diabetic patients. The studies also found that Bystolic was welltolerated, with a low incidence of traditional beta blocker side effects.Like other beta blockers, Bystolic decreases heart rate and myocardialcontractility, and suppresses renin activity. Bystolic is a selective beta 1blocker at doses less than or equal to 10 mg per day and has the addedpharmacological properties of producing vasodilation and reducing totalperipheral resistance.
"Bystolic is the newest beta blocker approved for the treatment ofhypertension in the U.S. and should prove useful due to its efficacy in abroad range of patients and its favorable side effect profile," said MichaelWeber, 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 DrugAdministration marketing approval for Bystolic. Bystolic represents animportant advance for patients with hypertension and the physicians who treatthem and will be an important new product for our Company."
Bystolic is already approved and successfully marketed for the treatmentof hypertension in more than 50 countries outside of North America. Mylanlicensed the U.S. and Canadian exclusive rights to nebivolol from JanssenPharmaceutica N.V., Belgium in 2001.
Forest licensed U.S. and Canadian rights to Bystolic from Mylan Inc. inJanuary 2006. Forest will market Bystolic in the U.S. and will pay Mylanundisclosed royalty payments as part of their collaboration agreement.
Forest expects Bystolic to be available to physicians, patients, andpharmacies in January 2008. Interested parties can register to receiveimmediate notification of Bystolic's availability, get more information onBystolic, or obtain prescribing information by visiting www.Bystolic.com or bycalling 1-800-678-1605.
Important Safety Information
Patients being treated with Bystolic should be advised against abruptdiscontinuation of therapy. Severe exacerbation of angina and the occurrenceof myocardial infarction and ventricular arrhythmias have been reportedfollowing the abrupt cessation of therapy with beta blockers. Whendiscontinuation is planned, the dosage should be reduced gradually over a oneto two week period and the patient carefully monitored.
Bystolic is contraindicated in severe bradycardia, heart block greaterthan first degree, cardiogenic shock, decompensated cardiac failure, sicksinus syndrome (unless a permanent pacemaker is in place), severe hepaticimpairment (Child-Pugh >B), and in patients who are hypersensitive to anycomponent of this product.
Like other beta blockers, Bystolic should be used with caution in patients