NEW YORK, Dec. 18 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Mylan Inc. (NYSE: MYL) 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
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. Interested parties can register to receive
immediate notification of Bystolic's availability, get more information on
Bystolic, or obtain prescribing information by visiting www.Bystolic.com or by
calling 1-800-678-1605.
Important Safety Information
Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a 1- to 2-week period and the patient carefully monitored.
Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, in patients treated concomitantly with beta blockers and calcium channel blockers of the verapamil and diltiazem type (ECG and blood pressure should be monitored), severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. Caution should also be used in diabetic patients as beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
In general, patients with bronchospastic disease should not receive beta blockers.
Bystolic should not be combined with other beta blockers.
The most common adverse events with Bystolic versus placebo (approximately 
1% and greater than placebo) were headache, fatigue, dizziness, diarrhea, nausea, insomnia, chest pain, bradycardia, dyspnea, rash, and peripheral edema.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; and Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan
medoxomil), an angiotensin receptor blocker, Benicar HCT(R)* (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product, and AZOR(TM)* (amlodipine and olmesartan medoxomil) a
calcium channel blocker and angiotensin receptor blocker combination product,
all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are
registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered
trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
About Mylan
Mylan Inc. is one of the world's leading quality generic and specialty
pharmaceutical companies. The Company offers one of the industry's broadest
and highest quality product portfolios, a robust product pipeline and a global
commercial footprint through operations in more than 90 countries. Through its
controlling interest in Matrix Laboratories Limited, Mylan has direct access
to one of the largest active pharmaceutical ingredient (API) manufacturers in
the world. Dey L.P., Mylan's fully integrated specialty business, provides the
Company with innovative and diversified opportunities in the respiratory and
allergy therapeutic areas.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform act of 1995. These statements involve a number of
risks and uncertainties, including the difficulty of predicting FDA approvals,
the acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in each of Forest
Laboratories' and Mylan's Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., 1-212-224-6714, Charles.Triano@frx.com, or Liesel
Enke of Fleishman-Hillard, 1-212-453-2427, Liesel.Enke@fleishman.com, for
Forest Laboratories, Inc.
Web site: http://www.frx.com
http://www.Bystolic.com
(FRX MYL)