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 http://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
one to two 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.
Like other beta blockers, Bystolic should be used with caution in
patients with peripheral vascular disease, thyrotoxicosis, 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 were headache, fatigue and
dizziness.
About Forest Laboratories and Its Products
Forest Laboratories (http://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.
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Related links:
http://www.frx.com
http://www.Bystolic.com
Photo Notes:Newscom:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
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.
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