NEW YORK, July 29 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Merck KGaA (Merck) of Darmstadt, Germany, announced today that
the United States Food and Drug Administration (FDA) has approved Campral(R)
(acamprosate calcium) Delayed-Release Tablets for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation. Treatment with Campral should be part of a
comprehensive management program that includes psychosocial support.
Forest expects Campral to be available to physicians, patients and
pharmacies around the end of the year. Developed by Merck, Campral is the
first new medication in nine years to be approved in the U.S. for the
treatment of alcohol dependence, a chronic disease that accounts for
approximately 100,000 deaths per year.(1) Nearly 14 million Americans have a
problem associated with alcohol.
"The approval of Campral offers a new therapeutic option for
alcohol-dependent patients in the United States, which we hope will enable
more patients to successfully control this complex and chronic disease," said
Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories,
Inc.
Campral was licensed to Forest in 2001. Under terms of the licensing
agreement, Forest is responsible for sales and marketing activities of the
product in the U.S.; Merck will manufacture and supply the product. Forest
will promote Campral to key healthcare providers, focusing on treatment
centers, addiction specialists and physicians most experienced with the
medical management of alcoholism.
About Campral
The mechanism of action of Campral in maintenance of alcohol abstinence is
not completely understood. Chronic alcohol exposure is hypothesized to alter
the normal balance between neuronal excitation and inhibition. Campral
interacts with neurotransmitter systems and is hypothesized to restore the
normal balance. This mechanism of action is different from that ascribed to
currently available medications, which either block the "high" associated with
alcohol or induce vomiting if alcohol is ingested.
FDA approval of Campral is based primarily on the Agency's review of
safety and efficacy data from four double-blind, placebo-controlled trials. In
three of these trials, Campral increased abstinence rates when used as part of
a multidisciplinary approach that included various types of psychosocial
support. In a fourth study, the Campral-treated group failed to show a
difference on the primary efficacy endpoint, cumulative abstinence duration.
In the latter trial, patients were not required to be abstinent prior to
randomization as required in the positive studies. In the clinical trial
program, side effects for Campral were generally mild with the most frequently
reported side effect being diarrhea.
Campral is also approved and available in 28 countries outside the United
States.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R), an
SSRI antidepressant indicated for the initial and maintenance treatment of
major depressive disorder and for generalized anxiety disorder; Celexa(R), an
antidepressant; Namenda(R), an N-methyl-D- aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe Alzheimer's
disease; Tiazac(R), a once-daily diltiazem, indicated for the treatment of
angina and hypertension; Benicar(R), (a) an angiotensin receptor blocker
indicated for the treatment of hypertension; Benicar HCT(TM), an angiotensin
receptor blocker and diuretic combination product indicated for the
second-line treatment of hypertension; and Aerobid(R), an inhaled steroid
indicated for the treatment of asthma.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including risk factors listed from
time to time in the Company's SEC reports, including the Company's Annual
Report on Form 10-K for the fiscal year ended March 31, 2004. Actual results
may differ materially from those projected.
(a) Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
About Merck KGaA
Merck is a global pharmaceutical and chemical company with sales of EUR
7.2 billion in 2003, a history that began in 1668, and a future shaped by
28,300 employees in 56 countries. Its success is characterized by innovations
from entrepreneurial employees. Merck's operating activities come under the
umbrella of Merck KGaA, in which the Merck family holds a 74% interest and
free shareholders own the remaining 26%. The former U.S. subsidiary, Merck &
Co., has been completely independent of the Merck Group since 1917. For
further information, please check the company Website: http:/www.merck.de
(1) Garbutt JC., et al. Pharmacological Treatment of Alcohol Dependence.
JAMA 1999; 281:1318-1325
SOURCE Forest Laboratories, Inc.
-0- 07/29/2004
/CONTACT: Charles E. Triano, Vice President, of Investor Relations,
Forest Laboratories, Inc., +1-212-224-6714, Charles.Triano@frx.com; or
Dr. Juergen Knackmuss of Merck KGaA, +011-49-6151-72-2578 for Forest
Laboratories, Inc./
/Web site: http:/www.merck.de /
(FRX)