NEW YORK, Nov. 15 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that the United States Food and Drug
Administration (FDA) has accepted the filing of its supplemental New Drug
Application (sNDA) to expand the indication of Namenda(R) (memantine HCl) to
include treatment of mild Alzheimer's disease. Namenda is currently available
for the treatment of moderate and severe Alzheimer's patients, making it the
only approved treatment in the U.S. for patients beyond the moderate stage of
the disease. Under existing FDA procedures, Forest should receive an initial
action letter from the FDA by the third quarter of 2005.
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"Forest is pleased the FDA has accepted our application," said Lawrence S.
Olanoff, M.D., Ph.D., Executive Vice President, Forest Laboratories. "If the
FDA approves the expansion of Namenda's indication as a treatment for moderate
to severe Alzheimer's to include the mild stage, Namenda could be the first
treatment in the U.S. approved to treat all stages -- mild through severe --
of this progressive disease."
The sNDA filing includes data from three studies: two double-blind,
placebo-controlled, studies of Namenda as monotherapy in mild to moderate
Alzheimer's disease and one double-blind, placebo-controlled study of Namenda
administered to patients already taking an acetylcholinesterase inhibitor.
Data from a U.S. clinical trial demonstrated that patients treated with
Namenda performed significantly better than patients who received placebo on
both primary outcome measures: the Alzheimer's Disease Assessment Scale --
cognitive subscale (ADAS-cog) (p=0.003), a measure of cognitive function, and
the Clinician's Interview-Based Impression of Change -- Plus version (CIBIC-
Plus) (p=0.004), a global measure of a patient's overall status. The six-
month study was conducted at 42 U.S. centers and included 403 patients with
mild to moderate Alzheimer's disease. Namenda was well tolerated, with
patients experiencing adverse events at overall rates that were comparable to
those on placebo.
In a similar monotherapy study conducted by H. Lundbeck in Europe, also
included in the sNDA filing, the difference in values for the primary
endpoints, the ADAS-cog and the CIBIC-Plus, was statistically significant in
favor of the Namenda treatment group versus the placebo group at multiple time
points. Although numerical improvement was observed at week 24, statistical
significance was not reached. The European study was conducted at 65 centers
and included 470 patients with mild to moderate Alzheimer's disease. As in
the U.S. trial, adverse event rates overall were similar for the two treatment
groups.
In the third, double-blind, placebo-controlled study, Namenda was
administered to patients with mild to moderate Alzheimer's disease currently
also receiving acetylcholinesterase inhibitor therapy. After 24 weeks of
treatment, the Namenda/acetylcholinersterase inhibitor group performed
numerically better on measures of cognitive (ADAS-cog) and global function
(CIBIC-Plus) than the placebo/acetylcholinersterase inhibitor group. However,
statistical significance was not reached at end point. The co-administration
of Namenda and acetylcholinesterase inhibitor therapy in mild to moderate
Alzheimer's disease was found to be well tolerated based on this study.
About Alzheimer's Disease
Alzheimer's is a progressive disease of the brain and the most common
type of dementia. Dementia is used to describe the progressive loss of
cognitive, intellectual, or functional abilities. Published reports project
that by 2050 more than 16 million people in the United States will have
Alzheimer's disease. Currently, all Alzheimer's medications approved in the
United States other than Namenda belong to a class of agents called
acetylcholinesterase inhibitors, which are indicated for patients with mild to
moderate symptoms of the disease.
About Namenda
Namenda (memantine HCl) is the first in a new class of medications with a
unique mechanism of action that focuses on the glutamate pathway, a new target
for the treatment of Alzheimer's disease. Indicated for the treatment of
moderate to severe Alzheimer's disease, Namenda was approved by the FDA
(October 2003) based on the results of three placebo-controlled studies, which
demonstrated Namenda's efficacy either as monotherapy or when used in
combination with another approved Alzheimer's disease drug. Results from two
studies in the U.S. -- both in moderate and severe Alzheimer's patients --
have been published in The New England Journal of Medicine and The Journal of
the American Medical Association. Results from the European study in nursing
home patients were published in the International Journal of Geriatric
Psychiatry.
Namenda (memantine HCl) is contraindicated in patients with known
hypersensitivity to memantine HCl or any excipients used in the formulation.
The most common adverse events reported with Namenda vs placebo (greater than
or equal to 5% and higher than placebo) were dizziness, confusion, headache,
and constipation. In patients with severe renal impairment the use of Namenda
has not been systematically evaluated and is not recommended.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Namenda(R)
(memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated
for the treatment of moderate to severe Alzheimer's disease; Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder; Celexa(R) (citalopram HBr), an antidepressant; Benicar(R) *
(olmesartan medoxomil), an angiotensin receptor blocker indicated for the
treatment of hypertension; Benicar HCT(TM) (olmesartan medoxomil
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product indicated for the second-line treatment of hypertension; Campral(R) *
(acamprosate calcium), a glutamate receptor modulator, indicated for the
maintenance of abstinence from alcohol in patients with alcohol dependence who
are abstinent at treatment initiation in conjunction with psychosocial
support; Aerobid(R) (flunisolide), an inhaled steroid indicated for the
treatment of asthma; and Tiazac(R) (diltiazem HCl), a once-daily diltiazem,
indicated for the treatment of angina and hypertension.
Forest Laboratories markets Namenda(R) (memantine HCl) in the United
States under license from Merz Pharma GmbH & Co. of Germany. Lundbeck, under
license from Merz, markets memantine as Ebixa(R)*, and Merz markets memantine
as Axura(R)*, each in a number of worldwide markets.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc., Campral(R)
is a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany, Ebixa(R) is a registered trademark of H.
Lundbeck A/S and Axura(R) is a registered trademark of Merz Pharma GmbH & Co.
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 and on form 10-Q
for the periods ended June 30, 2004 and September 30, 2004. Actual results may
differ materially from those projected.
SOURCE Forest Laboratories, Inc.
-0- 11/15/2004
/CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Charles.Triano@frx.com /
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/Web site: http://www.frx.com/
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