NEW YORK, July 25, 2005 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that the United States Food and Drug
Administration (FDA) has issued a non-approvable letter in response to its
supplemental New Drug Application (sNDA) to expand the indication of Namenda
(memantine HCl) to include treatment of mild Alzheimer's disease. Namenda was
approved by the FDA for the treatment of moderate to severe Alzheimer's
disease in October 2003.
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The FDA accepted the sNDA for review in November 2004. Upon completing
its review, the FDA acknowledged that it had informed Forest that a single
positive study in patients with mild to moderate Alzheimer's disease would be
adequate to support extending Namenda's claim to include mild patients. The
FDA further acknowledged that the six-month, U.S., mild to moderate study
which reached statistical significance at the required primary endpoints was
such a study. Nevertheless the FDA decided not to approve Namenda for mild
patients based upon this single positive study in light of two previously
disclosed, additional studies of Namenda in patients with mild to moderate
Alzheimer's disease -- a study of Namenda monotherapy conducted by H. Lundbeck
in Europe and a combination study conducted by Forest in the U.S. with Namenda
administered to patients already taking an acetylcholinesterase inhibitor. In
both of these studies, which were included in the sNDA filing, Namenda
performed numerically better than placebo; however, statistical significance
was not reached at the primary endpoints. In all three studies, Namenda was
found to be well tolerated. Forest plans to meet with the FDA to further
discuss the non-approvable letter. The Company also indicated that the non-
approvable status of Namenda for mild Alzheimer's disease would not impact its
current earnings per share guidance of $2.30 for the fiscal year ending March
31, 2006.
Namenda is currently approved for the treatment of moderate to severe
Alzheimer's disease. "Namenda offers a well tolerated and effective treatment
option to the millions of Americans suffering with moderate or severe
Alzheimer's disease," said Ivan Gergel, M.D., Senior Vice President of
Scientific Affairs at Forest Laboratories and President of Forest Research
Institute. "As the only approved treatment option for patients who have
progressed beyond the moderate stage of disease, and as a first-line therapy
that can be used alone or in combination with other approved treatments,
Namenda plays a very important role in the Alzheimer's disease treatment
paradigm."
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, and are indicated only for patients with mild to moderate symptoms
of the disease. Namenda can be used alone or in combination with an
acetylcholinesterase inhibitor for moderate- and severe-stage patients.
About Namenda
Namenda (memantine HCl) is the first in a class of medications with a
unique mechanism of action that focuses on the glutamate pathway, a target for
the treatment of Alzheimer's disease. Indicated for the treatment of moderate
to severe Alzheimer's disease, the FDA approved Namenda in October 2003 based
on three studies of Namenda used alone or in combination with another
Alzheimer's disease drug.
Namenda 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, dosage should be
reduced.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an angiotensin
receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R)
(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
combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and
Ibuprofen), an opioid and NSAID combination indicated for the short-term
management of acute, moderate to severe pain.
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, 2005. Actual results
may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma Inc.; Campral is a
registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
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) and as Akatinol(R), each in a number of markets worldwide. Ebixa,
Axura, and Akatinol are registered trademarks of Merz Pharma GmbH & Co.
SOURCE Forest Laboratories, Inc.
Charles E. Triano, Vice President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Charles.Triano@frx.com