NEW YORK, Jan. 7 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced that results of a U.S., Phase III study of Namenda(TM)
(memantine HCl) as monotherapy in mild to moderate Alzheimer's disease show
the drug demonstrated a statistically significant difference versus placebo
with respect to the study's primary efficacy measures of cognition and global
outcome. Results from a similar study conducted by H. Lundbeck in Europe
showed significance at some interim time points, but not at the study's
conclusion. Forest plans to seek approval for a mild to moderate indication
based on the positive outcome of the U.S. study.
"We are encouraged by the positive results that indicate treatment with
Namenda is associated with efficacy and tolerability among patients with mild
to moderate Alzheimer's disease," said Lawrence S. Olanoff, M.D., Ph.D.,
Executive Vice President, Forest Laboratories, Inc. "Based on this positive
preliminary analysis of the U.S. study, Forest plans to file a supplemental
New Drug Application for Namenda as a treatment for mild to moderate
Alzheimer's disease in mid-2004."
Study Design
The double-blind, parallel group, placebo-controlled Phase III studies
were designed to evaluate the safety and efficacy of Namenda given as
monotherapy at a daily dosage of 10 mg twice a day to patients with mild to
moderate Alzheimer's disease over a period of 6 months. The U.S. study was
conducted at 42 centers and included 403 patients with mild to moderate
Alzheimer's disease while the European study was conducted at 65 centers and
included 470 patients.
Study Results
Results from the U.S. study show that patients receiving Namenda performed
significantly better than patients receiving 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), a global measure of
overall status (p=0.004). Namenda was well tolerated in the study and Namenda
patients experienced adverse events at overall rates that were comparable to
patients on placebo.
In the European trial, in the prospectively defined primary analysis, the
difference in values for the primary endpoints, the ADAS-cog and the CIBIC-
plus, between the two groups was statistically significant in favor of the
memantine treatment group versus the placebo group at multiple time points,
while at week 24, although numerical improvement was observed, statistical
significance was not reached due to a higher than expected response in the
placebo group. As in the U.S. trial, adverse-event rates overall were similar
for the two treatment groups.
"The results of these studies represent an important step forward for all
patients, caregivers, and physicians who deal with this devastating illness on
a daily basis," said Howard Solomon, Chairman and Chief Executive Officer of
Forest Laboratories, Inc. "In the future, it is our hope that Namenda will be
approved for all stages of Alzheimer's disease."
Namenda's Mechanism of Action
Namenda is a low to moderate affinity NMDA (N-methyl-D-aspartate) receptor
antagonist approved for the treatment of moderate to severe Alzheimer's
disease. It is thought that overexcitation of NMDA receptors by the
neurotransmitter glutamate may play a role in Alzheimer's disease since
glutamate plays an integral role in the neural pathways associated with
learning and memory. The excitotoxicity produced by abnormal levels of
glutamate is thought to be responsible for neuronal cell dysfunction observed
in Alzheimer's disease. Namenda is thought to selectively block the
excitotoxic effects associated with abnormal transmission of glutamate, while
allowing for the physiological transmission associated with normal cell
functioning.
The development program for memantine was a joint effort between Merz
Pharmaceuticals and Forest. Merz obtained centralized approval for memantine
in the European Union in 2002. Merz Pharmaceuticals is a specialty
pharmaceutical company dedicated to research and development in the fields of
neurology and psychiatry.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Namenda(TM), an
N-methyl D-aspartate (NMDA) receptor antagonist indicated for the treatment of
moderate to severe Alzheimer's disease; Lexapro(TM), indicated for the initial
and maintenance treatment of major depressive disorder and Generalized Anxiety
(GAD); Celexa(TM), an antidepressant; Tiazac(R), a once-daily diltiazem,
indicated for the treatment of angina and hypertension; Benicar(R)*, 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 historical information contained herein, this release contains
"forward-looking statements" within the meaning of the Private Securities
Litigation 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, 2003, and Quarterly
Reports on Form 10-Q for the periods ending June 30, 2003, and September 30,
2003. Actual results may differ materially from those projected.
*Benicar(R) and Benicar HCT(TM) are registered trademarks of Sankyo Pharma, Inc.