SAN FRANCISCO, April 28 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE: FRX) announced today the results of a randomized, placebo-
controlled, PET (positron emission tomography) imaging pilot study designed to
measure the effect Namenda(TM) (memantine HCl) has on functional brain
activity in patients with mild to moderate Alzheimer's disease. The results
in this pilot study suggest that, compared to placebo-treated patients,
treatment with Namenda may positively affect cerebral glucose metabolism in
the brains of patients with mild to moderate Alzheimer's disease. The data
presented yesterday at the American Academy of Neurology (AAN) Annual Meeting
in San Francisco, California were from a subset of patients participating in a
previously reported Phase III study evaluating the efficacy of Namenda as
monotherapy in mild to moderate Alzheimer's disease.
Researchers use PET to visualize and quantify a medication's effect on the
brain of Alzheimer's patients over time. The Namenda PET study was conducted
in conjunction with the Phase III, randomized, placebo-controlled study which
showed that the use of Namenda produced statistically significant improvements
in measures of cognition and global function compared to placebo.
"By using the PET brain-imaging technique, we observed increased metabolic
activity of Namenda in areas of a patient's brain associated with language and
attention," said Steven G. Potkin, M.D., Professor in the Department of
Psychiatry and Human Behavior at the University of California, Irvine, and
lead investigator of the PET study presented at AAN. "While these data are
from a small number of patients and need to be confirmed in larger scale
studies, they indicate that Namenda may be able to reverse the cerebral
metabolic decrease often associated with disease worsening in patients with
mild to moderate Alzheimer's disease who do not receive treatment."
Study Results
In the randomized, double-blind, Phase III study, researchers at one
center used PET to measure the regional cerebral glucose metabolism of
patients with mild to moderate Alzheimer's disease taking 10 mg of Namenda
twice a day compared to patients taking placebo. PET images were taken at the
beginning of the study and 24 weeks later at the trial's close. The PET
imaging study was completed at the University of California at Irvine and
involved 10 patients evenly and randomly divided between the Namenda and
placebo treatment arms.
In the PET study, patients who received Namenda demonstrated a
statistically significant increase in glucose metabolism in several regions of
the brain associated with language and attention. In contrast, placebo-
treated patients showed metabolic declines in several of these same regions.
This pilot study was part of an overall Phase III trial of Namenda's
effect in mild to moderate Alzheimer's disease which found that patients who
received Namenda performed significantly better on co-primary outcome measures
of cognition and global function compared to patients given placebo. During a
period of six months, 403 patients with mild to moderate Alzheimer's disease
at 42 U.S. centers were given a daily dosage of 10 mg twice a day. The two
primary outcome measures were the Alzheimer's Disease Assessment Scale --
cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression
of Change -- Plus version (CIBIC-Plus). The ADAS-cog is a commonly used
measure of cognitive function frequently used to evaluate mild to moderate
Alzheimer's disease. It includes items which evaluate different types of
cognitive functions like memory and language. As assessed by the ADAS-cog,
patients receiving Namenda maintained cognitive abilities above baseline for
the entire 24-week study. Patients receiving placebo exhibited a progressive
decline during the study with the difference between the two treatment groups
being statistically significant (p=0.003). The CIBIC-Plus is a global measure
of a patient's overall status evaluating their cognition, behavior, and
activities of daily living. The results of the study reveal that patients
receiving Namenda had significantly better global status compared to those
taking placebo as assessed by the CIBIC-Plus (p=0.004). Namenda was well
tolerated. In the trial the most common adverse events reported with Namenda
were agitation, fall, influenza-like symptoms and somnolence.
Forest Laboratories plans to submit to the U.S. Food and Drug
Administration (FDA) a supplemental New Drug Application for a mild to
moderate Alzheimer's disease indication for Namenda in the second half of
2004.
About PET Imaging
PET is a non-invasive technology that can be used to measure metabolic,
biochemical, and functional activity in living tissue. One of the most
important functions of PET is its ability to model biological and
physiological functions in the body by detecting and modeling regional
concentrations of radioactivity in the brain using radioactively labeled
tracers. PET provides detailed information about functional brain activity
and estimates the brain's ability to utilize glucose, cerebral glucose
metabolism, in whole sections and in regions of the brain. Previous PET
studies have shown that progression of Alzheimer's disease is often associated
with a decrease in cerebral glucose metabolism.
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 recently approved by the
FDA based on the results of three placebo-controlled studies which
demonstrated Namenda's efficacy as monotherapy, or when used in combination
with the commonly prescribed drug, donepezil. Results from the two U.S.
studies in moderate to severe Alzheimer's disease have been published in The
New England Journal of Medicine and The Journal of the American Medical
Association.
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), an SSRI antidepressant
indicated for the initial and maintenance treatment of major depressive
disorder and for generalized anxiety disorder; 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.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
Except for historical information contained herein, this release contains
forward-looking statements that involve 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 subsequent quarterly reports on Form 10-Q.
Actual results may differ from those projected.
SOURCE Forest Laboratories, Inc.