NEW YORK, Sept. 24 /PRNewswire-FirstCall/ -- Forest Laboratories
(NYSE: FRX) announced today that an advisory committee to the U.S. Food and
Drug Administration (FDA) unanimously recommended the approval of Namenda(TM),
previously known by its generic name memantine HCl, for the treatment of
moderate to severe Alzheimer's disease. The FDA will consider the
recommendation of the Peripheral and Central Nervous System Drugs Advisory
Committee as it completes review of the New Drug Application for Namenda.
"Forest is pleased with today's unanimous vote to recommend the approval
of memantine," said Lawrence Olanoff, M.D., Ph.D., Executive Vice President of
Scientific Affairs at Forest Laboratories. "Memantine has shown a significant
and consistent benefit for moderate to severe Alzheimer's patients in
multiple, well-controlled trials when used alone or in combination with a
currently approved treatment. It is the first in a new class of Alzheimer's
medications with a mechanism of action that differs from currently available
therapies. We will work with the FDA to attempt to achieve the approval of
memantine as soon as possible. We expect memantine to be available within a
few months of FDA approval."
Meeting in Bethesda, Maryland, the Advisory Committee comprised of experts
in dementia and other neurological disorders, reviewed data from two U.S.
placebo-controlled Phase III clinical trials and an earlier trial conducted
among nursing home patients in Europe. Phase III data included a 28-week
monotherapy study of 252 patients published earlier this year in the New
England Journal of Medicine and a six-month, 401-patient study of Namenda used
in combination with an ongoing regimen of the commonly used Alzheimer's agent
donepezil. In clinical trials, Namenda has been safe and well tolerated.
The most common adverse advents observed in clinical trials are dizziness,
headache, fatigue and somnolence.
"The number of people suffering from moderate to severe disease is
significant today, and the prevalence of the disease will continue to grow
exponentially," said Steven DeKosky, MD, Chairman of Neurology at the
University of Pittsburgh and presenter at today's hearing. "Currently, this
is a population that is at risk of being left behind. Memantine, if approved,
should be an important addition to the treatments a physician can offer
patients."
About Namenda and Alzheimer's Disease
Namenda (memantine HCl) is the first of a new class of medications for
Alzheimer's disease with a mechanism of action distinct from currently
available drugs. Namenda is a low to moderate affinity NMDA
(N-methyl-D-aspartate) receptor antagonist. 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 and the eventual cell death 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.
Alzheimer's is a progressive disease of the brain that is the most common
type of dementia. The term dementia is used to describe the progressive loss
of cognitive, intellectual or functional abilities. The Alzheimer's
Association projects that by 2010 more than 5.5 million people in the United
States will have Alzheimer's disease. Currently, all Alzheimer's medications
approved in the United States belong to a class of agents called
acetylcholinesterase inhibitors, which are indicated for patients with mild to
moderate symptoms of the disease. Currently, there are no approved therapies
in the United States for people who have progressed beyond the mild to
moderate stages of the disease.
About Forest Laboratories
Forest Laboratories develops, manufactures, and sells ethical
pharmaceutical products that are used for the treatment of a wide range of
illnesses. Forest Laboratories' growing line of products includes:
Lexapro(TM), indicated for the treatment of major depressive 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; 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, 2003 and Quarterly
Reports on Form 10-Q for the periods ending, September 30, 2003. Actual
results may differ materially from those projected.
* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.