NEW YORK, Oct. 17 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that Namenda(TM) (memantine HCl), the first of a
new class of drugs for Alzheimer's disease, was approved by the U.S. Food and
Drug Administration (FDA) for the treatment of moderate to severe Alzheimer's
disease. Forest expects Namenda to be available to physicians, patients, and
pharmacies in January 2004. Namenda is the first NMDA receptor antagonist to
be approved for Alzheimer's disease and is also the only therapy approved for
the treatment of moderate to severe Alzheimer's disease.
"The approval of Namenda offers an important new therapeutic option for
patients suffering from moderate to severe Alzheimer's disease," said Howard
Solomon, Chairman and Chief Executive Officer of Forest Laboratories.
"Previously patients with moderate disease had only one class of options; now
they have an additional therapy available. And patients who had progressed
beyond the moderate stage of Alzheimer's disease had no approved therapeutic
option at all. We believe Namenda will provide a meaningful benefit to
millions of Americans suffering from Alzheimer's disease, whether as a
patient, caregiver, or family member."
Namenda will be available in pharmacies in January 2004. Interested
parties can sign up to receive immediate notification of Namenda's
availability, get more information on Namenda, or obtain the prescribing
information by logging on to on www.Namenda.com or by calling 1-877-2-NAMENDA
(1-877-262-6363).
Alzheimer's Disease and Namenda
"Alzheimer's is a disease in which every patient progresses," said Steven
DeKosky M.D., Chairman of Neurology at the University of Pittsburgh. "Until
today, there has not been an approved treatment option indicated for people
beyond moderate Alzheimer's. The moderate to severe stages stretch out for
years and can be the most difficult for both patients and caregivers to
manage. The loss of function and independence, including the ability to hold
conversations with loved ones or to wash and groom oneself is devastating. By
further delaying the loss of daily functions in patients with moderate to
severe Alzheimer's disease, Namenda offers physicians an opportunity to treat
and manage the disease in a new way and will enable us to assist a group of
patients that has been at risk of being left behind."
"As the number of people with Alzheimer's disease continues to grow to
epidemic proportions, there is a definite need for new treatment options that
can offer hope to millions of patients and families who so desperately need
it," said William Thies, Ph.D., Vice President, Medical and Scientific Affairs
for the Alzheimer's Association. "The Alzheimer's Association is a strong
advocate for developing a broad range of new treatments using a variety of
novel approaches, including new drugs. While we continue to search for
preventative therapies, the goal now is to provide physicians with multiple
strategies to safely and effectively maintain or improve functioning in people
with Alzheimer's along the entire course of the disease. In that spirit, the
Alzheimer's Association welcomes FDA approval of memantine for the treatment
of moderate to severe Alzheimer's disease."
Namenda's FDA approval is based on the Agency's review of safety and
efficacy 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 when used together with an ongoing regimen of the commonly
used Alzheimer's agent, donepezil. In trials, patients treated with Namenda
scored higher on measures of cognition, daily function, and/or global
performance. This development program for memantine was a joint effort
between Forest and its licensor, Merz Pharmaceuticals, who 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.
In clinical trials, Namenda has been safe and well tolerated. The most
common adverse events observed in clinical trials are dizziness, headache,
constipation, and confusion. Once available in pharmacies, Namenda will be
administered orally at a recommended dose of 10 mg BID following a four-week
titration.
Alzheimer's is a progressive disease of the brain and it is the most
common type of dementia. The term dementia is used to describe the
progressive loss of cognitive, intellectual, or functional abilities.
Published reports project that by 2010 more than 5.1 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. Namenda is the only approved therapy in the
United States for moderate to severe Alzheimer's disease.
Namenda's Mechanism of Action
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.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(TM),
indicated for the initial and maintenance 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 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 the quarterly
report on Form 10-Q for the period ended June 30, 2003. Actual results may
differ materially from those projected.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc.