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FDA Advisory Committee Recommends Approval for Namenda (Memantine HCl) For Moderate to Severe Alzheimer's Disease

NEW YORK, NY -- September 25, 2003 -- Forest Laboratories (NYSE: FRX) announced 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.

* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.


SOURCE: Forest Laboratories, Inc.

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