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FDA Approves Namenda (Memantine HCl) for Treatment of Moderate to Severe Alzheimer's Disease

NEW YORK, NY -- October 17, 2003 -- Forest Laboratories, Inc. (NYSE: FRX) announced today that Namenda™ (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 http://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.


SOURCE: Forest Laboratories

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