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Namenda(TM) (memantine HCl), First Drug Approved For Treatment of Moderate to Severe Alzheimer's Disease Now Available Nationwide

Tuesday, January 13, 2004 8:08 am EST



Public Company Information:


Forest Laboratories, Inc. (NYSE: FRX) announced today that Namenda(TM) (memantine HCl), the first and only medication approved for patients with moderate to severe Alzheimer's disease, is now available to physicians, patients, and pharmacies nationwide. Namenda was approved by the U.S. Food and Drug Administration (FDA) on October 16, 2003 following a unanimous recommendation for approval by the Peripheral and Central Nervous System Drugs Advisory Committee on September 24, 2003.

"The introduction of Namenda fulfills Forest's commitment to the Alzheimer's community to bring a much anticipated therapy to the United States as quickly as possible," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "We believe Namenda, with its distinct mechanism of action, will open up the possibility for both monotherapy and combined treatment approaches in patients with moderate to severe Alzheimer's disease."

Healthcare providers, patients and caregivers should call their local pharmacies to determine if Namenda is available in their area.

"Namenda's availability represents an important advance in the treatment of Alzheimer's disease. The millions of patients and caregivers who are suffering from moderate to severe Alzheimer's now have an effective new agent that works by an entirely different mechanism than the currently available drugs. Namenda has demonstrated therapeutic benefits in clinical trials when used alone or in combination with donepezil," said Dr. George Grossberg, Samuel Fordyce Professor and Director of Geriatric Psychiatry at the St. Louis University School of Medicine. "In real life terms, the availability and use of Namenda may translate into many people maintaining their ability to communicate with their family or independently dress and bathe themselves for longer periods of time."

"The Alzheimer's Association welcomes the availability of the first FDA approved drug for people with moderate to severe Alzheimer's disease. While Namenda is not a cure, the accessibility of additional treatment choices brings fresh hope to people with Alzheimer's. The Alzheimer's Association looks forward to establishing new partnerships with the National Institute on Aging, academia and industry to develop interventions that slow or stop the progression of Alzheimer's disease and prevent its onset," said William Thies, Ph.D., Vice President, Medical and Scientific Affairs for the Alzheimer's Association.

Namenda and Moderate to Severe Alzheimer's Disease

Namenda, approved on October 16, 2003 by the U.S. FDA, is the first and only medication indicated for treatment of moderate to severe Alzheimer's disease. Namenda is the first of a class of medications called NMDA receptor antagonists to be approved to treat Alzheimer's disease. Namenda has a mechanism of action distinct from other approved Alzheimer's treatments, which belong to a class of agents called acetylcholinesterase inhibitors and are indicated for the treatment of mild to moderate Alzheimer's disease.

Namenda's efficacy has been proven in multiple clinical studies that demonstrate its ability to provide cognitive and functional benefits to patients with moderate to severe Alzheimer's compared to placebo. Moderate to severe patients treated with Namenda performed better on scales measuring the common activities of daily living such as eating, walking, toileting, bathing, and dressing as compared to those patients on placebo. In clinical trials, Namenda has been safe with tolerability comparable to placebo. Namenda's safety and efficacy have been established in clinical studies when used alone or when used together with an ongoing regimen of the commonly used Alzheimer's agent, donepezil.

Alzheimer's is a progressive disease of the brain and is the most common type of dementia. The term dementia is used to describe the progressive loss of cognitive, intellectual, or functional abilities. Most patients with Alzheimer's disease will move through all the stages of the disease, including the moderate and severe stages which can last for many years and can be the most difficult for caregivers to manage. The average time a patient spends in the mild stage is relatively brief compared to the overall duration of the disease. Of the 4.5 million people in the U.S. currently living with Alzheimer's disease, the majorities are in the moderate to severe stages. Moderate and severe Alzheimer's disease patients require extensive care from their physicians as evidenced by the fact that 80% of visits made by patients with Alzheimer's disease are made by those with moderate or severe forms of the disease.

As Alzheimer's disease progresses, patients become increasingly impaired, increasing the burden on caregivers, both physically and emotionally. By the time a patient has reached the moderate to severe stages of Alzheimer's, they generally require assistance with common activities of daily living such as dressing, bathing, and toileting.

Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or to any excipients used in the formulation. The most common adverse events reported with Namenda vs. placebo (greater than or equal to 5% and greater than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment the use of Namenda has not been systematically evaluated and is not recommended.

Interested parties can get more information on Namenda and obtain the prescribing information by logging on to www.Namenda.com or by calling 1-877-2-NAMENDA (1-877-262-6363).

Namenda's Mechanism of Action

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 the neuronal cell dysfunction 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: Namenda(TM), an N-methyl D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Lexapro(TM), indicated for the initial and maintenance treatment of major depressive disorder and Generalized Anxiety Disorder (GAD); CelexaTM, 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.

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 Quarterly Reports on Form 10-Q for the periods ending June 30, 2003, and September 30, 2003. Actual results may differ materially from those projected.

*Benicar(R) and Benicar HCT(TM) are registered trademarks of Sankyo Pharma, Inc.