NEW YORK, Jan. 13 /PRNewswire-FirstCall/ -- 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.