Monday April 24, 9:02 am Eastern Time
Company Press Release
SOURCE: Novartis Pharmaceuticals Corporation
Novartis Receives FDA Marketing Clearance for New
Alzheimer's Disease Treatment
Exelon(R) (rivastigmine tartrate) capsules proven effective in multiple
trials in the three key domains of Alzheimer's disease - global
functioning (including activities of daily living and behavior) and
cognition
EAST HANOVER, N.J., April 24 /PRNewswire/ -- Novartis Pharmaceuticals Corporation announced today that the U.S.
Food and Drug Administration (FDA) has granted marketing clearance for Exelon© (rivastigmine tartrate) capsules, a
cholinesterase inhibitor for the treatment of mild to moderate Alzheimer's disease. Exelon therapy is proven effective in multiple
phase III trials in the three key domains used to assess the disease -- global functioning (including activities of daily living and
behavior) and cognition.
``When an Alzheimer's patient declines in any one of the three domains of the disease, it has a major impact on the lives of
patients and their caregivers,' said George T. Grossberg, MD, Director, Division of Geriatric Psychiatry, Saint Louis University
School of Medicine. ``Early diagnosis and treatment are extremely important. A new therapy such as Exelon, which can affect
symptoms early in the disease and is proven effective in all three critical domains of the illness, provides new hope for
Alzheimer's patients and their caregivers.'
PROVEN EFFICACY IN KEY MEASURES
In clinical trials, on average, patients treated with Exelon were considered clinically improved compared to those on placebo at
the end of six months. During the clinical trials, patients treated with 6-12 mg/day Exelon were far more likely to experience
substantial cognitive improvement and far less likely to show substantial decline than were patients given placebo. Moreover, at
26 weeks 81% of those given 6-12 mg/day Exelon had greater improvement/less worsening in cognitive function than did the
average placebo- treated patient. Patients treated with Exelon demonstrated significant improvement compared to placebo in
areas such as average total word recall and recognition, orientation and ability to speak.
In addition, patients treated with 6-12 mg/day Exelon demonstrated a significant improvement in global functioning as measured
by the CIBIC-Plus. The CIBIC-Plus is a structured instrument based on a comprehensive evaluation of patient cognition,
behavior and functioning, including assessment of activities of daily living. Fifty percent more patients treated with Exelon were
rated improved at week 26 on the CIBIC-Plus than patients given placebo. During the clinical trials, patients given Exelon
demonstrated fewer delusions than those given placebo and engaged in less purposeless activity (e.g., engaging in an activity for
no particular reason, such as repeatedly opening and closing a door, etc.). In clinical trials, higher therapeutic doses of Exelon
were associated with greater benefit.
LARGEST PHASE III CLINICAL PROGRAM FOR AN ALZHEIMER'S DISEASE THERAPY
Marketing clearance for Exelon was based on results of the largest phase III clinical program of an Alzheimer's disease
medication to date, involving more than 3,900 patients worldwide. Overall, nearly 5,300 patients have received Exelon in
clinical trials. More than 2,100 patients have been treated with Exelon for one year, 1,250 have been treated for two years and
168 have been treated for over three years. The six-month clinical trials with Exelon involved patients with mild to moderate
Alzheimer's disease, 94% of whom also suffered from a variety of medical illnesses common in the elderly, including
hypertension, type 2 diabetes and arthritis. Virtually all patients in the studies used concomitant medications, allowing
researchers to assess the efficacy and safety of Exelon in a patient population similar to a ``real world' population.
FUTURE AREAS OF STUDY
In an effort to evaluate the safety and efficacy of Exelon in all its potential applications, investigations with the medication
continue. Clinical programs are ongoing to examine the effect of Exelon in patients with mild cognitive impairment (MCI) and in
more severely ill out-patients, as well as patients in nursing homes with moderate to severe Alzheimer's disease. In addition, a
study of Exelon in patients with Lewy-body dementia has been recently completed.
ADVANCE IN ALZHEIMER'S DISEASE THERAPY
Exelon belongs to the class of drugs called cholinesterase inhibitors that block the breakdown of an important neurotransmitter
called acetylcholine. Acetylcholine is thought to play an important role in memory and cognition; scientists have learned that
levels of this neurotransmitter are dramatically lower in people with Alzheimer's disease. Acetylcholine is broken down and
inactivated by cholinesterase. Thus, by inhibiting cholinesterase, more acetylcholine is available for normal memory-related and
cognitive functioning.
``The FDA marketing approval for Exelon is an important milestone for Novartis and our rapidly expanding Neuroscience
franchise,' said David Epstein, Chief Operating Officer, Novartis Pharmaceuticals Corporation. ``Exelon underscores our
long-standing commitment to Alzheimer's disease research, patients and their caregivers.'
SIDE EFFECTS AND CONTRAINDICATIONS
The most common side effects seen with Exelon include nausea, vomiting, anorexia, dyspepsia and asthenia, which were usually
transient and generally mild to moderate in severity. [See important warnings in the prescribing information]. In general, adverse
reactions were less frequent later in the course of treatment. Exelon should not be used in patients with known hypersensitivity
to rivastigmine, other carbamate derivatives or other components of the formulation.
In controlled clinical trials, 26% of women and 18% of men in the high- dose group experienced weight loss of equal or greater
than 7% of their baseline body weight, compared to 6% and 4% of patients given placebo respectively. In most cases, weight
loss attenuates upon dose reduction or interruption of treatment. Also, weight loss attenuated in patients with long-term
treatment.
Exelon has been cleared for marketing in nearly 70 countries worldwide, including all 15 member states of the European Union,
Switzerland, New Zealand, Australia, Canada and Mexico.
UP TO FOUR MILLION AMERICANS AFFECTED BY ALZHEIMER'S DISEASE
``Just a few years ago, people with Alzheimer's disease and their families had very few options,' said Bill Thies, Vice President
of Medical and Scientific Affairs at the Alzheimer's Association. ``Today, we look forward to the future optimistically, as
research progresses and more treatment options become available.'
Alzheimer's disease is a neurodegenerative disease involving deterioration of the brain. Memory loss and the inability to perform
daily activities are hallmarks of this fatal disease. Alzheimer's disease, the fourth leading cause of death behind cardiovascular
disease, cancer and stroke, affects up to 4 million adults in the United States, and 10 million worldwide. It has an annual US
price tag of approximately $100 billion in direct (healthcare and related) and indirect (income) costs. It is estimated that
delaying the onset of the disease by five years could save the nation's healthcare system as much as $50 billion.
Novartis Pharmaceuticals Corporation recognizes that Alzheimer's patients very rarely suffer alone and has developed the
``Exelon Caregiver Partnership(TM)' a unique program designed to provide tailored educational resources and support to
caregivers, so they can more effectively care for their loved ones. In conjunction with this program, the company will introduce
its newly redesigned web site (http://www.AlzheimersDisease.com), created to provide caregivers with needed resources and
support and to offer healthcare professionals access to timely clinical information.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs
used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation,
cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to
improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, a world leader in
healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group
(including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group
recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business
of AstraZeneca in the second half of 2000.
People with Alzheimer's disease and their family members can obtain more information about Exelon by calling toll-free
1-877-4EXELON (1-877-439-3566). Please see full prescribing information.
SOURCE: Novartis Pharmaceuticals Corporation |
