July 09, 2007 01:15 ET
Exelon®Patch, the First and Only Skin Patch for the Treatment of Alzheimer's Disease, Receives First Worldwide Approval in US
EAST HANOVER, NJ--(Marketwire - July 9, 2007) -
-- Once-daily skin patch offers novel approach to treating mild to
moderate Alzheimer's disease, providing smooth and continuous delivery of
drug over 24 hours
-- Similar efficacy to highest doses of Exelon capsules with significant
improvement in memory and overall functioning compared to placebo
-- Exelon Patch preferred by caregivers in a study because it helps
manage patient care and gives visual reassurance that medication has been
-- Exelon Patch minimizes gastrointestinal side effects seen with oral
form of drug
Exelon Patch (rivastigmine transdermal system) has received its first
worldwide approval in the United States as an innovative way to deliver an
effective medicine for mild to moderate Alzheimer's disease patients
through a skin patch instead of an oral capsule.
This new therapy is the first and only transdermal treatment for this
degenerative condition affecting millions of people in the US. Exelon Patch
offers effective treatment based on placebo-controlled clinical trial
results showing significant benefits to patients in terms of their memory
and overall functioning.
Exelon Patch maintains steady drug levels in the bloodstream, improving
tolerability and allowing a higher proportion of patients to receive
therapeutic doses compared to the capsule form of the medication. It is
applied to the back, chest or upper arm, and provides smooth and continuous
delivery of medication through the skin over 24 hours.
Gastrointestinal side effects are commonly seen with this class of drugs
called cholinesterase inhibitors. The recommended dose of Exelon Patch
greatly reduces these side effects, with three times fewer reports of
nausea and vomiting than with the capsule form of the drug.
"Exelon Patch represents a significant advance in the treatment of this
debilitating disease," said George Grossberg, MD, Director of Geriatric
Psychiatry, St. Louis University School of Medicine, St. Louis, Missouri.
"The unique delivery system helps both the patient and the caregiver by
providing an easy way to manage their therapy. The patch provides a visual
reassurance for the caregiver that the patient is receiving their
medication and helps the patient stay engaged in their daily lives."
Exelon Patch is expected to be available in US pharmacies soon. The
medication was submitted for review in the European Union in late 2006.
The patch was designed with compliance in mind and was preferred to
capsules by 70% of caregivers as a method of drug delivery according to
clinical study data, because it helped them follow the treatment schedule,
interfered less with their daily life and was easier to use overall than
the oral medication.
The approval of Exelon Patch is based on results from the international
IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) clinical
trial, involving nearly 1,200 patients with mild to moderate Alzheimer's
disease. Exelon Patch showed similar efficacy to the highest doses of
Exelon capsules and the recommended dose (9.5 mg/24 hours) was generally
well tolerated by patients.
"Innovation isn't just about developing new compounds, but also about
meeting therapeutic needs by taking existing knowledge and applying it in
new ways," said James Shannon, MD, Global Head of Development at Novartis
Pharma AG. "Exelon Patch addresses an important medical need by delivering
a proven drug in an entirely new form that meets the needs of patients and
Alzheimer's disease is a progressive, degenerative disease that alters the
brain, causing impaired memory, thinking and behavior. Approximately 18
million people worldwide have Alzheimer's disease. In the US, more than
five million people suffer from Alzheimer's disease and almost 10 million
people provide care for someone living with dementia, most of which is
related to Alzheimer's disease. By 2030, the number of people in the US who
are age 65 and over with Alzheimer's disease is estimated to reach 7.7
million, 50% more than current levels.
The U.S. Food and Drug Administration also approved the use of Exelon Patch
in treating patients with mild to moderate Parkinson's disease dementia.
Parkinson's disease is a chronic and progressive neurological condition
that affects approximately 1.5 million people in the US. Parkinson's
disease dementia is a distinct and common disorder, one characterized by
impairments in executive function, memory retrieval, and attention, in
patients with an established diagnosis of Parkinson's disease for at least
two years. Two out of five people with Parkinson's disease are estimated to
have Parkinson's disease dementia.
Important Safety Information
Exelon Patch (rivastigmine transdermal system) is indicated for the
treatment of mild to moderate dementia of the Alzheimer's type and mild to
moderate dementia associated with Parkinson's disease. Exelon Patch is
contraindicated in patients with known hypersensitivity to rivastigmine,
other carbamate derivatives or other components of the formulation.
At higher than recommended doses, Exelon Patch use is associated with
nausea, vomiting, diarrhea, anorexia/decreased appetite and weight loss.
For this reason, patients administered the Exelon Patch should always be
started at a dose of 4.6 mg/24 hours and titrated to the maintenance dose
of 9.5 mg/24hours.
In a clinical trial, the most commonly observed adverse events occurring at
a frequency of at least 5% and greater than placebo with administration of
9.5 mg/24 hours were nausea, vomiting and diarrhea (7%, 6%, 8% for Exelon
Patch 9.5 mg/24 hours versus 5%, 3%, 6% for placebo, respectively). Weight
should be monitored during Exelon Patch therapy. In clinical trials for
dementia associated with Parkinson's disease, Exelon capsules have been
observed to increase the incidence or intensity of tremor.
As with other cholinomimetics, caution is recommended in patients with sick
sinus syndrome, conduction defects, gastroduodenal ulcerative conditions
(including those predisposed by concomitant medications), asthma or chronic
obstructive pulmonary disease, urinary obstruction, and seizures. For full
prescribing information go to www.ExelonPatch.com.
The foregoing press release contains forward-looking statements that can be
identified by forward-looking terminology, such as "expected to be," or
implied statements regarding potential future revenues from the Exelon
Patch. Such statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results to be materially different
from any future results, performance, or achievements expressed or implied
by such statements. There can be no guarantee that Exelon Patch will reach
any particular sales levels. In particular, management's expectation
regarding the commercial success of Exelon Patch could be affected by among
other things, uncertainties relating to product development, regulatory
actions or delays or government regulation generally, the ability to obtain
or maintain patent or other proprietary intellectual property protection
and competition in general, as well as factors discussed in the Form 20F
filed with the Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those described
herein anticipated, believed, estimated or expected. Novartis is providing
the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained
in this press release as a result of new information, future events or
Novartis has been a leader in the neuroscience area for more than 50 years,
having pioneered early breakthrough treatments for Alzheimer's disease,
Parkinson's disease, Attention Deficit Hyperactivity Disorder, epilepsy,
schizophrenia and migraine, many of which continue to be regarded as "gold
standards" to this day. Novartis Neuroscience continues to be at the
forefront of research and development of new compounds, is committed to
addressing unmet medical needs and to supporting patients and families
affected by these disorders.
Novartis Pharmaceuticals Corporation develops, manufactures markets and
sells leading innovative prescription drugs used to treat a number of
diseases and conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system, dermatological,
gastrointestinal and respiratory areas. 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 (NYSE: NVS), a world leader in offering
medicines to protect health, cure disease and improve well-being. Our goal
is to discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We are
strengthening our medicine-based portfolio, which is focused on strategic
growth platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, human vaccines and leading self-medication OTC brands.
Novartis is the only company with leadership positions in these areas. In
2006, the Group's businesses achieved net sales of USD 37.0 billion and net
income of USD 7.2 billion. Approximately USD 5.4 billion was invested in
R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 100,000 associates and operate in over 140 countries around
the world. For more information, please visit http://www.novartis.com.
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