- Once-daily patch provides smooth and continuous delivery of drug through skin, helps to achieve optimal dosing and offers potential for improved efficacy
- Shows similar efficacy to highest Exelon capsule doses; significant improvement in memory and ability to perform everyday activities compared to placebo
- Minimizes gastrointestinal side effects seen with oral form of drug, a common issue for this class of medicines
- Designed with compliance in mind, skin patch delivery preferred by caregivers because it helps manage patients and gives visual reassurance of treatment
Basel, September 24, 2007 - The European Commission has approved Exelon® patch (rivastigmine transdermal patch), an innovative way to deliver this effective medicine to patients suffering from mild to moderately severe Alzheimer's disease.
Exelon patch is the first and only transdermal treatment for Alzheimer's disease, a degenerative brain disorder affecting 18 million people worldwide and the third leading cause of death behind cardiovascular disease and cancer. The skin patch is applied once-daily to the back, chest or upper arm of patients.
"Exelon patch represents a therapeutic innovation that is designed specifically to meet the needs of patients, caregivers and physicians involved with this devastating disease," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
"The patch has been shown to increase compliance, reduce side effects, and allow medication to be delivered through the skin into the bloodstream smoothly and continuously over 24 hours, helping to achieve optimal dosing. All these benefits offer the potential for improved outcomes in patients," Shannon said.
The European Union approval, coming soon after the US approval in July 2007, was based on results from the international IDEAL (Investigation of Transdermal Exelon in ALzheimer's disease) study, which involved nearly 1,200 patients with mild to moderate Alzheimer's disease.
The patch showed similar efficacy to the highest doses of Exelon capsules, as well as significant improvement in memory and the ability to perform everyday activities compared to placebo. In addition, the IDEAL study demonstrated three times fewer reports of gastrointestinal side-effects (nausea and vomiting) with the patch than the oral form of the medication.
"The patch is an important new addition to existing oral treatment options since it provides visual reassurance that patients have 'taken' their medicine," said Bruno Dubois, Professor of Neurology at the Hôpital Pitié Salpétrière, Centre de Neuropsychologie, Paris, France. "Just having to apply a patch can help reduce the burden of daily life for people with Alzheimer's disease and their families."
Designed with compliance in mind, the patch was preferred by more than 70% of caregivers as a method of drug delivery because it helped them follow treatment schedules and was easier to use than an oral medicine.
"People with Alzheimer's disease and their caregivers welcome every new therapy for the disease," said Mark Wortmann, Executive Director of Alzheimer's Disease International - an umbrella organization of Alzheimer Associations around the world which offer support and advice to people with the disease and their carers. "I am pleased that the patch offers a new approach to treatment."
Exelon (rivastigmine) in capsule form has been approved since 1997 to treat patients with mild to moderate Alzheimer's disease in more than 70 countries.
Since 2006, Exelon in capsule form or oral solution has been the only member of the cholinesterase inhibitor class of medicines that is approved in both Europe and the US for treating mild to moderate Alzheimer's disease as well as Parkinson's disease dementia. On July 6, 2007, the US Food and Drug Administration (FDA) approved Exelon® Patch (rivastigmine transdermal system) for the treatment of mild to moderate Alzheimer's disease and Parkinson's disease dementia.
Alzheimer's disease affects one in 10 people over age 65, making it the most common form of dementia. The global direct costs of dementia in 2003, for example, were estimated at USD 156 billion.
The foregoing release contains forward-looking statements that can be identified by terminology such as "potential", "can", "estimated", or similar expressions, or by express or implied discussions regarding potential future revenues from Exelon Patch. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Exelon Patch 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 achieve any particular levels of revenue in the future. In particular, management's expectations regarding Exelon Patch could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected regulatory actions or delays or government regulation generally, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US 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 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 otherwise.
Novartis AG (NYSE: NVS) is 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 more than 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com
 Winblad B, Cummings J, et al. A 6-Month Double-blind, Randomized, Placebo-Controlled Study of a Transdermal Patch in Alzheimer's Disease - Rivastigmine Patch versus Capsule. International Journal of Geriatric Psychiatry May 2007: 22: 5:485-491.
 Winblad B, Cummings J, et al. Caregiver Preference For Rivastigmine Patch Relative to Capsule For Treatment of Probable Alzheimer's Disease. International Journal of Geriatric Psychiatry May 2007: 22: 5: 456-67.
 Alzheimer's Association. Alzheimer's Disease Facts and Figures, 2007.
 Wimo A, Jonsson L, Winblad B. An Estimate of the Worldwide Prevalence and Direct Costs of Dementia in 2003. Dementia and Geriatric Cognitive Disorders 2006; 21:175-181.
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