Patch Instead of Pills Makes Living with Alzheimer's Disease Easier

First ever skin patch for Alzheimer's disease reduces caregiver burden and can improve patient outcomes
 

DORVAL, QC, Feb. 12 /CNW/ - For the first time, Alzheimer's patients and their caregivers will have the visual reassurance of continuous delivery of a medication through the skin. Now there will be no pills to remember, no pills to swallow, and no worries about medication being taken properly. Exelon* Patch (rivastigmine), for the symptomatic treatment of mild to moderate Alzheimer's disease, is now available in Canada.
    
While Alzheimer's disease is a chronic condition, for which long-term treatment should be a primary goal, statistics show that approximately 50 per cent of patients stop treatment with oral cholinesterase inhibitors (including Exelon*), the group of drugs typically used to treat the early and middle stage symptoms of Alzheimer's disease, after only six months. Some patients simply forget to take their pills, have trouble swallowing them or have difficulty with side effects and can stop their medication which can cancel out any treatment benefits. The patch optimizes the way the medication is distributed throughout the body and allows patients to reach and maintain the maximum effective dose of medication with three times less reported side effects in comparison to Exelon* capsules.
    
Exelon* Patch was designed with compliance in mind, and preference study results show that the patch was chosen over Exelon* capsules by more than 70 per cent of Alzheimer's caregivers as a method of drug delivery. The patch provides visual reassurance that medication has been administered, reducing some of the burden associated with caring for a loved one affected by Alzheimer's disease. "I am relieved that a patch will be available for Alzheimer's patients like my husband. This disease is so tough on everyone - the patch is definitely going to make it easier for us," says Anne West, whose husband was diagnosed with Alzheimer's disease seven years ago. "I would like my husband to stay at home with me for as long as possible and with the patch, he and I can both see the medication is being given to him every day as it
should be."
    
Designed to provide smooth and continuous delivery through the skin for a 24-hour period, Exelon* Patch offers a unique treatment option that may allow patients to reach and maintain an optimal therapeutic dose for a longer period
of time.

"The approval of Exelon* Patch represents an important development in the treatment of this debilitating disease and responds to a critical need," says Dr. Sandra Black, Professor in the Division of Neurology in the Department of Medicine at the University of Toronto. "The unique delivery of the patch is very positive news for patients and their caregivers. It allows them to access and stay on the most effective dose with fewer side effects than the oral form. It will be an attractive option for patients that offers the possibility to delay the symptomatic progression of their disease."     

About Exelon* Patch      Exelon* Patch belongs to a class of drugs known as cholinesterase inhibitors (ChEIs), which are effective at slowing the progression of Alzheimer's disease. Although effective, ChEIs are commonly associated with gastrointestinal side effects.
    
Exelon* Patch study results demonstrate significant benefits to patients in terms of their memory and ability to perform everyday tasks, as well as helping their overall functioning. It is applied to the back, chest or upper arm, and provides smooth and continuous delivery of medication through the skin over 24 hours.
    
Treatment is initiated with Exelon* Patch 5 (9 mg/5 cm2, in vivo release rate of 4.6 mg/24h) once a day. If the starting dose is well tolerated, the dose should be increased to Exelon* Patch 10 (18 mg/10 cm2, in vivo release rate of 9.5 mg/24h) after a minimum of four weeks of treatment. Exelon* Patch 10 is the maximum recommended daily maintenance dose.
    
In 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, the target dose of Exelon* Patch 10 was well-tolerated and led to three times fewer reports of nausea and vomiting when compared to the highest doses of Exelon* capsules. Ninety-six percent of patients in the Exelon* Patch group of the IDEAL study achieved their target dose, indicating that side effects are minimal. The improved tolerability associated with Exelon* Patch offers a real potential to lessen the risk of stopping treatment and may help Alzheimer's disease patients live more
independently for a longer period of time.     

About Alzheimer's Disease     


Currently, more than 450,000 Canadians suffer from Alzheimer's or a related disease. In 2008 close to 100,000 Canadians will develop Alzheimer's or a related disease and by 2030 this number is estimated to rise to 750,000, a 65 per cent increase over the current levels. Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behaviour. The symptoms of Alzheimer's disease affect different people in different ways, but the most common symptoms begin with difficulty remembering new information. As the disease progresses, various abilities become impaired including involvement in daily activities and the
development of behavioral disturbances.     

Forward-Looking Statement     

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "may allow", "offers a real potential to" 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 otherwise.     

About Novartis Canada     

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada Inc. conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, ophthalmology and
organ transplantation. In 2006, the Company invested over $69 million in research and development. Novartis Pharmaceuticals Canada Inc. employs more than 800 people in Canada and its headquarters are located in Dorval, Quebec.

In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Canada, please consult www.novartis.ca.     

About Novartis     

Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more
information, please visit www.novartis.com.      <<
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  -30- /For further information: Ethan Pigott, Hill & Knowlton, Tel: (416)
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Posted: February 2008

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