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New Data Highlights Long Term Tolerability and Sustained Benefits of the Exelon Patch in the Treatment of Alzheimer’s Disease

  • Favorable safety profile demonstrated at one year
  • Patients receiving oral medication were able to switch to the patch with favorable tolerability
  • Low incidence of skin irritation from the patch at one year

BASEL, Switzerland, 26 August, 2007  – Exelon® (rivastigmine transdermal patch), which delivers rivastigmine to patients through the skin into the bloodstream, has been shown to be well tolerated by Alzheimer’s disease (AD) patients for up to one year of treatment with sustained benefits. The findings come from the 28-week, open-label extension phase of the IDEAL ( I nvestigation of trans D ermal E xelon in Alz heimer’s disease) trial.

In the study, presented at the 2007 Congress of the European Federation of Neurological Society (EFNS), patients who switched from the capsule to the Exelon patch had a very low incidence of gastrointestinal side effects such as nausea (2.4%) and vomiting (1.9%). In addition, there was a very low incidence of skin irritation at one year for patients using the patch daily. The overall adverse event profile for the open-label extension phase was similar to that seen in the double-blind phase of the IDEAL study 3  with no new safety or tolerability issues reported.

“The IDEAL trial extension showed that the Exelon patch has long term benefit to patients, with a favorable safety and tolerability profile” said Dr L Frolich, Central Institute for Mental Health, Ruprecht-Karls-University of Heidelberg, Germany. 

The once-daily patch is applied to the back, chest or upper arm, and provides smooth and continuous delivery of medication through the skin over 24 hours 3 .

Designed with compliance in mind, the Exelon patch was preferred to capsules by more than 70% of caregivers in the IDEAL study as a method of drug delivery because it helped them follow the treatment schedule, interfered less with their daily life, and was easier to use overall than an oral medication 4 .

“A patch can offer unique advantages over oral medications for AD patients and their families such as improving compliance. The Exelon patch may offer an effective means to optimize drug delivery and improve clinical outcome.” said Roger Lane, Disease Area Section Head for Dementia, Novartis Pharma AG.

About the IDEAL STUDY
IDEAL ( I nvestigation of Trans D ermal E xelon in Al zheimer’s disease) was a 24 week, multi-centre, randomized, double-blind, double-dummy, placebo- and active-controlled trial to compare the efficacy, safety and tolerability of the once-daily Exelon patch with conventional twice-daily Exelon capsules in patients with moderate AD.

There were four target dose groups:
Once daily Exelon Patch 9.5 mg/24hr
Once daily Exelon Patch 17.4 mg/24 hr
Twice daily Exelon capsules (6-12 mg rivastigmine / day)
Placebo

IDEAL was conducted in 21 countries and involved 100 centers (23 in the US) and 1,195 patients aged 50-85 years old with a score of 10 to 20 in the Mini-Mental State Examination (MMSE), the most widely-used test for assessing memory problems or dementia.

Results of the IDEAL study show that once-daily Exelon patch demonstrated similar efficacy to the highest doses of rivastigmine capsules (12mg/day) and provided significant benefits to patients across memory, cognition and activities of daily living. The Exelon patch also provided benefit in global functioning compared with placebo 3 .

The target dose of the Exelon patch (9.5 mg/24 hours) was generally well tolerated in the clinical study – with three times fewer reports of gastrointestinal side effects (nausea and vomiting) than the oral form of the medication 3 .

In the 28-week, open-label extension of the IDEAL study, patients were allowed to switch to the Exelon patch (9.5 mg/24hr for four weeks followed by titration up to 17.4 mg/24hr) from the original clinical trial, regardless of which arm of the study they started in. More than 700 patients participated in the extension phase of the study.

About Exelon
Since 1997, Exelon (rivastigmine) has been used to treat mild to moderate Alzheimer’s disease in more than 70 countries. Exelon is the only cholinesterase inhibitor to be approved for both mild to moderate Alzheimer’s disease and Parkinson’s disease dementia in both Europe and the United States.

The US Food and Drug Administration approved Exelon ® Patch (rivastigmine transdermal system) on July 6, 2007 for the treatment of both mild to moderate Alzheimer’s disease and Parkinson’s disease dementia. In July 2007, the patch was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP), the body that reviews drug applications for all 27 EU member states as well as Iceland and Norway. The European Commission generally follows the recommendation and is expected to issue a decision on the Exelon patch within three months.

Alzheimer’s disease
Alzheimer’s disease is a progressive disease that alters the brain, causing impaired memory, thinking and behavior. Affecting one in 10 individuals over the age of 65, it is the most common form of dementia and the third leading cause of death in this age group behind cardiovascular disease and cancer. The worldwide direct costs for dementia were estimated at US$ 156 billion in 2003.

Disclaimer
The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as “can,” “expected”, “may”, “generally follows,” “estimated” or similar expressions, or by express or implied statements regarding potential future regulatory approvals of the Exelon patch, or potential future revenues from the Exelon patch. Such statements reflect the current views of Novartis regarding future events, and 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 the Exelon patch will be approved for sale in the EU or any additional markets.  Nor can there be any guarantee that the Exelon patch will reach any particular sales levels. In particular, management’s expectation regarding the Exelon patch could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, unexpected clinical trial results, including unexpected additional analysis of existing clinical data and unexpected new clinical data; government, industry, and general public pricing pressures; competition in general; the ability to obtain or maintain patent or other proprietary intellectual property protection, as well as factors discussed in Novartis AG’s Form 20-F filed 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 described herein as 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
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 approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/" target=blank>http://www.novartis.com .

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References
1     Alzheimer Dis Assoc Disord. 2005 Jan-Mar;19(1):29-36. Links Cognition, function, and caregiving time patterns in patients with mild-to-moderate Alzheimer disease: a 12-month analysis. Feldman HH, Van Baelen B, Kavanagh SM, Torfs KE.
2      Int J Geriatr Psychiatry. 2004 Sep;19(9):817-24. Links A longitudinal study of Alzheimer's disease: rates of cognitive and functional decline. Suh GH, Ju YS, Yeon BK, Shah A.
3     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.
4     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.

 

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Corinne Hoff
Novartis Global Media Relations
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Novartis Pharma Communications
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Posted: August 2007

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