Exelon� Granted EU Marketing Authorization As First Treatment For Dementia Associated With Parkinson's Disease By European Commission

09 Mar 2006

Novartis announced today that Exelon� (rivastigmine tartrate) has been granted European marketing authorization by the European Commission for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease (PD) in all 25 European member states.

This makes Exelon, currently indicated for Alzheimer's dementia, the first medication available to treat dementia in Parkinson's patients in the European Union and the only cholinesterase inhibitor to be authorized for more than one type of dementia. Exelon has already received marketing authorization for dementia associated with PD in Switzerland and several Latin American countries, including Brazil.

The EU approval is based on the results of the EXPRESS study, a large-scale, randomized, well-controlled study involving 541 patients from 12 study centers in Europe and Canada and follows the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) earlier this year.

"Exelon provides an important advance in the therapy of dementia associated with Parkinson's disease", said Professor Werner Poewe, Head of Neurology, University Hospital, Innsbruck, Austria. "In the EXPRESS study, patients taking Exelon showed significant benefits regarding memory, concentration and behavioral problems. Patients and their caregivers reported in particular an increased interest and ability to conduct social conversations. This does not only translate into a better quality of life for PD patients suffering from dementia but also a substantial improvement in the quality of life for their families," Werner Poewe concluded.

At any one time, up to 40 percent of people with Parkinson's disease suffer from dementia . Patients with dementia associated with Parkinson's disease typically have problems with memory, concentration, activities of daily living, as well as depression, anxiety, apathy and hallucinations . However, probably due to the absence of treatment, current diagnosis rates are low.

"When my husband developed dementia associated with Parkinson's disease, I became a nervous wreck. He would ask me the same question again and again and again," said Mrs I., spouse of PD patient suffering from dementia. "Since he has started taking this new medicine he pays more attention, we have conversations and he can go to the shop by himself. It is wonderful. I know it won't go away completely, but these tablets have really changed our lives. Everything is different now."

About the EXPRESS study

The regulatory submissions were based on the EXPRESS study (EXelon in PaRkinson's disEaSe dementia Study), published in December 2004 in the New England Journal of Medicine . EXPRESS is the first large-scale clinical study assessing the efficacy and safety of any treatment in Parkinson's disease patients with dementia. Patients taking Exelon showed statistically significant benefits on a range of symptoms, such as maintaining or improving memory, concentration and behavioral problems. They were also able to cope better with everyday activities like watching TV or talking about current events.

The side effects associated with Exelon during this study were mild to moderate in nature and included nausea and vomiting. Importantly, motor scale assessments showed that Parkinsonian symptoms were not worsened overall relative to baseline or placebo. Mild to moderate tremor was reported in 10% of Exelon-treated patients, but this resulted in relatively few withdrawals from the study.

About Exelon

Since 1997, Exelon has been widely used to treat mild to moderately severe Alzheimer's dementia in over 70 countries. It belongs to a class of drugs known as cholinesterase inhibitors (ChEI's) which increase the activity of the neurotransmitter acetylcholine in the brain.

Among the ChEI's, Exelon is the only treatment that inhibits both enzymes involved in the breakdown of this neurotransmitter - acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). This may offer additional benefits over treatments which inhibit AChE alone. Exelon can maintain both memory and thinking, help with behavioral problems and affect how patients cope with the activities of daily living. It may help them communicate better, interact socially, participate in hobbies and in activities of daily living.

About Parkinson's Disease Dementia

Parkinson's disease is a chronic and progressive neurological condition estimated to affect 6.3 million people worldwide . Dementia is thought to occur in up to 40 percent of patients diagnosed with this disease and may affect up to 80 percent of Parkinson's patients in advanced age and severe diseaseError! Bookmark not defined.1, . Parkinson's patients have a six-fold increase in the risk of developing dementia compared with elderly people without Parkinson's disease.

Like Alzheimer's, dementia associated with Parkinson's disease is thought to result partly from a cholinergic deficit, which causes decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine.

Dementia associated with Parkinson's disease differs clinically from Alzheimer dementia. Patients with dementia associated with Parkinson's disease generally suffer from an impairment of executive function like the ability to plan or organize and goal-directed behavior. Furthermore they have more severe visuospatial deficits, apathy, severe attentional deficits with fluctuations and frequent visual hallucinations.

This release contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "may offer", "may help", "goal is", or similar expressions, or by express or implied discussions regarding potential new indications for Exelon, or regarding potential future revenue from Exelon. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Exelon to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Exelon will be approved for any additional indications in any market or regarding potential future revenue from Exelon. In particular, management's expectations regarding commercialization of Exelon could be affected by, among other things, additional analysis of Exelon clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays in government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in the Company'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.


References

1) Cummings JL. Intellectual impairment in Parkinson's disease: clinical, pathological and biochemical correlates. J Geriatr Psychiatry Neurol 1988;1:24-36.

2) Huber SJ, Paulson GW, Shuttleworth EC. Relationship of motor symptoms, intellectual impairment, and depression in Parkinson's disease. J Neurol Neurosurg Psychiatry 1988;51:855-858.

3) Emre M et al. Rivastigmine for the dementia associated with Parkinson's Disease. N Engl J Med 2004;351:29-38.

4) Corey-Bloom J, Anand R, Veach J. A randomized trial evaluating the efficacy and safety of ENA713 (rivastigmine tartrate), a new acetylcholinesterase inhibitor, in patients with mild to moderately severe Alzheimer's disease. Int J Geriatr Psychopharmacol 1998;1:55-65.

5) R�sler M, Anand R, Cicin-Sain A et al. Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomized controlled trial. Br Med J 1999;318:633-40.

6) Global Declaration on Parkinson's Disease launched by the Working Group on PD at the 7th World PD International Symposium, 7th December 2003 in Mumbai, India. http://www.epda.eu.com/globaldeclaration-about.shtm.

7) McKeith IG and Mosimann UP. "Dementia with Lewy bodies and Parkinson's disease." Parkinsonism & Related Disorders 10 (2004) S15-S18.

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