CHMP adopts positive opinion recommending approval of Exelon� as first symptomatic treatment of mild to moderately severe dementia associated with idiopathic Parkinsonís disease in the EU
Basel, Switzerland, January 30, 2006 - Novartis announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending that the European Commission grant a marketing authorization for Exelon� (rivastigmine tartrate) for the symptomatic treatment of mild to moderately severe dementia associated with idiopathic Parkinsonís disease (PD) later this year.
This decision coincides with the approval of Exelon as the first treatment for dementia associated with PD in Switzerland. Exelon already received marketing authorization for this indication in several Latin American countries, including Brazil. This makes Exelon, currently indicated for Alzheimerís dementia, the only cholinesterase inhibitor to be authorized for more than one type of dementia.
ďThis is encouraging news for Parkinsonís patients who are affected by dementia,Ē said James Shannon, Global Head of Development, Novartis Pharma AG. ďAlthough movement symptoms of Parkinsonís disease can be managed quite well with current treatments, dementia associated with Parkinsonís disease could not be treated until now. Novartis hopes that Exelon will soon be approved for this new indication in many more countries around the world.Ē
Since 1997, Exelon has been widely used to treat mild to moderate Alzheimerís disease dementia in over 70 countries. It belongs to a class of drugs known as cholinesterase inhibitors (ChEIs) which increases the communication between certain nerve cells in the brain.
Exelon is the first medication worldwide that has also shown significant benefits in the treatment of Parkinsonís patients suffering from dementia in a large-scale, randomized, well-controlled study involving 541 patients from 12 study centers in Europe and Canada. Based on this study, submissions to health authorities were made.
At any one time, up to 40 percent of people with Parkinsonís disease suffer from dementia. Patients with dementia associated with Parkinsonís 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.
ďDementia associated with Parkinsonís disease is a significant emotional, economic and social burden for patients and their families,Ē said Mary Baker, President of the European Parkinsonís Disease Association, London. ďWe therefore welcome therapies like Exelon which give new hope to families caring for a loved one with dementia and may improve the quality of life of the whole family.Ē
About the EXPRESS study
The regulatory submissions were based on the EXPRESS study (EXelon in PaRkinsonís 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 Parkinsonís 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.
Exelon is a treatment for mild to moderate Alzheimerís disease. It belongs to a class of drugs known as cholinesterase inhibitors (ChEIís) which increase the activity of the neurotransmitter acetylcholine in the brain. Among the widely used ChEIís, 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 Parkinsonís Disease Dementia
Parkinsonís 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 Parkinsonís patients in advanced age and severe disease1,. Parkinsonís patients have a six-fold increase in the risk of developing dementia compared with elderly people without Parkinsonís disease.
Like Alzheimerís disease, dementia associated with Parkinsonís 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 Parkinsonís disease differs clinically from Alzheimer disease. Patients with dementia associated with Parkinsonís 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 Companyís business, which can be identified by the use of forward-looking terminology such as ďwould makeĒ, ďmayĒ, ďis committed to addressingĒ, ďhopes that . will soonĒ, ďgoal isĒ, 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, managementís 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 companyís 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 Companyís 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.
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimerís disease, Parkinsonís disease, attention deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine. Novartis continues to be active in the research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and their families affected by these disorders.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat 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. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Groupís businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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