FDA Advisory Committee Recommends Approval Of Novartis Pharmaceuticals Corporation's Exelon(R) (rivastigmine tartrate) In The Treatment Of Dementia Associated With Parkinson's Disease
If approved, Exelon would be the first and only medication available for the treatment of dementia associated with Parkinson's disease. Exelon is currently approved for the treatment of mild to moderate Alzheimer's disease.
About 40% of patients with Parkinson's disease are estimated to also develop dementia, which can have a devastating effect on patients and their families. The risk for developing dementia among Parkinson's patients is approximately four to six times higher than among elderly people without this disease. No approved medications are available to treat dementia in Parkinson's patients.
"We are very pleased with the Advisory Committee's recommendation in support of the efficacy and safety of Exelon for the treatment of dementia associated with Parkinson's disease," said Alex Gorsky, Head of Pharma North America and CEO, Novartis Pharmaceuticals Corporation. "Novartis is committed to developing therapies to help patients with dementia and their caregivers. We will continue to work closely with the FDA as the Agency finalizes its review of Exelon for the treatment of Parkinson's patients with dementia."
The FDA Advisory Committee's recommendation will be considered by the FDA in making its decision regarding the sNDA for Exelon capsules for the treatment of dementia associated with Parkinson's disease, which is expected during the third quarter of this year. The committee's recommendation was based on a review of results from the EXelon in PaRkinson's disEaSe dementia Study (EXPRESS). EXPRESS is the first large-scale, prospective, randomized, double-blind, placebo-controlled, multicenter study with an Alzheimer's disease medication to demonstrate statistically significant improvement in the treatment of symptoms of dementia associated with Parkinson's disease.
Published in the New England Journal of Medicine in December 2004, EXPRESS included 541 patients and is the first and only prospective, large-scale trial to show benefits in patients with dementia associated with PD. The outcomes were better in patients treated with Exelon compared to placebo (sugar pill) in both the primary and secondary variables. There was statistically significant improvement in overall functioning in patients treated with Exelon relative to deterioration seen in those treated with placebo, in cognition and certain aspects of behavior. Patients treated with Exelon also had less deterioration in their ability to perform activities of daily living than patients who received placebo. Patients enrolled in the study had mild to moderate dementia, which developed at least two years after they were diagnosed with Parkinson's disease.
Exelon was generally well tolerated. The most frequent side effects associated with Exelon were nausea and vomiting, which were mild to moderate in nature. More patients treated with Exelon reported increased tremor than did patients on placebo, but this rarely resulted in withdrawal from the study and the rating scale used to measure motor function in Parkinson's disease (UPDRS III) did not show a significant deterioration relative to baseline nor a statistically significant increase in tremor between Exelon and placebo.
In March 2006, Exelon was granted European marketing authorization for the treatment of dementia associated with Parkinson's disease in all 25 European member states, making it the only medication available to treat dementia associated with Parkinson's in the European Union. In addition to the EU, Exelon has also been approved to treat dementia associated with Parkinson's disease in 14 other countries around the world.
Parkinson's disease is a chronic and progressive disease of the nervous system. According to the National Parkinson Foundation, Parkinson's disease affects 1.5 million Americans and dementia is one of the complications most feared by Parkinson's disease patients. In addition to cognitive impairment, neuro-psychiatric symptoms (e.g., depression, hallucinations, anxiety and apathy) are also common. These symptoms impact the patient's quality of life, course of the disease and caregiver distress.
As with Alzheimer's disease, dementia in Parkinson's disease patients is associated with a cholinergic deficit, which results in decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. This deficit contributes to the cognitive and behavioral problems observed in these patients.
Safety Information About Exelon
Exelon is approved for mild to moderate Alzheimer's disease. It has been administered to over 3 million patients worldwide and is cleared for marketing in over 70 countries.
Exelon use is associated with significant stomach-related side effects, including nausea, vomiting, loss of appetite, and weight loss. If therapy is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose in order to avoid the possibility of severe vomiting and its potentially serious consequences.
In clinical studies, stomach-related side effects occurred more frequently as doses were increased. The weight loss associated with Exelon occurred more commonly among women receiving high doses in clinical studies. Because these side effects can be serious, caregivers should be encouraged to monitor for these adverse events and inform the physician if they occur. People at risk for certain heart conditions or stomach ulcers should notify their doctor before starting Exelon therapy. In clinical studies, some patients also experienced fainting, weakness, and upset stomach. For more information, please see complete prescribing information at http://www.Exelon.com.
The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "if approved", "would be", and "can have", or implied statements regarding potential future approvals of, or potential future revenues from Exelon. 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 will reach any particular sales levels. In particular, management's expectation regarding the commercial success of Exelon 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.
Novartis Pharmaceuticals Corporation develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, Attention Deficit Hyperactivity Disorder, epilepsy, schizophrenia and migraine, many of which continue to be regarded as "gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News) -- 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 Group's 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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