Neupro Now Approved in Europe for All Stages of Parkinson's Disease
In Europe, SCHWARZ PHARMA's Parkinson's patch has been also approved for the treatment of the signs and symptoms of advanced-stage Parkinson's disease in combination with levodopa.
MONHEIM, Germany, January 16, 2007 - SCHWARZ PHARMA announces that the European Commission has given marketing authorization for Neupro® (rotigotine transdermal patch), for the treatment of all stages of Parkinson's disease. Neupro® is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on-off" fluctuations).
"Transdermal administration of a dopamine agonist offers a promising option for patients suffering from Parkinson's disease," says Iris Loew-Friedrich, MD, PhD, CSO SCHWARZ PHARMA AG. "Rotigotine, a new chemical entity, is combined with an innovative formulation technology, the first Parkinson's patch, to offer patients good symptom control over twenty-four hours."
Neupro® is available in the European market since March 2006 for the treatment of early stage idiopathic Parkinson's disease as monotherapy (i.e. without levodopa). The drug has already been launched by SCHWARZ PHARMA in Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece and Spain.
Neupro®, with the active ingredient rotigotine, is a non-ergoline dopamine receptor-agonist formulated as a transdermal delivery system, a patch. The patch is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. It, therefore, covers symptoms not only during the day, but also at night. Multinational clinical studies with patients in early and advanced stages of Parkinson's disease have shown efficacy and safety in Parkinson's disease patients and a potential for long term benefit. In more than 20 clinical trials, more than 2,000 patients with early or advanced Parkinson’s disease have been treated with rotigotine transdermal patch. Rotigotine exhibits a promising receptor profile, rapid metabolism and low potential of pharmacokinetic drug-drug interactions. The patch administration of rotigotine offers the convenience of once daily-dosing and easy usage.
Parkinson’s disease is a disorder of the central nervous system. The patients - roughly four million worldwide - suffer from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists attempt to compensate for this lack of dopamine.
SCHWARZ PHARMA (headquartered in Monheim, Germany) is a pharmacutical company with approximately 4,400 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2005 the SCHWARZ PHARMA group achieved global sales of nearly € 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.
Corporate Communications: Antje Witte, Tel: +49 2173 48 1866;
Bettina Ellinghorst, Tel.: +49 2173 48 2329
This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation affecting SCHWARZ PHARMA AG, exchange rate fluctuations and hiring and retention of its employees.
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