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FDA Approves SCHWARZ PHARMA's Neupro(R) (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA

Posted on: Thursday, 10 May 2007, 09:00 CDT

MONHEIM, Germany, May 10 /PRNewswire/ -- SCHWARZ PHARMA announced today that the U.S. Food and Drug Administration (FDA) has approved Neupro(R) (Rotigotine Transdermal System) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease.

"This is an important step forward for the patients suffering from Parkinson's disease. Following approval and launch within Europe, Neupro will now be available for patients in the USA," comments Iris Loew-Friedrich, MD, PhD, CSO SCHWARZ PHARMA AG. "We intend to submit a supplemental New Drug Application for the treatment of advanced Parkinson's disease to the FDA by the end of 2007."

Neupro, with once daily dosing, is the first non-ergolinic dopamine agonist transdermal system capable of delivering medication over a 24-hour period. The once-daily transdermal patch Neupro will be available in the U.S. in three strengths (2 mg/24 hours; 4 mg/24 hours; and 6 mg/24 hours).

Neupro, with the active ingredient rotigotine, is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a patch, designed for once-a-day application. Rotigotine is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functioning. The system is applied to the skin once a day and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies in patients with early stages of Parkinson's disease were completed at the end of 2003. In 15 clinical trials, more than 1,500 patients with Parkinson's disease have been treated with rotigotine transdermal system. The clinical trials have shown efficacy and safety in early Parkinson's disease. Rotigotine exhibits a low potential of pharmacokinetic drug-drug interactions. The administration of rotigotine transdermal system offers the convenience of once daily dosing and easy usage.

Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa. Since March 2006, the drug has been available on the European market and has been launched by SCHWARZ PHARMA in 14 countries within Europe, e.g. Germany, the UK, Austria, Denmark, Ireland, Norway, Switzerland, Sweden, Greece, Spain, Finland and Poland.

Parkinson's disease is a progressive disorder of the central nervous system. The patients - roughly four million worldwide, including approximately one million people in the U.S. - suffer primarily 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 are drugs that attempt to compensate for this lack of dopamine.

Important Safety Information

Neupro was found to have a proven safety and tolerability profile. The most frequently reported adverse events in clinical trials were nausea, application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Other adverse effects with Neupro included peripheral edema, fluid retention, hallucinations, symptomatic orthostatic hypotension, weight gain, elevated heart rate, elevated blood pressure and syncope. Neupro is contraindicated in patients who have demonstrated hypersensitivity to rotigotine or to the components of the transdermal system. Neupro contains sodium metabisulfite which may cause allergic-type reactions including anaphylactic symptoms in people who may be sensitive to sulfites, including those with asthma. For full prescribing information, please visit http://www.neupro.com/.

SCHWARZ PHARMA (headquartered in Monheim, Germany) is a research driven pharmaceutical company with approximately 4,000 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 2006 the SCHWARZ PHARMA group achieved global sales of euro 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.

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.

All SCHWARZ PHARMA press releases are distributed by e-mail at the same time they become available on the website. Please go to http://www.schwarzpharma.com/, press room, news subscription to register online, change your selection or discontinue this service.

SCHWARZ PHARMA

CONTACT: Antje Witte, +49-2173-48-1866, orantje.witte@schwarzpharma.com, or Michael Davis, +1-262-238-5446, both ofSCHWARZ PHARMA

Web site: http://www.schwarzpharma.com/http://www.neupro.com/

Source: PRNewswire

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