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Treatment for Parkinson's Disease, Restless Legs Syndrome

Update: Neupro Now FDA Approved - May 9, 2007

Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA

After Neupro was approved in Europe recently, Schwarz Pharma is now confident being able to launch the drug in the USA.

MONHEIM, Germany, March 1, 2006 -- Schwarz Pharma announced today that it has received an action letter from the US Food and Drug Administration (FDA). The FDA states that Neupro (rotigotine transdermal system) for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease is approvable.

"This is a big positive step forward for the product. We anticipate responding to the action letter within six months ", comments Iris Loew-Friedrich, MD, PhD, Member of the Executive Board Schwarz Pharma AG. "The FDA requires additional analyses and summaries from the existing database."

Mid of February 2006, the European Commission adopted the European Medicines Agency’s (EMEA) positive opinion granting marketing authorization for Neupro for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy. Schwarz Pharma will launch Neupro in the first European markets within the next few weeks.

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 and provides rotigotine continuously to the body for 24 hours. Multinational clinical studies in patients with early stage 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 patch. Rotigotine exhibits a D3/D2/D1 receptor profile, rapid metabolism and low potential of pharmacokinetic drug-drug interactions. The patch administration of rotigotine offers the convenience of once daily-dosing as well as a simple titration scheme.

Results of a rotigotine phase III study conducted in Europe show that rotigotine transdermal patch is also effective in treating patients with advanced Parkinson’s disease. This outcome confirms favorable results from a phase III study completed in the USA at the end of 2004. Schwarz Pharma plans to submit marketing applications in the US and Europe at the end of 2006.

Schwarz Pharma is also developing a rotigotine patch for treating Restless Legs Syndrome. The double-blind and placebo-controlled phase III trial program started in May 2005; first results are expected in the first quarter of 2007.

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.

Posted: March 2006

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