Healthcare Industry News:  rotigotine transdermal system 

Biopharmaceuticals Drug Delivery Neurology

 News Release - September 5, 2006

SCHWARZ PHARMA's Parkinson Patch Offers Additional Benefits

MONHEIM, Germany, September 5 (HSMN NewsFeed) -- At the EFNS congress SCHWARZ PHARMA presented new data from clinical trials with NeuproŽ (rotigotine transdermal patch) for patients with early and advanced stage of Parkinson's disease: Patients switched easily overnight to the Parkinson's patch, NeuproŽ can improve quality of sleep and showed continuous improvement in long-term treatment.

SCHWARZ PHARMA presented new clinical data of its Parkinson's Patch at the 10th Congress of the European Federation of Neurological Societies (EFNS) held from September 2 - 5 in Glasgow, UK. The data presented for NeuproŽ, included patients with early as well as advanced stage Parkinson's disease and were discussed with experts.

NeuproŽ, with the active ingredient rotigotine, is a dopamine receptor-agonist innovatively formulated as a transdermal delivery system, a patch. The patch is applied once a day to the skin and releases rotigotine continuously through the skin into the body over 24 hours. In February 2006, NeuproŽ was approved for the treatment of early stage Parkinson's disease by the European Commission. The Parkinson's patch has been launched in Europe: in Germany, the UK and Austria with additional countries to follow. The variation application for rotigotine transdermal patch for the treatment of patients with advanced stage Parkinson's disease was submitted to the European Medicines Agency (EMEA) in the second quarter 2006.

Open-label clinical trial results presented at the EFNS showed that patients treated with a dopamine agonist (e.g. ropinirole, pramipexole) were able to easily switch overnight to an effective regimen of rotigotine transdermal patch.

A report from two open-label trials showed that transdermal rotigotine improved sleep quality in Parkinson's disease patients to a clinically significant extent. In particular, a decrease in the number of sleep-related motor disturbances and a reduction in the frequency of nocturia were observed.

Long-term experience with rotigotine transdermal patch was also presented and discussed at the EFNS. More than 200 patients with early stage Parkinson's disease were observed in an open-label follow-up over a period of 85 weeks after a 24 week double-blind treatment. The interim results indicate that rotigotine treated patients experienced the same side effects seen in other trials with rotigotine and a continued improvement in symptoms.

In a phase III trial, also presented at the EFNS, which was conducted in Europe and other regions, 506 patients with advanced stage idiopathic Parkinson's disease were randomized. This double-blind, placebo- and active-comparator (pramipexole) controlled trial had an up to 7-week titration phase and a 16-week maintenance phase. Rotigotine transdermal patch was added to stable levodopa treatment. The primary parameters were the change from baseline in the absolute 'off' time and the response rate. Response was defined as a decrease in absolute 'off' time from baseline by at least 30%. Also, non-inferiority to pramipexole was shown and a favorable increase in 'on' time without troublesome dyskinesia was observed.

The most common adverse events associated with the use of rotigotine transdermal system were application site reactions as well as nausea, headache, somnolence and vomiting.

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.

At the EFNS congress, SCHWARZ PHARMA was represented with a booth as well as a number of scientific poster presentations on clinical and pre-clinical results of rotigotine to treat Parkinson's disease and Restless Legs Syndrome. In addition SCHWARZ PHARMA hosted a satellite symposium with scientific experts and a press conference.

SCHWARZ PHARMA (headquartered in Monheim, Germany) is a stock listed company with approximately 4,200 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 EUR 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.

Contact: Antje Witte, Tel: +49 2173 48 1866; Bettina Ellinghorst, Tel.: +49-2173 48 2329

Ricarda Cramer, International Marketing Manager Neupro, Tel.: +49-2173-48-2391

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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Source: Schwarz Pharma

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