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Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome
Date:10/8/2007

oints following optimal rotigotine

treatment

* Rotigotine treatment led to a 4.3 plus or minus 3.3 point increase in

"sleep satisfaction" (RLS-6 Item 1) and a 4.9 plus or minus 3.0 point

reduction of symptom severity "during the night" (RLS-6 Item 3)

* "Daytime tiredness and sleepiness" (RLS-6 Items 4 and 6) scores were

reduced by 2.4 plus or minus 2.7 points

* All effects were first observed during the titration period and were

sustained over 24 months of open-label treatment

* The most common adverse events were application and instillation site

reactions (50%), nasopharyngitis (12%), back pain (11%) and nausea (11%)

"We are pleased to report these promising findings, which show that rotigotine has potential as an important therapy in the management and treatment of RLS," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB. "Clinical data strongly support the development of rotigotine for RLS, and we will work closely with regulatory authorities in both the United States and Europe in order to bring this important medication to market."

Neupro(R) (Rotigotine Transdermal System) is currently approved in the United States for the treatment of early-stage idiopathic Parkinson's disease and in Europe for the treatment of patients with early-stage Parkinson's disease and in combination with levodopa for advanced-stage Parkinson's disease. Applications for the use of rotigotine transdermal system in patients with moderate-to-severe RLS are currently being prepared for submission to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA).

About Neupro(R) (Rotigotine Transdermal System)

Rotigotine transdermal system 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 neurotran
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SOURCE UCB, Inc.
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