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Observational study in routine clinical practice setting showed that Neupro® (rotigotine transdermal patch) improved day- and night-time symptoms of Restless Legs Syndrome

For the attention of European medical writers/journalists only

Brussels (Belgium), 21st June 2012 – 0700CET – Neupro® (rotigotine transdermal patch) improved both day- and night-time symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS) in a large, three-month, non-interventional, observational study of 687 adult patients in routine clinical practice conducted in Germany.1

The study aimed to gather “real-life” data on rotigotine transdermal patch in the treatment of RLS and indicated that the effects seen in placebo-controlled clinical trials were reflected in daily clinical practice.1 Results consistent with clinical analysis from the pivotal trials were presented today at the 16th International Congress of Parkinson’s Disease and Movement Disorders in Dublin, Ireland.

“The efficacy, safety and tolerability profile of rotigotine transdermal patch has been documented in several placebo-controlled trials,” said Dr Cornelius Bachmann, Georg August University, Göttingen, Germany. “This observational study examined the effects of rotigotine transdermal patch on RLS symptoms in the real world, and indicated that it was effective in daily clinical practice.”

Effectiveness in the study was assessed using the validated RLS-6 scale, which uses an 11-point scale (from 0 = not present to 10 = very severe) to establish the severity profile of different day- and night-time symptoms across six items.2 Measurements were taken at baseline, an interim visit and the end of treatment. Item 2 (improvement in symptom severity when falling asleep) and Item 3 (improvement in symptom severity during the night) were defined as primary variables.

Among 564 patients with sufficient data for efficacy assessments the mean rotigotine transdermal patch dose of longest duration was 2.4±1.4* mg/24hr.1 Up to 501 patients were available for effectiveness assessment at end of treatment, within individual items. At baseline, 57.8% of patients reported frequent RLS symptom onset during the day.1 Rotigotine transdermal patch improved day-time and night-time symptoms, as indicated by a mean reduction in all individual RLS-6 item scores.1

Results for individual items1
• 70.5% of patients reported an improvement in their satisfaction with sleep (Item 1, n=501)
• 67.9% of patients reported an improvement in symptom severity when falling asleep (Item 2, n=501). Item 2 was defined as a primary variable
• 69.6% of patients reported an improvement in symptom severity during the night (Item 3, n=500). Item 3 was defined as a primary variable
• 74.7% of patients reported an improvement in symptom severity during the day when at rest (Item 4, n=499)
• 43.9% of patients reported an improvement in symptom severity during the day when active (Item 5, n=501)
• 68.5% of patients reported an improvement in daytime sleepiness / tiredness (Item 6, n=498)

Adverse events experienced by 1% or more of patients were skin reactions (10.4%), nausea (5.7%), headache (2.8%), dizziness (2.8%), fatigue (2.0%), sleep disorder (1.2%) and hypertension (1.0%)1 with most adverse events being mild to moderate in intensity.

*Neupro® (1 mg, 2mg, 3 mg/24 h) is approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Notes to Editors

About Neupro® in the European Union
Neupro® (rotigotine) is approved in the European Union 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). Neupro® is also approved in the European Union for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults.

Neupro® in the European Union Important Safety Information
Neupro® is contraindicated in case of hypersensitivity to the active substance or to any of its excipients, and in case of magnetic resonance imaging (MRI) or cardioversion. Neupro® should be removed if the patient has to undergo MRI or cardioversion to avoid skin burns.

It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the risk of postural/orthostatic hypotension associated with dopaminergic therapy and reported during Neupro® treatment. Neupro® has been associated with somnolence and episodes of sudden sleep onset. Patients treated with dopamine agonists including Neupro®, have been reported pathological gambling, increased libido and hypersexuality. Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper treatment.

Hallucinations have been reported, and patients should be informed that hallucinations can occur.
Cases of cardiopulmonary fibrotic complications have been reported in some patients treated with ergot-derived dopaminergic agents. Neuroleptics given as antiemetic should not be given to patients taking dopamine agonists. Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.

External heat, from any source should not be applied to the area of the patch. Exposure of a skin rash or irritation to direct sunlight could lead to changes in the skin color. If a generalized skin reaction (e.g. allergic rash) associated with the use of Neupro® is observed, Neupro® should be discontinued.

Caution is advised when treating patients with severe hepatic impairment or acute worsening of renal function, a dose reduction might be needed.

The incidence of some dopaminergic adverse events, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa. This should be considered when prescribing Neupro®.

Neupro® contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.

Neupro® should not be used during pregnancy. Breast-feeding should be discontinued.

In restless legs syndrome augmentation may occur. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.

At the beginning of therapy, dopaminergic adverse reactions, such as nausea and vomiting, may occur. These are usually mild or moderate in intensity and transient, even if treatment is continued.

Adverse drug reactions reported in more than 10% of Parkinson’s patients treated with Neupro® are nausea, vomiting, application site reactions, somnolence, dizziness and headache. The majority of these application site reactions are mild or moderate in intensity.

Adverse drug reactions reported in more than 10% of RLS patients treated with Neupro® are nausea, application site reactions, asthenic conditions (including fatigue, asthenia, malaise) and headache. The majority of these application site reactions are mild or moderate in intensity.

All Neupro® supply should be stored in a refrigerator (2oC-8oC). There is no need for patients to transport Neupro® patches in special containers and they must not be stored in a freezer compartment.

Please refer to the European Summary of Product Characteristics for full prescribing information (Revised August 2011):
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000626/human_med_000926.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124

References
1. Bachmann CG, Berkels R et al. Effectiveness and safety of rotigotine transdermal patch in restless legs syndrome: results from a German observational study in a practice setting. Presented at the 16th International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Dublin, Ireland 17th – 21st June 2012.
2. Kohnen R, Stiasny-Kolster K, Oertel WHBH, Trenkwalder C. Severity rating of restless legs syndrome: validation of the RLS-6 scales. Sleep 2004;27:A342
For further information

Eimear O Brien, Director, Brand Communications, UCB
T
+32.2.559.9271, eimear.obrien@ucb.com
Antje Witte, Investor Relations, UCB
T
+32.2.559.9414, antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T
+32.2.559.9178, France.nivelle@ucb.com

About UCB
UCB, Brussels, Belgium (
www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).

Forward looking statements
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There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

RTG-PRR-013364 – Date of preparation May 2012


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