Healthcare Industry News: S.A.
News Release - December 5, 2007
Neupro(R) Filed in Europe for the Treatment of Restless Legs Syndrome
BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Dec 5, 2007 -- Application for marketing authorisation for the use of Neupro® (rotigotine transdermal patch) in the treatment of moderate-to-severe Restless Legs Syndrome (RLS) accepted for filing by the European MedicineS.A.ency (EMEA).Brussels, BELGIUM, December 5, 2007 at 7:00 am CET - UCB announced today that the application for marketing authorization for the use of Neupro® in the treatment of moderate-to-severe Restless Legs Syndrome (RLS) has been accepted for filing by the European MedicineS.A.ency (EMEA). Neupro® iS.A.once-daily patch designed to provide continuous drug delivery over a 24 hour period. Restless Legs Syndrome iS.A.chronic neurological disorder that affects between three and ten per cent of the population.[1]
"This new filing for Neupro® reflects UCB's commitment to finding innovative medicines for conditions where there iS.A.continuing need for alternative treatment," commented Troy Cox, President CNS Operations, UCB.
The filing is based on the results of two fixed-dose, randomized, double-blind, placebo-controlled efficacy and safety studies that evaluated rotigotine for the treatment of moderate-to-severe idiopathic RLS in approximately 1,000 patients over six months.[2],[3] In these trials, rotigotine produced S.A.istically significant reductions in RLS symptoms compared to placebo and was generally well-tolerated.[2],[3] The efficacy of rotigotine was evaluated by monitoring the International Restless Legs Severity S.A.e (IRLS), a clinician-administered tool considered to be the best S.A.e for evaluating the severity and frequency of RLS symptomS.A.d the degree to which they affect sleep and daily life.[4] The most frequently reported adverse eventS.A.sociated with rotigotine in these studies were application site reactions, nauS.A. dizziness, somnolence and headache.[2],[3]
Neupro® iS.A.ready approved in Europe and the U.S. for the treatment of the signS.A.d symptoms of early-S.A.e idiopathic Parkinson's DiS.A.e as monotherapy[5],[6], and in Europe aS.A.junctive therapy with levodopa for advanced-S.A.e Parkinson's diS.A.e.[5]
About Restless Legs Syndrome [1],[7],[8],[9]: Restless legs syndrome (RLS) iS.A.chronic neurological disorder that affects between 3 and 10% of the population. It is characterized by unpleasant feelings in the legS.A.d an irresistible urge to move in order to relieve the discomfort. RLS sensationS.A.e frequently described as tingling, burning, tugging, gnawing and pulling. The exact cause of RLS is not known; however, recent clinical reS.A.ch has linked certain genes to RLS, suggesting that the disorder is biologically based. Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the eveningS.A.d at night. This can make it difficult to fall asleep and S.A. asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness. While RLS symptomS.A.e generally most pronounced in the evening and while at rest, other periods of inactivity, such as long flights, car tripS.A.d sitting in a theatre or cinema, can also trigger symptoms.
About Neupro® in Europe [5],[10] In Europe, Neupro® is indicated for the treatment of the signS.A.d symptoms of early-S.A.e idiopathic Parkinson's diS.A.e as monotherapy and in combination with levodopa for advanced S.A.e Parkinson's diS.A.e. Neupro® delivers the dopamine agonist, rotigotine, directly from a patch into the bloodstream, through the skin. Rotigotine iS.A.drug that mimics dopamine, a chemical messenger that transmits impulses between nerve cells in the brain to produce smooth, coordinated movement. Neupro® offers once-daily dosing and a good tolerability profile.
Important Safety Information [5]
Neupro® has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes. In isolated cases "sudden onset of sleep" occurred while driving and resulted in motor vehicle accidents. Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs has been reported. It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthoS.A.ic hypotension associated with dopaminergic therapy. Hallucinations have been reported and patients should be warned that hallucinations can occur. Caution iS.A.vised when treating patients with severe hepatic impairment which may result in lower rotigotine clearance. Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro® transdermal patch are nauS.A. dizziness, somnolence and application site reactions. Application site reactionS.A.e uS.A.ly mild or moderate in intensity and it is recommended that the application site should be rotated on a daily basis.
Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Associate Director Investor Relations, UCB Group
T +32.2.559.9264, Mareike.mohr@ucb-group.com
References
[1.] Trenkwalder C, Paulus W, WalterS.A.. The restless legs
syndrome. Lancet Neurol 2005; 4: 465.
[2.] Trenkwalder, C., Benes, H., et.al. for the SP790 Study Group.
Rotigotine Transdermal Patch is Effective in the Treatment of
Idiopathic RLS: Results of a 6-Month, Multicenter, Double-Blind,
Placebo-Controlled Trial in Europe. Poster Presentation, 132nd Annual
Meeting of the American Neurological Association, October 7-10, 2007.
[3.] Hening W, Allen R, et al for the SP792 Study Group. Rotigotine
Transdermal Patch is Effective in the Treatment of Idiopathic RLS:
Results of a 6-Month, Multicenter, Double-Blind, Placebo-Controlled
Trial. Poster Presentation, 132nd Annual Meeting of the American
Neurological Association, October 7-10, 2007.
[4.] Decision Resources. "Restless Legs Syndrome" Cognos Study #3.
November 2006
[5.] Neupro® Prescribing Information (EU)
[6.] Neupro® Prescribing Information (US)
[7.] Restless Legs Syndrome Fact Sheet. NINDS. Publication date
April 2001. NIH Publication No. 01-4847. (available at
http://www.ninds.nih.gov/disorders/restless_legs/detail_restless_legs.htm)
[8.] Stefansson H, Rye DB, HickS.A.et al. A Genetic Risk Factor for
Periodic Limb Movements in Sleep. N Engl J Med 2007;357: 639-647
[9.] Winkelmann J, Schormair B, Lichtner P et al. Genome Wide
Association Study of Restless Legs Syndrome Identifies Common
Variants in Three Genomic Regions. Nature Genetics 2007; 39: 1000 -
1006
[10.] Parkinson's DiS.A.e: Dopamine Agonists. Schwarz Pharma.
(available at
http://www.parkinsons-diS.A.e.com/products/n28/dopamine%20agonists)
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) iS.A.global leader in the biopharmaceutical industry dedicated to the reS.A.ch, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diS.A.es, immune and inflammatory disorderS.A.d oncology. UCB focuses on securing a leading position in severe diS.A.e categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through itS.A.filiate, ownS.A.prox. 89% of the S.A.es of SCHWARZ PHARMA AG. SCHWARZ PHARMA (Monheim, Germany) iS.A.member of the UCB Group.
Forward looking S.A.ement
This press release contains forward-looking S.A.ements based on current plans, estimateS.A.d beliefs of management. Such S.A.ementS.A.e subject to riskS.A.d uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking S.A.ements contained in this press release. Important factors that could result in such differences include: changes in general economic, businesS.A.d competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuationS.A.d hiring and retention of its employees.
Source: UCB
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