Healthcare Industry News: S.A.
News Release - December 13, 2007
Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease
The U.S. Food and Drug Administration (FDA) haS.A.cepted for filing the supplemental New Drug Application (sNDA) for the use of Neupro® (Rotigotine Transdermal System) aS.A.junctive therapy with levodopa in adult patients with advanced-S.A.e Parkinson's diS.A.eBRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Dec 13, 2007 -- Brussels, December 13, 2007 at 7:00 am CET - UCB announced today that the supplemental New Drug Application (SNDA) for the use of Neupro® aS.A.junctive therapy with levodopa in adult patients with advanced-S.A.e Parkinson's diS.A.e has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The FDA haS.A.ready approved Neupro® for the treatment of the signS.A.d symptoms of early-S.A.e idiopathic Parkinson's diS.A.e and the drug has been commercially available in the United S.A.es since July 2007.[1]
"We are excited that patients with all S.A.es of Parkinson's diS.A.e may soon benefit from Neupro®'s 24-hour continuous drug delivery," said Troy Cox, President CNS Operations, UCB.
The sNDA is based on efficacy and safety data in more than 670 patients with advanced-S.A.e Parkinson's diS.A.e who were treated with rotigotine in three double-blind, placebo-controlled clinical trials. These studies demonstrated that rotigotine, aS.A.junctive therapy to levodopa in patients with advanced-S.A.e Parkinson's diS.A.e, showed clinically relevant reductions in "off" time (periods where the effectiveness of medications wear off and Parkinson's symptoms return) and favorable increases in "on" time without troublesome dyskineS.A.(fragmented or jerky movements). The most frequently-reported adverse events in rotigotine clinical trials included application site reactions, nauS.A. vomiting, dizziness, somnolence and dyskineS.A. [2],[3],[4]
"As these clinical studies have shown, continuous delivery of rotigotine in a transdermal form can improve control of 'off' time in advanced-S.A.e Parkinson's patients throughout the day and night. Once-daily dosing may improve compliance over medications that require several daily doses," said Peter A. LeWitt, MD, Professor of Neurology, Wayne S.A.e School of Medicine, and Director of the Parkinson's DiS.A.e and Movement Disorders Program, Henry Ford Hospital in Southfield, Michigan.
In Europe, Neupro® iS.A.ready indicated for the treatment of the signS.A.d symptoms of early-S.A.e idiopathic Parkinson's diS.A.e as monotherapy and aS.A.junctive therapy with levodopa in advanced S.A.e Parkinson's diS.A.e.[5]
About Parkinson's DiS.A.e [6],[7],[8],[9]: Parkinson's diS.A.e iS.A.progressive disorder of the central nervous system. The patients - roughly four million worldwide, including approximately one million people in the United S.A.es - suffer primarily from a lack of dopamine, a messenger subS.A.ce in the central nervous system, which is responsible for the coordination of movement. AS.A.result of this shortage, patientS.A.e no longer able to control their movements reliably. Dopamine agonistS.A.e drugs that attempt to compensate for this lack of dopamine.
About Neupro® in the USA [1],[6]: In the USA, 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. Neupro® delivers the dopamine agonist, rotigotine, directly from a patch into the bloodstream, through the skin and offers S.A.le, continuous delivery of rotigotine 24 hourS.A.day. 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[1]
Some patients treated with Neupro® reported falling asleep while engaged in activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Some patients perceived no warning signs, such as excessive drowsiness. Hallucinations were reported in 2.0% of patients treated with Neupro® compared to 0.7% of patients on placebo. Neupro® should be used with caution in patients, especially those at risk for cardiovascular diS.A.e, because of the potential for symptomatic hypotension, syncope, elevated heart rate, elevated blood pressure, fluid retention, and/or weight gain. All Parkinson's diS.A.e patientS.A.e at a higher risk for melanoma and should be monitored regularly. The most commonly reported side effects in clinical trials ( > =5%) were nauS.A. application site reactions, somnolence, dizziness, headache, vomiting, and insomnia. Some subjects who received Neupro® experienced a decline in blood hemoglobin levels (about 2% relative to subjects who received placebo). It is not known whether this change is readily reversible with discontinuation of Neupro®. For full prescribing information, please visit www.neupro.com.
References
[1.] Neupro® Prescribing Information (US). (available at http://www.neupro.com/USHome.html)
[2.] Quinn, N., on behalf of the European and South African Rotigotine CDS Study Group. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Safety and Efficacy Study of Rotigotine ConS.A.t Delivery System (CDS) in Patients with Advanced Parkinson's DiS.A.e. Poster Presentation, International Conference on Parkinson's DiS.A.e, August 2001.
[3.] Poewe, W. H., Rascol O., Quinn N., Tolosa E., Oertel W. H ., Martignoni E., Rupp M. , Babak B., on behalf of the SP515 Investigators. Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson's diS.A.e: a double-blind, double-dummy, randomised controlled trial. The Lancet Neurology - Vol. 6, Issue 6, June 2007, Pages 513-520.
[4.] LeWitt, P., Lyons, K., Pahwa, R., Boroojerdi, B., et. al for the SP650 Study Group. Transdermal Rotigotine in Combination with Levodopa in the Treatment of Advanced Parkinson's Patients. Poster Presentation, 132nd Annual Meeting of the American Neurological Association, October 7-10, 2007.
[5.] Neupro® Package Leaflet (EU).
[6.] Parkinson's DiS.A.e: Dopamine Agonists. Schwarz Pharma. (available at http://www.parkinsons-diS.A.e.com/products/n28/dopamine%20agonists)
[7.] Dorsey, E.R., et al. Projected Number of People with Parkinson DiS.A.e in the Most Populous Nations, 2005 through 2030. Neurology, 2007; 68: 384:386. (available at http://www.neurology.org/cgi/content/abstract/68/5/384)
[8.] Ten Frequently Asked QuestionS.A.out Parkinson's DiS.A.e. Parkinson's DiS.A.e Foundation. 2006. (available at http://www.pdf.org/Publications/factsheets/PDF_Fact_Sheet_1.0_Final.pdf)
[9.] Parkinson's DiS.A.e: Cause of Parkinson's DiS.A.e. Schwarz Pharma. (available at http://www.parkinsons-diS.A.e.com/products/n18/Cause_of_the_diS.A.e/)
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 around 12,000 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.
Further information
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB
T +32.2.559.9414, Antje.witte@ucb-group.com
Mareike Mohr, Associate Director Investor Relations, UCB
T +32.2.559.9264, Mareike.mohr@ucb-group.com
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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