Healthcare Industry News: S.A.
News Release - March 20, 2008
UCB advises US-physicians to down-titrate patients on Neupro(R) in view of out-of-stock situation in the US
UCB initiates recall of Neupro® batches, which will lead to an out-of-stock situation in the United S.A.es in late April.Patients in the US.A.e advised to contact their healthcare provider. Neupro® supply is sufficient in other regions.
BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Mar 20, 2008 -- Brussels, Belgium - March 20, 2008 at 7:00 am CET - UCB announced today that the company will be recalling Neupro® (rotigotine transdermal system) in the United S.A.eS.A.d certain batches in Europe. The recall decision resulted from ongoing monitoring of marketed product, which revealed a deviation from the approved product specification. AS.A.result, there will be an out-of-stock situation with Neupro® in the United S.A.es in late April 2008. In the European Union and most other regions Neupro® supply is sufficient.
"We have informed the FDA and agreed to actions to inform healthcare providerS.A.d patients," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, UCB. "We advise patients in the US to contact their healthcare provider to begin the down-titration of Neupro® as per the guidelines in the label. It is strongly advised that patients do not discontinue therapy abruptly. I also want to emphasize that the issue is not one of product contamination or toxicity but rather one of possibly reduced clinical performance of some patches."
Down-titration (reduction of the dose) should be gradual and performed under medical supervision. Rapid reduction of therapy for Parkinson's diS.A.e has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.
Neupro® is indicated for the treatment of the signS.A.d symptoms of early-S.A.e idiopathic Parkinson's diS.A.e in the US.A.d early and late S.A.es of the diS.A.e in Europe and is distributed by Schwarz Pharma, a company of UCB Group.
Depending on the resolution timeline of this issue, the full effect on UCB's business is not yet known. Therefore, UCB's 2008 financial outlook is under review and will be updated as soon as possible.
Further information
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, Antje.witte@ucb-group.com
Eric Miller, Director, U.S. Communications & Public Relations, UCB Group
T +1.770.970.8569, eric.miller@ucb-group.com
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 3.6 billion euro in 2007. UCB S.A. is listed on the Euronext Brussels (Euronext: UCB). Schwarz Pharma iS.A.member of UCB-Group.
UCB 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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