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 States and 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 States 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 and 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 disease has been associated with a symptom complex resembling neuroleptic malignant syndrome or akinetic crises.
Neupro® is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease in the US and early and late stages of the disease 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 research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease 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 Statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
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Contact: Source: UCB
