Healthcare Industry News: rotigotine
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 USUCB initiates recall of NeuproŽ batches, which will lead to an out-of-stock situation in the United States in late April.
Patients in the US are advised to contact their healthcare provider. NeuproŽ 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 NeuproŽ (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 NeuproŽ in the United States in late April 2008. In the European Union and most other regions NeuproŽ 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 NeuproŽ 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.
NeuproŽ 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.
Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
T +32.2.559.9414, Antje.email@example.com
Eric Miller, Director, U.S. Communications & Public Relations, UCB Group
T +1.770.970.8569, firstname.lastname@example.org
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.
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