Neupro® patches should be stored in the refrigerator.
Physicians not to initiate any new patients on Neupro® to prioritise
supply for existing patients.
Brussels, Belgium - June 4, 2008 at 6:00 pm CEST - UCB announced
today that the company will submit a variation to the EMEA (European
Medicines Evaluation Agency) to implement a full cold-chain storage
and distribution system for Neupro® (rotigotine transdermal patch) in
Europe. In agreement with the EMEA, over the next few months, UCB
will be replacing current Neupro® supply with product that has been
refrigerated from manufacture.
Based on data generated to date, refrigerated storage of Neupro®
patches substantially reduces the development of crystals, which can
result from the current manufacturing process. Crystallisation in the
patch can lead to a change in visual appearance and can theoretically
reduce its clinical efficacy, but it is of no clinical relevance in
most instances. To date, UCB has not seen a change in the pattern of
clinically relevant adverse events, including lack of efficacy, which
could be attributed to crystal formation.
All Neupro® supply should be stored in a refrigerator. There is no
need for patients to transport Neupro® patches in special containers
and they must not be stored in a freezer compartment.
In agreement with the EMEA, and in order to prioritise supply for
existing patients, new patients will not be initiated on Neupro®. The
company is committed to working with the EMEA so that, as soon as
possible, Neupro® can be available again to all patients across
Europe, including new patients with Parkinson's Disease and Restless
Legs Syndrome (RLS).
"I want to emphasise that the issue is not one of product
contamination or toxicity. Patients should use the patches they have
and keep their supply in the refrigerator. Even if they notice
crystals on their patch, it is important that patients do not stop
taking their existing medication without speaking to their doctor,"
said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, UCB. "Over
the next few months we will be systematically supplying Neupro® that
has been refrigerated from manufacture to pharmacies."
In agreement with the EMEA, UCB chose a fast-track standardized
regulatory procedure that allows companies to quickly implement
changes to information on the safe use of their product.
Neupro® is indicated for the treatment of the signs and symptoms of
early-stage and late-stage idiopathic Parkinson's disease in Europe
and early stages of the disease in the US and is distributed by
Schwarz Pharma, a company of UCB Group.
About Neupro® in Europe and important safety information
Neupro® (rotigotine transdermal patch) is currently approved for the
treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease as monotherapy and as adjunctive therapy with
levodopa for advanced-stage Parkinson's disease.
The Committee for Medicinal Products for Human Use (CHMP) of the EMEA
has recently issued a positive opinion recommending that the European
Commission grants a marketing authorisation for rotigotine
transdermal patch in the symptomatic treatment of patients with
moderate-to-severe idiopathic RLS.
Rotigotine has been associated with somnolence and episodes of sudden
sleep onset, particularly in patients with Parkinson's disease.
Sudden onset of sleep during daily activities, in some cases without
awareness of any warning signs, has been reported. Pathologic
gambling, increased libido and hypersexuality have been reported in
patients treated with dopamine agonists for Parkinson's disease,
including rotigotine.
It is recommended to monitor blood pressure, especially at the
beginning of treatment, due to the general risk of orthostatic
hypotension associated with dopaminergic therapy. Hallucinations have
been reported and patients should be warned that hallucinations can
occur. Caution is advised when treating patients with severe hepatic
impairment which may result in lower rotigotine clearance. Adverse
drug reactions reported in more than 10% of patients treated with
Neupro® transdermal patch are nausea, dizziness, somnolence and
application site reactions. Application site reactions are usually
mild or moderate in intensity and it is recommended that the
application site should be rotated on a daily basis.
Therapy must not be discontinued abruptly. Abrupt withdrawal of
dopamine agonists has been associated with a syndrome resembling
neuroleptic malignant syndrome or akinetic crises.
Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, Antje.witte@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.
For the pdf-version of this press release, please click on the link
below:
