* FDA recommends reformulation of Neupro® in the U.S.
* In Europe and other countries, Neupro® is not impacted by this
* UCB has already made progress in reformulation and remains committed to
bringing Neupro® to U.S. patients suffering from Parkinson's disease and
Restless Leg Syndrome
Brussels (Belgium) - April 23, 2010 - regulated information - UCB announced
today that the U.S. Food and Drug Administration (FDA) has provided a complete
response letter recommending reformulation of Neupro® (Rotigotine Transdermal
System) before making it available in the U.S. market for the treatment of
Parkinson's disease (PD) and restless legs syndrome (RLS). FDA's response is to
an NDA Supplement that UCB submitted in June 2009, with a proposal for new
refrigerated storage conditions to alleviate crystallization on the patches.
"FDA agrees that the proposed new refrigeration conditions significantly inhibit
the degree of crystallization on the patches, but has recommended that the
definitive resolution of the crystallization is to reformulate the drug
product," said Prof. Dr. Iris Loew-Friedrich, Executive Vice President and Chief
Medical Officer of UCB. "This FDA decision does not impact product supply and
availability in Europe and the rest of the world. It does not change previous
assessments made by the European and other international authorities regarding
the cold chain storage process."
More than 50 000 patients are being treated by Neupro® in Europe. In the U.S.,
a Patient Access Program is ongoing and UCB will continue this program.
"We have already been working on a room-temperature stable, improved formulation
of Neupro® and have made significant progress in this area," the Chief Medical
Officer of UCB added. "Neupro® has made a meaningful difference for many people
with Parkinson's disease and Restless Legs Syndrome. We are committed to
obtaining FDA approval so that people in the U.S. who live with these diseases
can benefit from Neupro."
About Neupro® in Europe
Neupro® (rotigotine) is approved in the European Union for the treatment of the
signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy
(i.e. without levodopa) or in combination with levodopa, i.e. over the course of
the disease, through to late stages when the effect of levodopa wears off or
becomes inconsistent and fluctuations of the therapeutic effect occurs. Neupro®
is also approved in the European Union for the symptomatic treatment of moderate
to severe idiopathic restless legs syndrome in adults.
Neupro® in Europe Important Safety Information
Neupro® is contraindicated in case of hypersensitivity to the active substance
or to any of its excipients, and in case of magnetic resonance imaging (MRI) or
cardioversion. Neupro® should be removed if the patient has to undergo MRI or
It is recommended to monitor blood pressure, especially at the beginning of
treatment, due to the general risk of orthostatic hypotension associated with
Neupro® has been associated with somnolence episodes of sudden sleep onset
episodes. Patients treated with dopamine agonists including Neupro®, have been
reported as exhibiting signs of pathological gambling, increased libido and
Symptoms suggestive of neuroleptic malignant syndrome have been reported with
abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper
Neupro® contains sodium metabisulphite, a sulphite that may cause allergic-type
reactions including anaphylactic symptoms and life threatening or less severe
asthmatic episodes in certain susceptible people.
Hallucinations have been reported, and patients should be informed that
hallucinations can occur.
Cases of cardiopulmonary fibrotic complications have been reported in some
patients treated with ergot-derived dopaminergic agents. Neuroleptics given as
antiemetic should not be given to patients taking dopamine agonists.
Ophthalmologic monitoring is recommended at regular intervals or if vision
External heat, from any source should not be applied to the area of the patch.
Exposure of a skin rash or irritation to direct sunlight could lead to changes
in the skin color. If a generalized skin reaction (e.g. allergic rash)
associated with the use of Neupro® is observed, Neupro® should be discontinued.
Caution is advised when treating patients with severe hepatic impairment or
acute worsening of renal function, a dose reduction might be needed.
The incidence of some dopaminergic adverse events, such as hallucinations,
dyskinesia, and peripheral oedema generally is higher when given in combination
with L-dopa. This should be considered when prescribing Neupro®.
Neupro® should not be used during pregnancy. Breast-feeding should be
Augmentation may occur in Restless Legs Syndrome patients. Augmentation refers
to the earlier onset of symptoms in the evening (or early afternoon), increase
in severity of symptoms, and spread of symptoms to involve other body parts.
Adverse drug reactions reported in more than 10% of Parkinson's patients treated
with Neupro® are nausea, vomiting, application site reactions, somnolence,
dizziness and headache.
Adverse drug reactions reported in more than 10% of RLS patients treated with
Neupro® are nausea, application site reactions, asthenic conditions and
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.
Please refer to the European Summary of Product Characteristics for full
prescribing information (Approved 15th March
Neupro® is a registered trademark of the UCB Group of companies.
Antje Witte, Investor Relations, UCB
T +32.2.559.9414,firstname.lastname@example.org <mailto:email@example.com>
Nancy Nackaerts, External Communications, UCB
T +32.2.559.9264,firstname.lastname@example.org <mailto:email@example.com>
Andrea Levin, Public Relations Manager U.S., CNS, UCB
UCB, Brussels, Belgium (www.ucb.com <
http://www.ucb.com>) is a biopharmaceutical
company dedicated to the research, development and commercialization of
innovative medicines with a focus on the fields of central nervous system and
immunology disorders. Employing approximately 9 000 people in over 40 countries,
UCB generated revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext
Brussels (symbol: 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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