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Tuesday 13 April, 2010

UCB

New data showed sustained 5-year benefit of Neu...






Latest safety and efficacy results for rotigotine in the treatment of moderate
to severe restless legs syndrome presented at major North American neurology
congress


Atlanta (U.S.) - 13 April 2010  - press release - New data presented at the
62(nd) American Academy of Neurology annual meeting in Toronto, Canada, showed
that patients with moderate to severe Restless Legs Syndrome (RLS) using
rotigotine achieved sustained improvements in symptoms over 5 years of
treatment[1].


"Many people with RLS will have spent months or years trying to get a diagnosis
and find a treatment that can help them. So these 5-year results provide
additional evidence that once they start using rotigotine people with RLS may
experience long term relief from their symptoms, and a significant proportion
may become symptom free," said Diego Garcia-Borreguero, MD, Director Sleep
Research Institute, Madrid, Spain.


This study of rotigotine in patients with moderate to severe RLS was the longest
ever open label prospective follow-up of a placebo-controlled phase II trial in
RLS. The final 5-year results confirm the safety and efficacy of rotigotine(
)seen at previous interim analyses[2,3], with over a third of patients followed
up remaining symptom free after five years of treatment.


Of the 295 patients with moderate to severe RLS who entered the study, 126 (43%)
completed the 5-year follow up.  The mean dose of rotigotine was 2.43mg/24 hours
after initial titration and 3.09mg/24 hours at the end of the study. Fifty nine
per cent of patients were classified as remitters (IRLS< 10), and 39% as
symptom-free (IRLS=0).


The study looked at improvement in symptoms based on the International Restless
Legs Syndrome Study Group Rating Scale (IRLS)[4]()(*). The total IRLS score
ranges from 0 (no symptoms) to 40 (very severe symptoms). A score of >20
indicates severe RLS. The mean IRLS* score was 27.8 at baseline, improving by
18.7 points to 9.0 at the end of the study. Sustained improvements were also
seen in quality of life and other RLS rating scales.


Most adverse events (AEs) were mild to moderate in intensity, the most common
AEs being application site reactions (58%), nasopharyngitis (19%), back pain
(14%), nausea (12%) and fatigue (11%). Thirty per cent of patients discontinued
the study due to an AE.


A comparison of 1, 2 and 5-year efficacy data (with 220, 191 and 126 patients
respectively) showed that improvements in RLS symptoms remained stable
throughout the follow-up period. Improvements in IRLS scores were 17.4 points at
1 year[2], 17.2 points at 2 years[3], and 18.7 points at 5 years[1].


* The International Restless Legs Syndrome Study Group Rating Scale (IRLS)[4] is
a ten-item scale developed and validated by The International Restless Legs
Syndrome Study Group and considered to be the best scale for evaluating the
severity and frequency of RLS symptoms and the degree to which they affect sleep
and daily life. It is administered by clinicians and includes questions related
to the severity of sensory and motor symptoms, sleep disturbance, daytime
somnolence and impact of RLS on activities of daily living and mood.



For further information
On-site at meeting

Andrea Levin / Public Relations Manager, CNS, UCB, Inc.
Office:  770.970.8352 / Mobile: 404.483.7329 /andrea.levin@ucb.com
<mailto:andrea.levin@ucb.com>

Eimear O Brien, Associate Director, Global CNS Communications
T +32 2 559 9271,eimear.obrien@ucb.com <mailto:eimear.obrien@ucb.com>

Antje Witte, Investor Relations UCB
T +32.2.559.9414,antje.witte@ucb.com <mailto:antje.witte@ucb.com>



Notes to Editors

About Restless Legs Syndrome[5,6]()
Restless Legs Syndrome (RLS) is a neurological disorder characterized by
unpleasant sensations in the legs and an uncontrollable urge to move when at
rest in order to relieve these feelings. It effects between 3 and 10% of the
population to some extent. Some researchers estimate that RLS affects as many as
12 million Americans. However, others estimate a much higher occurrence because
RLS is thought to be under-diagnosed and in some cases mis-diagnosed. Most
people with RLS have difficulty falling asleep and staying asleep. Left
untreated the condition causes exhaustion and daytime fatigue. Many people with
RLS report that their job, personal relations and activities of daily living are
strongly affected as a result of their exhaustion. They are often unable to
concentrate, have impaired memory, or fail to accomplish daily tasks. Most than
80% of people with RLS also experience a more common condition known as periodic
limb movement disorder (PLMD)


About Neupro(®) in Europe[7](
)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
cardioversion. ()

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.

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
hypersexuality.

Symptoms suggestive of neuroleptic malignant syndrome have been reported with
abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper
treatment.

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
abnormalities occur.

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
discontinued.

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
headache.

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 15(th) March 2010):


http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pdf



About Neupro(®) in the U.S.
Neupro(® )(Rotigotine Transdermal System) is indicated in the U.S. for the
treatment of the signs and symptoms of early-stage idiopathic Parkinson's
disease.

In April 2008, UCB recalled Neupro(®) from the U.S. market after ongoing
monitoring revealed that specific batches of Neupro(®) had deviated from their
approved specification. Neupro(®) is currently not available in the U.S. UCB is
working with the U.S. FDA so that Neupro(®) can be available to patients with
early-stage Parkinson's disease as soon as possible.


Important Safety Information - U.S.
Some patients treated with Neupro(®) reported falling asleep while engaged in
activities of daily living, including operation of motor vehicles, which
sometimes resulted in accidents. Some patients perceived no warning signs, such
as excessive drowsiness. Hallucinations were reported in 2.0% of patients
treated with Neupro(®) compared to 0.7% of patients on placebo. Neupro(®)
contains metabisulfite. Neupro(®) should be used with caution in patients,
especially those at risk for cardiovascular disease, because of the potential
for symptomatic hypotension, syncope, elevated heart rate, elevated blood
pressure, fluid retention, and/or weight gain. All Parkinson's disease patients
are at a higher risk for melanoma and should be monitored regularly. The most
commonly reported side effects in clinical trials were nausea, application site
reactions, somnolence, dizziness, headache, vomiting, and insomnia. Some
subjects who received Neupro(®) experienced a decline in blood hemoglobin levels
(about 2% relative to subjects who received placebo). It is not known whether
this change is readily reversible with discontinuation of Neupro(®).


Neupro(®) is not approved or available in Canada for the treatment of idiopathic
Parkinson's disease or for the treatment of Restless Legs Syndrome.

Neupro(®) is a registered trademark of the UCB Group of companies.


References

[1] Högl B, Trenkwalder C, Garcia-Borreguero D, Kohnen R, Poewe W,
Stiasny-Kolster K, Bauer L, Fichtner A, Schollmayer E, Oertel W for the SP710
study group. Long-term safety and efficacy of rotigotine in patients with
idiopathic RLS: 5-year results from a prospective multinational open-label
follow-up study. Presented at the 62(nd) American Academy of Neurology annual
meeting, Toronto, Canada (April 10-17 2010)


[2] Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Högl B, Trenkwalder C,
Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP710 Study
Group. One year open-label safety and efficacy trial with rotigotine transdermal
patch in moderate to severe idiopathic restless legs syndrome. Sleep Medicine
2008;9(8):865-73.


[3] Trenkwalder C, Garcia-Borreguero D, PoeweW, et al; for the Rotigotine SP
710 Study Group. Improvements over 24 months in patients with moderate to severe
idiopathic restless legs syndrome treated with rotigotine transdermal patch -
results from a multinational, multicentre, open-label, follow-up trial.
Presented at the 59th American Academy of Neurology annual meeting, Boston, MA.
(April 28 - May 5 2007)


[4] Walters AS, LeBrocq C, Dhar A, et al; for The International Restless Legs
Syndrome Study Group. Validation of the International Restless Legs Syndrome
Study Group Rating Scale for restless legs syndrome. Sleep Medicine
2003;4(2):121-132


[5] 

http://www.ninds.nih.gov/disorders/restless_legs/detail_restless_legs.htm
(accessed March 15th 2010)


[6] Trenkwalder C, Paulus W, Walters AS. The restless legs syndrome. Lancet
Neurol 2005; 4: 465.


[7] Neupro(®) European Summary of Product Characteristics (Approved march
15(th) 2010)


http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pdf



About 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 more than 9 000 people in
over 40 countries, UCB produced 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.


For the pdf-version of this press release, please click on the link below:



[HUG#1402984]





    Press release (PDF): 

http://hugin.info/133973/R/1402984/357404.pdf