Press ReleaseSource: UCB, Inc.

Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early
Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in
Patients with Parkinson's Disease
Monday October 8, 7:30 am ET
- Data Presented at the 132nd Annual Meeting of the American Neurological
Association in Washington, D.C. -
ATLANTA, Oct. 8 /PRNewswire/ -- UCB, Inc. presented data from two clinical
trials that showed Neupro® (Rotigotine Transdermal System), a once-daily
non-ergolinic dopamine agonist patch, is effective in controlling early
morning motor impairment, provides improvement in sleep quality, and is
generally well-tolerated for long-term use in patients with Parkinson's
disease. Studies examining patients who have either early or advanced-stage
Parkinson's disease were also presented.
"Neupro offers continuous delivery of a dopamine agonist for 24 hours,
leading to stable plasma levels," said Rajesh Pahwa, M.D., Professor of
Neurology and Director of the Parkinson Disease and Movement Disorder Center
at the University of Kansas Medical Center. "These data showed that Neupro
has a positive effect on patients' early morning symptoms, improves quality
of sleep, and is generally well-tolerated for long-term use in patients with
Parkinson's disease." Dr. Pahwa is an investigator for the long-term, open-
label study.
An open-label, single-arm, exploratory 18-week study investigated the
efficacy of Neupro® on early morning motor impairment and sleep disorders.
Fifty-four patients with mostly advanced-stage Parkinson's disease and
unsatisfactory control of these symptoms received Neupro® in doses from 4 to
16 mg/24 hours during a 4-week maintenance period. Motor improvement upon
waking and changes in sleep disturbances were assessed.
Forty-nine percent of patients treated per protocol with Neupro® showed
considerable improvement in early morning motor function sufficient to meet
response criteria (greater than or equal to 30% improvement of UPDRS III
score). Nocturnal akinesia -- inability to move at night -- was reduced by
56%, and improvement was also noted in nocturnal dystonia -- painful muscle
contraction -- and cramps. Neupro® improved sleep quality, reduced excessive
daytime sleepiness, decreased night-time urinary symptoms (nocturias), and
appeared generally well-tolerated. The most frequently reported adverse
events in patients treated with Neupro® were application site reactions
(20%), nausea (19%), and somnolence (11%).
Additionally, new, interim safety data from a four-year, open-label
extension of a separate pivotal Phase III, double-blind clinical trial were
presented. These data, in 216 patients with early-stage Parkinson's disease,
showed Neupro® was generally well-tolerated at 33 months of treatment.
Patients were tapered to their Neupro® starting dose and re-titrated over a
3-week period. Neupro® doses were limited to <6 mg/24 hours the first year,
after which doses <16 mg/24 hours were allowed.
The majority of participants (73%) remained in the study at 33 months, with
few discontinuations related to adverse events (13%) and a low incidence of
dyskinesia (6.5%). The most frequently reported adverse events among
patients treated with Neupro® in this trial were somnolence (41%),
application site reactions (23%), most of which were rated as mild (95%),
nausea (18%) and dizziness (20%).
"We are pleased to present important data which help demonstrate the
benefits of Neupro in patients with early and advanced-stage Parkinson's
disease," said Iris Loew-Friedrich, MD, PhD, Global Head of Development,
UCB. "We look forward to continuing the Neupro clinical development program
and are working to make this unique therapy available for U.S. patients with
advanced stages of the disease."
About Neupro®
Neupro®, with the active ingredient rotigotine, is a non-ergolinic dopamine
receptor-agonist formulated as a transdermal delivery system, a patch,
designed for once-a-day application. Neupro® is designed to mimic the action
of dopamine, a naturally-produced neurotransmitter crucial for proper motor
functioning. The system is applied to the skin once a day and provides
rotigotine continuously to the body for 24 hours. Patients receiving Neupro®
initiate treatment with a 2 mg/24 hours patch and titrate in 2 mg/24 hours
increments each week until the optimal effect is observed, up to a maximum
dose of 6 mg/24 hours. The administration of Neupro® offers simple,
once-daily dosing, and it is easy to use.
Neupro® is approved in the United States for the treatment of the signs and
symptoms of early-stage idiopathic Parkinson's disease, and in Europe for
the treatment of patients with early Parkinson's disease and in combination
with levodopa for advanced Parkinson's disease.
About Parkinson's Disease
Parkinson's disease is a progressive disorder of the central nervous system.
The patients -- roughly four million worldwide, including approximately one
million people in the United States -- suffer primarily from a lack of
dopamine, a messenger substance in the central nervous system, which is
responsible for the coordination of movement. As a result of this shortage,
patients are no longer able to control their movements reliably. Dopamine
agonists are drugs that attempt to compensate for this lack of dopamine.
Important Safety Information
Neupro® is indicated for the treatment of the signs and symptoms of
early-stage idiopathic Parkinson's disease. 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® 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®. For full prescribing
information, please visit www.neupro.com.
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialisation 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 more
than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion
euro in 2006 on a pro forma basis. UCB is listed on the Euronext Brussels
Exchange and owns approximately 88% of the shares of SCHWARZ PHARMA AG.
SCHWARZ PHARMA AG (Monheim, Germany) is a member of UCB Group.

Source: UCB, Inc.
Rayilyn Brown
Board Member AZNPF
Arizona Chapter National Parkinson's Foundation
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