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Friday 20 February, 2009


UCB announces top-line outcomes for proof-of-co...

Lacosamide in migraine prophylaxis and rotigotine in fibromyalgia
syndrome did not achieve statistical significance for their primary

Brussels, Belgium, 20 February 2009 at 6:00 PM (CET) - press release,
regulated information - UCB announced today top-line results from two
proof-of-concept Phase IIa clinical trials to assess the efficacy and
safety of lacosamide in migraine prophylaxis, and the efficacy and
safety of rotigotine in fibromyalgia syndrome. These trials were
designed to determine whether there is justification for further
clinical development of lacosamide and rotigotine in these
indications.  The respective studies did not achieve statistical
significance for their primary endpoints. UCB will evaluate
development plans once full analyses are available.

Phase IIa study: lacosamide in migraine prophylaxis
The multicentre, randomized, double-blind, placebo-controlled trial
was designed to evaluate the efficacy of lacosamide (100 mg/day and
300 mg/day) compared to placebo in reducing the frequency of
migraine. The primary efficacy variable was the mean reduction of
migraine rates during the 14-week maintenance period compared to the
average frequency during the 4-week baseline period. Patients in this
trial (218) had a history of episodic migraine with or without aura
for at least 1 year and a well-documented three month retrospective
history of migraines prior to enrolment. The trial did not meet its
primary endpoint. However, a reduction in headache frequency was
consistently observed in all treatment groups.

Phase IIa study: rotigotine in fibromyalgia syndrome
The multicentre, randomized, double-blind, placebo-controlled trial
was designed to investigate the efficacy and safety of rotigotine (4
mg/24 h and 8 mg/24 h) compared to placebo in adult patients (240)
with signs and symptoms of fibromyalgia syndrome. The primary
efficacy variable was the reduction in pain for patients taking
rotigotine as measured by the average Likert pain score at baseline
to the last two weeks of the 13 week treatment period. The study
results did not achieve statistical significance for its primary
endpoint. Only primary efficacy and safety data have been reviewed at
this time.

About UCB
UCB, Brussels, Belgium ( 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 10 000 people in
over 40 countries, UCB aims to achieve revenues of at least EUR3.3
billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).

For further information
Antje Witte, Corporate Communications & Investor Relations, UCB
T +32.2.559.9414,

Richard Simpson, Investor Relations, UCB
T +32 2 559 94 94,

About Migraine
Migraine is a common, disabling primary headache disorder. It
typically affects one side of the head and may be pulsating, of
moderate to severe intensity, and aggravated by routine activity.
Migraine headache can last up to two to three days and is commonly
accompanied by nausea and vomiting, and/or intolerance to normal
levels of light and sound. Migraine is two to three times more common
in women than men.

About Fibromyalgia
Fibromyalgia is an idiopathic, chronic, pain syndrome defined by
widespread musculoskeletal pain and generalized tender points. Other
common symptoms include sleep disturbances, fatigue, headache,
morning stiffness and anxiety. Fibromyalgia is usually considered a
disorder of women aged 20 to 50 years; however, it has also been
observed in men, children, adolescents and older persons.
Fibromyalgia is more common in relatives of people with fibromyalgia,
suggesting the contribution of genetic factors.

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

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