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Thursday 25 September, 2008

UCB

UCB withdraws EU marketing authorisation applic...





Brussels, BELGIUM, September 25, 2008 at 06:00 pm CET - press
release, regulated information:  UCB announced today that it is
withdrawing the European Marketing Authorisation Application with the
European Medicines Agency (EMEA) for Vimpat® (lacosamide) in the
treatment of diabetic neuropathic pain.

UCB has taken this decision based on the EMEA's Committee for
Medicinal Products for Human Use (CHMP) view that the magnitude of
the clinical effect of lacosamide in diabetic neuropathic pain has
not been convincingly established. Following thorough consultation
with the agency, UCB would need to initiate an additional clinical
trial to further substantiate the magnitude of effect of lacosamide
in diabetic neuropathic pain.

Vimpat® was approved by the European Commission for the adjunctive
treatment of partial-onset seizures with or without secondary
generalisation in patients with epilepsy, aged 16 years and over, at
the end of August. The product is being launched in the EU from
mid-September 2008.

Vimpat® is currently under active review by the U.S. Food and Drug
Administration (FDA) for the adjunctive treatment of partial-onset
seizures in patients with epilepsy, aged 16 years and over.

At the end of July, UCB announced that it had received an action
letter (not-approvable letter) from the U.S. FDA for lacosamide for
the treatment of diabetic neuropathic pain in adults.

The financial guidance for 2008 and 2009 given by UCB remains
unchanged.

About Diabetic Neuropathic Pain
Diabetic neuropathic pain is a painful and potentially debilitating
complication of diabetes often characterized by a stabbing or burning
sensation in the legs, feet and/or hands.  It is caused by damage or
dysfunction to the peripheral nervous system as a result of diabetes
or impaired glucose tolerance.  Diabetic neuropathic pain often
substantially interferes with sleep, recreational activities,
mobility, and normal work and social activities, and many patients
with the condition experience a significantly reduced quality of
life.

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
commercialisation of innovative medicines with a focus on the fields
of central nervous system and immunology disorders. Employing around
12 000 people in over 40 countries, UCB achieved revenue of 3.6
billion Euro in 2007. 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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