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Tuesday 29 July, 2008


UCB receives not-approvable letter from FDA for...

Brussels, BELGIUM, July 29, 2008 at 6 pm CEST - press release,
regulated information:  UCB announced today that it received a
not-approvable letter from the U.S. Food and Drug Administration
(FDA) for lacosamide for the treatment of diabetic neuropathic pain
in adults.

The company will seek clarification from the FDA of its position and
of the additional information required to obtain final marketing

UCB confirmed that lacosamide (Vimpat®) is also currently under
active review by the FDA for the adjunctive treatment of partial
onset seizures in patients with epilepsy, age 16 and over.

In June 2008, the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMEA) issued a positive
opinion recommending that the European Commission grant a marketing
authorization for Vimpat® (lacosamide) for the adjunctive treatment
of partial onset seizures with or without secondary generalization in
patients with epilepsy, age 16 and over. Vimpat® is also under review
by the EMEA for the treatment of diabetic neuropathic pain in adults.

About Vimpat® (lacosamide)
Vimpat®  is an investigational therapy for the reduction of pain and
discomfort in patients with diabetic neuropathic pain - a common and
painful complication of diabetes.

Vimpat® is the first agent of its kind to be clinically studied for
the treatment of diabetic neuropathic pain. Preclinical studies
indicate that Vimpat® has a novel, dual mode of action.

One aspect of Vimpat®'s mode of action involves a unique modulation
of sodium channels in the nervous system.  Sodium channels play a
crucial role in regulating the activity level of the nervous system.
Vimpat® targets an aspect of sodium channels that regulates activity
in over-excited cells, with limited effect on normal cell activity.

Vimpat® also binds to the collapsin response mediator protein-2
(CRMP-2).  The nature of the interaction between Vimpat® and CRMP-2
is not completely known. Vimpat® is the first drug for which an
interaction with CRMP-2 has been described.

Vimpat's® precise mechanism of action in humans remains to be fully

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. With the overall prevalence of diabetes in the U.S. estimated
at 20.8 million people, it is thought that as many as 5 million have
diabetic neuropathic pain.

Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414,
Eimear O'Brien, Global CNS Communications Manager, UCB
T +32.2.559.9271,
Andrea Levin, Public Relations Manager, CNS, UCB U.S.
T +1.770.970.8352,

About UCB
UCB is a global leader in the biopharmaceutical industry dedicated to
the research, development and commercialization of innovative
pharmaceutical and biotechnology products in the fields of central
nervous system disorders, allergy/respiratory diseases, immune and
inflammatory disorders and oncology. Employing approximately 12,000
people in more than 40 countries, UCB achieved revenue of 3.6 billion
euro in 2007. UCB is listed on the Euronext Brussels Exchange..

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