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UCB (0GD8)

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Wednesday 03 September, 2008


Vimpat�® Approved in Europe

First New Epilepsy Treatment for Partial-Onset Seizures in Three

  * A novel mode of action
  * Improved seizure control when added to a wide range of
    antiepileptic drugs
  * High long-term retention rate
  * Multiple formulations for ease of use
  * Soon to be launched in Germany and the UK

Brussels, BELGIUM - September 3, 2008 at 7:00 am CEST - press
release, regulated information: UCB announced today that the European
Commission (EC) has approved Vimpat® (lacosamide) as adjunctive
therapy in the treatment of partial-onset seizures with or without
secondary generalisation in patients with epilepsy aged 16 years and
older. Vimpat® is the first new antiepileptic drug (AED) for
partial-onset seizures in three years and offers a new treatment
option for European patients living with uncontrolled partial-onset

Professor Elinor Ben-Menachem, Clinical Trial Investigator,
Department of Clinical Neuroscience, Goteborg University, Sweden
said, "Vimpat® offers new hope for improved seizure control in adult
patients with partial onset seizures.  The novel mode of action of
Vimpat® makes it different from all other antiepileptic drugs
currently available. Vimpat® should be considered a valuable
treatment option for adult patients with partial-onset seizures who
need additional seizure control."

Roch Doliveux, Chief Executive Officer, UCB said, "The approval of
Vimpat® underscores the importance of UCB's continued drive to
develop innovative medicines that improve lives. UCB is pleased to
make this important new antiepileptic drug available to European
physicians and patients."

A novel mode of action
Preclinical studies indicate that Vimpat® has a novel mode of action.
While the precise mechanism by which Vimpat® exerts its antiepileptic
effect in humans remains to be fully elucidated, in preclinical
studies Vimpat® has been shown to modulate sodium channel activity
differently compared with other sodium channel blocking AEDs. Sodium
channels play a crucial role in regulating the activity of the
nervous system to help nerve cells communicate. Sometimes sodium
channels become abnormally overactive which may produce a seizure.
Vimpat® mode of action is thought to reduce this sodium channel
over-activity. The regulation of the activity of nerve cells may
contribute to the control of seizures.

Preclinical studies also suggest that Vimpat® binds to the collapsin
response mediator protein-2 (CRMP-2), a phosphoprotein which is
mainly expressed in the nervous system and is involved in neuronal
differentiation and control of axonal outgrowth. The nature of the
interaction between Vimpat® and CRMP-2 is not completely known.
Vimpat® is the only AED known to interact with CRMP-2.

Improved seizure control when added to a wide range of antiepileptic
The European Commission approval is based on data from three
multicentre, randomized, placebo-controlled clinical trials that
evaluated the efficacy and safety of Vimpat® adjunctive treatment in
over 1,300 partial-onset seizure patients aged 16 years and older who
were not adequately controlled with between one to three concomitant
AEDs and with or without additional vagus nerve stimulation. Patients
entering these trials were experiencing on average 10-15 seizures per
month and most patients (84%) were uncontrolled on two to three AEDs.

In clinical trials Vimpat® improved seizure control when added to a
wide range of first and second generation antiepileptic drugs. Pooled
analysis shows that treatment with Vimpat® 200 mg/day and 400 mg/day
reduced seizures by half in 34% and 40% of patients with
partial-onset seizures, respectively, compared with 23% in the
placebo group.  Vimpat® was generally well tolerated with the most
common adverse events (>=10% and greater than placebo) reported in
these trials including dizziness, headache, nausea and diplopia.

High long-term retention rate
In a long-term study, patients treated with Vimpat® achieved
sustained reductions in partial-onset seizures. Seventy seven per
cent of 370 patients who took part in this open-label trial completed
at least 12 months of Vimpat® treatment, 61% completed at least 24
months, and 56% completed at least 30 months of treatment.

Multiple formulations for ease of use
Vimpat® has been approved as oral tablet (50mg, 100mg, 150mg, 200mg),
oral syrup (15mg/ml) and solution for infusion (10mg/ml), to allow
for additional dosage formulation options. Vimpat® solution for
infusion is an alternative for patients when oral administration is
temporarily not feasible.

About Epilepsy
Epilepsy is a chronic neurological disorder affecting 50 million
people worldwide. It is caused by abnormal, excessive electrical
discharges of the nerve cells or neurons in the brain. Epilepsy is
characterised by a tendency to have recurrent seizures and defined by
two or more unprovoked seizures. There are many different seizure
types and epileptic syndromes. Approximately, 20-30% of people living
with epilepsy have uncontrolled seizures or significant side effects
secondary to medication highlighting the ongoing need for the
development of new antiepileptic drugs.

Further information
Antje Witte, Vice-President Corporate Communications & Investor
Relations, UCB Group
T +32.2.559.9414, [email protected]

Eimear O'Brien, Global CNS Communications Manager, UCB Group
T +32.2.559.9271, [email protected]

About UCB
UCB (Brussels, Belgium, is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialization of innovative medicines with focus on the fields of
central nervous system and immunology disorders. Employing around 12
000 people in over 40 countries, UCB achieved revenue of EUR 3.6
billion 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.

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


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