UCB SA - BNP Paribas Fortis

Parkinson’s disease. Following a recall in the U.S. and an agreement with the EMEA to cease
promotion of the product and not to add any new patients in 2008, Neupro® has now been reintroduced
in full in the EU, and discussions are ongoing with the FDA in relation to distribution in the U.S., the
outcome of which is not certain.
Restless legs syndrome is a neurological condition that is characterised by an irresistible urge to move
one’s legs. The cause is unknown, but is suspected to be related to a lack of dopamine in the brain. It is
a lifelong condition without cure, with few treatments available to assist with moderate-to-severe
restless legs syndrome. The prevalence of restless legs syndrome was approximately 54 million
sufferers in the seven major markets in 2008, with an estimated market size of €100 million for the five
major European markets and approximately two times this market size in the U.S., although this is
being diminished by the increased genericisation of the leading products. Neupro® was approved to
treat the symptoms of moderate-to-severe idiopathic restless legs syndrome in adults in the EU in
September 2008, and was launched in mid 2009.
Diabetic neuropathic pain is associated with a functional abnormality of the nervous system, of which
there are several sub-types. Symptoms differ depending on the nerves affected, and it is very difficult to
treat with only 40-60 per cent. of patients achieving partial relief. However, it is estimated that this
condition affects 10 million patients in the seven major markets, with an approximate market size of
€390 million in 2008.
The CNS development pipeline of the UCB Group includes, among others, brivaracetam for the
treatment of epilepsy, Neupro® (rotigotine transdermal system) for the treatment of advanced
Parkinson’s disease in the U.S., rotigotine nasal spray for the treatment of restless legs syndrome and
Vimpat® to treat both epilepsy (monotherapy indication in the U.S.) and diabetic neuropathic pain in
the U.S. and EU.
Strategy/Trend
The UCB Group has established itself as an important participant in the CNS market through innovation
in drug discovery and development as well as a strong commercial performance. The UCB Group has
established an independent presence within the CNS market which will support the ongoing
development and commercialization of future CNS products. This includes products whose indications
extend beyond the area of epilepsy, in particular into the treatment of Parkinson’s disease, restless leg
syndrome, diabetic neuropathic pain and fibromyalgia.
Major Products
Vimpat®
In September 2008, the new antiepileptic drug Vimpat® was approved in Europe as adjunctive therapy
for the treatment of partial-onset seizures with or without secondary generalisation in patients with
epilepsy aged 16 years and older. In the U.S., the FDA approved Vimpat® in October 2008 as an addon
therapy for the treatment of partial-onset seizures in people with epilepsy aged 17 years and older.
Vimpat® has a novel mode of action and, in clinical trials, improved partial-onset seizure control in a
significant number of people with uncontrolled partial-onset seizures, when added to a wide range of
first and second generation antiepileptic drugs. UCB believes that Vimpat® therefore has the potential
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