UCB SA - BNP Paribas Fortis

Keppra® is one of the core products of the UCB Group, indicated for the treatment of certain types of
epilepsy. During its period of patent protection it was a key product for the UCB Group, with a leading
market share in terms of revenue in all key markets. U.S. patent protection for Keppra® expired in
November 2008, however generic erosion of Keppra® sales has remained within expectations. In
addition, such erosion has been partially compensated however by the launch of Keppra®XR in the
U.S. and of Vimpat® in Europe during 2008, and the expansion of Keppra® into major emerging
markets such as China, India and Korea, where sales in 2008 increased by 88 per cent. over 2007, to
€10 million. Further, sales of Keppra® in Europe increased by 29 per cent. during 2008. The impact of
U.S. generic erosion has remained within expectations, with a brand retention of 23 per cent. 35 weeks
after the loss of exclusivity.
In Japan, Keppra® is being co-developed by UCB and Otsuka Pharmaceuticals, with a file submitted to
the Japanese PMDA for regulatory approval in November 2008. At present, first generation older AEDs
lead sales in Japan, with only three second generation AED approvals since 2006. Approval for
Keppra® in Japan is anticipated during 2010.
Keppra®XR
The once daily formulation, Keppra®XR (extended release tablets), was approved as an add-on therapy
for the treatment of partial-onset seizures in people with epilepsy who are 16 years of age and older in
the U.S. in September 2008. Keppra®XR offers patients simplified treatment and another opportunity
to achieve improved seizure control. Sales of Keppra®XR in the U.S. in the first half of 2009 were €20
million.
Product Pipeline
Brivaracetam is a broad-spectrum anti-epileptic product in development, for which headline Phase III
efficacy and safety data were seen in April 2009. One efficacy trial and the safety trial met their
primary endpoints, but a second efficacy study did not meet its primary endpoint. Further detailed
analysis of the clinical data in these trials is needed in order to better understand the potential of the
drug. A significant pipeline is in place containing additional products for the treatment of CNS
disorders, with a Phase III trial ongoing for the use of Vimpat® as a diabetic neuropathic pain treatment
in addition to further epilepsy indications in the U.S..
Separately, the Issuer is, in conjunction with Jazz Pharmaceuticals, developing Xyrem®, a treatment for
fibromyalgia which has recently completed two positive Phase III studies and is in the process of full
data analysis and preparation of the registration files in the EU. UCB is currently marketing Xyrem® in
the EU for the treatment of narcolepsy with cataplexy in adult patients.
For a more detailed description of the product pipeline in the CNS field see Section 7, “Research and
Development” of this Part VI.
(b) Immunology
Summary
The overall immunology market includes the treatment of autoimmune diseases, inflammation and
allergy and comprises several therapeutic categories of drugs. These drugs target the treatment of a
variety of autoimmune and inflammatory conditions, such as inflammatory bowel disorders (including
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