UCB SA - BNP Paribas Fortis

to become a first choice treatment to add to both older and newer antiepileptic drugs. Vimpat® has
been approved in multiple oral and intravenous formulations.
Within days of its European approval, Vimpat® was launched in Germany and the UK, and physicians
responded positively to the product. Over 13,000 patients have been prescribed Vimpat® in Europe as
of June 2009, resulting in net sales of approximately €5 million as at 30 June 2009. Specifically, around
6,000 patients in Germany and 1,800 in the UK benefit from Vimpat®, and in Germany the Issuer
believes that the launch outperformed the two most recent AED launches. Vimpat® was launched in
the U.S. in June 2009, and 2,900 patients received a prescription in the first two months with net sales
estimated at €18 million by 30 June 2009.
Neupro®
The UCB Parkinson’s disease patch, Neupro®, delivers treatment to mimic the action of dopamine
continuously through the skin, providing stable drug levels in the bloodstream 24 hours a day. In the
U.S., Neupro® was launched in 2007 for the treatment of the signs and symptoms of early-stage
idiopathic Parkinson’s disease. UCB recalled Neupro® from the U.S. market in March 2008, after
ongoing monitoring revealed a deviation from the approved product specification and crystal
formulation in some batches. In December 2008, the Issuer received a Complete Response Letter from
the FDA which concluded that there was substantial evidence of effectiveness of Neupro® in patients
with advanced Parkinson’s disease. However, the Issuer must first resolve the issue of crystal formation
in the patches before re-launching the drug in the U.S. The dialogue between the Issuer and the FDA
regarding this issue is ongoing, with an extensive update on Neupro® and data concerning the coldchain
storage and distribution system being submitted to the FDA in July 2009, however the outcome of
such dialogue is not certain.
In Europe, Neupro® is indicated for the treatment of the signs and symptoms of early-stage idiopathic
Parkinson’s disease as monotherapy, or in combination with levodopa over the course of the disease,
through to late stages. A complete cold-chain storage and distribution system successfully implemented
by September 2008 has helped control the crystal formation issue and allowed existing patients to
continue their therapy. In June 2009 this storage and distribution system was approved by the EU and
Neupro® is available again to all patients suffering from Parkinson’s disease, including to new patients,
in Europe.
Neupro® was also approved by the EMEA for the treatment of restless leg syndrome in September
2008, and following approval of the cold chain storage and distribution system within the EU was
launched there. There are now approximately 30,000 patients in Europe currently being prescribed
Neupro®.
The FDA accepted the supplemental new drug application for Neupro® as a treatment for moderate-tosevere
restless leg syndrome in December 2007. A response was provided in December 2008
concluding that there was substantial evidence of effectiveness of Neupro® in patients with restless leg
syndrome. As discussed above, dialogue with the FDA regarding approval of Neupro® in both this
indication and in relation to Parkinson’s disease is ongoing, and remains subject to FDA approval of the
cold-chain storage and distribution system proposed by the Issuer.
Keppra®
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