UCB SA - BNP Paribas Fortis

IIb dose-ranging study results published in August 2009 were positive, and further testing continues.
The FDA has granted priority review status to epratuzumab for the treatment of patients with systemic
lupus erythematosus once the clinical trial programme is completed.
UCB is responsible for the global development of epratuzumab in autoimmune diseases as part of the
license agreement in place between the molecule’s originator, Immunomedics Inc., a U.S. based
biotechnology company, and UCB.
The UCB Group is also developing products for the treatment of osteoporosis, with the intention of
developing a product which accelerates the healing process in bones for both osteoporosis and fracture
patients. UCB is working in collaboration with Amgen Inc. to develop CDP7851 (sclerostin
monoclonal antibody), an anabolic therapy for bone loss disorders. Following encouraging first-inhuman
data, UCB and Amgen Inc. initiated a Phase II study in postmenopausal osteoporosis, which is
expected to be completed in 2012.
(d) Development Pipeline
The following table illustrates the current main development projects of the UCB Group and their
current stage of development:
Product Indication Phase I Phase II Phase III Regulatory
Status
CNS
Keppra®
(levetiracetam)
Epilepsy – adjunctive
therapy (Japan)
Neupro® (rotigotine) Advanced Parkinson’s
disease (U.S.)
Neupro® (rotigotine) Restless leg syndrome
(U.S.)
brivaracetam Epilepsy – adjunctive
therapy
Keppra®XR Epilepsy – monotherapy
(U.S.)
Vimpat® (lacosamide) Epilepsy – monotherapy
(U.S.)
Vimpat® (lacosamide) Diabetic neuropathic
pain (EU & U.S.)
Immunology
A11250830/2.25/23 Oct 2009 70
Decision by
year end
Results
expected by
Q4 2009
Results
expected by
Q4 2011
Decision
H2 2009
Filed
November
2008
CRL
December
2008
CRL
December
2008