UCB's Progress On-Track - Analyst Blog

UCB (UCBJF) recently provided an update on its pipeline progress during the fourth quarter of 2010.

Brivaracetam

The company announced the initiation of a late-stage trial of brivaracetam in December 2010. The candidate is being studied as an adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The trial will evaluate the efficacy and safety of brivaracetam 100 mg/day and 200 mg/day on seizure frequency. UCB plans to report topline data from the trial in the first half of 2013.

Vimpat

UCB also initiated a European phase III trial of Vimpat (lacosamide) during the fourth quarter. The trial is aimed at evaluating the efficacy and safety of Vimpat (200 to 600 mg/day) as a monotherapy in adult patients newly diagnosed with epilepsy and experiencing partial-onset seizures or generalized tonic-clonic seizures, when compared with carbamazepine controlled release (400 to 1200 mg/day). The non-inferiority design of the trial is meant to show a similar benefit-risk balance between lacosamide and carbamazepine. UCB plans to report topline data from the trial by the end of 2014.

During the fourth quarter, the company reported results from a mid-stage trial of Vimpat, evaluating Vimpat as adjunctive therapy in children aged 2-17 years with uncontrolled partial-onset seizures. It was observed in the study that the profile for Vimpat in children aged 5-11 years was similar to that in healthy adults. The data from this study were used to determine the dose range for subsequent pediatric studies.

Epratuzumab

Further, in December 2010, UCB along with partner Immunomedics Inc. (IMMU) initiated patient enrollment in the phase III trials (EMBODY 1 and EMBODY 2) for epratuzumab in patients with moderate-to-severe systemic lupus erythematosus (SLE). Initial results from these trials are expected in the first half of 2014.

CDP6038

UCB initiated patient enrollment in a phase IIb trial of CDP6038, earlier than planned. CDP6038 is being studied for the treatment of moderate-to-severe rheumatoid arthritis. The trial is designed to evaluate the efficacy and safety of CDP6038 administered subcutaneously for 12 weeks in patients with active rheumatoid arthritis having previously failed TNF blocker therapy. Topline results from the trial are expected in the third quarter of 2012.

Our View

Based on the aforesaid developments at UCB, we have a Zacks #3 Rank (short-term Hold rating) on the company.