UCB (UCBJF) recently reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against the approval of Xyrem for the treatment of fibromyalgia syndrome in adults.
We note that Xyrem is already marketed in the European Union (EU) for the treatment of narcolepsy with cataplexy in adults. UCB markets the drug in the EU under a license from Jazz Pharmaceuticals Inc. (JAZZ).
In January, UCB provided an update on its pipeline products. 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.
UCB also initiated a European phase III trial of Vimpat (lacosamide) during the fourth quarter of 2010. In this trial, the drug is being evaluated as a monotherapy in adult patients newly diagnosed with epilepsy and experiencing partial-onset seizures or generalized tonic-clonic seizures.
Additionally, during the fourth quarter, the company reported results from a mid-stage trial of Vimpat, evaluating the candidate as an adjunctive therapy in children aged 2-17 years with uncontrolled partial-onset seizures.
Further, in December 2010, UCB along with partner Immunomedics Inc. (IMMU) initiated patient enrollment in 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.
UCB initiated patient enrollment in a phase IIb trial of CDP6038, which is being studied for the treatment of moderate-to-severe rheumatoid arthritis. Top-line results from the trial are expected in the third quarter of 2012.
We currently have a Zacks #2 Rank (short-term Buy rating) on UCB.
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