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Belgian biopharmaceutical firm UCB has provided an update on recent clinical developments as well as on its previous financial guidance for 2007.
Commenting on UCB’s performance in the second half of 2007, CEO Roch Doliveux said: “UCB is well on track to deliver on its targets for 2007.”
He said the second half of 2007 saw successfully launches in the USA of Neupro (rotigotine transdermal system) and Xyzal (levocetirizine dihydrochloride).
Vimpat (lacosamide) had been filed with European and US regulatory authorities for adjunctive treatment of partial-onset seizures in adults with epilepsy and for treating diabetic neuropathic pain.
He said Neupro (rotigotine transdermal system) had been filed with European and US regulators for treating restless legs syndrome, and with US regulators as adjunctive therapy with levodopa in adults with advanced Parkinson’s disease.
UCB reported positive Phase III results from a study evaluating Keppra XR (levetiracetam), a once-daily extended-release formulation as adjunctive therapy in refractory epilepsy patients with partial onset seizures.
The phase III clinical programme for Rikelta (brivaracetam) had started as adjunctive therapy in patients with refractory partial-onset epilepsy.
The EMEA had adopted a negative opinion on the market authorisation application for Cimzia (certolizumab pegol) in treating patients with Crohn’s disease. UCB has submitted an appeal requesting re-examination of the opinion, with a decision expected in early 2008.
The regulatory application of Cimzia in rheumatoid arthritis in the US had been submitted, with acceptance expected in January 2008 and filing in Europe planned.