UCB: Positive Outlook for Keppra

UCB has reported significant top-line phase III results for its epilepsy medicine Keppra over placebo in reducing the frequency of partial onset seizures in pediatric patients. While these results demonstrate Keppra’s broad potential to reduce the burden of epilepsy across a wider-range of patients, they also point to a positive future for UCB’s epilepsy franchise.

The phase III, double-blind, randomized, multicenter, placebo-controlled study evaluated the efficacy and tolerability of Keppra (levetiracetam) (2050 mg/kg/day) as adjunctive therapy in the treatment of partial onset seizures in 116 children aged from one month to four years. Prior to the study, children were experiencing at least two partial onset seizures per week despite treatment with one or two other antiepileptic drugs. In the study, 43.1% of Keppra-treated patients experienced at least a 50% reduction in seizure frequency during the five-day evaluation period compared with 19.6% of the placebo-treated patients.

Epilepsy is a neurological condition that makes people susceptible to seizures – a change in sensation, awareness, or behavior brought about by a brief electrical disturbance in the brain. According to the World Health Organization, epilepsy affects approximately 50 million people worldwide, with the incidence of epilepsy being most prominent in the very young and very old. However, the control of childhood seizures remains an underdeveloped area, and Datamonitor rates it as the fourth top unmet need in the treatment of epilepsy.

Launched in 2000 in the US and EU as adjunctive therapy for the treatment of partial onset seizures in adults, Keppra has rapidly reached market leader status, with epilepsy specific seven major market sales exceeding $527 million in 2005. This was achieved by the drug offering a novel mode of action and through gaining numerous indication expansions.

UCB has emerged as the number one epilepsy company, and the acquisition of Schwarz Pharma AG in January 2007 has strengthened the company’s epilepsy pipeline through the addition of Schwarz’s phase III product lacosamide to UCB’s brivaracetam and seletracetam.

This most recent data for Keppra in children supports Datamonitor’s prediction that Keppra’s ever expanding indication portfolio will continue to grow UCB’s epilepsy franchise in the short-term. In addition, with a strong late-stage pipeline, UCB’s epilepsy franchise is forecast to grow by 34% from its estimated present value in 2006 to $941 million in 2015.