First evidence of efficacy for UCB's Keppra®* in the adjunctive treatment of myoclonic seizures

Brussels, BELGIUM, 31 March 2005) - UCB today announced the first evidence from a major study showing that Keppra® (levetiracetam) is effective for adjunctive treatment of myoclonic seizures in adolescent and adult patients with Idiopathic Generalized Epilepsy. Keppra® is the first antiepileptic drug (AED) ever to generate proof of efficacy in this group of patients through a prospective randomized controlled study. These are the first results from a series of clinical studies designed to establish the efficacy of Keppra® in a broad spectrum of seizure types.

The top line findings of this double-blind, multicenter, randomised placebo-controlled study in 122 patients show that Keppra® demonstrates highly favourable efficacy and safety in the adjunctive treatment of previously uncontrolled idiopathic generalised epilepsy with myoclonic seizures. Full results will be presented at the end of August 2005 at the International Epilepsy Congress taking place in Paris.

"This study was conducted in patients who had not responded to previous treatment, so we are especially delighted with such positive results in this difficult to treat population," said Dr Soheyl Noachtar, Associate Professor of Neurology at the University of Munich.

"Keppra® may help avoid one of the pitfalls of epilepsy therapy where myoclonic seizures can be aggravated, rather than controlled, by some AEDs," he continued.

"We are very excited about this data" said Dr Melanie Lee, Senior Executive Vice President R&D for UCB. "We plan to file in both the US and EU to extend Keppra®'s existing indication to include add-on therapy for myoclonic seizures in patients with idiopathic generalised epilepsy in Q3 2005.

"This would bring the benefit of Keppra® to a wider population of people with epilepsy, offering the opportunity of seizure freedom without life-affecting side effects to more patients, and to physicians, the opportunity to prescribe an AED which is proven to be effective against both partial and myoclonic seizures", she concluded.

Keppra® is currently licensed as add-on therapy for partial onset seizures with or without secondary generalisation.

* Keppra® is a registered trademark of the UCB Group

Epilepsy can broadly be categorised into two main types:

1. localization-related or focal epilepsy, in which patients experience partial seizures with or without secondary generalisation (around 60 per cent of epilepsies), and
2. generalised epilepsy in which patients experience a variety of primary generalized seizures such as absences, myoclonic seizures, and primary generalized tonic-clonic seizures (approximately 40 per cent of epilepsies).

Idiopathic Generalized Epilepsy (IGE) encompasses the most important group of syndromes within generalized epilepsy, including Childhood Absence Epilepsy, Juvenile Absence Epilepsy and Juvenile Myoclonic Epilepsy. The susceptibility to develop these syndromes is believed to be determined genetically.

IGE with myoclonic seizures (juvenile myoclonic epilepsy - JME) comprises 8-10% of all epilepsies.