News Release

KEPPRA international Phase IV SKATE study results show favourable efficacy

More than 50% reduction in partial seizures achieved in 49% of patients

Peer-Reviewed Publication

Ketchum UK

PARIS, France (May 17, 2003) - First interim results from UCB Pharma's ongoing Phase IV SKATE (Safety of KEPPRA as Adjunctive Therapy in Epilepsy) study shows favourable rates of efficacy for KEPPRA (levetiracetam) in a broad population of difficult to treat patients. Phase IV studies are considered to be close to clinical practice and specifically explore the safety of a treatment that has been registered for a particular indication. In this case the results of the SKATE study, similarly to the KEEPER study (the US equivalent Phase IV trial), show a high proportion of patients with partial onset seizures experienced an overall significant clinical improvement when treated with KEPPRA. The SKATE study showed that seizure frequency was reduced by half or more in 49% of patients1. This efficacy was confirmed across different partial seizure types1 and in addition, the results also showed a substantial seizure freedom rate of 17.2% over the entire study duration (sixteen weeks). It makes KEPPRA a good candidate for possibly becoming a first-choice add-on antiepileptic drug (AED).

The interim results were based on data from 731 patients recruited from nine countries; Belgium, Czech Republic, Germany, Finland, France, Netherlands, Switzerland, UK and Argentina with 117 investigators.

SKATE study design
The SKATE trial is a Phase IV, open-label, multi-centre trial studying the safety and efficacy of KEPPRA as an adjunctive therapy in adult patients with uncontrolled partial seizures, which began in April 2000. The interim results were based on a 16-week treatment period in a broad population of refractory patients, with between one and fourteen partial-onset seizures per month, averaged over the three month-period preceding the selection visit.

SKATE Study Results

Patient demographics
The mean age of patients involved in the SKATE study was 38.4 years and the mean duration of time the patients had been diagnosed with epilepsy was 21 years, with a median baseline partial seizure frequency of four seizures per month. Out of the 731 patients in the study, most patients could be diagnosed as highly refractory - with two thirds of patients having tried a treatment and failed with 3 or more AEDs prior to study entry - and were still uncontrolled; the majority of patients (67%) entered the study on two or more concomitant AEDs.

High retention
Overall the results showed a retention rate for KEPPRA with 84.4% of patients having completed the study, which is considered very high.

Efficacy
The SKATE results showed favourable efficacy in controlling partial seizures with seizure frequencies reduced by half or more in 49% of patients (353/720) as well as a seizure freedom rate of 17.2% over the whole study period.

KEPPRA was also effective in the different subtypes of partial seizure. In simple partial seizures 36.6% of patients (90/246) experienced a reduction in seizures greater or equal to 50% and 17.9% were seizure free from this specific subtype.

While 49.8% of patients (286/574) with complex partial seizures experienced a reduction in seizures greater or equal to 50% and 20.9% were seizure free from complex partial seizures.

In addition, 65% of patients (167/257) with secondarily generalised tonic-clonic seizures experienced a reduction in seizures greater or equal to 50 %, and nearly half (46.3%) were without this type of seizure.

Safety
The adverse event profile was consistent with that seen in the Phase III clinical development program, with the five most commonly reported adverse events leading to discontinuation as follows; somnolence (2.2%), asthenia (fatigue) (1.8%), convulsions (1.8%), headache (1.4%) and dizziness (1.4%)1. Overall, the most common adverse events were predominantly mild to moderate in severity and rarely led to discontinuation (8.6%).

Commenting on the significance of the study, Professor Christian Elger, Klinik für Epileptologie, University of Bonn, commented "The SKATE study clearly shows that KEPPRA offers unparalleled efficacy in terms of seizure control and seizure freedom rates across several partial seizure types, but also an unmatched tolerability profile. The SKATE study provides data that supports Keppra in the therapeutic armamentarium by identifying this newer antiepileptic as an optimal first choice add-on therapy". He continued, "Given KEPPRA's efficacy in the SKATE study, I am sure that clinicians around the world will be interested in the final results of SKATE - and indeed in results of ongoing trials including those looking at KEPPRA in monotherapy, in primary generalised seizures and in children".

UCB Global Medical Manager CNS, Dr Peter Verdru commented, "We are pleased that these results confirm the phase III trials that allowed the registration of Keppra and are entirely in line with the results from KEEPER, the phase IV study conducted in the US. It has encouraged us at UCB Pharma to continue our commitment to investing in clinical research that may lead to the improvement of the quality of life of people with epilepsy."

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* Keppra is a registered trademark of the UCB Group. Please consult your national product information and regulatory status as they may differ from one country to the other. ** SKATE and KEEPER are trademarks of the UCB Group.

For further information please contact:
Amanda Boswell
Ketchum (onsite contact)
Tel: 44-771-205-1958
Fax: 44-207-611-3850
Email: amanda.boswell@ketchum.com

Elizabeth Park
Ketchum (office contact)
Tel: 44-207-611-3624
Fax: 44-207-611-3850
Email: elizabeth.park@ketchum.com

References:
1.SKATE. Safety of KEPPRA as adjunctive therapy in epilepsy; first interim analysis. A presentation made at 2nd UCB Global Epilepsy Summit 2003, 16-17 May 2003 Paris(France)-Orlando (USA)

Notes to editors:

  • KEPPRA is currently indicated only as adjunctive treatment of partial onset seizures, with or without secondary generalisation, in adults with epilepsy.
  • The Phase III programme consists of trials conducted for regulatory purposes (registration)
  • The KEPPRA Phase IV programme involves 2 trials; KEEPERTM in the USA and SKATE in the rest of the world: KEEPER: was conducted in the US in 1030 patients. The SKATE trial is ongoing involving more than 16 countries and over 1,400 patients, 300 investigators.
  • Clinical research with levetiracetam is ongoing, including paediatric, Primary Generalised Seizure and monotherapy trials.
  • In April 2000 the USA became the first country to launch KEPPRA, closely followed by Switzerland in May 2000.
  • KEPPRA is now available in the following countries; Argentina, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France (via hospital pharmacies), Germany, Greece, Hong-Kong, Ireland, Italy, Luxembourg, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK and USA.
  • On March 6, 2003, the approval for marketing KEPPRA in Canada was obtained.
  • A partial seizure (I) involves just part of the brain, and can be either 'simple' (Ia) when consciousness is not affected, 'complex' (Ib) when consciousness is affected or secondary generalised (Ic) when either a simple or complex seizure spreads to involve the whole brain.
  • New antiepileptic agents first have to prove themselves as adjunctive (add-on) therapy - usually in partial seizures - before applying for approval as monotherapy.
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