October 2002

From Ketchum

New data confirm KEPPRA®'s place at the forefront of epilepsy management

New AED reaches 150,000 patient-years milestone enhancing confidence in efficacy, safety and tolerability amongst the medical community

Madrid, Spain. (8 October 2002). Data from a new study, presented at the 5th European Congress on Epileptology in Madrid, further demonstrate the favourable safety and tolerability profiles of KEPPRA® (levetiracetam), helping to confirm its place at the forefront of the management of epilepsy. KEPPRA® is currently indicated as adjunctive treatment of partial onset seizures, with or without secondary generalisation, in adults with epilepsy.

Data presented for the first time today by Elinor Ben-Menachem MD PhD, Professor at Sahlgrenska University Hospital, Gothenburg, Sweden, show that KEPPRA® was safe and well-tolerated when used for long-term treatment up to 7 .13 years (mean exposure was approximately 3 years). The data also showed that the anti-epileptic effect of KEPPRA® was sustained over the duration of the study. KEPPRA® showed a high retention rate of 54.3% (an estimation of efficacy and safety). The incidence of adverse events reported in this trial is very similar to the incidence described in previous studies, confirming the safety and tolerability profile for KEPPRA®.

Commenting on the data, Professor Ben-Menachem said, "Our study shows that long-term treatment with KEPPRA® gives sustained antiepileptic effect, with a high retention rate and an adverse event profile similar to that seen in the randomised controlled previous trials. This is good news for physicians, who can confidently choose KEPPRA® to treat their patients, without compromising their quality of life with increased risk of adverse events."

Commenting of the findings of the study, Professor José Serratosa, Chairman of the Scientific Advisory Committee of the 5th European Congress on Epileptology said, "The balance between efficacy and low incidence of adverse events is a difficult one to achieve in the treatment of epilepsy. Also, during 150,000 patient-years exposure, no serious safety issues have emerged with levetiracetam. These new and other data show that levetiracetam could help doctors and patients achieve that balance and continue to build confidence in the medical community that levetiracetam represents an advance in the treatment of many patients with epilepsy."

KEPPRA® received approval by the European Commission in September 2000. It is estimated that 50 million people world-wide have epilepsy2. The mean prevalence for active epilepsy (i.e. continuing seizures with the need for treatment) is approximately 8.2 per 1,000 of the general population -- although this may be higher in developing countries.

KEPPRA® spokesperson Dr Peter Verdru, Global Medical Manager CNS said "We are very pleased to have been involved in the study presented today, which further support pre-marketing data for KEPPRA®, also conducted by UCB. We continue to be committed to investing in clinical research that may lead to the improvement of the quality of life of people with epilepsy".

KEPPRA® was discovered and developed in UCB's research laboratories. The Group, based in Brussels, Belgium, is a fast growing global pharmaceutical company. It is also committed to technically innovative products in films and fine chemicals for coatings. UCB employs 10,000 people around the world, of whom about half are in the Pharma Sector. Its pharmaceutical research division includes the following fields: respiratory, including allergy and asthma, and neurology. UCB Pharma's principle products include Zyrtec®, Xyzal® (anti-allergic), KEPPRA® (anti-epileptic), Nootropil® (cerebral function regulator) and Atarax® (tranquilliser).

® KEPPRA is a registered trademark of the UCB Group

References:
1. Jacobs A, et al. Long-term evaluation of the safety and tolerability of levetiracetam in patients with epilepsy. Poster presentation at 5th European Congress on Epileptology, Madrid , October 8, 2002.
2. WHO Factsheet number 165: Epilepsy: Etiology, Epidemiology and Prognosis.
http://www.who.int/inf-fs/en/fact165.html

Notes to editors:

  • 150 000 patient-years -- Amount of standard units sold divided by 360 days of treatment , 2000 mg per day.
  • Jacobs, A. et al. -- This was a long-term, multi-centre, non-comparative, open-label follow-up study in which KEPPRA® was taken as adjunctive treatment. The subjects were examined at 12-week intervals using standard safety and efficacy assessment. Out of 505 enrolled patients, 274 (54.3%) remained in the study until the trial was stopped. The mean exposure was almost 3 years with a maximum of more than 7 years. The mean daily dose of KEPPRA® was slightly below 3000 mg. The antiepileptic effect of KEPPRA® remained stable over the years. The highest incidence of treatment-emergent Adverse Events (AEs) was reported for convulsions, accidental injury, infection and headache. A total of 168 subjects (33.2%) experienced at least one study-emergent serious AE and 11 (2.1%) subjects died (not related with KEPPRA®).
  • UCB continued to make a significant investment in future clinical research for KEPPRA®, including paediatric, Primary Generalised Seizure and monotherapy trials.
  • The KEPPRA Phase IV programme involves 2 trials; KEEPER in the USA and SKATE in the rest of the world:
  • KEEPER: was conducted in the US in 1030 patients. Results to be presented at the AES conference in Seattle in December 2002.
  • The SKATE trial is ongoing involving more than 16 countries and 1,300 patients. Preliminary results of the SKATE trial in 800 patients will be presented by May 2003.
  • KEPPRA® is now available in the following European countries; Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Spain, Switzerland, Sweden and the UK.
  • In April 2000 the USA became the first country to launch KEPPRA®, closely followed by Switzerland in May 2000. Switzerland, as a non-EU member, has its own medicinal products review committee. As a result, the approval and launch of KEPPRA® in Switzerland was able to precede that of the rest of Europe.
  • 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 anti-epileptic agents such as KEPPRA® first have to prove themselves as adjunctive (add-on) therapy -- usually in partial seizures -- before applying for approval as monotherapy.











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