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New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy
Date:9/24/2008

PORTO, Portugal, September 24 /PRNewswire/ --

- Novel Treatment Also Demonstrated Significant Improvement in Quality of Life and Reduction in Depressive Symptoms

Positive data from three phase III studies presented today at the 8th European Congress of Epileptology, Berlin, Germany, demonstrated that Zebinix(TM) (1) (eslicarbazepine acetate), a novel once daily anti-epileptic agent, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy, in combination with other anti-epileptic agents.(2,3,4)

Zebinix(TM) is one of the proposed EU trade names for eslicarbazepine acetate.

In addition, treatment with Zebinix(TM) also significantly improved patient quality of life, reduced depressive symptoms and demonstrated sustained reduction in partial seizure frequency during a one-year open label period.(5,6,7)

"When assessing the potential of anti-epileptic agents it is as important to consider the implications on the quality of a patient's day-to-day life, as well as effective seizure control," said Professor E. Ben-Menachem, University of Goteborg, Sweden. "In addition to sustained reductions in seizure frequency, Zebinix(TM) also demonstrated a significant improvement in patient quality of life and reduction in depressive symptoms."

Professor Christian Elger, Director and Head of the Department of Epileptology at the University of Bonn, Germany, added "these data suggest that Zebinix(TM) may become an important treatment option for patients whose seizures are not adequately controlled with existing anti-epileptic agents."

Epilepsy is one of the most common neurological diseases affecting almost one in 100 people.(8) Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge with over half of patients not achieving adequate seizure control with current anti-epileptic drugs.(9)

Zebinix(TM), a new anti-epileptic drug that selectively inhibits the rapid firing nerve cells that cause seizures, has been developed to address the need for a new anti-epileptic agent that offers a reduction in seizure frequency combined with a favourable tolerability profile. Zebinix(TM) is currently under review by the EMEA (European Medicines Agency) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs. A US NDA (New Drug Application) is expected later in 2008 or early 2009.

About the trials

The three phase III, multi-centre, randomised, placebo controlled trials involved more than 1,000 patients from 23 countries. Patients had a history of at least four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs.(2,3,4)

During the trials, patients were randomised to eslicarbazepine acetate or placebo and after a 2-week titration period, were assessed over a 12 week maintenance period, with continued follow-up over a one year open-label period.(2,3,4,7)

Efficacy

Over the 12 week maintenance period, Zebinix(TM) 800mg and 1200mg reduced seizure frequency by over one third, and was significantly more effective than placebo. This significant decrease in seizure frequency was sustained over the one-year open label treatment period and was consistent regardless of baseline therapy..(2,3,4) Similar positive findings were observed in the responder rate (greater-than-or-equal-to 50% decrease in seizure frequency) for Zebinix(TM) 800mg and 1200mg that ranged between 32% and 43% across all three phase III trials. (2,3,4)

Tolerability

The safety profile of Zebinix(TM) was favourable. The majority of treatment related adverse events were mild or moderate in severity and after 6 weeks, no relevant differences in the incidence of adverse events were apparent between patients treated with eslicarbazepine acetate and patients treated with placebo. In patients treated with Zebinix(TM) the incidence of CNS side effects was low. (2,3,4)

Quality of life and depressive symptoms

The effect of Zebinix(TM) on quality of life was analysed using the Quality of Life Epilepsy Inventory-31 (QOLIE-31) scale. There was a statistically and clinically significant improvement from baseline during long-term open-label therapy, including:5

- 16 per cent mean relative improvement in overall quality of life

(p<0.0001).

- 51 per cent improvement in worry about seizures (p<0.0001)

- 41 per cent improvement in social function (p<0.001)

Improvement in depressive symptoms was also measured using the Montgomery Asberg Depression Rating Scale (MADRS). Zebinix(TM) demonstrated a significant improvement in depressive mood and symptoms from baseline (p<0.0001).(6)

Notes to Editors

About partial seizures and their treatment

Epilepsy is one of the most common neurological diseases, affecting almost 1 in 100 people.(8) Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge - up to 58% of patients with partial seizures do not achieve seizure control with current antiepileptic drugs.(9)

Furthermore, adverse events, such as dizziness and somnolence, are highly prevalent with existing anti-epileptic agents and may affect as many as 97% of patients.(10) Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency combined with a favourable safety profile.

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain. In partial-onset epilepsy, these bursts of electrical activity are initially focused in specific areas of the brain, but may become more generalised; the symptoms vary according to the affected areas. Nerve impulses are triggered via voltage-gated sodium channels in the nerve cell membrane.

About Zebinix(TM)

Zebinix(TM) is a novel voltage-gated sodium channel blocker that has been designed to reduce the frequency of partial-onset seizures when used in combination with other anti-epileptic drugs.

This treatment has the potential to offer a new therapeutic option for patients who continue to suffer partial seizures despite receiving other anti-epileptic agents, with the potential for additional benefits in terms of improvements in quality of life and depressive symptoms.(2,3,4,5,6,7)

About BIAL

Founded in 1924, BIAL is an international pharmaceuticals group with products available in nearly 30 countries over four continents. BIAL group is the largest Portuguese pharmaceutical company and is based in S. Mamede do Coronado, Portugal.

BIAL is strongly committed to therapeutic innovation on research and development every year. This commitment has been recognised in the group's recent integration into the EFPIA (European Federation of Pharmaceutical Industries and Associations), which is dedicated to encouraging research and the development of new therapeutic options.

Key research areas for BIAL are the central nervous system, the cardiovascular system and allergology. BIAL's dedication to research is further demonstrated by the research grants and awards offered by the BIAL Foundation.

Further information about BIAL can be found at http://www.bial.com

References

(1). Zebinix(TM) is one of the proposed EU trade names for Eslicarbazepine acetate

(2). Elger C, Halasz P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-301 Study. Abstract and oral communication, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(3). Hufnagel A, Ben-Menachem E, Gabbai A et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-302 Study. Abstract and oral communication, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(4). Lopes-Lima J, Gil-Nagel A, Maia J et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in adults with refractory partial-onset seizures: BIA-2093-303 Study. Abstract and oral communication, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(5). Cramer J, Maia J, Almeida L, Soares-da-Silva P. Quality-of-life improvement during long-term treatment with eslicarbazepine acetate. Abstract and poster, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(6). Hodoba D, Członkowska A, Cramer J. Depressive symptoms improvement during long-term treatment with eslicarbazepine acetate. Abstract and poster, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(7). Guekht A, Elger C, Halasz P et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate: results of a 1-year open-label extension study. Abstract and oral communication, presented at the 8th European Congress on Epileptology, Berlin, Germany, 21-25 September 2008.

(8). WHO Atlas: Epilepsy Care in the World. WHO 2005

(9). Brodie MJ. Management strategies for refractory localization-related seizures. Epilepsia 2001;42(Suppl 3):27-30

(10). Mei PA, Montenegro MA, Guerreiro MM, Guerreiro CA. Pharmacovigilance in epileptic patients using antiepileptic drugs. Arq Neuropsiquiatr 2006 Jun;64(2A): 198-201. Epub 2006 Jun 9

For more information please contact:

BIAL (head office)

Francisco Osorio

Tel.: +351-22-986-6100

Mobile: +351-96-346-9968

francisco.osorio@bial.com

Paul Gittins

Red Health

Tel.: +44-207-025-6571

Mobile: +44-7958-533-462

paul.gittins@redconsultancy.com


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