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Beyond Seizure Control in the Treatment of Epilepsy With New Anti-Epileptic Drug, Zebinix(TM)
Date:12/8/2008

PORTO, Portugal, December 8 /PRNewswire/ --

- Data Highlight The Efficacy, Safety and Significant Improvement in Quality of Life and Depressive Symptoms With Zebinix(TM) (Eslicarbazepine Acetate)

Positive data from three phase III studies presented today at the American Epilepsy Society (AES) Congress, Seattle, USA, show that Zebinix(TM)(1) (eslicarbazepine acetate), a novel once-daily anti-epileptic agent, significantly reduced the frequency of partial seizures and has the potential to significantly improve quality of life and depressive symptoms in patients with partial refractory epilepsy, in combination with other anti-epileptic agents.(2),(3),(4)

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

Zebinix(TM) 800mg and 1200mg once-daily significantly reduced the frequency of partial seizures by over one third during the 12 week maintenance period of the studies.(5),(6),(7),(8) In addition, new data presented for the first time at AES demonstrates that the reduction in seizure frequency was sustained over a one-year open-label treatment period. This sustained reduction over one year has now been demonstrated in all three phase III studies for Zebinix(TM).(9),(10),(11)

"The impact of epilepsy on quality of life and the development of depression cannot be underestimated. We must go beyond seizure control and ensure this is taken into consideration when assessing new treatments for epilepsy," said Joyce Cramer, research scientist at Yale University School of Medicine, USA and President of The Epilepsy Therapy Project. "During clinical studies, Zebinix(TM) has demonstrated that in addition to effective seizure control and good tolerability, it also provides significant improvement in quality of life and a reduction in depressive symptoms in long-term follow-up. Zebinix(TM) has the potential to become an important treatment option for patients with epilepsy who are not achieving seizure control with their existing medications."

Epilepsy is one of the most common neurological diseases affecting almost one in 100 people.(12) 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.(13)

Zebinix(TM), a new anti-epileptic drug that selectively inhibits the rapid firing of nerve cells that causes 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 European Medicines Agency (EMEA) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs. A U.S. New Drug Application (NDA) is currently being prepared with an anticipated submission to the U.S. Food and Drug Administration in early 2009.

About the trials

The three phase III, multi-centre, randomised, placebo controlled trials involved an aggregate of 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.(8)

During the trials, patients were randomised to various dosages of 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)-(11)

Efficacy

Over the 12 week maintenance period, Zebinix(TM) 800mg and 1200mg once-daily 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)-(11) 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 once-daily that ranged between 32% and 43% across all three phase III trials.(5)-(7)

Tolerability

The safety profile of Zebinix(TM) was favourable. The majority of treatment related adverse events were mild or moderate in intensity. After 6 weeks, the incidence of new CNS side effects was low in patients treated with Zebinix(TM).(2)-(11) These results parallel findings from earlier Phase 2.(16)

Quality of life and depressive symptoms

The effect of Zebinix(TM) on quality of life was assessed 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 a mean relative improvement in overall quality of life (p<0.001 - p<0.01 across the three studies) and improvements in individual elements of the QOLIE-31 scale including seizure worry, emotional wellbeing, energy/fatigue, medication effects and social function.(2)-(4)

Improvement in depressive symptoms was also measured using the Montgomery Asberg Depression Rating Scale (MADRS). During long-term, open-label therapy, Zebinix(TM) demonstrated a statistically significant improvement from baseline in the overall MADRS score (p<0.0001) and individual domains of the MADRS scale including pessimistic thoughts, concentration difficulties, apparent sadness and inner tension.(2)-(4)

Notes to Editors

About partial seizures and their treatment

Epilepsy is one of the most common neurological diseases, affecting almost 1 in 100 people.(12) Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge - up to two-thirds of patients with partial seizures do not achieve seizure control with current anti-epileptic drugs.(13)-(14)

Furthermore, adverse events, such as lightheadedness (dizziness), somnolence, and cognitive slowing, are highly prevalent with existing anti-epileptic agents and may affect as many as 97% of patients.(15) 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.2-11 BIAL submitted a marketing authorization application to the EMEA in March 2008. BIAL licensed the rights to commercialise eslicarbazepine acetate for the U.S. and Canadian markets to Sepracor Inc., a U.S., research-based pharmaceutical company that is currently preparing an NDA for submission to the U.S. Food and Drug Administration.

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). Cramer J, Elger C, Halasz P et al. An Evaluation of Quality of Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-301 Study.QOL 301. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(3). Soares-da-Silva P, Martins-da-Silva A, Gabbai AA et al. An Evaluation of Quality of Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-302 Study. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(4). Pereira H, Lopes-Lima J, Gil-Nagel A et al. An Evaluation of Quality of Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-303 Study. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(5). Czapinski P, Halasz P, Elger C et al. An Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-on Treatment in Adults with Refractory Partial-Onset Seizures: BIA-2093-301 Study. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(6). Ben-Menachem E, Gabbai AA, Hufnagel A et al. An Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-on Treatment in Adults with Refractory Partial-Onset Seizures: BIA-2093-302 Study. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(7). Gil-Nagel A, Lopes-Lima J, Maia J et al. An Evaluation of Efficacy and Safety of Eslicarbazepine Acetate (ESL) as Add-on Treatment in Adults with Refractory Partial-Onset Seizures: BIA-2093-303 Study. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(8). Elger C, French J, Halasz P et al. An Evaluation of Efficacy and Safety of Eslicarbazepine Acetate as Add-On Treatment in Patients with Partial-Onset Seizures: Pooled Analysis of Three Double Blind Phase III Clinical Studies. Oral presentation at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(9). Halasz P, Elger C, Guekht A et al. Long-Term Treatment of Partial Epilepsy with Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension to Study BIA-2093-301. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(10). Gabbai AA, Ben-Menachem E, Maia J et al. Long-Term Treatment of Partial Epilepsy with Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension to Study BIA-2093-302. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA, USA.

(11). Lopes-Lima J, Gil-Nagel A, Maia J et al. Long-Term Treatment of Partial Epilepsy with Eslicarbazepine Acetate (ESL): Results of a One-Year Open-Label Extension to Study BIA-2093-303. Poster presented at the American Epilepsy Society (AES) Congress, 5-9 December 2009, Seattle, WA,

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

(13). Mattson, RH, Cramer, JA, et al. Comparison of carbamazepine, phenobarbital, phenytoin and primidone in partial and secondarily generalized tonic clonic seizures. New England Journal of Medicine 313:145-151, 1985.

(14). Mattson, RH, Cramer, JA, et al, VA Cooperative Study Group. A comparison of valproate with carbamazepine for the treatment of partial seizures and secondarily generalized tonic-clonic seizures in adults. New England Journal of Medicine, 327:765-771, 1992.

(15). 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

(16). Elger, C; Bialer, M; Cramer, JA; et al. Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia 2007; 48: 497-504.

    Media contacts

    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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