Eisai Europe Limited

Novel Once-Daily Epilepsy Treatment now Available in France

Hatfield, England (ots/PRNewswire) - Reimbursement granted for Zebinix(R) as adjunctive therapy for adults with

partial-onset seizures

Eisai Europe Limited announces the launch of Zebinix(R) (eslicarbazepine acetate) in France. Upon launch, this novel epilepsy drug will receive full reimbursements from the French health authorities.

Once-daily eslicarbazepine acetate is indicated as an adjunctive (add-on) therapy for adults with partial-onset seizures, with or without secondary generalisation (where the seizure extensively affects a patient's consciousness by spreading to both sides of the brain).[1]

"Whilst epilepsy can be managed with medication, a third of epilepsy patients still suffer from uncontrollable seizures after treatment, putting them at risk of poor health, reduced likelihood of employment and an increased risk of psychological comorbidities, such as depression and anxiety,[2] commented, Arnaud Biraben, Consultant Neurologist, Pontchaillou Hospital, France. "The launch of eslicarbazepine acetate in France is a welcome addition to our treatment armamentarium which may help uncontrolled patients manage their condition and see an improvement in their health-related quality of life".

Epilepsy is one of the most common neurological disorders affecting more than six million people across Europe.[3] In France, in excess of 500,000 patients suffer from the condition with an annual cost to health services estimated at more than EUR3.5 billion.[4]

Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe Ltd commented; "The availability of Zebinix(R) in France provides patients with uncontrolled seizures a new option that may help to match their individual treatment needs." She added; "Eisai is committed to provide patients and their families with improved quality of life by bringing effective treatments to those that need it, as displayed by our human health care mission".

"The launch of Zebinix(R) is a positive step for patients in France who do not achieve adequate seizure control, commented Michaël Perrin, Director of Eisai Epilepsy franchise. Eisai is working with the regional health authorities to ensure the treatment is available as soon as possible to patients that require it the most".

Eslicarbazepine acetate was approved in April 2009 by the European Commission following data which showed that it reduces seizure frequency and has an overall positive efficacy and safety profile.[1,5] Eslicarbazepine acetate is already available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, England, Finland, Germany, Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Spain (co-promotion with BIAL, the developer of Zebinix (R)) and Wales.

*Exclusively by BIAL

Notes to Editors

Zebinix(R) is the EU trade name for eslicarbazepine acetate

Zebinix(R) is under license from BIAL

About epilepsy, partial-onset seizures and their treatment

Epilepsy is a chronic neurological disease characterised by abnormal discharges of neuronal activity causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body. Patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.[6]

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain. In partial-onset seizures, these bursts of electrical activity are initially focused in specific areas of the brain,[7] but may become more generalised;[7] the symptoms vary according to the affected areas.[8]

Treatment of partial-onset seizures, the most common type of epilepsy, presents a constant challenge - Up to 30% of patients with partial seizures do not achieve remission despite appropriate therapy with anti-epileptic drugs.[9] Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency.

About Zebinix(R)(eslicarbazepine acetate)

Eslicarbazepine acetate is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.[1] Eslicarbazepine acetate is a once-daily, voltage-gated sodium channel blocker.[10,11] It preferably targets the inactivated state of the sodium ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing.[11] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[12] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[10,13,14]

Clinical data

The EU approval was based on data from a phase II and three phase III clinical trials.[10,12,13,14] Patients recruited in the phase III trials had a history of at least four partial seizures per month despite treatment between one to three concomitant anti-epileptic drugs.[10,13,14]

During the trials, patients were randomised to various dosages of Zebinix(R) 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.[10,13,14]

Efficacy

Over the 12-week maintenance period, Zebinix(R) 800mg and 1200mg once-daily significantly reduced seizure frequency, and was significantly more effective than placebo.[10,13,14,15] Long-term safety and maintenance of therapeutic effect was demonstrated in one-year open-label extensions of these studies. [15,16,17]

Tolerability and drug interactions [10,12,13,14,18]

In the Phase III clinical trials adverse events mainly occurred during the first 6 weeks of treatment and the majority of patients experienced adverse events of mild to moderate intensity. After the initial 6 weeks of treatment there were no observed differences in the incidence of side effects between patients treated with Zebinix(R) and the placebo group. The most common treatment-emergent adverse events in the pivotal studies were dizziness, headache and somnolence.

License Agreement

Eisai Europe Limited , a European subsidiary of Eisai Co., Ltd. , announced in February 2009 that it had entered into a license and co-promotion agreement with BIAL - Portela & C(a), S.A. (Headquarters: São. Mamede do Coronado, Portugal, Chairman: Luís Portela & CEO: António Portela, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's anti-epileptic drug Zebinix(R)(eslicarbazepine acetate) in Europe.

About Eisai Europe in Epilepsy

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in the European market.

In Europe, Eisai currently has three marketed treatments including:

        - Zonegran(R) (zonisamide) as adjunctive therapy in adult patients with
          partial-onset seizures, with or without secondary generalisation
        - Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients
          with partial-onset seizures, with or without secondary generalization
        - Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
          with Lennox-Gastaut Syndrome in patients >4 years 

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

        - Neuroscience, including: Alzheimer's disease, multiple sclerosis,
          neuropathic pain, epilepsy, depression
        - Oncology including: anticancer therapies; tumour regression, tumour
          suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
        - Vascular/Immunological reaction including: acute coronary syndrome,
          atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease 

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and Belgium.

For further information please visit our web site http://www.eisai.com

About BIAL

Founded in 1924, BIAL is an international pharmaceutical group with products available in more than 40 countries throughout four continents. BIAL is a privately held Portuguese research based pharmaceutical company and the largest Portuguese pharmaceutical company, based in S. Mamede do Coronado, Portugal, responsible for the research and development of eslicarbazepine acetate (Zebinix(R)).

It is the partner of choice for many companies, having a strong presence in the Iberian Peninsula as well as in over 10 countries in Latin America and in around 20 French or Portuguese speaking African countries.

BIAL is strongly committed to therapeutic innovation investing more than 20% of its turnover in research and development every year. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy. BIAL currently has several other innovative programs under development, which the company expects to bring to the market within the next years, thereby strengthening its position throughout Europe.

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

        References
        1. Summary of Product Characteristics Zebinix(R) (eslicarbazepine acetate)(updated
        November 2011)
        2. Titlic, M. Basic, S. Hajnek, S. Comorbidity psychiatric disorders in epilepsy: a
        review of literature. Bratisl Lek Listy (Bratislava Medical Journal) 2009; 110 (2): 105
        - 109
        3. Epilepsy must become a higher priority in Europe. The Lancet Neurology. 2010 Oct;
        9(10): 941
        4. Comité National Epilepsie (Last accessed 21.02.2012)
     http://www.comite-national-epilepsie.fr
        5. Cramer JA, Elger C, Halasz P, et al, editors. An evaluation of quality of life and
        depressive symptoms during    long-term treatment with eslicarbazepine acetate:
        BIA-2093-301 study [abstract 3.197]. American Epilepsy Society Congress; 2008 5-9
        December; Seattle, WA.
        6. Epilepsy Research UK. What is Epilepsy? Fact sheet. Avaiable from URL:
     http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (accessed March
        2012)
        7. Epilepsy Action. Describing Seizure Types. Avaiable at URL
     http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March 2012)
        8. NHS Choices. Symptoms of Epilepsy. Available at URL
     http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed March 2012)
        9. Rauchenzauner M, Luef G. Update on the treatment of partial onset epilepsy: a role
        of eslicarbazepine. Neurophsyiactric Disease and Treatment. 2010 Nov; 6(1): 723-730
        10. Elger C, Halász P, Maia J et al. Efficacy and safety of eslicarbazepine acetate as
        adjunctive treatment in adults with refractory partial-onset seizures: A randomized,
        double-blind, placebo-controlled, parallel-group phase III study. Epilepsia 2009;
        50(3):454-463.
        11. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093).
        Neurotherapeutics. 2007 Jan;4(1):88-96.
        12. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on Placebo-controlled
        Exploratory Trial in Adult Patients with Partial-onset seizures. Epilepsia,
        48(3):497-504, 2007
        13. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver P.
        Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy;
        Epilepsy Research 2010;89:278-285.
        14. Lopes-Lima J, Gil-Nagel A, Maia J et al. Efficacy and safety of 800 and 1200 mg
        eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset
        seizures. Acta Neurol Scand 2009: 120: 281-287.
        15. Halász P, Elger C, Guekht A, et al. Long-term efficacy and safety of
        eslicarbazepine acetate: Results of a 1-year open-label extension study in
        partial-onset seizures in adults with epilepsy.  Epilepsia, 51(10):1963-1969, 2010.
        16. 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 of study
        BIA-2093-303 (Abstract No. 3.227). Epilepsia. 2008;49(Suppl. 7):441-2.
        17. Gabbai A, 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 of study
        BIA-2093- 302 (Abstract No. 3.208). Epilepsia. 2008;49(Suppl. 7):432-3.
        18. Cramer J, Maia J, Almeida L, et al. Quality-of-life improvement during long-term
        treatment with eslicarbazepine acetate (Abstract No. T278) Epilepsia 2009:50 (Suppl.
        4):123. 

Contact:

Media Enquiries, Eisai Europe Ltd, Cressida Robson,  
+44-7908-314-155, Cressida_Robson@eisai.net; Tonic Life
Communications,
Benjamyn Tan / Leah Peyton,
+44-(0)207-798-9262, +44-(0)7788-191434,
benjamyn.tan@toniclc.com / eisaiepilepsy@toniclc.com


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