Novel Once-Daily Epilepsy Treatment now Available in France (1)

HATFIELD, England, April 18, 2012 /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

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