Bial-Portela & CA, SA, and Eisai Europe Limited, the European subsidiary of Eisai Co, Ltd, announced that the novel once daily anti-epileptic Zebinix (eslicarbazepine acetate) received marketing authorisation from the European Commission as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.

Epilepsy is one of the most common neurological diseases, affecting approximately one in 100 people. Treatment of partial-onset seizures, the most common type of epilepsy, remains a constant challenge and up to 40 per cent of patients with partial seizures do not achieve seizure control with current anti-epileptics.

The efficacy, safety and tolerability of eslicarbazepine acetate (ESL) has been demonstrated in three phase-III double-blind, randomised placebo-controlled trials in 1,049 patients with partial onset seizures. For each randomised control trial patients were given the option of entering a one year open label extension study.

ESL demonstrated significant and sustained reductions in seizure frequency and significant increases in responder rates (greater than or equal to 50 per cent decrease in seizure frequency). These studies also demonstrated that patients continued to take ESL with retention rates ranging from 68 to 79 per cent at one year (five to seven). The median daily dose throughout this one year treatment was 800mg. Treatment-emergent adverse events affecting >10 per cent of patients in the pivotal studies were dizziness, headache and somnolence.

The studies found that patients taking ESL also showed statistically significant improvement in scores of health related quality of life measures such as reduced 'seizure worry', improvements in 'cognitive functioning' and reduced 'medication effects', all factors which significantly affect the lives of patients living with epilepsy.

ESL can be given as a true one tablet once a day regimen at its median daily dose as defined in clinical trials as 800mg (five to seven). It works by selectively inhibiting the rapid firing of neurones. ESL interacts with site two of the voltage-gated sodium channel, stabilising its inactive form and preventing its return to the active open state, thereby reducing repetitive neuronal firing. ESL has a much higher affinity for the inactivated state of the channel compared with the resting state which means it is less likely to interfere with normal neuronal function.

"A significant number of patients with partial-onset seizures remain uncontrolled on existing epilepsy therapies and the inability to control seizures can have a devastating impact on the quality of a patient's day to day life and functioning," said professor Christian Elger, director and head of the Department of Epileptology at the University of Bonn, Germany and the lead author of one of the pivotal studies - published earlier this year in Epilepsia.

Under the terms of a deal with Bial announced in February this year, Eisai received a sole license to market, promote and distribute ESL within Europe.

"The EU approval of Zebinix represents a significant milestone for Bial in our efforts to bring this novel treatment to patients with partial-onset seizures," said Luís Portela, president and chief executive officer of Bial. "We will work closely with our European partner Eisai to launch Zebinix across the EU during 2009 and into 2010."

Yutaka Tsuchiya, chairman & CEO of Eisai Europe said, "The effective treatment of patients with partial-onset seizures remains a major challenge for clinicians and the carers of patients with epilepsy, and we are delighted to be working with Bial towards bringing to patients such a promising new treatment for epilepsy. Zebinix joins our existing family of anti-epileptics, which includes zonisamide and rufinamide and a new molecule currently entering phase three clinical development studies. When launched, Zebinix will help us to fulfil our Corporate mission of 'human health care' (hhc); to provide innovative, high quality medicines to meet the ever changing unmet medical needs of patients and their families as well as health care professionals."

Eslicarbazepine acetate (ESL) is a novel voltage-gated sodium channel blocker. It specifically targets the inactivated state of the ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing.

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

Eisai is one of the worlds leading R&D-based pharmaceutical companies, that 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).