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Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)
Date:6/28/2009

e three pivotal phase III studies demonstrated that add-on therapy with once-daily Zebinix(R) (800mg and 1200mg) was effective in reducing partial-onset seizures in patients not controlled with one of the most commonly used anti-epileptics, carbamazepine (CBZ), (p<0.01 and p<0.0001 respectively)(3).

Across the clinical studies conducted, eslicarbazepine acetate has demonstrated a favourable safety profile(5). This has been further reinforced by a pooled analysis indicating that most adverse events begin within the first weeks of treatment but after six weeks, no relevant difference was found between eslicarbazepine acetate and placebo(4).

Zebinix(R), researched and developed by BIAL, received marketing authorisation from the European Commission in April 2009, as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. Under the terms of a deal with BIAL, announced in February this year, Eisai Europe Ltd received a sole license to market, promote and distribute ESL within Europe**. Eisai and BIAL plan to launch Zebinix(R) across Europe during 2009 and into 2010, providing a novel and effective treatment to patients with partial-onset seizures who are not adequately controlled with their existing medications. The rights to commercialise the product in the U.S. and Canadian markets were licensed to Sepracor Inc., in late 2007 (the proposed name for eslicarbazepine acetate in the U.S. and Canada is STEDESA(TM)). In June 2009, Sepracor announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) for STEDESA(TM) as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, and the NDA is currently under formal review.

Notes to Editors

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

** European Territories

Austria, Belgium, Bulga
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SOURCE BIAL
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