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News Release

FOR IMMEDIATE RELEASE
April 28, 2009
For Print (PDF 63KB)

Novel Anti-epileptic ZEBINIX® Approved in the European Union
- New Option for Treatment of Patients with Partial-Onset Seizures -


Eisai Europe Limited (Headquarters: Hatfield, UK, Chairman & CEO: Yutaka Tsuchiya, “Eisai Europe”), the European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), and Bial - Portela & Ca, S.A. (Headquarters: São Mamede do Coronado, Portugal, CEO: Luís Portela, “Bial”) announced today that the anti-epileptic drug, Zebinix® (eslicarbazepine acetate), for which Eisai Europe obtained rights from Bial to market in Europe, was approved by the European Commission on April 21st, as an adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation.

Zebinix® is a novel once daily anti-epileptic drug developed by Bial and it is believed to exert an antiepileptic effect by regulating the activity of sodium channels. The efficacy and safety of Zebinix® when used in combination with other anti-epileptic drugs have been shown in clinical data from three Phase III studies (multi-centre, randomized, double-blind, placebo-controlled trials) conducted in 23 countries with more than 1,000 patients with refractory partial-onset seizures. Zebinix® demonstrated significant reductions in seizure frequency and a significant increase in responder rates (≥ 50% reduction in seizure frequency) across all three Phase III studies. In addition, Zebinix® showed a sustained decrease in seizure frequency and a significant improvement in quality of life during the long-term (one-year) open label studies conducted subsequent to those Phase III studies.

Epilepsy has a high prevalence among central nervous system diseases and affects about 3.4 million people in Europe. There are many patients with epilepsy whose condition is difficult to treat with existing anti-epileptic drugs for seizure control. The impact of seizures on patients’ quality of life should not be underestimated.

With the approval of Zebinix®, Eisai Europe will launch Zebinix® during FY2009 and FY2010 across Europe, under the terms of a license and co-promotion agreement signed with Bial on February 19th this year.

Eisai has been selling two other anti-epileptic drugs, Zonegran® for partial-onset seizures and Inovelon® for Lennox-Gastaut Syndrome, in Europe. Eisai will bring Zebinix®, a new treatment option, to patients with epilepsy as early as possible and make further contributions to addressing the diversified needs and improving quality of life of patients with epilepsy.


[Please refer to the following notes for product and company profile of Bial]

Contact:
PR Department
Eisai Co., Ltd.
+81 - (03) - 3817 - 5120


< Notes to Editors >


 • About Zebinix® (EU)
Brand Name : Zebinix®
Generic Name :eslicarbazepine acetate
Indication :Zebinix® is indicated as an adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation.
Dosage &
Administration :

Zebinix® must be added to an existing therapy. The recommended initial dose is 400mg once daily. After one or two weeks, the dose must be increased to 800mg once daily. Depending on the response to the treatment of each patient, the dose can be increased to 1200mg once daily.
Formulation :Tablet
Date of Approval :April 21st, 2009

 • About Bial - Portela & Ca, S.A.
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.

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 approximately 20% of its turnover in research and development every year. Key research areas for Bial are the central nervous system, the cardiovascular system and allergology. 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 www.bial.com