Eisai Signs License Agreement in Europe for an Anti-epileptic Drug
Eisai Europe Limited (Headquarters: London, Chairman & CEO: Yutaka Tsuchiya), a European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), announced that it entered into a license and co-promotion agreement with Bial - Portela & Ca, S.A. (Headquarters: São Mamede do Coronado, Portugal, CEO: Luís Portela, “Bial”), which gives Eisai Europe Ltd. rights to sell Bial's anti-epileptic drug ZEBINIX® (eslicarbazepine acetate) in Europe.
ZEBINIX® is a novel anti-epileptic drug which is currently being developed by Bial. It is believed to exert its antiepileptic effect by regulating the activity of sodium channels. Study data suggest that once a day ZEBINIX® not only reduces seizure frequency significantly, but also improves the quality of life of patients and their depressive symptoms. ZEBINIX® was submitted to the European Medicines Agency (EMEA) by Bial in March 2008 and is now under review by the EMEA for approval for adjunctive therapy in adults with partial-onset seizures. Approval is anticipated in 1Q fiscal year 2009.
Among central nervous system diseases, epilepsy has a high prevalence amongst central nervous system diseases and affects about 3.4 million people in Europe. The ultimate objective of pharmacological treatment of epilepsy is to eliminate seizures for patients, but there are many patients with epilepsy whose condition is difficult to treat with existing anti-epileptic drug for seizure control. The impact of seizures on patients’ quality of life and also on development of the depressive symptoms should not be underestimated.
This agreement allows Eisai to bring a new treatment option for patients with epilepsy in Europe, adding ZEBINIX® to its already marketed epilepsy treatment such as Zonegran® and Inovelon®. Eisai will remain committed to make further contributions in addressing the diversified needs of and improving benefits to patients with epilepsy and their families.
Eisai Co., Ltd.
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<Notes to Editors>
ZEBINIX® (eslicarbazepine acetate) is a novel once a day anti-epileptic drug which is currently being developed by Bial. It exerts its antiepileptic effect by blocking the voltage-gated sodium channels. Data from the three Phase III, multi-centre, randomized, double-blind, placebo-controlled trials with more than 1,000 patients with refractory partial-onset seizures from 23 countries showed its clinical efficacy when used in combination with other anti-epileptic drugs. In addition, ZEBINIX® has been demonstrated to improve quality of life and reduce depressive symptoms of patients, during one year open-label extension studies of the above three Phase III trials.
About Bial - Portela & Ca, S.A.
Founded in 1924, Bial - Portela & Ca, S.A. (“Bial”), headquartered in the suburbs of Porto, Portugal, is a research-based and the largest Portuguese pharmaceutical group. Bial makes aggressive investment in R&D, focusing especially on the therapeutic areas of CNS, cardio-vascular diseases, and allergies. Various products developed by Bial are currently available in more than 30 countries worldwide, primarily in Europe, Africa, and Latin America. Its turn over in 2007 was 147 million euros.
For further information about Bial, please visit http://www.bial.pt