Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix
LONDON, February 19 -- eisai Set to Become an Emerging Leader in the Treatment of Epilepsy
Eisai Europe Ltd (London; Chairman & CEO Yutaka Tsuchiya), the European subsidiary of eisai Co., Ltd. (Tokyo, President & CEO: Haruo Naito), and bial-Portela & CA, S.A., (S. Mamede do Coronado, Portugal, CEO Dr Luis Portela) today announced the signing of a licence and co-promotion agreement in which eisai receives a sole license to market, promote and distribute the novel once daily anti-epileptic Zebinix(R) (eslicarbazepine acetate), within Europe(1).
Under the terms of the agreement, bial will receive EUR95million consisting of an upfront payment plus milestone payments for further epilepsy approvals within Europe. bial will maintain ongoing development and production rights and the option to co-promote with eisai throughout Europe and will supply finished product to eisai.
Zebinix(R), subject to approval by the European Medicines Agency (EMEA), will initially be indicated for the adjunctive treatment of partial-onset seizures, with or without secondary generalisation, in patients 18 years and older with epilepsy. Zebinix(R) was submitted to the EMEA by bial in March 2008 and approval is anticipated in Q2 2009.
The safety and efficacy of Zebinix(R) has been shown in three phase III double-blind, randomised placebo-controlled trials in 1,049 patients with partial onset seizures. Additionally, these subjects were followed up long term in an open label extension. In these studies, Zebinix(R) demonstrated significant sustained improvements in seizure frequency, reduced depressive symptoms, and significantly improved scores in health related quality of life.
"It is as important to consider the implications on the quality of a patient's day-to-day life, as well as effective seizure control, when making the therapeutic evaluation
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SOURCE eisai Europe Ltd and bial
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