Under the terms of the agreement, Bial will receive E95 million 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, 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 generalization, in patients 18 years and older with epilepsy. Zebinix was submitted to the EMEA by Bial in March 2008 and approval is anticipated in second quarter of 2009.
Zebinix is a novel once a day anti-epileptic drug, which 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 three Phase III trials.
Yutaka Tsuchiya, chairman and CEO of Eisai Europe, said: We are delighted to be working with Bial to bring to patients such a potentially promising new treatment for epilepsy. Zebinix joins our existing successful portfolio of anti-epileptics, which includes Zonegran and Inovelon.