Eisai has secured a licence to market Bial’s novel once-daily anti-epileptic Zebinix, which has just been recommended for approval in Europe.
Under the terms of the agreement, Bial will receive 95 million euros, consisting of an upfront payment plus milestones for further epilepsy approvals within Europe. The Portuguese firm will keep development and production rights and the option to co-promote Zebinix (eslicarbazepine).
The compound is for the adjunctive treatment of partial-onset seizures, with or without secondary generalisation, in patients in epileptics aged 18 and above. Bial says it expects the drug to be approved in the second quarter, having just received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The Sao Mamede Do Coronado-based group said the safety and efficacy of Zebinix has been shown in three Phase III trials in 1,049 patients with partial onset seizures. Additionally, these subjects were followed up long-term and Zebinix demonstrated “significant sustained improvements in seizure frequency, reduced depressive symptoms, and significantly improved scores in health-related quality of life”.
Epilepsy expert Elinor Ben-Menachem of the University of Gothenburg, Sweden, appears to like the look of eslicarbazepine. She said that “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 of a new anti-epileptic. As such, “in addition to sustained reductions in seizure frequency, Zebinix also demonstrated a significant improvement in patient quality of life and reduction in depressive symptoms”.
Bial chief executive Luis Portela said the partnership with Eisai “is a landmark event” for the firm as it represents “the first results of our R&D efforts in the CNS area”. Yutaka Tsuchiya, chairman of Eisai Europe added that Zebinix “joins our existing successful portfolio of anti-epileptics, which includes Zonegran (zonisamide) and Inovelon (rufinamide).
A New Drug Application is currently being prepared with an anticipated submission to the US Food and Drug Administration in the next few months. Bial has already lined up Sepracor as its marketing partner there.
