Companies expect to gain approval from the EMEA by the second quarter.
Eisai Europe will pay €95 million, or about $120 million, to market, promote, and distribute Bial-Portela’s antiepileptic drug in Europe. Zebinix is currently being reviewed by the EMEA, and the companies expect to gain approval in the second quarter.
Bial will maintain ongoing development and production rights as well as have the option to co-promote throughout Europe.
Zebinix was submitted to the EMEA in March 2008 as an adjunctive treatment of partial-onset seizures with or without secondary generalizations in epileptic patients 18 years and older. In three Phase III trials with 1,049 participants, Zebinix reportedly demonstrated improvements in seizure frequency, reduced depressive symptoms, and improved quality of life.
The Portuguese company’s drug will join Eisai’s existing portfolio of antiepileptics, which includes Zonegran and Inovelon. Zonegran is approved as a combination therapy to treat partial seizures in adults, and Inovelon as an adjunctive therapy in Lennox-Gastaut syndrome, a form of childhood epilepsy.