Eisai updates on epilepsy drugs Zonegran, Zebinix and perampanel at IEC

Japanese drug major Eisai (TYO: 4523) presented new data at the International Epilepsy Congress taking place in Rome, Italy, regarding its epilepsy drug portfolio, notably: Zonegran (zonisamide) monotherapy and pivotal pediatric clinical trial results; a clinical update on Zebinix (eslicarbazepine acetate) and new global Phase III perampanel results, including the latest findings from Study 305.

Eisai and privately-held Portuguese drugmaker BIAL, which licensed Zebinix to the Japanese firm in 2009 for an upfront consideration of 95 million euros ($136 million at current exchange rates) presented 25 abstracts, highlighting an extensive development program for the drug. The presentations evaluated the use of eslicarbazepine acetate as monotherapy, its efficacy and safety in children with partial-onset seizures, its cognitive effects when used as an add-on therapy in children and its potential for use in elderly patients with partial-onset seizures, with positive results reported.

Zebinix is approved in Europe as adjunctive therapy for use in adults with partial-onset seizures with or without secondary generalisation. At a press briefing by the companies in Rome, BIAL’s international strategic marketing manager, Francisco Osorio, told The Pharma Letter that the drug is now launched in a total of 14 countries, but the companies are still negotiating with the relevant national authorities on reimbursement. In the USA, said Mr Osorio, it is in discussion with North American partner for the drug, Sunovian Pharmaceuticals, with the Food and Drug Administration, which in 2010 issued a complete response letter for eslicarbazepine.