February 27th, 2018 – BIAL and WhanIn Pharm. Co., Ltd, announced today an exclusive license agreement for the commercialization of Zebinix® (eslicarbazepine acetate) in South Korea.
Eslicarbazepine acetate is BIAL’s proprietary once daily anti-epileptic for the treatment of partial-onset seizures, with or without secondary generalization. It is marketed in several European markets and in the US and Canada.
“BIAL is committed to addressing the needs of patients and healthcare professionals worldwide and the control of seizures is a continual challenge. We are delighted to partner with WhanIn and thus be able to offer this treatment option for patients with focal epilepsy across South Korea,” comments António Portela, Chief Executive Officer of BIAL, Porto, Portugal.
“We are impressed by BIAL’s continuing efforts to develop innovative new drugs for a healthier future and very pleased to establish thispartnership. This agreement will allow us to strengthen our leading position in relevant therapeutic areas and Zebinix® will become the growth engine of our company in the 2020s” says Wonbum Lee, Chief Executive Officer & President of WhanIn, Seoul, South Korea.
WhanIn will initiate the necessary procedures to submit the marketing authorization application to the Ministry of Food and Drug Safety (MFDS) as earlier as possible, enabling eslicarbazepine acetate to be a new therapeutic option for healthcare professionals and patients in need in South Korea.
In Europe, eslicarbazepine acetate is indicated as a monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Eslicarbazepine acetate is also indicated in Europe as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.1 In the United States eslicarbazepine acetate is approved for the treatment of partial-onset seizures in adults, adolescents and children (four years of age and older).