SK Biopharmaceuticals’ Latin American partner Eurofarma has submitted its new drug application (NDA) to Brazil’s health authority, ANVISA, for a fast-track or prioritized approval of the antiseizure medication, cenobamate.The two sides forged a partnership in which SK Biopharmaceuticals, a Korea-based biotech, out-licensed cenobamate to Eurofarma, a Brazilian pharmaceutical company, for the development and commercialization of the epilepsy treatment in 17 Latin American markets.

SK Biopharmaceuticals的拉丁美洲合作伙伴Eurofarma已将其新药申请（NDA）提交给巴西卫生局ANVISA，以快速或优先批准抗癫痫药物cenobamate。双方建立了合作关系，韩国生物技术公司SK Biopharmaceuticals将cenobamate授权给巴西制药公司Eurofarma，在17个拉丁美洲市场开发和商业化癫痫治疗。

Under the terms of the agreement, SK Biopharmaceuticals will receive royalties on sales generated in those markets.There are over 6 million people living with epilepsy in Latin America and the Caribbean, with more than half not receiving any form of medical care, according to the National Center for Biotechnology Information and the World Health Organization.SK Biopharmaceuticals expects to further provide treatment options to patients in the region with cenobamate through Eurofarma.

根据协议条款，SK Biopharmaceuticals将从这些市场产生的销售额中获得版税。根据国家生物技术信息中心和世界卫生组织的数据，拉丁美洲和加勒比地区有600多万癫痫患者，其中一半以上没有接受任何形式的医疗护理。SK Biopharmaceuticals预计将通过Eurofarma进一步为该地区的患者提供治疗选择。

Cenobamate has been previously launched in the United States, Europe, Canada, Israel, and SK Biopharmaceuticals has forged partnerships for cenobamate in Korea, Japan, China, Southeast Asia, and the Middle East and Africa.“We will be collaborating with our partner, Eurofarma, to ensure that patients in Brazil and other Latin American countries gain access to cenobamate sooner than expected, as well as with other regional partners to rapidly launch the antiseizure medication in untapped markets,” said Donghoon Lee, CEO and president of SK Biopharmaceuticals.  Source: skbp.com.

Cenobamate之前已在美国，欧洲，加拿大，以色列推出，SK Biopharmaceuticals已与Cenobamate在韩国，日本，中国，东南亚以及中东和非洲建立了合作伙伴关系。SK Biopharmaceuticals首席执行官兼总裁Donghoon Lee表示：“我们将与我们的合作伙伴Eurofarma合作，以确保巴西和其他拉丁美洲国家的患者比预期更快地获得新生胺，并与其他区域合作伙伴合作，在未开发的市场快速推出抗癫痫药物。”。来源：skbp.com。