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SK Biopharmaceuticals’ Partner Eurofarma Submits Prioritized NDA for Cenobamate in Brazil

09 Oct 2024
Admin
News Article

SK Biopharmaceuticals’ Partner Eurofarma Submits Prioritized NDA for Cenobamate in Brazil

Overview

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.

Collaboration for Epilepsy Treatment

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.
Under the terms of the agreement, SK Biopharmaceuticals will receive royalties on sales generated in those markets.

Epilepsy in USA

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 & Cenobamate

SK Biopharmaceuticals expects to further provide treatment options to patients in the region with cenobamate through Eurofarma.
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.

Words from the CEO: SK Biopharmaceuticals

“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.