SK Biopharm and Eurofarma Seek Approval for Cenobamate in Brazil for Epilepsy Treatment
Key Insights
SK Biopharm (search) and Eurofarma (search) have submitted a New Drug Application (NDA) to ANVISA for cenobamate, aiming to provide a new treatment option for epilepsy (search) patients in Brazil.
Cenobamate, already available in the U.S., Europe, and Canada, is poised to address the significant unmet needs in Latin America, where over half of epilepsy (search) patients lack adequate care.
Eurofarma (search) will distribute cenobamate across 17 Latin American countries, including Brazil and Mexico, with SK Biopharm (search) set to receive milestone payments and royalties upon approval and commercialization.
SK Biopharm (search) and its partner Eurofarma (search) have announced the submission of a New Drug Application (NDA) to the Brazilian health regulatory agency (ANVISA) for cenobamate, an innovative epilepsy (search) drug. This submission marks a significant step toward expanding access to this treatment for epilepsy patients in Brazil and other Latin American countries.
Addressing Unmet Needs in Latin America
Cenobamate, marketed as Xcopri in the United States, has already been launched in the U.S., Europe, and Canada, with plans for launch in Israel in 2024. Its introduction in Latin America is particularly crucial, as the region faces substantial challenges in epilepsy (search) care. It is estimated that over half of the six million epilepsy patients in Latin America do not receive adequate treatment. The availability of cenobamate is expected to fill this gap and significantly improve the quality of life for many patients.
Commercialization Strategy
Eurofarma (search), a leading pharmaceutical company in Latin America with a strong sales network and expertise in central nervous system (CNS) disorders, will be responsible for distributing cenobamate across 17 Latin American countries, including Brazil and Mexico. SK Biopharm (search) anticipates receiving milestone payments and royalties based on the achievement of regulatory approval and successful commercialization.
Executive Perspectives
Lee Dong-hoon, President of SK Biopharm (search), emphasized the importance of this collaboration, stating, "We are working closely with our partner Eurofarma (search) to ensure that epilepsy (search) patients in Brazil and Latin America can receive Cenobamate prescriptions as soon as possible." He further added, "We will do our best to achieve rapid launches through our partners in the remaining regions where the drug has not yet been released."
SK Biopharm's Global Expansion
The push to introduce cenobamate in Latin America is part of SK Biopharm (search)'s broader strategy to expand its global footprint. The company has established partnerships for technology exports to 30 countries, including the United States, Europe, Japan, China, Canada, Israel, the Middle East/North Africa, and South Korea. Clinical trials in the Asian region are also in the final stages, suggesting that further launches of cenobamate through regional partners are expected to continue.
Cenobamate's Clinical Impact
Cenobamate offers a novel mechanism of action, providing a new therapeutic option for patients with epilepsy (search) who have not achieved adequate seizure control with existing treatments. Its availability in Latin America could potentially transform the treatment landscape for many patients who currently lack access to effective therapies.