SK Biopharm Epilepsy New Drug 'Cenobamate', Full-Scale Global Expansion Begins

Partnership with Latin American Company Europharma
Technology Export Contract for Cenobamate

Market Expansion Opportunity Expected in the US After 'Vimpat' Patent Expiration

SK Biopharm's epilepsy new drug 'Cenobamate' US launch name 'Xcopri'

[Asia Economy Reporter Chunhee Lee] SK Biopharm's innovative epilepsy drug 'Cenobamate' is expanding into the global market.

On the 15th, SK Biopharm announced that it signed a technology licensing agreement with its local partner Eurofarma to commercialize Cenobamate in the Latin American region. With this, Cenobamate has successfully entered four continents: starting with the United States, then North America, Europe, Asia, and now Latin America.

The contract size includes a non-refundable upfront payment of $15 million (approximately 19.8 billion KRW) and milestone payments totaling $62 million (approximately 81.7 billion KRW) based on development, approval, and sales stages. Additionally, royalties based on sales revenue after commercialization have been secured.

Eurofarma, headquartered in Brazil, is a major pharmaceutical company in Latin America specializing in sales and marketing of central nervous system treatments and has a sales network throughout Latin America. SK Biopharm plans to enter 17 Latin American countries, including Brazil and Mexico, through Eurofarma. It is known that more than half of the over 6 million epilepsy patients in Latin America do not receive adequate treatment.

Cenobamate is an epilepsy drug for adult partial seizure treatment. In 2019, SK Biopharm became the first Korean company to independently carry out the entire process from candidate discovery to clinical trials and FDA approval without technology licensing. Furthermore, SK Lifescience, the local subsidiary in the U.S., has taken charge of direct sales.

SK Biopharm has begun expanding its market through technology transfer agreements with local partners in overseas regions excluding the U.S. Starting with a technology transfer contract with Avel Therapeutics in February 2019, which included an upfront payment of $100 million (approximately 131.8 billion KRW) and a total contract value of $530 million, SK Biopharm has succeeded in technology transfers to Japan, China, Canada, Israel, and now Latin America, achieving entry into four continents. The upfront payments and milestone receipts secured through these agreements amount to $278.22 million and 5 billion yen, totaling approximately 414.1 billion KRW at current exchange rates.

In Europe, sales approval has been obtained in eight major countries including Germany, the United Kingdom, and Austria, with sales either launched or preparations underway. Domestically, multinational Phase 3 clinical trials involving 540 adult patients are currently underway in Korea, China, and Japan. The goal is to complete the trials within 1 to 2 years and launch domestically in 2025.

Active expansion is also underway in existing markets. The U.S. product, 'Xcopri,' recorded sales of 31.7 billion KRW in the first quarter, nearly tripling compared to the same period last year.

Particularly, with the patent for 'Vimpat' (active ingredient lacosamide), the largest competitor in the existing epilepsy market, expiring in March, there were concerns about a decline in market share due to the launch of generic versions. However, it is now expected to become an opportunity.

Hana Kang, a researcher at Ebest Investment & Securities, commented, "As prescriptions for Vimpat sharply decrease, generics and originals within lacosamide formulations are competing for market share. This creates room in epilepsy patients' insurance drug prices, allowing for additional prescriptions of Xcopri."

This content was produced with the assistance of AI translation services.