SK Biopharmaceuticals Launches Epilepsy Drug 'Cenobamate' in Japan

Completed entry into South Korea, China and Japan
Targeting the world's second-largest epilepsy market

SK Biopharmaceuticals has launched its new epilepsy drug cenobamate in Japan, the world's second-largest epilepsy market. With sales beginning in Japan following launches in China and South Korea earlier this year, the company has completed its entry into the three major Northeast Asian markets.

Product image of cenobamate, SK Biopharm's novel epilepsy drug. SK Biopharm

On November 13, SK Biopharmaceuticals announced that its Japanese partner, Ono Pharmaceutical, had begun selling cenobamate (marketed in Japan as Exiscopri) in the country. The launch came about two months after the drug received approval from Japan's Ministry of Health, Labour and Welfare in September. The product is available as 12.5 mg, 50 mg, 100 mg and 200 mg tablets for patients with partial-onset seizures. Cenobamate was launched in China in March this year, in South Korea early this month, and now in Japan.

Japan is the world's second-largest epilepsy market after the United States, with an estimated 1 million patients. SK Biopharmaceuticals signed a licensing agreement with Ono Pharmaceutical in October 2020 for the development and commercialization of the drug in Japan. As sales in Japan ramp up, the company is expected to generate royalty revenue based on local sales.

Cenobamate demonstrated efficacy in a Phase 3 clinical trial in Asia involving adult patients with partial-onset seizures in South Korea, China and Japan whose seizures were not adequately controlled with existing antiseizure medications. During the six-week maintenance period, the proportion of patients who experienced no seizures was 12.4% in the 100 mg group, 30.1% in the 200 mg group and 52.4% in the 400 mg group, compared with 2.6% in the placebo group. The most common adverse reactions were dizziness and somnolence.

Cenobamate has been approved as a treatment for partial-onset seizures in adults in about 50 countries and regions worldwide, including the United States and Europe. In the United States, its subsidiary SK Life Science sells the drug directly, while in other major markets the company works with regional partners.

Lee Dong-hoon, president of SK Biopharmaceuticals, said, "With cenobamate now launched in Japan following its launches in South Korea and China, we have established a foundation for full-scale commercialization in major Northeast Asian markets. We will extend the success we have built in the United States to Asian markets and continue to grow with strategies tailored to the characteristics of each region."

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