SK Biopharmaceuticals' epilepsy drug cenobamate has gone on sale in Japan, giving it a presence in all three Northeast Asian countries: South Korea, China and Japan. We looked at what the sales footprint, which began in the United States, moved through Europe and has now widened to Asia, means for the company's revenue structure.
SK Biopharmaceuticals (CEO Lee Dong-hoon) said on the 13th that its partner, Japan's Ono Pharmaceutical, has launched cenobamate in the local market and begun sales. The product name used in Japan is "Ekiscopri (エキスコプリ)." The launch came about two months after Japan's Ministry of Health, Labour and Welfare granted approval for the new drug in September. The company disclosed that four products have been launched in Japan.
The launch is the result of a multiyear partnership. In October 2020, SK Biopharmaceuticals teamed up with Ono Pharmaceutical to jointly pursue the development and commercialization of cenobamate in Japan. Ono Pharmaceutical handles local sales. The structure puts a local drugmaker already established in the Japanese market at the forefront of entry. That only about two months passed between approval and launch indicates that preparations for sales had been under way in advance of approval.
The structural significance becomes clear when looking at the change in sales regions. Cenobamate expanded its market centered on the United States and later widened its stage to Europe. With Korea, China and Japan now added through the Japan launch, its sales regions have been divided into three pillars: North America, Europe and Northeast Asia. It is a shift from a structure that relied on results in one region to a sales network spanning multiple continents. As the number of regions has grown, so have the channels through which revenue can be generated.
The company said the launch has "established a commercialization base" in the three Northeast Asian countries. It added that it would "expand cenobamate's success, built mainly in the United States, to the Asian market," making clear its intention to make Asia its next stage of expansion. SK Biopharmaceuticals plans to widen its reach to major Asian markets and solidify its standing in the global market.
The company also disclosed product information. The adverse reactions seen in more than 20% of patients in clinical trials were dizziness and drowsiness. For a new drug entering a new market, local medical staff decide whether to prescribe it based on such safety information.
What remains to be watched is performance after launch. Whether the company's plan to carry the experience built in the United States over to Asia translates into actual results will be gauged by how well cenobamate establishes itself in the newly opened Japanese market. With entry into the three Northeast Asian countries complete, sales performance by region is expected to become the yardstick for evaluating the company's expansion strategy.