SK Biopharmaceuticals has launched its new epilepsy drug 'cenobamate' in Japan. The company plans to strengthen its global position by expanding its presence into key Asian markets.
The company said Friday that its Japanese partner, Otsuka Pharmaceutical, has begun sales of the innovative epilepsy new drug cenobamate (Japanese product name: Ekisukopuri) in Japan.
This launch took place approximately two months after the approval by Japan's Ministry of Health, Labour and Welfare (MHLW) last September. Following its sales start in China in March this year, cenobamate was successively launched in South Korea and Japan this month, marking the beginning of sales in all three Northeast Asian countries: South Korea, China, and Japan.
Japan is the world's second-largest epilepsy market by single-country scale, following the United States, with an estimated 1 million patients. The cenobamate launched by Otsuka Pharmaceutical in Japan consists of 12.5mg, 50mg, 100mg, and 200mg tablets for patients with focal seizures.
Cenobamate demonstrated efficacy in the Asian Phase 3 clinical trial (study 035) conducted among adult patients with focal seizures in South Korea, China, and Japan whose seizures were not adequately controlled by existing anti-seizure medication.
The proportion of patients achieving complete seizure freedom during the six-week maintenance period was 12.4% in the cenobamate 100mg group, 30.1% in the 200mg group, and 52.4% in the 400mg group, compared to 2.6% in the placebo group. The most common adverse reactions (occurring in 20% or more) in the cenobamate treatment groups were dizziness and somnolence.
In October 2020, SK Biopharmaceuticals signed a technology transfer agreement with Otsuka Pharmaceutical for the development and commercialization of cenobamate in Japan.
With sales in Japan expected to gain momentum following this launch, royalty (running technical fee) revenue proportional to local sales is anticipated in the future.
Cenobamate has currently obtained approval as a treatment for adult focal seizure epilepsy in approximately 50 countries and regions worldwide, including the United States and Europe.
In the U.S., it is sold directly by its subsidiary SK Life Science, while in other key markets, business operations are conducted through regional collaborations.
Lee Dong-hoon, president of SK Biopharmaceuticals, said, "With the launch of cenobamate in Japan following South Korea and China, we have established a solid foundation for full-scale commercialization in major Northeast Asian markets."
He added, "We will expand the success experience built around the U.S. to Asian markets and drive continuous growth through strategies tailored to the characteristics of each regional market."
in THEBIO
