SK Biopharmaceuticals, Ono Pharmaceutical Enter Licensing Agreement for Cenobamate in Japan

SK Biopharmaceuticals and Ono Pharmaceutical announced that they have entered into an exclusive licensing agreement for Ono to develop and commercialize cenobamate in Japan. Cenobamate is a treatment for partial-onset seizures (POS) that received FDA approval in 2019.

As per terms of the deal, SK Biopharmaceuticals will receive an upfront payment of JPY 5 billion (US $47 million) from Ono. SK Biopharmaceuticals will also be eligible to receive up to JPY 48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double digit royalties on net sales generated in Japan.

SK Biopharmaceuticals will conduct a Phase 3 clinical study1 for partial-onset seizures in adults in Northeast Asia (Japan, China, and Korea). In addition, SK Biopharmaceuticals has an option for co-promotion with Ono in the Japanese market.

"We are very pleased to form a strategic partnership with Ono that will mutually benefit both sides," said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals. "This agreement would give SK Biopharmaceuticals an unprecedented opportunity not only to expand our presence in one of Asia's largest pharmaceuticals markets but also to further create social value by reaching out to patients with epilepsy in Japan."

"We are very delighted to enter into this collaboration with SK Biopharmaceuticals on cenobamate discovered and developed by SK Biopharmaceuticals," said Gyo Sagara, President, Representative Director of Ono. "We believe that cenobamate will be a new treatment option for patients suffering from epilepsy in Japan."

About SK Biopharmaceuticals Co., Ltd.

SK Biopharmaceuticals and its U.S. subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. 

Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. 

About Ono Pharmaceutical Co., Ltd.

Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on the oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. 

About Cenobamate 

Cenobamate was discovered and developed by SK Biopharmaceuticals and SK life science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.

Cenobamate is approved in the United States as an anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults, and is available under the brand name XCOPRI® (cenobamate tablets) CV. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe.

XCOPRI® is a registered trademark of SK Biopharmaceuticals Co., Ltd.