Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; 'ONO') today announced that it has entered into an exclusive license agreement with SK Biopharmaceuticals, Co., Ltd. for the development and commercialization of cenobamate, SKBP's antiepileptic drug, in Japan.
Cenobamate, discovered and developed by SKBP, was approved for the indication of partial-onset seizures in adult patients by FDA in November 2019 and launched under the brand name XCOPRI in May 2020.
Under the terms of the agreement, ONO will have exclusive rights to develop and commercialize cenobamate in Japan. SKBP will conduct a Phase 3 clinical study with cenobamate for the treatment of partial-onset seizures in adult patients in Japan. Further, SKBP retains an option right for co-promotion activities with ONO in Japan.
ONO will pay to SKBP a one-time upfront payment of JPY5 billion and up to an additional JPY48.1 billion at the time of filing an application and its approval in Japan and if certain commercial milestones are achieved. ONO will also pay to SKBP double digit royalties based on net sales 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 hope that cenobamate will be a new treatment option for patients suffering from epilepsy in Japan.'
'We are very pleased to form a strategic partnership with Ono Pharmaceutical that will mutually benefit both sides,' said Jeong Woo Cho, President and CEO of SK Biopharmaceuticals. 'This agreement would give us an unprecedented opportunity not only to expand our presence in one of Asian largest pharmaceuticals market but also to further create social value by reaching out to patients with 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, SKBP is focused on early research in oncology.
Both SKBP and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, the parent company of SKBP, 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.
Cenobamate was discovered and developed by SKBP 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 -aminobutyric acid type A (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, SKBP entered into an exclusive licensing agreement with Arvelle Therapeutics GmbH to develop and commercialize cenobamate in Europe.
Epilepsy is a chronic brain disorder in which neuronal activity in the brain becomes abnormal, causing seizures. It is reported that there is about 1 million patients suffering from epilepsy in Japan. Although the majority of epilepsy patients require long-term medication, about 30% of patients have not been well controlled for epileptic seizures with currently available antiepileptic drugs. Epilepsy is still a disease with high unmet needs.