By Judy Ya-Hsuan Lin
Epilepsy haunts 3.4 million people in the U.S., accounting for roughly 1.2% of the population. Globally, it affects more than 65 million, which is about 1-in-26 people. It is sometimes referred to as a long-term condition, as people often live with it for many years or life. Although epilepsy usually cannot be cured for most patients, seizures can be controlled such that it has little or no impact on their lives. Conventional treatments for epilepsy include anti-epileptic drugs (AEDs), surgery to remove small parts of the brain causing seizures, insertion of a small electrical device inside the body to control seizures, and implementation of ketogenic diets.
Among all these different treatments, AEDs are less invasive while imposing fewer risks for patients to induce other complications. AEDs include carbamazepine, phenytoin, valproate, oxcarbazepine, lamotrigine, etc. These options allow patients and clinicians to choose which AED controls seizures the best, but offering another epileptic medication would provide patients with another perhaps better option.
Credits for An Extra Treatment Option
On October 13th, SK Biopharmaceuticals, based in South Korea and Ono Pharmaceutical headquartered in Osaka, Japan, announced its collaboration by entering a licensing agreement for an FDA-approved AED cenobamate in Japan. The collaboration allows SK Pharmaceuticals to receive 5 billion JPY, equivalent to US$ 47.4 million, and an additional milestone payment of 48.1 billion JPY as well as double-digit royalties on net sales yielded in Japan.
“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.”
Cenobamate & Clinical Trials
Discovered and developed by SK Biopharmaceuticals and SK life science, their U.S. subsidiary, cenobamate is believed to reduce repetitive neuronal impulses by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABA) ion channel. Cenobamate has received many approvals worldwide. For instance, the US FDA approved cenobamate, an anti-seizure medication (ASM), to treat partial-onset seizures in adults, available under the brand name XCOPRI®. In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe.
SK Biopharmaceuticals plans to conduct a Phase 3 clinical study for partial-onset seizures in adults in Northeast Asia (Japan, China, and Korea). The Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of cenobamate as adjunctive therapy in subjects with partial-onset seizures, with an optional open-label extension.
“The initiation of the Phase 3 clinical trial in Asia is a major milestone for cenobamate in our continuous effort to address unmet needs in epilepsy and central nervous system disorders worldwide,” said Jungshin Park, Vice President of SK Biopharmaceuticals’ drug development business. “SK Biopharmaceuticals has been planning to enter Asian markets after launching our anti-seizure medication in the U.S. and forming a partnership for commercialization in Europe. We are pleased to move forward as intended to expand our global footprint.”
Editor: Rajaneesh K. Gopinath, Ph.D.
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