We will grow the new epilepsy drug candidate "opacalim" into a blockbuster drug.
Lee Dong-hoon SK Biopharmaceuticals(326030) said this at a press briefing held at the Westin Josun Seoul in Jung District, Seoul, on the 26th. SK Biopharmaceuticals selected opacalim as the next-generation drug candidate to follow the new epilepsy drug Cenobamate. The company made an investment of about 1.1 trillion won to bring in opacalim from a U.S. corporations.
Epilepsy is a disease in which nerve cells in a specific part of the brain become abnormally excited and repeatedly cause seizures. Opacalim is considered to have fewer side effects than existing drugs. Lee said, "By adding opacalim to Cenobamate, our goal is to have two blockbuster drugs between 2030 and 2040," adding, "We will become strong in central nervous system (CNS) therapeutics in the United States."
◇ Brought in epilepsy drug candidate "opacalim" from a U.S. corporations
SK Biopharmaceuticals announced that it would introduce the new epilepsy drug candidate opacalim from Biohaven in the United States on the day. Opacalim is a next-generation candidate that controls seizures and is considered to reduce side effects. SK Biopharmaceuticals holds exclusive rights to development and commercialization.
Opacalim is currently in phase 2/3 clinical trials. SK Biopharmaceuticals plans to apply for approval with the U.S. Food and Drug Administration (FDA) around 2028 if there are no particular issues with the clinical results. The target product launch is 2029. The patent period for opacalim is said to run until 2039.
SK Biopharmaceuticals signed a license-in (technology introduction) agreement for opacalim with Biohaven and will invest up to $795 million (about 1.0996 trillion won). The amount includes a $400 million (553.2 billion won) upfront payment and $395 million (546.3 billion won) in milestones tied to development and approval stages. Lee said, "By combining the strengths of Cenobamate and opacalim, we will expand the playing field (market) in the United States."
◇ "Fewer side effects… suitable for patients for whom safety is critical"
SK Biopharmaceuticals already has the new epilepsy drug Cenobamate. It was approved by the U.S. FDA in late 2019 and has been sold since the following year under the name Xcopri. SK Life Science, the U.S. subsidiary of SK Biopharmaceuticals, sells it directly.
Lee said, "Cenobamate works well and is regarded among epilepsy specialists as a drug effective for severe patients," adding, "Physicians who are not specialists, on the other hand, tend to prescribe drugs with fewer side effects, and opacalim can complement this aspect."
Yu Chang-ho, head of strategy at SK Biopharmaceuticals, said, "Even with the same epilepsy, different patients need different drugs," adding, "Cenobamate is used for patients who need powerful efficacy, and opacalim can be given to patients for whom safety is more important." He also noted, "It has the advantage of allowing epilepsy patients to try it easily from the early stage and broadening prescriptions."