Donghoon Lee, CEO of SK Biopharm: "Comprehensive Epilepsy Solution Within Reach"... 1.1 Trillion Won Investment

Introduction of Epocalim, Epilepsy Candidate Compound

Contract Worth 1.0996 Trillion Won Signed with U.S. Biotech

Superior Safety and Tolerability Compared to Xcopri

Great Potential for Use in Combination Therapy and Beyond

SK Biopharm will invest around 1 trillion won in the introduction of a follow-up new drug to its flagship epilepsy treatment cenobamate (product name: Xcopri). The company’s strategy is to secure a pipeline that covers both severe patients who require highly potent medications and early-stage patients for whom safety is paramount, thus building a “comprehensive epilepsy solution.”

SK Biopharm CEO Donghoon Lee is explaining about the introduction of a new drug candidate for epilepsy at a press briefing held on the 26th at the Westin Chosun Seoul in Jung-gu, Seoul. SK Biopharm

On the 26th, during a meeting with the press at the Westin Chosun Seoul in Jung-gu, Seoul, Donghoon Lee, CEO of SK Biopharm, explained the background behind licensing in the epilepsy drug candidate “Opacalim,” stating, “It clearly differs from the existing treatment Xcopri in terms of tolerability and safety.” He further commented, “This is a golden opportunity to build a comprehensive epilepsy solution—administering Xcopri to severe patients in need of strong efficacy and Opacalim to early-stage patients.”

He added, “Data from the open-label extension (OLE) study showed a significantly lower incidence of adverse events, and most of the reported side effects spontaneously resolved as mild cases. This makes it suitable for early-stage patients to use without burden.”

On the same day, SK Biopharm announced through a public filing that it had signed a contract with US biotech firm Biohaven to introduce Opacalim as well as other potassium channel (Kv7) activator compounds and a related new drug discovery platform. The total contract is valued at $795 million (approximately 1.0996 trillion won), with $400 million paid as upfront payments regardless of clinical milestones. Of this amount, $350 million will be paid upon closing the deal, with the remaining $50 million to be paid subsequently.

Opacalim is currently undergoing phase 2 and phase 3 clinical trials for adult patients with partial onset seizures (POS). If the clinical studies and regulatory procedures progress as scheduled, the first major topline results of the RISE3 trial are expected by the end of this year. The company aims to release further clinical results in 2028 and target a US market launch as early as 2029.

CEO Lee described this contract as a “turning point for SK Biopharm to advance further into the global market.” If Opacalim receives approval as planned, SK Biopharm will move beyond a business structure centered solely on Xcopri and will secure a second commercialized product. With this, the company plans to transform itself into a new drug developer that directly sells multiple innovative drugs in the global market.

SK Biopharm also expressed confidence in competing with “Azetucalner” by Xenon Pharmaceuticals, which, like Opacalim, targets the Kv7 potassium channel.

Changho Yoo, Head of Strategy at SK Biopharm, stated, “Opacalim is expected to enter the market about a year later than Xenon, but we believe its ability to overcome the shortcomings of the competing substance will allow it to sufficiently penetrate the market even as a latecomer,” adding, “Unlike the competing substance, it exhibits strong efficacy comparable to GABA-related drugs, but without acting on GABA.”

This content was produced with the assistance of AI translation services.