The acquisition of the Opacalim license isn’t the end; it’s just the beginning, declared Lee Dong-hoon, Chief Executive Officer (CEO) of SK Biopharmaceuticals, during a press conference held on Wednesday afternoon at the Westin Chosun Seoul. He elaborated that the aim is to compete on a global stage, focusing on big pharma and biotech companies in the U.S. and Europe, rather than limiting ourselves to the Korean market.
That same day, SK Biopharmaceuticals announced a landmark deal to acquire the epilepsy drug candidate Opacalim from global biotech firm Biohaven Pharmaceuticals, in a transaction valued at up to 795 million USD. The agreement includes an upfront payment of 400 million USD, with 350 million USD due upon closing and the remaining 50 million USD payable after one year.
Opacalim, a selective potassium channel Kv7 activator, is currently in Phase 2 and 3 clinical trials for adult partial-onset seizures (POS). The company is targeting to secure initial topline results from the RISE3 clinical trial by year-end, with plans to launch in the U.S. as early as 2029, following the announcement of second clinical results in 2028.
Lee addressed the slight delay in their product pipeline, stating that he had committed to delivering a second product by the second half of 2025, but they’re about eight months behind schedule. They’ve thoroughly evaluated most products on the market, aiming to acquire assets closer to market-ready products rather than early-stage pipeline candidates.
The strategic choice of Opacalim by SK Biopharmaceuticals is rooted in its potential synergy with their existing Xcopri business. The company can leverage its established sales and marketing infrastructure in the U.S. epilepsy market, eliminating the need to build a new sales network from scratch for the incoming product.
Yoo Chang-ho, head of SK Biopharmaceuticals’s strategy division, explained the complementary nature of their product portfolio: It can offer Xcopri to patients requiring strong efficacy, while Opacalim will be ideal for those prioritizing safety and tolerability. This approach allows us to provide comprehensive solutions to a broader patient base.
SK Biopharmaceuticals expressed strong confidence in Opacalim’s clinical success potential. The potassium channel modulation mechanism has already demonstrated clinically validated seizure suppression capabilities through existing drugs, suggesting lower development risks compared to entirely novel mechanisms.
Yoo emphasized that they’ve conducted a comprehensive evaluation of all available data. The thorough assessment of both preclinical and clinical data has reinforced the conviction in achieving success in clinical trials.
The patent duration is another crucial factor in this acquisition. While Xcopri’s substance patent is set to expire in 2032, Opacalim’s extends until 2039. There’s potential for further extension through mechanisms like Patent Term Extension (PTE) under U.S. patent law.
Lee highlighted the long-term impact of this acquisition, stating that with Opacalim in our portfolio, it’s looking at potential cash flow extending into the 2040s. This isn’t just about incremental revenue; it provides them with extended strategic planning horizons and enhanced decision-making flexibility.
Looking ahead, SK Biopharmaceuticals plans to pursue additional inorganic growth opportunities beyond Opacalim. The company has identified disease-modifying therapies (DMT) targeting root causes of neurological disorders and rare forms of epilepsy as key areas for future investment.
Lee concluded that this pipeline acquisition marks just the beginning of the expansion strategy. It’s committed to advancing disease-modifying therapies and will continue to seek inorganic growth opportunities to broaden the reach in rare epilepsy indications.
