SK Biopharmaceuticals brings in Opakalim in a deal worth up to 1.1 trillion won, targeting the global epilepsy market

[Financial News] SK Biopharmaceuticals is accelerating the expansion of its Central Nervous System (CNS) business by licensing in the late-stage epilepsy drug candidate Opakalim (BHV-7000) from U.S. biotech company Biohaven for up to 1.1 trillion won. As the company secures a near-commercialization-stage candidate following its in-house drug cenobamate, sold in the U.S. as Xcopri, expectations are also rising for a stronger epilepsy portfolio built around cenobamate and Opakalim.
On the 26th, SK Biopharmaceuticals disclosed that it had signed a global exclusive license agreement with Biohaven Bioscience Ireland for Opakalim, as well as Kv7 channel activator compounds and related discovery platforms.
The total deal value is up to $795 million, or about 1.1 trillion won, with an upfront payment of $400 million, or about 553.2 billion won. SK Biopharmaceuticals will pay $350 million at closing and an additional $50 million one year later. This is the largest-ever deal by a Korean pharmaceutical or biotech company for in-licensing a new drug substance.
Opakalim is an oral epilepsy treatment candidate that selectively activates Kv7.2 and Kv7.3 potassium channels, which help regulate excessive neuronal excitation.
Global Phase 2 and 3 trials, RISE2 and RISE3, are currently underway in patients with refractory focal seizures. RISE3 completed patient enrollment in June, and key trial results are expected in the second half of this year.
In a previously disclosed open-label extension study, 54% of patients who took 75 mg of Opakalim once daily showed a reduction of more than 50% in seizure frequency compared with baseline for six consecutive months. However, because the results came from an open-label extension study, the final efficacy and safety profile must still be confirmed in the ongoing Phase 2 and 3 trials.
What stands out in this deal is that cenobamate and Opakalim act through different mechanisms. While cenobamate is growing in the U.S. market on the back of its strong seizure-suppressing effect, SK Biopharmaceuticals believes Opakalim can differentiate itself through safety and tolerability.
At the press conference, Yoo Chang-ho, head of strategy at SK Biopharmaceuticals, said, "Efficacy is a given, but Opakalim’s distinctive differentiators in the market will be tolerability and safety." He added, "Depending on patient needs, cenobamate and Opakalim could have complementary effects."
SK Biopharmaceuticals is also banking on the fact that it can leverage the sales and marketing organization it has already built through direct U.S. sales of cenobamate for Opakalim as well. By bringing in a new product without having to build a separate commercialization team from scratch, the company expects to save time and costs while maximizing synergies between the two products.
Lee Dong-hoon, president of SK Biopharmaceuticals, described the deal not simply as securing a pipeline asset, but as the starting point for a transition into a multi-product company. "There is a world of difference between a single-product and a multi-product biopharma company," he said. "We will be able to grow the value of our epilepsy portfolio by combining cenobamate and Opakalim."
If Opakalim is commercialized, SK Biopharmaceuticals will have two epilepsy treatments with different mechanisms in the same therapeutic area. That would broaden prescribing options based on patient characteristics and could also support revenue growth by leveraging its existing U.S. sales network.
Lee said, "Opakalim is not the end, but the beginning," and outlined a strategy to expand the product lineup through additional licensing deals and in-house drug development. Having already proven its commercialization capabilities in the U.S. CNS market through cenobamate, SK Biopharmaceuticals is now drawing attention to whether Opakalim can help the company evolve from a single-product model into a pharmaceutical firm with multiple global products.
[email protected] Kang Jung-mo Reporter