SK Biopharmaceuticals以最高7.95亿美元从Biohaven引进癫痫候选药Opakalim及Kv7平台全球独家许可

SK Biopharmaceuticals (326030.KS) will spend up to 1.1 trillion won ($795 million) to in-license a late-stage epilepsy drug candidate. The move secures the company's second global drug candidate after cenobamate, its in-house epilepsy treatment sold in the United States under the brand name XCOPRI, and is aimed at strengthening its position in central nervous system (CNS) disorders. With a U.S. launch possible as early as 2029, analysts see the deal as securing a follow-on growth driver ahead of 2032, when cenobamate's key compound patent expires.
SK Biopharmaceuticals said on the 26th that it had signed a worldwide exclusive license agreement with Biohaven Bioscience Ireland covering the epilepsy drug candidate Opakalim (BHV-7000), other potassium channel (Kv7) activator compounds and the Kv7 discovery platform.
The deal is worth up to $795 million, or about 1.0995 trillion won, the largest in-licensing agreement for an overseas drug candidate ever signed by a Korean pharmaceutical or biotech company. The non-refundable upfront payment alone is $400 million, or about 553.2 billion won, more than half the total value. SK Biopharmaceuticals will pay up to $395 million in milestone payments tied to development and regulatory approval stages, plus separate royalties on net sales after launch.
It is the first time SK Biopharmaceuticals has in-licensed a CNS drug candidate from an outside party. In 2024, the company brought in the radiopharmaceutical therapy (RPT) candidate SKL35501 from Full-Life Technologies in a deal worth up to about 792.1 billion won, and last year it licensed SKL37321 from WARF, the technology transfer arm of the University of Wisconsin, in a deal worth about 842.5 billion won. Both were preclinical oncology assets, whereas this agreement secures a late-stage Phase 2/3 asset in CNS, a field where the company has built expertise for more than 30 years.
Opakalim suppresses seizures by selectively activating Kv7.2/7.3 potassium channels, which regulate the excitability of nerve cells in the brain. It is currently in global Phase 2/3 trials in adults with partial-onset seizures. The company aims to obtain its first topline results late this year, report a second set of trial results in 2028 and launch in the U.S. market as early as 2029.
SK Biopharmaceuticals expects synergy from the complementary profiles of Opakalim and cenobamate. Cenobamate is competitive in severe cases on the strength of its efficacy, while Opakalim's advantages are its relatively strong safety and tolerability. "Based on cenobamate's efficacy and Opakalim's tolerability and safety, we are also reviewing the possibility of combination use going forward," said Yoo Chang-ho, head of SK Biopharmaceuticals' strategy division.
Securing a second product to prepare for cenobamate's patent expiry is another key element of the deal. Cenobamate's core U.S. compound patent expires in October 2032. Follow-on method-of-use patents run through 2039, but patent disputes are under way as Indian generic makers have filed one after another with the U.S. Food and Drug Administration (FDA) for generic approval. Zenara Pharma in particular is seeking early market entry before expiry against both the compound patent and the follow-on patents. If Opakalim launches in 2029 as planned, the company can begin building a new revenue stream roughly three years before the compound patent expires. SK Biopharmaceuticals says the strategy will reinforce a virtuous cycle of securing long-term cash flow and reinvesting it in follow-on research and development.
Another advantage is that the company can use the U.S. direct sales network it has already built. Through its U.S. subsidiary SK Life Science, SK Biopharmaceuticals has a dedicated local sales force of more than 150 people and a network of major epilepsy centers and neurologists. It can sell cenobamate and Opakalim together without large additional investment in sales infrastructure, promising synergy in costs and marketing.
The agreement gives the company rights not only to Opakalim but also to the Kv7 discovery platform and related compounds. That goes beyond adding a second product, providing a base for continuously discovering follow-on drugs using the same mechanism. "SK Biopharmaceuticals will enter an entirely new phase of directly marketing multiple products in the U.S. market," said Lee Dong-hoon, president of SK Biopharmaceuticals. "Our goal is to become a company that sells two blockbusters directly in the United States."