SK Biopharm licenses Biohaven's Kv7 activator Opakalim in $795M deal, targeting 2029 US launch
核心洞察
SK Biopharm signed a licensing-in agreement worth up to $795 million to acquire worldwide exclusive rights to Opakalim (搜索) (BHV-7000), a Kv7 potassium channel activator for epilepsy (搜索), from Biohaven (搜索).
Opakalim (搜索)'s novel mechanism selectively activates Kv7.2/7.3 (搜索) channels, offering a significantly reduced risk of CNS side effects such as drowsiness and dizziness compared with existing epilepsy (搜索) treatments.
A global Phase 2/3 trial (RISE3) in adult patients with partial-onset seizures (搜索) is underway, with first top-line results expected by year-end and a US launch targeted as early as 2029.
SK Biopharmaceuticals (搜索) Co., a pharmaceutical affiliate of South Korea's SK Group, has signed a "licensing-in" agreement worth around 1.9 trillion won (US$795 million) to acquire worldwide exclusive rights to develop and commercialize Opakalim (搜索) (BHV-7000), a next-generation epilepsy (搜索) drug candidate, from Biohaven (搜索) Bioscience Ireland Ltd. The announcement was made Wednesday at a press conference at the Westin Joseon Seoul in Jung-gu.
The deal marks a pivotal step in SK Biopharm's evolution from a single-product company into a multi-product enterprise selling several innovative drugs directly in the United States.
Deal Structure and Financial Terms
Under the agreement, SK Biopharm will own exclusive licenses to Opakalim (搜索) and the Kv7 potassium channel activator compound, along with Biohaven (搜索)'s Kv7 discovery platform. The deal is valued at up to $795 million, including an upfront payment and development and regulatory milestones.
The upfront payment totals $400 million — $350 million payable at closing and an additional $50 million due one year later. Milestone payments tied to development and regulatory progress are capped at $395 million, with tiered royalties on US net sales to be paid separately. Under the terms of the agreement, some milestones and royalties will be passed on to original developer Knop Bioscience (搜索). The transaction is subject to customary merger control approvals before it can be finalized.
Terms of the contract will run for 10 years after the product's launch, or until the latest of the expiration of the patent or the expiration of exclusive licensing rights.
Mechanism of Action and Clinical Differentiation
Opakalim (搜索) is a selective potassium channel (Kv7.2/7.3 (搜索)) activator that works through a novel mechanism to regulate excessive neuronal excitation in the brain. Its key differentiator is a significantly reduced risk of central nervous system side effects — such as drowsiness and dizziness — commonly seen with existing epilepsy (搜索) treatments, along with a strong tolerability profile.
Vlad Coric, chairman and CEO of Biohaven (搜索), called Opakalim (搜索) "the most promising asset designed to deliver meaningful efficacy with a reduced side-effect burden," adding that SK Biopharm is "the uniquely ideal partner that successfully established Xcopri and has been offering patients with partial-onset seizures (搜索) a new drug in the US since 2020."
Clinical Development Timeline
A global Phase 2/3 trial in adult patients with partial-onset seizures (搜索) is currently under way. SK Biopharm plans to obtain the first top-line results from the RISE3 trial by year-end, release a second set of clinical results in 2028, and launch the drug in the US market as early as 2029.
Commercial Strategy
If Opakalim (搜索) receives approval, SK Biopharm intends to deploy the direct-sales infrastructure of its US subsidiary SK Life Science (搜索). The company plans to share the more than 150-strong specialist sales force and neurologist network built through Xcopri — currently the top-selling branded epilepsy (搜索) drug in the US — to maximize marketing cost synergies and strengthen market presence by offering complementary treatment options tailored to unmet patient needs.
SK Biopharm President and CEO Lee Dong-hoon said the company had "entered a completely new phase" by moving beyond a single-product model to sell multiple innovative drugs directly in the US market. "Securing a late-stage candidate from a NYSE-listed company signals that our standing has changed," he said. "We will continue to build trust in Korean biotech through tangible results and present a new growth model."
Broader Portfolio Momentum
SK Biopharm is also accelerating lifecycle management and global expansion of its flagship drug, cenobamate. The company completed a US new drug application for a suspension formulation earlier this year and plans to submit supplemental NDAs within the year to expand indications to include primary generalized tonic-clonic seizures and pediatric patients. On the international front, it launched commercialization in China through partner Ignis Therapeutics in March and has completed rollouts in Peru, Chile and Brazil through Latin American partner Eurofarma. Regulatory and launch procedures for Japan and South Korea are also progressing on schedule.