SK Biopharmaceuticals to In-License Epilepsy Drug Candidate ‘Opakalim’

Paves the Way to Launch its Second Innovative Drug Directly in the U.S.

 

-  Announces agreement to in-license near-commercial candidate at a press conference

-  Targets U.S. commercial launch as early as 2029… Upfront and milestone payments related to the Kv7 platform of up to $795M, plus tiered royalties to Biohaven on U.S. net sales of opakalim and additional royalties on ex-U.S. net sales of opakalim and on certain other products

-  Strong potential of success and clear differentiation points validated… Stepping up to another level

 

SEOUL, South Korea, August 26, 2026 – SK Biopharmaceuticals Co., Ltd. (www.skbp.com/ CEO: Donghoon Lee) held a press conference on August 26^th and announced that it has entered into an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven Ltd. and/or its wholly owned subsidiaries ("Biohaven").

 

This in-licensing is part of SK Biopharmaceuticals’ ongoing strategy to leverage its commercial infrastructure through the addition of a new product (second product). Upon regulatory approval, as planned, the company will step up beyond its status as a ‘one commercial product company’ and become the only drug development company in South Korea that directly markets multiple innovative medicines in the global market.

 

Opakalim is a selective Kv7 potassium channel activator that has garnered attention as a novel anti-seizure therapy for epilepsy. In clinical studies conducted to date, the candidate has demonstrated a favorable safety and tolerability profile. The candidate is currently in Phase 2/3 studies for treatment of partial-onset seizures (POS) in adults. Provided clinical milestones remain on track, initial top-line results from the RISE 3 trial are expected by the end of this year. Following a second data readout in 2028, SK Biopharmaceuticals aims to launch the product in the U.S. market as early as 2029.

 

The agreement provides for upfront and milestone payments related to the Kv7 platform totaling up to $795 million.[1] This amount consists of $400 million in upfront cash consideration, with $350 million payable at closing and an additional $50 million payable one year after closing, and up to $395 million in development and regulatory milestone payments. Under the agreement, a portion of milestones and royalty payments is payable to Knopp Biosciences, the original developer. Closing of the transaction is subject to receipt of required antitrust clearances and other customary closing conditions.

 

Upon closing, SK Biopharmaceuticals will obtain exclusive global development and commercialization rights to opakalim. The company will also obtain access to the Kv7 discovery platform and related Kv7 targeting compounds generated through the platform, opening up additional opportunities to expand its pipeline in the future through this strategic arrangement.

 

SK Biopharmaceuticals commented, “As with any clinical-stage product candidate, risks associated with clinical trials, regulatory approval, and commercialization remain.” However, the company added, “Our company has accumulated end-to-end capabilities spanning discovery, clinical trials, regulatory approvals, and commercialization in the epilepsy field over the past 30 years. Following an extensive evaluation by our epilepsy experts, we believe the candidate has strong potential for success and offers meaningful differentiation, particularly with respect to its favorable tolerability profile.”

 

Cenobamate (U.S. brand name: XCOPRI®), SK Biopharmaceuticals’ innovative anti-seizure medication, has settled on a growth trajectory by becoming the No. 1 branded new drug in the U.S. epilepsy market this year. Upon regulatory approval of opakalim, SK Biopharmaceuticals plans to prioritize the launch of opakalim through its U.S. subsidiary, SK Life Science Inc., where it has built a dedicated epilepsy commercial organization with a purpose-built neurology field force of over 150 professionals and established coverage of epilepsy-center and neurologists.

 

In particular, this strategic approach is expected to enhance SK Biopharmaceuticals’ ability to address the diverse unmet needs of patients with epilepsy by combining the distinct strengths of cenobamate and opakalim. With two differentiated assets, the company aims to broaden treatment options and deliver meaningful benefits to more patients. This in-licensing transaction also represents an important step toward building a differentiated epilepsy portfolio focused on improving patient outcomes.

 

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, “Opakalim is one of the most exciting assets we have advanced; a selective Kv7.2/7.3 activator designed to deliver meaningful efficacy with low incidence of the burdensome central nervous system side effects, including sedation and dizziness, associated with so many antiseizure medicines.” Dr. Coric added, “SK Biopharmaceuticals is an ideal partner having launched XCOPRI and is the only company to bring a new antiseizure medicine for partial-onset (focal) seizures to patients in the U.S. since 2020.”

 

“As this news has been long awaited, the agreement to in-license opakalim carries immense strategic significance to our company,” said Donghoon Lee, CEO of SK Biopharmaceuticals. "This propels SK Biopharmaceuticals to another level – transitioning into a multi-product company that directly commercializes therapies in the U.S. market.”

 

He also stated, “Beyond introducing early-stage candidates from Asian biotech companies and U.S. research institutions, we have now agreed to in-license a late-stage candidate with near-term trial readouts from a publicly listed U.S. biopharmaceutical company. This clearly signals that our company has stepped into the major leagues across all dimensions.”

 

“Going forward, we will continue to lead the way in restoring market trust in K-Bio and establishing a new benchmark for sustainable growth through tangible achievements,” he concluded.

 

Meanwhile, SK Biopharmaceuticals is continuously strengthening its mid-to-long-term growth and profitability foundations through lifecycle management initiatives for cenobamate, such as indication expansion and formulation diversification. Early this year, the company submitted a New Drug Application (NDA) for an oral suspension formulation and is pursuing supplemental New Drug Applications (sNDAs) within the year to expand the label to include primary generalized tonic-clonic (PGTC) seizures and pediatric patients.

 

Global market expansion is also being conducted in parallel. In China, commercialization commenced in March through SK Biopharmaceuticals’ local partner, Ignis Therapeutics. In Latin America, cenobamate was also successfully launched this year in Peru, Chile, and Brazil through SK Biopharmaceuticals’ partner, Eurofarma. Procedures for regulatory approval in Japan and launch preparations in South Korea are also progressing smoothly.

 

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Advisors

Nomura Securities International, Inc. is serving as exclusive financial advisor and Paul Hastings LLP is serving as legal counsel to SK Biopharmaceuticals. J.P. Morgan Securities LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Biohaven.

About Opakalim and the Kv7 Ion Channel Platform

Opakalim is a next-generation, selective Kv7.2/7.3 potassium channel activator targeting a clinically validated mechanism of action for the treatment of epilepsy. Opakalim is differentiated from both first- and second-generation Kv7 activators by its selectivity for the Kv7.2/7.3 heteromeric channels that are the predominant regulators of neuronal excitability, with substantially less activity at GABA receptors. This selectivity profile is hypothesized to contribute to opakalim's favorable tolerability, including the low rates of somnolence, dizziness, and fatigue observed in clinical studies to date. Opakalim has been studied in more than 1,200 participants across multiple clinical trials. There are currently two Phase 2/3 randomized, double-blind, placebo-controlled studies (NCT06132893 and NCT06309966) evaluating opakalim versus placebo as adjunctive therapy for refractory focal onset epilepsy, along with an open-label extension study (NCT06443463) assessing long-term efficacy and safety.

About Biohaven

Biohaven Ltd. is a public U.S. biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments across immunology, neuroscience, and oncology. Biohaven is advancing an innovative portfolio of therapeutics built on proven drug development experience and multiple proprietary drug development platforms, including Kv7 ion channel modulation for epilepsy. For more information, visit www.biohaven.com.

 

About SK Biopharmaceuticals Co., Ltd. And SK Life Science, Inc

SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea’s second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals, and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME's 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit https://sk-inc.com/en/main/mainpage.aspx. For more information about SK Biopharmaceuticals, visit www.skbp.com/eng.

 

SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean biopharmaceutical company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit www.SKLifeScienceInc.com.