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Biohaven与SK生物制药就新型Kv7离子通道平台及抗癫痫药物候选药Opakalim达成全球战略合作

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  • SK Biopharmaceuticals to provide upfront and milestone payments related to the Kv7 platform up to$795 million, along with tiered royalties toBiohavenranging from the mid-teens to low twenties onU.S. net sales of opakalim.

  • Opakalim, the lead candidate fromBiohaven'sKv7 platform, is a next-generation, selective Kv7.2/7.3 potassium channel activator currently in Phase 2/3 development for focal epilepsy, with topline results from the RISE3 trial expected in 2H 2026. It is designed to offer an easy-to-use, once-daily oral treatment without the need for titration and a low incidence of burdensome CNS side effects.

  • The agreement pairsBiohaven'sinnovative, wholly owned Kv7 platform with the proven epilepsy commercial platform of SK Biopharmaceuticals, the team that launched XCOPRI®.  The deal gives opakalim an established path to patients worldwide through SK Biopharmaceuticals' commercial capabilities without Biohaven building its own capital-intensive infrastructure.

  • The transaction delivers non-dilutive capital, while retaining meaningful long-term upside in opakalim through milestones and royalties, materially strengtheningBiohaven'sbalance sheet and extending its runway to advance a differentiated pipeline.

 

NEW HAVEN, Conn.andSEOUL, South Korea, Aug. 26, 2026 /PRNewswire/ --Biohaven Ltd.and/or its wholly owned subsidiaries ("Biohaven") (NYSE: BHVN) and SK Biopharmaceuticals Co., Ltd. ("SK Biopharmaceuticals") today announced a strategic global licensing and collaboration agreement under which SK Biopharmaceuticals will obtain an exclusive worldwide license toBiohaven'sKv7 ion channel platform, led by opakalim (BHV-7000), a next-generation, selective Kv7.2/7.3 potassium channel activator in Phase 2/3 development for focal epilepsy, with RISE3 trial topline results expected in 2H 2026. Following the close of the transaction, the companies will collaborate to advance opakalim through development andU.S. Food and Drug Administration(FDA) approval, combiningBiohaven'sinnovative Kv7 platform with SK Biopharmaceuticals' global development and regulatory capabilities and its proven commercial track record of bringing antiseizure medicines to patients worldwide.

 

Vlad Coric, M.D., Chairman and Chief Executive Officer ofBiohaven, commented, "This is a landmark partnership that has the potential to deliver a novel treatment for millions of patients with epilepsy who still need better seizure control without exacerbating CNS adverse effects. Opakalim is one of the most exciting assets we have advanced; a selective Kv7.2/7.3 activator designed to deliver meaningful efficacy without the burdensome central nervous system side effects, including sedation and dizziness, associated with so many antiseizure medicines. 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 theU.S. since 2016. Pairing our scientific innovation with SK Biopharmaceuticals' established epilepsy development and commercialization expertise gives opakalim, if approved, its fastest and strongest path to patients worldwide. This partnership also brings$400 millionin near-term, non-dilutive capital toBiohavenwhile preserving substantial long-term upside for our shareholders."

 

Under the terms of the agreement, SK Biopharmaceuticals to make upfront and milestone payments up to$795 millionrelated to the Kv7 platform plus tiered royalties toBiohavenranging from the mid-teens to low twenties onU.S. net sales of opakalim.Biohavenwill receive$400 millionin cash consideration, consisting of$350 millionpayable at closing and an additional$50 millionpayable in 2027, andBiohavenis eligible to receive an additional$150 millionin development and regulatory milestone payments plus royalties on global net sales of opakalim. In addition, SK Biopharmaceuticals will assume responsibility for Kv7 program costs going forward under the terms of the agreement, including certain specifiedKnopp Biosciencesand Kv7 future milestone obligations totaling$245 millionand mid-single digit royalty obligations toKnopp Biosciences.

 

Donghoon Lee, President and Chief Executive Officer of SK Biopharmaceuticals, commented, "Our experience building XCOPRI into a therapy for epilepsy patients worldwide, from clinical development through global commercialization, has given us a deep understanding of what it takes to bring a differentiated CNS medicine to patients. We see opakalim as a highly complementary addition to our epilepsy portfolio, with a mechanism and tolerability profile that could extend our ability to serve patients who may benefit from additional treatment options. We look forward to a close, collaborative partnership with theBiohaventeam through NDA submission and beyond."

 

With a history of more than 30 years, SK Biopharmaceuticals is the first global biopharmaceutical company in more than a decade, as well as the first Korean company, to independently discover, develop, and commercialize a novel antiseizure medicine. Through itsU.S. subsidiarySK Life Science, Inc., the company markets XCOPRI® (cenobamate) for partial-onset (focal) seizures in adults in theU.S., where it has built a dedicated epilepsy commercial organization with a purpose-built neurology field force of over 150 professionals and established epilepsy-center and neurologist coverage. That mature infrastructure, paired with SK Biopharmaceuticals' global development, regulatory, and commercialization capabilities, has led to the steady, double-digit growth of XCOPRI and expanded its reach to patients worldwide.

 

Dr. Coricadded, "Beyond opakalim, this transaction validatesBiohaven'sstrategy of building differentiated, novel platforms that create value for patients and investors while pursuing monetization pathways beyond typical public-market equity raises. With such a robust pipeline,Biohavenhas the potential to create value in numerous ways, including an outright sale, license agreements and partnerships with companies looking to expand their clinical-stage pipelines. Rather than stand up a commercial organization of our own for opakalim, we structured a partnership with a leading strategic partner in epilepsy to drive long-term revenue potential of this novel mechanism. This structure allowsBiohavento receive an upfront payment for our development efforts while sharing in future upside of opakalim through milestones and royalties. A strengthened balance sheet, coupled with a meaningfully lower go-forward burn and a world-class partner, lets us sharpen our focus and invest in the next wave ofBiohaveninnovation, from our MoDE and TRAP extracellular protein degraders in immunology to our programs in neuroscience, metabolic conditions, and rare diseases. We are building a diversified, self-sustaining engine for long-term value creation."

 

Summary of Financial Terms

  • Near-Term Cash Consideration toBiohaven:

    $400 million—$350 million payable at closing and$50 million payable in 2027

  • Development and Regulatory Milestones toBiohaven:$150 million U.S. Royalties: Tiered royalties on U.S. net sales of opakalim ranging from the mid-teens to low twenties

  • Ex-U.S. Royalties: Mid-single digit royalty on net sales of opakalim outside the U.S.

  • Assumption of Knopp and Future Kv7 Obligations: SK Biopharmaceuticals will assume certain specified Biohaven obligations, including upto $185 million payable to Knopp Biosciences upon U.S and EU approval, plus a mid-single digit worldwide royalty — separate from, and in addition to, SK Biopharmaceuticals' milestone and royalty obligations to Biohaven. SK Biopharmaceuticals will also assume up to $60 million in additional obligations for milestones related to future Kv7 pipeline programs.

 

All figures are expressed inU.S. dollars. Closing of the licensing and collaboration agreement is contingent on completion of review under applicable regulatory and antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in theU.S., and other customary closing conditions.

 

About Opakalim andBiohaven'sKv7 Ion Channel Platform

 

The lead asset inBiohaven'sKv7 platform is opakalim (BHV-7000), 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.Biohavenis currently conducting 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.

 

AboutBiohaven

 

Biohaven Ltd.(NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments across immunology, neuroscience, and oncology.Biohavenis advancing an innovative portfolio of therapeutics built on proven drug development experience and multiple proprietary platforms, including Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. 

 

About SK Biopharmaceuticals

 

SK Biopharmaceuticals Co., Ltd., together with its U.S. subsidiary SK Life Science, Inc., is a global biopharmaceutical company focused on the discovery, development, and commercialization of treatments for central nervous system disorders. The company independently developed and commercializes XCOPRI (cenobamate) for the treatment of partial-onset seizures in adults, and continues to build a global pipeline spanning CNS disorders and oncology.

文章关键词: BiohavenSK生物制药新型Kv7离子通道平台Opakalim
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