{"id":133231,"date":"2026-08-26T21:27:50","date_gmt":"2026-08-26T21:27:50","guid":{"rendered":"https:\/\/www.europesays.com\/korea\/133231\/"},"modified":"2026-08-26T21:27:50","modified_gmt":"2026-08-26T21:27:50","slug":"sk-biopharm-secures-up-to-1-trillion-won-scale-epilepsy-drug-candidate-expands-direct-sales-in-the-u-s","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/korea\/133231\/","title":{"rendered":"SK Biopharm secures up to $1 trillion-won scale epilepsy drug candidate \u2026expands direct sales in the U.S."},"content":{"rendered":"

\"SKSK Biopharm CEO Lee Dong-hoon speaks during a press conference on the 26th. Photo=SK Biopharm<\/p>\n

SK Biopharm has secured a late-stage epilepsy drug candidate through a contract worth up to $795 million (about 100,996 billion won). Following its self-developed cenobamate (U.S. product name: Xcopri), it is securing a second drug candidate it will sell directly in the United States, as it moves to expand its product portfolio.<\/p>\n

SK Biopharm (CEO Lee Dong-hoon) said on the 26th that it held a press conference at the Westin Chosun Seoul and signed an agreement to introduce the epilepsy drug candidate \u2018Opakalim\u2019 from Biohaven, a biotech company listed on the New York Stock Exchange (Chairman and CEO Dr. Vlad Coric).<\/p>\n

The deal size totals up to $795 million, including an upfront payment and development and regulatory-stage milestones. The upfront payment totals $400 million: $350 million upon closing and $50 million one year after closing. Depending on progress in development and regulatory review, SK Biopharm plans to pay milestones of up to $395 million. Some milestones and royalties will be paid to the original developer, Knopp Biosciences.<\/p>\n

Opakalim is a candidate epilepsy therapy in the selective potassium channel Kv7 activator class. Phase 2 and Phase 3 trials are currently under way in adult patients with focal seizures.<\/p>\n

If SK Biopharm\u2019s clinical and regulatory steps proceed as planned, it plans to secure the first topline results of its RISE3 trial by the end of this year. It is also proceeding to a second clinical result in 2028, with a goal of launching in the United States as early as 2029.<\/p>\n

\"(From(From left) the SK Biopharm logo and the Biohaven logo. Image=SK Biopharm<\/p>\n

After closing the agreement, SK Biopharm will secure worldwide exclusive development and commercialization rights for Opakalim. It will also secure rights related to the Kv7 discovery platform and Kv7-family compounds developed based on the platform, together with Opakalim.<\/p>\n

Biohaven said Opakalim was designed to be developed as a selective Kv7.2\/7.3 activator to reduce central nervous system side effects that can appear with existing epilepsy treatments, such as drowsiness and dizziness, while providing therapeutic efficacy. Biohaven Chairman and CEO Dr. Vlad Coric said, \u201cOpakalim is one of the most promising assets among the assets we have developed so far,\u201d adding that he sees SK Biopharm as a commercialization partner in the United States.<\/p>\n

It has also built a commercialization foundation for a U.S. launch. If Opakalim is approved as a new drug, SK Biopharm plans to sell locally in the United States using a sales organization of 150 or more people at its U.S. subsidiary, SK Life Sciences, along with major epilepsy centers and a network of neurologists.<\/p>\n

\"PressPress conference venue where SK Biopharm announced the acquisition of the epilepsy drug candidate Opakalim. Photo=SK Biopharm<\/p>\n

The company also expects that it can share its sales infrastructure with cenobamate, which is currently being sold in the United States. However, because Opakalim is still an investigational candidate at the clinical stage, the commercialization timetable and performance could differ depending on clinical results and whether it is approved.<\/p>\n

SK Biopharm is also pursuing an expansion of cenobamate\u2019s indications and diversification of its formulations. Earlier this year, it completed a new drug application (NDA) for the suspension formulation. The company plans to file additional new drug applications (sNDA) within this year to expand indications and age groups for patients with generalized tonic-clonic seizures and pediatric patients.<\/p>\n

It is also expanding cenobamate\u2019s overseas business. In China, the company began commercialization in March through its partner, Ignis Therapeutics. In Latin America, it launched in Peru, Chile, and Brazil through Eurofarma. Procedures for approvals in Japan and launches in South Korea are also under way.<\/p>\n

SK Biopharm CEO Lee Dong-hoon said, \u201cThrough this Opakalim acquisition deal, SK Biopharm will enter a new stage of directly selling multi-products in the U.S. market.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"SK Biopharm CEO Lee Dong-hoon speaks during a press conference on the 26th. Photo=SK Biopharm SK Biopharm has…\n","protected":false},"author":2,"featured_media":133232,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[67869,67897,20695,43439,67894,67892,67893,34635,67896,67890,67895,29171,67870,21962,43124,112,241,39897,240,444,31111,67891],"class_list":["post-133231","post","type-post","status-publish","format-standard","has-post-thumbnail","category-sk","tag-biohaven","tag-biotech-company","tag-ceo","tag-chairman","tag-contract-size","tag-dr-vlad-coric","tag-drug-candidate","tag-epilepsy","tag-knopp-biosciences","tag-lee-dong-hoon-ceo-president","tag-milestones","tag-new-york-stock-exchange","tag-opakalim","tag-park-yong-jun","tag-press-conference","tag-seoul","tag-sk","tag-sk-biopharm","tag-sk-group","tag-united-states","tag-upfront-payment","tag-westin-chosun-seoul"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/133231","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/comments?post=133231"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/133231\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media\/133232"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media?parent=133231"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/categories?post=133231"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/tags?post=133231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}