[Edaily Reporter KIM SAE-MI ] SK BIOPHARMACEUTICALS(326030)SK Biopharm is acquiring “Opakalim” (BHV-7000), a late-stage clinical-phase epilepsy drug candidate developed by U.S.-based Biohaven, for up to approximately 1.1 trillion won. This is a large-scale investment aimed at expanding its global pipeline in the epilepsy field, following “cenobamate.”
SK BIOPHARMACEUTICALS announced on the 26th that it has signed a worldwide exclusive license agreement with Biohaven Bioscience Ireland Limited for Opakalim, other potassium channel (Kv7) activator compounds, and the “Kv7 Discovery Platform.”
The deal is valued at up to $795 million (approximately 1.0996 trillion won). Of this amount, the non-refundable upfront payment totals $400 million (approximately 553.2 billion won). SK Biopharm will pay $350 million upon closing the transaction and an additional $50 million one year after the closing date.
Milestone payments, which are contingent on development and approval milestones, total up to $395 million (approximately 546.3 billion won). Up to $335 million has been allocated for Opakalim, and up to $60 million for other Kv7 activator compounds. Following commercialization, separate ongoing royalties will also be paid based on the product’s net sales brackets.
The total contract value amounts to 156% of SK BIOPHARMACEUTICALS’ consolidated revenue from last year. In particular, the upfront payment alone—which is guaranteed—totals 553.2 billion won. This is interpreted as a major bet on a late-stage clinical candidate for epilepsy.
Opakalim is an oral epilepsy drug candidate that selectively activates the Kv7.2 and Kv7.3 potassium channels, which regulate excessive excitation of neurons. Unlike some existing or developing antiepileptic drugs, Biohaven highlights as a key differentiator the potential to minimize GABA receptor activity, thereby reducing central nervous system side effects such as dizziness and drowsiness.
Global Phase 2/3 clinical trials “RISE2” and “RISE3” are currently underway in patients with refractory partial seizures. Biohaven completed patient enrollment for RISE3 last June and plans to release topline results in the second half of this year. RISE3 compares Opakalim 50 mg and 75 mg with a placebo to evaluate changes in the average seizure frequency over 28 days.
In a previously disclosed open-label extension (OLE) study for partial seizures, 54% of patients receiving a once-daily dose of 75 mg of Opakalim experienced a reduction in seizure frequency of at least 50% compared to pre-treatment levels over a consecutive 6-month period. However, since these results are from an open-label extension study conducted without a placebo control, efficacy must be definitively confirmed in the Phase 2/3 clinical trials.
In addition to Opakalim, this agreement includes worldwide exclusive rights to Biohaven’s other Kv7 activator compounds and its Kv7 discovery platform, which enables the identification of new candidates. This move goes beyond the introduction of a single new drug, securing a foundation for Biohaven to independently expand its Kv7 pipeline in the future.
To ensure continuity in development, Biohaven will continue to conduct the ongoing clinical trials, while SK BIOPHARMACEUTICALS will bear the related costs. The transaction is subject to the fulfillment of certain conditions precedent, including the completion of a review under the U.S. Hart-Scott-Rodino (HSR) Antitrust Improvements Act.
Meanwhile, SK BIOPHARMACEUTICALS is scheduled to hold a press conference at 2:00 p.m. today at the Westin Chosun Hotel in Seoul to explain the rationale behind the acquisition of Opacalym and its future development and commercialization strategies.
