SK Biopharmaceuticals to Introduce Biohaven's Epilepsy Drug Candidate in a 1.1 Trillion Won Deal

[Financial News] SK Biopharmaceuticals is moving to expand its central nervous system (CNS) business by in-licensing a late-stage epilepsy drug candidate from U.S. biotech company Biohaven. On the 26th, the company said it had signed a global exclusive license agreement with Biohaven Bioscience Ireland for Opakalim (BHV-7000), as well as potassium channel (Kv7) activator compounds and related discovery platforms.
The total deal value could reach as much as $795 million, or about 1.1 trillion won. Of that, the upfront payment amounts to $400 million, or about 553.2 billion won, accounting for more than half of the total. The structure calls for $350 million to be paid at closing, followed by an additional $50 million one year later.
Development and regulatory milestones could add up to $395 million. Up to $335 million has been allocated to Opakalim, while as much as $60 million is set aside for follow-on Kv7 activator compounds. The company will also pay separate royalties based on sales after the product is launched.
Opakalim is an oral epilepsy drug candidate that selectively activates the Kv7.2 and Kv7.3 potassium channels, which help suppress excessive neuronal excitation.
Global phase 2/3 trials, RISE2 and RISE3, are currently under way in patients with refractory focal seizures. Biohaven completed patient enrollment for RISE3 in June and plans to release key results in the second half of this year.
In a previous open-label extension study, 54% of patients who received 75 mg of Opakalim once daily showed a reduction of more than 50% in seizure frequency from baseline over a continuous six-month period. However, because the findings came from an open-label extension study, the final efficacy and safety profile must still be confirmed in the ongoing phase 2/3 trials.
Another reason this deal is drawing attention is that it goes beyond the acquisition of a single candidate. SK Biopharmaceuticals has secured global exclusive rights not only to Opakalim, but also to other Kv7 activators held by Biohaven and the Kv7 Ion Channel Platform, which is used to discover new candidates.
Meanwhile, SK Biopharmaceuticals has built its CNS competitiveness by directly selling its own epilepsy drug cenobamate, marketed in the U.S. as Xcopri.

[email protected] Kang Jung-mo Reporter