"We will become a company with two blockbuster epilepsy drugs, following Exkopia with the introduction of Opakalim," said Lee Dong-hoon, CEO of SK Biopharm, during an emergency press conference held on August 26 at the Westin Chosun in Seoul. He added, "We are entering a completely new phase of direct sales in the U.S. market with multiple products," expressing confidence in demonstrating what true big biotech is.
On the same day, SK Biopharm announced that it has signed a global exclusive licensing agreement with Biohaven for the epilepsy drug candidate Opakalim (BHV-7000), other Kv7 activator compounds, and the Kv7 discovery platform. The deal is valued at up to $795 million (approximately 1.1 trillion won), with an upfront payment of $400 million (about 553.2 billion won) that does not require repayment.
Upon closing the transaction, SK Biopharm will receive $350 million initially, followed by an additional $50 million a year later. The remaining amount will be paid through milestone payments (up to $395 million) based on development and approval stages, as well as royalties based on net sales after product launch.
Opakalim is a drug candidate that selectively activates Kv7.2/7.3 potassium channels to regulate the excitability of brain neurons and suppress seizures. Global Phase 2 and 3 clinical trials, including RISE2 and RISE3, are currently underway for patients with refractory focal seizures. Biohaven completed patient enrollment for RISE3 in June and is expected to announce key results in the second half of this year.
If clinical and approval processes proceed as planned, the first top-line results from the RISE3 trial are anticipated by the end of this year. Following the second clinical results announcement in 2028, SK Biopharm aims to launch the product in the U.S. market as early as 2029.
The company plans to enhance its competitiveness in the central nervous system (CNS) field by securing a follow-up pipeline while also obtaining a platform capable of discovering new drugs, following its own developed epilepsy drug, Cenobamate.
SK Biopharm stated, "Having sold Cenobamate directly in the U.S., we have experienced the entire process from drug discovery to clinical trials, FDA approval, and commercialization. By adding Opakalim, which is in the later stages of clinical trials, we can aim for synergy in the epilepsy field and expand our product portfolio simultaneously." It added, "Upon Opakalim's approval, we plan to focus on its launch and commercialization using our established network of over 150 dedicated sales personnel and key epilepsy centers and neurologists in the U.S. through our subsidiary, SK Life Science."
* This article has been translated by AI.
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