SK Biopharmaceuticals has made a winning move of 1 trillion won to secure a second product that will..

Down payment alone is 553.2 billion…Biggest Technology Introduction Match of All Time
Opakalim 2029 U.S. Launch and Blockbuster Development Goals
XCO-Free and Multi-Produce Transition to ‘Two-Top’

사진 확대 Lee Dong-hoon, CEO of SK Biopharmaceuticals, explains the background of the introduction of “Opakalim,” a new epilepsy drug candidate, and future growth strategies at a press conference held at the Westin Chosun Hotel in Seoul on the 26th. [SK Biopharmaceuticals]

SK Biopharmaceuticals has made a winning move of 1 trillion won to secure a second product that will succeed the new epilepsy drug “Senova Mate (US name: Exco Free).” The plan is to launch “Opakalim,” a new drug candidate for late-stage epilepsy in the U.S. as early as 2029, grow it into the second blockbuster following Senovamate, and leap from a single product company to a “multi-product” global pharmaceutical company.

Lee Dong-hoon, CEO of SK Biopharmaceuticals, stressed at a press conference held at the Westin Chosun Hotel in Seoul on the 26th, “We will be a pharmaceutical company with two blockbusters after 2030.” Yoo Chang-ho, head of SK Biopharmaceuticals’ strategic division, also said, “Opakalim decided on this deal because it judged that there was sufficient blockbuster potential.”

On the same day, SK Biopharmaceuticals signed a contract from Biohaven in the U.S. to secure a global exclusive license for Opacalim, a candidate for a new next-generation epilepsy drug, other potassium channel (Kv7) activator compounds, and a Kv7 new drug discovery platform. The total contract size is up to $795 million (about KRW 1.996 trillion), the largest technology introduction contract ever in the domestic pharmaceutical and bio industries. The down payment is also the largest ever at $400 million (about 553.2 billion won), more than half of the total contract size.

Currently, Opakalim is conducting two global clinical trials for adult partial onset patients. The first top-line results are expected later this year, and the second clinical results are expected in 2028. If the development and permission proceed as planned, the goal is to launch in the U.S. in 2029. Material patents are until 2039, and SK Biopharmaceuticals is also expecting the possibility of increasing the life of its products until after 2040, by extending the patent period.

What SK Biopharmaceuticals paid attention to as it made a down payment of more than 550 billion won is the possibility and tolerability of Opakalim’s clinical success. Based on more than 30 years of experience in developing new epilepsy drugs, the company has thoroughly inspected patient retention rates, discontinuation rates, and non-clinical data in open extended trials (OLE). “By comprehensively evaluating the clinical and non-clinical data accumulated so far, we have confidence in the possibility of clinical success,” said Yoo.

In the market, Xenon Pharmaceuticals’ “Azetucalner” is considered a competitive drug. Although development is ahead of Opakalim with the same Kv7 family, SK Biopharmaceuticals believes that Opakalim has room to differentiate in terms of side effects of the central nervous system such as dizziness and drowsiness. Azetucalner’s OLE showed dizziness in 23.3%, drowsiness in 16.4%, falls in 14.2%, and memory impairment in 10.5%. On the other hand, Opakalim reported 5% of dizziness in the 75mg administration group in an open extension test. “We decided that Opacalim could be a winner in the Kv7 market even if it comes to the market one to two years later by sufficiently compensating for the shortcomings of Xenon products,” said Yoo.

XCOPRI and OPACALIM target the same adult partial attack market, but SK Biopharmaceuticals plans to take different roles in the two products. If XCOPRI has expanded its market to include severely ill patients and epilepsy specialists, its strategy is to expand its prescription base to general neurologists with Opakalim, which is based on tolerability. CEO Lee said, “80% of exopri’s prescriptions come from epilepsy specialists,” adding, “While we continue to supply exopri to severe patients and epilepsy specialists, general neurologists can take exopri and opacalim together.”

If Opakalim is commercialized as planned, SK Biopharmaceuticals’ growth timetable will also be longer. The company plans to secure R&D investment capacity by the 2040s by continuing cash flows generated by XCOPRI to Opakalim. Based on this, investment in new fields such as epilepsy disease control therapy (DMT), rare epilepsy, radioactive drug therapy (RPT), and target proteolytic agents (TPD) is also planned to be expanded.

CEO Lee said, “We expect more opportunities to open up with this deal,” adding, “The next two to three years will be an important momentum, and it will be a pharmaceutical and bio company that generates abundant cash flows over the next 14 to 15 years.”