SK Biopharmaceuticals signs $530 million European deal

SK Biopharmaceuticals, a wholly-owned subsidiary of SK Holdings, signed a $530 million agreement with a Swiss company to sell its epilepsy drug in Europe.

The exclusive licensing deal with Arvelle Therapeutics is for the commercialization of Cenobamate in 32 countries. SK Biopharmaceuticals will receive an upfront payment of $100 million and be entitled to so-called milestone payments of up to $430 million.

Under the terms of the agreement, SK Biopharmaceuticals may obtain “a significant equity stake” in Arvelle.

Cenobamate is designed to treat intractable central nervous system diseases, such as epilepsy, in adults.

The partnership is focusing on rising demand for the treatment of seizure disorders in Europe and other global markets, the bio company added. It is expected that the market for the drug will increase from $6.2 billion in 2018 to $7 billion in 2021, according to Global Data.

SK’s bio affiliate submitted an application last year to the U.S. Food and Drug Administration (FDA) for the approval of Cenobamate. The U.S. regulator is reviewing the results of clinical trials, and a determination could be announced as early as November, according to SK Biopharmaceuticals.

This is the first time a Korean pharmaceutical company has submitted a new drug application (NDA) to the U.S. authority for a product developed on its own.

Should the drug receive FDA approval, SK will be permitted to sell Cenobamate in the largest biopharmaceutical market in the world, by the first half of 2020 at the earliest. According to SK, the new epilepsy drug could generate 1 trillion won ($889 million) in revenue in the United States alone.

“We are very pleased about entering into this licensing agreement with Arvelle, as it provides important validation of the global potential for Cenobamate as a new treatment option for adults with partial-onset seizures,” said President and CEO of SK Biopharmaceuticals Cho Jeong-woo.

“Arvelle’s experienced leadership team and focus on CNS disorders make them the ideal partner.”

“Given the data generated in clinical trials and the FDA acceptance of the NDA, we believe Cenobamate has the potential to be an important antiepileptic drug treatment option for adult patients suffering from partial-onset seizures,” said Mark Altmeyer, Arvelle CEO.

Arvelle Therapeutics is funded by investors with strong focusses on biopharmaceuticals. The list includes NovaQuest Capital Management, Life Science Partners, BRV Capital Management, Andera Partners and H.I.G. BioHealth Partners.

BY PARK EUN-JEE [park.eunjee@joongang.co.kr]