SK Biopharma's sleep disorder drug cleared in Europe

SK Biopharmaceuticals Co., a biopharma unit under South Korea’s SK Group, will soon be able to reap the first royalty sales from a license deal for its sleep disorder drug Sunosi (solriamfetol) as the drug has won EU approval.

After a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last November, SK Biopharmaceuticals said on Tuesday that the drug was cleared to treat European patients with obstructive sleep apnea (OSA) and excessive daytime sleepiness.

SK Biopharmaceuticals discovered the compound and signed a license deal with Aerial Biopharma in 2011 after completing a phase 1 study.

The license to develop and commercialize the compound was acquired by Jazz Pharmaceuticals in 2014, and the company then completed phase 3 trials to file a New Drug Application (NDA) for the drug with the FDA in December 2017. Marketing approval was granted in the U.S. in March 2019.

It marks the first approved novel drug in its pipeline and the first central nervous system drug developed by a Korean company approved in both the U.S. and Europe.

Jazz Pharmaceuticals is planning to launch the drug in Germany by mid this year and then in France and the U.K. early next year.

SK Biopharmaceuticals holds development and marketing rights for the drug in 12 Asian countries including Korea, China and Japan.

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