SK Biopharm's New Sleep Disorder Drug Approved for Sale in Europe

Technology Exported New Drug Sunosi, Approved for Sale in Europe Following US Approval Last Year

SK Biopharm's New Drug Development Research Scene

[Asia Economy Reporter Choi Dae-yeol] SK Biopharm announced on the 21st that Solriamfetol, a sleep disorder treatment new drug it exported technology for, has received marketing authorization from the European Medicines Agency (EMA).

Under the product name Sunosi in the US and Europe, this new drug was discovered by SK Biopharm, which completed Phase 1 clinical trials before exporting the technology. Jazz Pharmaceuticals, the global leader in sleep disorder diseases, acquired global commercial and rights including the US and Europe and completed Phase 3 clinical trials. Jazz received approval from the US Food and Drug Administration (FDA) last year and launched the product, and has now obtained marketing authorization in Europe as well. In Europe, the marketing authorization application was submitted to the EMA in November 2018, and in November last year, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval.

This drug is intended to be used in Europe for the treatment of adult patients with narcolepsy. Narcolepsy is a disorder characterized by sudden sleepiness regardless of one's will, and symptoms such as hallucinations, sleep paralysis, and seizures when falling asleep or waking up. Additionally, it has been approved as a treatment to improve wakefulness and alleviate daytime sleepiness in adult patients with obstructive sleep apnea who have not achieved satisfactory results in treating daytime sleepiness despite continuous primary therapies such as positive airway pressure therapy. The company explained that it is the only new drug approved in Europe for treating daytime sleepiness caused by obstructive sleep apnea in adults.

Jazz plans to sequentially launch the drug starting with Germany in mid-this year, followed by France and the UK by early next year. Additional clinical trials targeting patients with excessive daytime sleepiness due to major depressive disorder are planned. Expanding indications is expected to potentially increase the market size. According to the contract between the two companies, SK Biopharm will receive royalties on a certain portion of sales in the US and Europe. Specific contract details have not been disclosed. SK Biopharm holds the sales rights in 12 Asian countries including Korea, China, and Japan, and is currently reviewing the launch schedule in the Asian region.

Jung-woo Cho, CEO of SK Biopharm, said, "We will continue to develop innovative new drugs not only through in-house development but also by promoting excellent partnerships like the collaboration with Jazz Pharmaceuticals, striving to continuously launch innovative new drugs and improve patients' quality of life."