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SK unit files new sleep disorder drug for FDA approval

Collected: 2017.12.22

Distributed: 2017.12.26

Source: Go Direct

SK Biopharmaceuticals, an affiliate of South Korea`s SK Group, has filed a new drug application with the U.S. Food and Drug Administration for the company’s SKL-N05, a novel drug to treat sleep disorders.

SK Biopharmaceuticals has developed SKL-N05 (Solriamfetol) jointly with Jazz Pharmaceuticals with a goal to launch it in the U.S. in early 2019, according to the South Korean company

The Nasdaq-listed Jazz is the world`s leading pharmaceuticals company in the therapeutic area of sleep disorder. It generates more than 1 trillion won ($926 million) in annual sales from its well-known sleep disorder treatment medicine Xyrem.

Upon approval from the FDA, SK Biopharm will receive royalty payments from the U.S. partner. Additional profits are expected from the company’s exclusive marketing rights to 12 countries in Asia, including China and Japan.

A phase 3 study of 880 sleep disorder patients demonstrated SK’s novel drug is two times more effective than Xyrem, said SK Biopharm, which aims to focus on developing new medicines to treat diseases in the central nervous system.

By Shin Chan-ok and Minu Kim

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