April 20, 2024

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[THE INVESTOR] SK Biopharmaceuticals, the drug-making arm of SK Group, said on Dec. 22 it has submitted a New Drug Application to the US Food and Drug Administration seeking marketing approval for SKL-N05, an investigational medicine for the treatment of excessive sleepiness.

The company and its partner Ireland-headquartered Jazz Pharmaceuticals completed phase 3 clinical trials of the drug candidate this year with results showing statistically-significant improvements in ability of patients with narcolepsy or obstructive sleep apnea to stay awake. SK Biopharmaceuticals licensed the rights to SKL-N05 to the NASDAQ-listed Jazz Pharmaceuticals in 2011.

The Korean drug maker said it hopes to secure royalties through US sales as early as 2019 and plans to expand its market to Asian countries including Japan and China when the medicine successfully sets itself up in the US. Jazz Pharmaceuticals is also hinging hopes on the potential therapy to strengthen its position in sleep disorder segment.

Generic players have been challenging the firm as its current wake-promoting therapy and the largest source of revenue -- Xyrem -- will soon lose its patent protection.

“Excessive sleepiness due to narcolepsy or obstructive sleep apnea can affect a person’s ability to function at work or home, and many patients unfortunately might suffer for years before their condition is properly addressed,” Karen Smith, executive vice president at Jazz Pharmaceuticals, said in a statement.

If SKL-N05 hits the market it could affect as many as 275,000 people in the US who use breathing machines to sleep because of obstructive sleep apnea and who aren’t sufficiently helped by drug therapy.

Meanwhile, SK Biopharmaceuticals is looking to further expand its presence in the US market with self-developed epilepsy treatment Cenobamate, which is in the final clinical trials. It aims to file for FDA approval of that drug next year.

“We expect blockbuster sales of Cenobamate which could generate about 1 trillion won (US$926.78 million) annually in the US alone,” SK Biopharmaceuticals said.

By Park Han-na (hnpark@heraldcorp.com)