New medication for sleep disorders to enter phase 3 clinical trial in U.S.
SK Holdings, the holding company of SK Group, announced plans Monday to commence enrollment of a phase 3 clinical trial of its new medication for sleep disorders developed by its affiliate SK Biopharmaceuticals.
The third step of the clinical trial, which will be led by Jazz Pharmaceuticals, U.S. drugmaker and SK Biopharmaceuticals’ partner, will take place in the U.S. and Europe with patients suffering from narcolepsy and sleep apnea, the Korean company said.
The Korean drugmaker exported the global license of the drug, which was recognized for its high effectiveness and safety, to the U.S. partner in 2011.
The new drug, called SKL-N05, is expected to hit the shelves as early as 2018.
A man walks past the headquarters of SK Group in central Seoul. (Yonhap)
Jazz Pharmaceuticals plans to win sales approval from the Food and Drug Administration in the U.S. after completing the trial tests by 2017.
SK Holdings has been ramping up its efforts to grow biotech businesses for years, which will be the company’s new cash cow along with those for telecommunications, semiconductors and petrochemicals.
The holding firm of the nation’s third-largest conglomerate also established SK Biotech, a manufacturer of raw materials for medicine, in April.
An official from the Korean biotech company said SK would receive royalties during the clinical trials from the U.S. pharmaceutical firm and after the drug goes on sale.
With sales rights for the new medication in 12 Asian countries including China, Japan and Korea, SK also plans to conduct marketing promotions in the Asian markets.
Around 15 percent of those living in the West experience severe daytime sleepiness more than three times a week due to lethargy and sleep apnea.
“Besides the upcoming clinical trials for the sleep disorder drug, SK Biopharmaceuticals is also working on developing medicines for epilepsy, chronic constipation and irritable bowel syndrome,” said Cho Dae-sik, chief executive of SK Holdings, in a press release.
By Kim Young-won (email@example.com)