SK Holdings, the holding company of SK Group, announced on June 1 that its new medication for sleep disorders developed by SK Biopharmaceuticals, or SKL-N05, will enter phase 3 clinical trials in the U.S.
SK Biopharmaceuticals is a subsidiary of SK Group that has a 100 percent share. The company focuses on the development of new drugs.
The third step of the clinical trial, which will be led by Jazz Pharmaceuticals of the U.S., SK Biopharmaceuticals’ new drug development partner, will take place in North America and Europe with patients suffering from narcolepsy and sleep apnea. Jazz Pharmaceuticals is the world’s biggest pharmaceutical company in the sleep disorder sector.
After SK independently developed SKL-N05, it verified its high effectiveness and safety of the treatment. Accordingly, the company exported the global license of the drug to its U.S. partner in 2011. Jazz Pharmaceuticals plans to complete phase 3 clinical trials by 2017 and to put the new drug on sale in 2018 after winning sales approval from the Food and Drug Administration (FDA) in the U.S.
Under the technology export deal, SK will receive engineering fees during the clinical trials from Jazz Pharmaceuticals and royalties after the drug goes on sale according to its sales. Since the company has sales rights for the new medication in 12 major Asian countries including Korea, Japan, and China, SK will conduct marketing promotions in the Asian markets after the release of the new drug.
Meanwhile, 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. The new drug market size related to sleep disorders amounts to US$3 billion (3.34 trillion won), showing an annual average growth of more than 6 percent.
Cho Dae-sik, chief executive of SK Holdings, said, “Besides the upcoming clinical trials for sleep disorder treatments, SK Biopharmaceuticals is also working on developing medicines for epilepsy, chronic constipation, and irritable bowel syndrome, which are highly competitive. The company will also strive to develop innovative new treatments for the global market in the future.”