SK Biopharmaceuticals(www.skbp.com) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for SKL-N05(Solriamfetol) which signed a license deal with U.S.-based Jazz Pharmaceuticals, the global leader in sleep disorder disease. If the FDA approves SKL-N05, Jazz Pharmaceuticals expects to launch in the US in early 2019. 

SK Biopharmaceuticals had discovered the compound, and signed a license deal with Aerial Biopharma in 2011. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize SKL-N05 from Aerial Biopharma. 

Clinical trials have been conducted in patients with excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy, and it has been shown excellent efficacy and safety in long-term treatment. Jazz Pharmaceuticals announced its clinical results in June 2017 at APSS(Annual meeting of the Associated Professional Sleep Societies LLC) in the United States. 

Jazz Pharmaceuticals has worldwide (except Asia) development, manufacturing, and commercialization rights to solriamfetol. SK Biopharmaceuticals maintains rights to 12 major Asian countries including Korea, Japan and China, and plans to prepare for entry into the Asian market in the future. 

SK believes that the development of new drugs will be a key growth driver for future generations and has been steadily investing for more than 20 years. SK Biopharmaceuticals has been leading the development of innovative drugs targeting the global market and plans to leap to become a global comprehensive pharmaceutical company through the achievement of new drug commercialization.