SK BioPharm, a pharmaceutical unit of SK Group, announced on July 3 that its U.S. partner Jazz Pharmaceuticals will start sales of innovative new sleep disorder drug Solriamfetol (product name: Sunosi) in the U.S. market on July 8 following the FDA approval in March.
This is the first time that an innovative drug developed by a domestic company in the area of central nervous system has been approved by the FDA and released to the global market. Solriamfetol is a project that represents 26 years of research efforts by SK Group. It will be the first successful central nervous system drug targeting the global market.
SK BioPharm finished the Phase I clinical trial of Solriamfetol and licensed-out the technology. Jazz, which acquired global commercialization rights, received approval from the FDA after completing Phase III clinical trials. Solriamfetol is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to improve the alertness of adult patients with narcolepsy and excessive daytime sleepiness due to obstructive sleep apnea (OSA).
Jazz, the global leader in sleep disability treatment, is recognized for its high understanding of diseases and an exceptional sense in developing unexplored markets.
SK BioPharm will receive royalties based on sales when Solriamfetol is launched in the U.S. market. In addition, the company has sales rights in 12 countries in Asia including Korea, China, and Japan, and has begun to establish market analysis and licensing strategies for commercialization in these markets. In particular, it applied for a license for European sales in November 2018, and it is expected to be approved within the fourth quarter of this year.
Meanwhile, SK BioPharm's proprietary drug Cenobamate is under FDA review for new drug approval, and the decision will be out on Nov. 21 (U.S. local time).