Solriamfetol, a sleep disorder drug developed by South Korea’s SK Biopharmaceuticals and licensed out to U.S-based Jazz Pharmaceuticals, will debut in the U.S. next month.
According to industry sources on Thursday, Jazz Pharmaceuticals decided to begin marketing of the central nervous system drug in July, which will be sold under the brand name of Sunosi.
SK Biopharmaceuticals discovered the compound and signed a license deal with Aerial Biopharma in 2011 after a phase I study was completed. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize the compound from Aerial Biopharma. Jazz Pharmaceuticals completed phase 3 trials and filed a New Drug Application (NDA) for the drug with the FDA in Dec. 2017.
The FDA approved Solriamfetol for the treatment of patients with excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy.
It marks the first approved novel drug in the pipeline of the company, and the first FDA-approved central nervous system drug developed by a Korean company.
SK Biopharmaceuticals expects to see royalty proceeds from sales of Solriamfetol from the second half of this year. SK Biopharmaceuticals holds development and marketing rights for the drug in 12 countries including Korea, China and Japan.
According to market research firm Global Data, demand for narcolepsy treatments are estimated to nearly double from $1.6 billion in 2019 to $2.9 billion in 2025 in the U.S. alone.
By Kim Byung-ho and Minu Kim
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