Jazz Pharmaceuticals, SK Biopharmaceuticals’ U.S. partner, said that it has received sales approval for Sunosi (Ingredient: solriamfetol), a new sleep disorder drug, from the Canadian health authorities.
With the approval, hospitals can prescribe the drug to treat adult patients suffering from excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).
SK Biopharmaceuticals discovered Sunosi and completed its phase 1 clinical trial before licensing out the substance to Aerial BioPharma in 2011. Afterward, Jazz Pharmaceuticals took over the global commercialization rights, including the U.S. and Europe, to complete the phase 3 clinical trials for the drug.
Jazz Pharma has launched the drug in the U.S. and EU after receiving sales approval from the U.S. Food and Drug Administration and European Medicine Agency for Sunosi in March 2019 and January 2020, respectively.
According to Jazz, the drug posted sales of $12.1 million (about 14 billion won) in the second quarter of this year, a 41.1 percent rise compared to the same period last year. The company also recorded sales of about $23.7 million in the first half of 2021, up 125.7 percent from the same period the previous year.
"The Health Canada approval of Sunosi represents an important advancement for Canadians living with chronic, and often debilitating, sleep disorders. EDS associated with narcolepsy or OSA is a serious condition with limited treatment options available," Jazz Pharma Canada CEO Paul Petrelli said. "Jazz is proud to introduce this new therapeutic option to the Canadian market as we continue innovating to transform the lives of patients and their families."
Industry experts also expect that SK Biopharmaceuticals will additionally profit from the Canadian approval of Sunosi.
The company is eligible to receive milestones based on Sunosi's net sales and a certain percentage of royalties from Jazz under the terms of their previous contract. SK Biopharmaceuticals also still owns the rights to Sunosi in 12 Asian countries, including Korea, China, and Japan.