SK Biopharmaceuticals and its partner Jazz Pharmaceuticals announced Monday that the US Food and Drug Administration has accepted for standard review their new drug application seeking marketing approval for solriamfetol, an investigational drug to treat narcolepsy, a sleep disorder.
Jazz Pharmaceuticals expects the US FDA to make a decision on the approval by Dec. 20, 2018, in accordance with the Prescription Drug User Fee Act. With the approval, the drugmaker hopes to begin selling the drug, which has obtained orphan drug designation, in the US from early 2019.
Solriamfetol is an investigational drug designed to treat excessive sleepiness in adult patients with narcolepsy, a debilitating neurological disorder characterized by excessive sleepiness, or obstructive sleep apnea, characterized by pauses in breathing during sleep.
The drug compound was originally discovered by SK Biopharmaceuticals, but licensed out to Aerial Biopharma in 2011. Later, Aerial Biopharma sold its rights to solriamfetol to Jazz Pharmaceuticals in 2014.
Now, Jazz Pharmaceuticals holds the worldwide development, manufacturing and commercialization rights for narcolepsy drug, with the exception of 12 markets in Asia, where SK Biopharm retains its rights.
If solriamfetol is commercialized in the US, SK Biopharmaceuticals is expected to reap in double-digit royalties from the drug’s sales in the US, the company said.
“We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol,” said Karen Smith, Jazz Pharmaceuticals’ Chief Medical Officer.
In addition to the narcolepsy drug, SK Biopharmaceuticals has a number of other drugs under development, targeting rare diseases like infantile spasms and constipation-dominant irritable bowel syndrome, as well as neurological diseases including epilepsy and attention deficit hyperactivity disorder.
The one closest to commercialization is Cenobamate, an epilepsy drug wrapping up Phase 3 trials in global locations. The Korean drugmaker said it hopes to file a new drug application for cenobamate with the US FDA by as early as the end of this year.
As it prepares to make its first tangible profits, SK Biopharmaceuticals is also reviewing plans for an initial public offering. The company is considering a listing on both the US-based Nasdaq as well as Korean bourses. It has yet to finalize the details of the IPO, according to a SK Biopharm spokesperson.
By Sohn Ji-young (firstname.lastname@example.org)