37. Xcopri

FDA Building 2

Active ingredient: cenobamate
Disease: partial-onset adult seizures
Peak sales estimate: $840 million
Approved: Nov. 21, 2019
Company: SK Life Science

The scoop: SK Life Science, the U.S. subsidiary of South Korean drugmaker SK Biopharmaceuticals, picked up its first FDA approval with seizure medication Xcopri last November, as it looks to transition to a commercial-stage enterprise after more than a decade of R&D. The company plans to launch the drug itself in 2020, without marketing partners, and through its own sales force—which could make it the first Korean company to independently discover, develop and sell a product in the U.S., according to SK. The FDA gave Xcopri the green light after two phase 2 studies showed reductions in seizures compared to placebo, while nearly 20% of patients in the trials’ maintenance phases reported no seizures at all. Shortly after the approval, news got out that parent SK Biopharmaceuticals is planning an $850 million IPO. The company also claims another member of this year's list—sleep disorder drug Sunosi in collaboration with Jazz Pharmaceuticals—and is shepherding treatments for Lennox-Gastaut syndrome, ADHD, schizophrenia and other neurological conditions through its pipeline. — Conor Hale

37. Xcopri

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