20. Wakix

FDA Building 2

Active ingredient: pitolisant
Disease: narcolepsy
Peak sales estimate: n/a
Approved: Aug. 15, 2019
Company: Harmony Biosciences

The scoop: Pennsylvania-based Harmony Biosciences spent two years prepping and building up its infrastructure for its first-ever drug launch, and this year it scored approval for Wakix, the only narcolepsy drug that’s not a scheduled substance, executives told FiercePharma. France’s Bioprojet originally developed the drug and launched it in Europe after a 2016 approval there. Harmony acquired U.S. rights to the drug in the fall of 2017 and at the time raised $270 million in equity financing. Earlier this year, Harmony secured a $200 million debt facility to further support the rollout. Along the way, Harmony has established an in-house sales force, a medical science liaison team, a market access team and more. Wakix will challenge another 2019 approval in Jazz’s Sunosi, plus Jazz’s established Xyrem and other narcolepsy options. — Eric Sagonowsky

20. Wakix

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