After two years of preparations and building up infrastructure, Harmony Biosciences is nearly ready for its first drug launch. The FDA Thursday approved Wakix, or pitolisant, to treat excessive daytime sleepiness in adults suffering from narcolepsy.
The company won FDA approval after securing about $500 million in financing and building itself “from scratch” over the last two years, CEO John Jacobs told FiercePharma. A Philadelphia-area drug company, Harmony started in October 2017 and has built up an in-house sales force, a medical science liaison team, a market access team and more, Jacobs said. Harmony plans to launch the med in the fourth quarter.
As for the drug, France’s Bioprojet developed pitolisant and launched the med 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.
The drug works through a novel mechanism of action—increasing the synthesis and release of histamine in the brain—and is the only med approved for the condition that’s not scheduled as a controlled substance, Harmony's chief medical officer Jeffrey Dayno told FiercePharma. Despite several narcolepsy options already existing, Jacobs said there’s still an unmet need as some patients are unsatisfied with their drugs or don’t want to take scheduled medicines. Wakix is a once-daily tablet.
The FDA evaluated Wakix's efficacy based on data from two placebo-controlled studies comprising 261 patients. Harmony scored a priority review at the FDA in February.
In the marketplace, Wakix will go up against Jazz Pharmaceuticals' new sleepiness med Sunosi, which just launched last month, plus other older meds such as Jazz’s Xyrem and Teva’s Provigil. Jacobs declined to go into details about Harmony’s launch plans, but he did say he expects Wakix will be a “really nice option” for doctors and patients because it works uniquely, because it isn’t a scheduled therapy and because it isn’t a stimulant. Jazz's Xyrem pulled in $1.4 billion last year; the company hasn't started reporting Sunosi sales.
Outside of its drug launch, Harmony has ambitions to score new uses for the drug and acquire new treatments to expand its portfolio, the execs said.