Press Releases

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PLYMOUTH MEETING, PA, December 5, 2018 — Harmony Biosciences, LLC (Harmony) announced today that the company has received four industry awards for its Know Narcolepsy® disease awareness educational campaign and healthcare professional educational video series. The company was selected as an Award of Excellence winner in two categories for Launch Campaign and Physician Education by the 32nd Annual Rx Club Show, and two Honorable Mentions for its Video Programs as part of the PR News Healthcare Communications and Digital Awards.

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PLYMOUTH MEETING, PA, October 9, 2018 — Results of a three-part survey of those living with narcolepsy (n=200), treating physicians (n=251) and the general public (n=1,203) bring to light the serious impact of this rare, chronic neurologic disorder on daily life. The Know Narcolepsy™ survey, conducted by Versta Research among a total of 1,654 respondents on behalf of Harmony Biosciences, LLC, in collaboration with patient advocacy organization, Narcolepsy Network, highlighted that narcolepsy is life-changing for the majority (86 percent, n=172) of those surveyed living with the disorder. However, 78 percent (n=938) of the general public surveyed agreed they have no idea what it must be like to live with narcolepsy, which impacts up to 200,000 Americans.

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PLYMOUTH MEETING, PA, September 27, 2018 — Harmony Biosciences, LLC (Harmony) announced today that French pharmaceutical company Bioprojet SCR (Bioprojet) presented new human abuse potential (HAP) data on pitolisant at the 24th Congress of the European Sleep Research Society (ESRS) in Basel, Switzerland. Pitolisant is an investigational product in the U.S. that was studied in Europe and approved by the European Medicines Agency (EMA) in 2016 for the treatment of adult patients with narcolepsy with or without cataplexy. Harmony acquired exclusive rights in 2017 to develop and register pitolisant in the U.S.

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PLYMOUTH MEETING, PA, September 12, 2018 — Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, today announced the opening of its completed, 15,651 square foot headquarters in Plymouth Meeting, PA, located at 630 W. Germantown Pike. The company, established in October 2017, was honored to host Pennsylvania Governor Tom Wolf at a ribbon-cutting ceremony, as well as Chris Molineaux, President and Chief Executive Officer of Life Sciences Pennsylvania (LSPA).

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PLYMOUTH MEETING, PA, September 11, 2018 — Harmony Biosciences, LLC (Harmony) presented new data on pitolisant at the 7 th International Symposium on Narcolepsy in Beverly, MA. Pitolisant is an investigational product that has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. Long term data (up to 5-years) from the Harmony III open-label, naturalistic study were presented in a platform presentation. These data assessed the safety, tolerability and durability of effect of pitolisant, the first potent and highly selective histamine 3 (H3 ) receptor antagonist/inverse agonist. If approved, pitolisant would represent the first new therapy in the U.S. in over a decade for the treatment of both EDS and cataplexy in patients with narcolepsy.

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PLYMOUTH MEETING, PA, September 5, 2018 — Harmony Biosciences, LLC (Harmony) today announced that it will present scientific data on its investigational product, pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 7th International Symposium on Narcolepsy in Beverly, MA from September 9-13.

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PLYMOUTH MEETING, PA, May 31, 2018 — Harmony Biosciences, LLC (Harmony), a Paragon Biosciences, LLC, portfolio company, today announced that it will present scientific data on its investigational product, pitolisant, which is being studied for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy, at the upcoming 32nd Annual Meeting of the Associated Professional Sleep Societies, known as "SLEEP", in Baltimore, MD from June 3-6.

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PLYMOUTH MEETING, PA, May 21, 2018 — Harmony Biosciences, LLC (Harmony), today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA). Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. These designations signal FDA’s interest in the development program for pitolisant and provide opportunities for frequent interaction with the Agency, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review.

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