Press Releases

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PLYMOUTH MEETING, PA, November 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today that data from two clinical studies evaluating the long-term safety and efficacy, as well as the human abuse potential of WAKIX® (pitolisant), have been published in SLEEP. WAKIX is a first-in-class medication with a novel mechanism of action and is approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first and only U.S. Food and Drug Administration (FDA) approved product for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

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PLYMOUTH MEETING, PA, September 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today the recipients of the inaugural Patients at the Heart Grant, a competitive grant opportunity to fund innovative, patient-centric programs for the narcolepsy community. Applicants were asked to submit proposals describing the goals of their program and how it will benefit people living with narcolepsy, as well as an evaluation plan with measurable indicators of success.

The original 2019 grant award was $50,000, but following the review of each application, the Patients at the Heart Grant review committee selected four organizations to receive grants totaling $65,000. The review committee was comprised of a diverse group of experts including cross-functional Harmony executives, a healthcare professional specializing in sleep disorders medicine and research, and a person living with narcolepsy.

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PLYMOUTH MEETING, PA, September 16, 2019 — Harmony Biosciences, LLC, (Harmony) announced today it will present clinical data on the efficacy and safety of WAKIX® (pitolisant) at the World Sleep 2019 meeting in Vancouver, Canada, from September 20-25, 2019. In an oral presentation, results will be presented from a randomized, double-blind, active- and placebo-controlled, four-sequence, four-way crossover study that evaluated the abuse potential of pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in non-dependent, recreational stimulant users. In addition, seven scientific posters will be presented, including a new post-hoc analysis of pooled data from two randomized, placebo-controlled, seven- and eight-week studies of pitolisant in adults with narcolepsy that evaluated the efficacy of WAKIX in patients with a high burden of narcolepsy symptoms.

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PLYMOUTH MEETING, PA, August 15, 2019 — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

“We are extremely proud to bring WAKIX to market for those living with narcolepsy, a chronic, debilitating, rare neurologic disorder,” said Harmony’s Chairman and Chief Executive Officer, John C. Jacobs. “At Harmony we share a vision to develop novel treatment options for people living with rare diseases, with a focus on those that affect the central nervous system. The approval of WAKIX strengthens our commitment to making that vision a reality.”

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PLYMOUTH MEETING, PA, June 17, 2019 — Harmony Biosciences, LLC (Harmony) today announced the launch of the first Patients at the Heart Grant, a competitive grant opportunity to fund innovative patient-centric programs for the narcolepsy community. As part of Harmony’s overall commitment to supporting the comprehensive needs of people living with narcolepsy, Harmony has committed an initial $50,000 to this program.

“Keeping patients at the heart of everything we do is our main focus,” said Cate McCanless, Harmony’s Vice President, External Affairs. “We recognize there is an unmet need for support within the narcolepsy community and are hopeful we receive innovative ideas from organizations that allow us to support people living with narcolepsy and their families.”

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PLYMOUTH MEETING, PA, June 4, 2019 — Harmony Biosciences, LLC (Harmony) announced today it will present data on the safety and tolerability of pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 33rd Annual Meeting of the Associated Professional Sleep Societies, known as “SLEEP” in San Antonio, Texas from June 8-12. In addition to integrated data from clinical studies on the safety and tolerability of pitolisant, Harmony’s presentations will highlight data from a human abuse potential study of pitolisant, the pitolisant U.S. expanded access program, and an analysis of pitolisant in combination with other medications for the treatment of narcolepsy.

“As a company dedicated to novel treatments for rare disorders, we are pleased to share a broad range of data for pitolisant at this year’s SLEEP meeting,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D.

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PLYMOUTH MEETING, PA, April 29, 2019 — Harmony Biosciences, LLC (Harmony) today announced it will present data on the efficacy and safety of pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 2019 American Academy of Neurology (AAN) annual meeting in Philadelphia, May 4-10. Harmony is a biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases.

“We are pleased to have the opportunity to present data on pitolisant at this year’s AAN annual meeting demonstrating our commitment to investigating treatment options for people living with rare diseases such as narcolepsy,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D.

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PLYMOUTH MEETING, PA, March 13, 2019 — Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has entered into a $200 million debt facility with CR Group L.P. (CRG), a premier healthcare-focused investment firm, to provide additional working capital to fuel the company’s continued growth.

“This financing illustrates our confidence in the continued growth of the company and, importantly, in the significant potential of Harmony to bring new treatment options to those who live with rare diseases,” said John C. Jacobs, President and CEO of Harmony. “In addition to our original private equity raises totaling $295 million, the flexibility and strength afforded by this debt facility positions the company extremely well to achieve our future goals and address unmet medical needs, in line with our mission.”

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PLYMOUTH MEETING, PA, February 12, 2019 — Harmony Biosciences, LLC (Harmony), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant, and has granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy. A Priority Review designation by the FDA indicates that, if approved, pitolisant would provide a significant improvement in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.

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PLYMOUTH MEETING, PA, February 4, 2019— Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been certified as a great workplace by independent analysts at Great Place to Work®. Harmony earned this credential based on extensive ratings by its employees in an anonymous survey that provides benchmarks, framework and assessment to recognize outstanding workplace cultures.

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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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