Press Releases

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PLYMOUTH MEETING, PA, July 30, 2020 — Harmony Biosciences (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare, neurological diseases, announced today that the company is a recipient of Life Sciences Pennsylvania’s (LSPA) 2019 Patient Impact Award. Harmony was selected as an honoree based on the company’s continued efforts to support patients living with narcolepsy.

“At Harmony, patients are at the heart of everything we do. It is an honor to be recognized by LSPA for our work to contribute to the health and wellbeing of people living with narcolepsy,” said Cate McCanless, Vice President of External Affairs at Harmony. “We are proud to be recognized as a company that is making a difference in the lives of patients through our continued focus on scientific innovation, advocacy, and patient education.”

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PLYMOUTH MEETING, PA, June 2, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it uploaded two posters with data on the efficacy and safety of WAKIX® (pitolisant) to the American Academy of Neurology (AAN) Science Highlights virtual platform. The abstracts of these posters are also included in an online supplement of the journal Neurology in the “Sleep Medicine: Focus on Therapies 2” poster session.

“We are pleased to have an opportunity to share these important data via this innovative approach with the broader neurology community,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “These data on the efficacy and safety of WAKIX strengthen the body of scientific evidence that supports WAKIX as a potential treatment option for adult patients living with narcolepsy.”

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PLYMOUTH MEETING, PA, April 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing new treatment options for people living with rare diseases, today announced the company will expand narcolepsy community support efforts and reinforced its commitment to provide affordable access to treatment for people who have experienced a change in insurance or financial instability during the ongoing COVID-19 pandemic.

Harmony’s Patients at the Heart grant program underscores the company’s ongoing commitment to support the comprehensive needs of people affected by narcolepsy. The second annual Patients at the Heart grant program is being launched with increased funding to further support patient-centric organizations working to address the challenges of people living with narcolepsy during this time. The company’s patient support program will continue to provide medication free of charge for eligible patients who have lost health insurance or are underinsured, while providing “contactless” shipping for home delivery.

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PLYMOUTH MEETING, PA, April 29, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been recognized nationally among the top 10 biopharmaceutical companies on the 2020 Fortune Best Workplaces in Health Care & Biopharma™ list. Harmony earned this accolade based on an independent analysis conducted by Great Place to Work®, following results of a comprehensive, anonymous survey examining employee satisfaction and their workplace experiences.

“At Harmony, we put the wellbeing of the patients we serve and each of our employees at the heart of all we do,” said John C. Jacobs, President and CEO. “Being recognized by Fortune as a Best Workplace is an honor and speaks to the dedication our team has to upholding our company’s core values, maintaining a supportive and inclusive culture, and delivering value to patients by embracing innovation.”

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PLYMOUTH MEETING, PA, March 30, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that Sleep Medicine has published an article which reviews the mechanism of action (MOA) of available treatments for patients with narcolepsy.

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PLYMOUTH MEETING, PA, February 3, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical 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 for the second year in a row by independent analysts at Great Place to Work®. Harmony earned this credential based on ratings by its employees in an anonymous survey that provides benchmarks, framework and assessment to recognize outstanding workplace cultures.

“At Harmony, we keep patients at the heart of everything that we do, and everyone has ownership in the success of our company,” said John C. Jacobs, President and CEO. “We were deeply honored that, for the second year in a row, Harmony team members who participated in the survey rated the company as a ‘great place to work’ and cited our culture of one-team attitude, honest and transparent ways of working, and the ability to make a difference for patients and the broader community as contributing to an overall positive workplace experience.”

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PLYMOUTH MEETING, PA, January 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has completed a $200 million debt facility with OrbiMed Advisors LLC (“OrbiMed”), one of the leading investors in the healthcare industry, to provide additional capital to fuel the company’s continued growth.

“We are pleased to announce the completion of this debt facility with OrbiMed, a leading healthcare public and private market investment firm,” said John C. Jacobs, Chairman and CEO of Harmony. “With this financing, Harmony will be well positioned to continue to develop new medications consistent with our goal of helping additional people living with rare diseases.”

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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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