Harmony Biosciences, a Plymouth Meeting, PA-based biopharmaceutical company and a member of the Paragon Biosciences corporate family, raised $270M in equity financing.
Backers included Valor Equity Partners, Fidelity Management & Research Company, HBM Healthcare Investments, Vivo Capital, venBio Partners, Novo Holdings and Nan Fung Life Sciences.
In addition to the funding, Harmony Biosciences, LLC, acquired the exclusive US right to develop, register and market the drug pitolisant from Paris, and Rennes, France research-based pharmaceutical company Bioprojet SCR. The company, established and guided by Paragon and its team, intends to use the funds to facilitate this acquisition and accelerate development and registration of a novel drug for adults suffering from narcolepsy.
Developed after decades of research by Bioprojet co-founders Dr. Jeanne-Marie Lecomte and Prof. Jean-Charles Schwartz, Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons. The drug is approved in the European Union (EU) and distributed under the tradename WAKIX® for the treatment of narcolepsy in adult patients with and without cataplexy. Currently no H3-receptor antagonist/inverse agonist has been approved by the US Food & Drug Administration (FDA).
It has been recently approved by the European Medicines Agency (EMA) to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness (EDS), with or without cataplexy.
Led by CEO Bob Repella, Harmony, along with the Paragon family of companies, is focused on providing novel treatment options to patients with orphan and rare conditions, with an emphasis on central nervous system disorders. With Paragon’s resources and expertise, Harmony and Bioprojet will continue collaborative research/development under the guidance of a joint development committee. Harmony intends to establish an expanded access program (EAP) for pitolisant in the US in early 2018 and expects to submit a new drug application (NDA) for the treatment of narcolepsy in adult patients during the first half of 2018.