Biopharmaceutical company Harmony Biosciences, LLC, a member of the Paragon Biosciences corporate family, has acquired the exclusive US right to develop, register, and market the drug pitolisant from French company Bioprojet SCR. Harmony also announced that it completed a $270 million equity financing to facilitate this acquisition and accelerate its ability to address unmet needs for patients with sleep and other central nervous system disorders.
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).
Pitolisant 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. Cataplexy is characterized by sudden and uncontrolled muscle weakness or paralysis. Pitolisant increases the release of the brain chemical histamine to increase a patient’s wakefulness and alertness.
Harmony and the Paragon family of companies are dedicated to biomedical innovation for patients suffering from challenging and debilitating but often ignored diseases. Harmony raised over $270 million from highly experienced equity investors including Valor Equity Partners, Fidelity Management & Research Company, HBM Healthcare Investments, Vivo Capital, venBio Partners, Novo Holdings, and Nan Fung Life Sciences.
Pitolisant was developed after decades of research by Bioprojet co-founders Dr Jeanne-Marie Lecomte and Jean-Charles Schwartz.
“Bioprojet is proud to partner with Harmony. With our collaborative best-in-class approach, we plan to help bring much needed relief to thousands of people suffering from these debilitating diseases and to research and develop pitolisant for other unsatisfied medical conditions,” says Schwartz in a release.
Harmony is led by CEO Bob Repella, a veteran of the pharmaceutical industry with significant experience in bringing drugs to market to treat orphan and rare disorders.
“We’re excited to research, develop and seek US approval for pitolisant, a potential first-in-class therapy to treat patients with narcolepsy,” Repella says. “In addition to working with the FDA, Harmony will be working closely with healthcare providers, advocacy organizations, and other stakeholders to help address the unmet needs of the patient community.”
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.
Octagon Capital Group served as financial advisor to Harmony Biosciences in connection with the financing and acquisition transactions. Bionest Partners Finance served as financial advisor to Bioprojet in connection with the acquisition transaction. Katten Muchin Rosenman LLP served as legal counsel to Harmony. McDermott Will & Emery served as legal counsel to Bioprojet.