Harmony and BioProjet License Potential Treatment for Sleep and Wake Disorders

Rare Daily Staff

Harmony Biosciences entered an exclusive licensing agreement with French biotech Bioprojet to develop, manufacture, and commercialize TPM-1116, which will be evaluated for the treatment of sleep and wake disorders including narcolepsy.

TPM-1116 is a new highly potent and selective oral orexin-2 receptor (OX2R) agonist discovered by Teijin Pharma and represents a new chemical series of OX2R agonists with the potential for a best-in-class clinical profile.

Narcolepsy is a rare neurologic disease characterized by excessive daytime sleepiness associated with uncontrollable sleep urges and cataplexy (sudden loss of muscle tone while awake often triggered by pleasant emotions). Narcolepsy and other hypersomnolence disorders continue to be a large market opportunity with significant unmet medical need. The agreement will accelerate the development of this orexin-2 receptor agonist and is expected to further Harmony’s offerings in the sleep/wake space.

“Orexin agonism is an exciting area of sleep disorder research and represents the next novel mechanism of action for the treatment of narcolepsy since the launch of Wakix. We also see potential synergies between TPM-1116 and our lead product, Wakix (pitolisant), and new formulations of pitolisant, because of the interplay between histamine and orexin in the hypothalamus,” said Jeffrey Dayno, president and CEO of Harmony Biosciences. “We believe TPM-1116, a new chemical series of orexin 2 agonist, could emerge with a potential best-in-class clinical profile based on its potency and selectivity, along with its strong preclinical safety profile and potential for once daily dosing.”

Under the agreement, Harmony will pay Bioprojet an upfront license fee of $25.5 million for the exclusive right to develop, manufacture and commercialize TPM-1116 in the U.S. and Latin American territories. In addition, Harmony is obligated to pay up to $127.5 million upon achievement of development and regulatory milestones and up to $240 million upon achievement of sales-based milestones. Finally, Harmony will pay a royalty rate in the mid-teens on sales of product in the licensed territories.

“This new project to develop a potentially best-in-class orexin-2 receptor agonist will extend the productive collaboration between Bioprojet and Harmony in the field of sleep medicine beyond the successful commercialization of WAKIX in narcolepsy and the discovery of novel formulations of pitolisant to extend the pitolisant franchise,” said Jean-Charles Schwartz, co-founder of Bioprojet and member of the French and European Academies of Science.

Photo: Jeffrey Dayno, president and CEO of Harmony Biosciences