Harmony Biosciences Partners with Bioprojet for TPM-1116

Harmony Biosciences inks agreement with Bioprojet to develop, manufacture and commercialize TPM-1116

Overview

Harmony Biosciences Holdings, a specialized company in developing and delivering treatments for rare neurological diseases, has announced an exclusive licensing agreement with Paris-headquartered pharmaceutical company, Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists with the potential for a best-in-class clinical profile.

Innovative Treatments for Diseases with Unmet Needs

• 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 leadership in the sleep/wake space, reinforcing its commitment to advancing innovative treatments for patients living with unmet medical needs, according to Jeffrey M. Dayno, the president and CEO.

Words from Harmony Biosciences Holdings

• "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, and new formulations of pitolisant, because of the interplay between histamine and orexin in the hypothalamus," Dayno said.
• "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. We look forward to working with Bioprojet and advancing the development program for TPM-1116 as part of our growth strategy."

Words from Bioprojet

"We are pleased that 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 Professor Jean-Charles Schwartz, co-founder of Bioprojet and member of the French and European Academies of Science.

Terms of Agreement

• 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 US 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.

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