TPM-1116 preclinical data suggest a potential best-in-class profile for the treatment of narcolepsy and other sleep/wake disorders.


Summary: Harmony Biosciences has secured an exclusive license from Bioprojet to develop, manufacture, and commercialize TPM-1116, an oral orexin-2 receptor agonist, in the United States and Latin America. This drug, aimed at treating narcolepsy and other sleep disorders, shows promise based on its selectivity and potency. Harmony will pay Bioprojet $25.5 million upfront, with potential future payments up to $367.5 million based on developmental, regulatory, and sales milestones, plus royalties on sales. 

Key Takeaways: 

  • Harmony Biosciences has entered into an exclusive licensing agreement with Bioprojet to develop, manufacture, and commercialize TPM-1116, a selective oral orexin-2 receptor agonist, in the United States and Latin American territories.
  • Under the agreement, Harmony will pay Bioprojet an upfront license fee of $25.5 million, with potential additional payments up to $127.5 million based on development and regulatory milestones, and up to $240 million based on sales milestones, plus mid-teen percentage royalties on sales.
  • TPM-1116 is being evaluated for the treatment of narcolepsy and other sleep/wake disorders, with the potential to offer a best-in-class clinical profile due to its potency, selectivity, and preclinical safety profile. 

Harmony Biosciences Holdings Inc announced an exclusive licensing agreement with 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.

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 treatments for patients living with unmet medical needs, according to Jeffrey M. Dayno, MD, Harmony Biosciences president and CEO. 

“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 says in a release. 

He continues, “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.” 

Terms of the 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 United States 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.

“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,” says professor Jean-Charles Schwartz, co-founder of Bioprojet and member of the French and European Academies of Science, in a release. 

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