Harmony Biosciences Secures Exclusive Rights to Promising Narcolepsy Treatment

Harmony Biosciences Holdings

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), in a strategic move to bolster its portfolio in sleep/wake disorders, has entered into an exclusive licensing agreement with Bioprojet. The partnership focuses on the development, manufacture, and commercialization of TPM-1116, a novel orexin-2 receptor (OX2R) agonist poised to transform the treatment landscape for narcolepsy and other hypersomnolence disorders.

TPM-1116 is distinguished by its highly potent and selective activation of the OX2R, signaling a new chemical series of OX2R agonists with the potential to offer a superior clinical profile. This collaboration underlines Harmony’s commitment to addressing the significant unmet medical needs within the sleep disorder community.

Narcolepsy, characterized by excessive daytime sleepiness, cataplexy, and fragmented night-time sleep, affects millions worldwide, often leading to severe impairment in daily functioning. Current treatments offer symptom relief but often come with side effects or fail to fully address the range of symptoms experienced by patients. The introduction of TPM-1116 could herald a new era in narcolepsy management, emphasizing the critical role of orexin, a neurotransmitter involved in wakefulness and arousal, in sleep regulation.

Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences, expressed enthusiasm about the potential of orexin agonism as a groundbreaking approach in sleep disorder treatment. “The synergy between TPM-1116 and our lead product, WAKIX, along with new formulations of pitolisant, underscores our holistic strategy in tackling narcolepsy through multiple mechanisms,” Dayno noted. He highlighted the compound’s promising preclinical safety profile and the convenience of once-daily dosing as key factors that could set TPM-1116 apart as a leading treatment option.

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The agreement entails an upfront payment of $25.5 million from Harmony to Bioprojet for the exclusive rights to TPM-1116 in the U.S. and Latin American territories. Additional payments could total up to $127.5 million based on developmental and regulatory milestones, with up to $240 million tied to sales achievements. Furthermore, Harmony will pay royalties in the mid-teens on sales within the licensed territories.

Professor Jean-Charles Schwartz, Co-Founder of Bioprojet and a renowned figure in the scientific community, lauded the extension of their collaboration with Harmony. “This project not only capitalizes on our shared success with WAKIX but also paves the way for further innovations in sleep medicine,” he remarked.

The strategic partnership between Harmony and Bioprojet represents a significant step forward in the quest for more effective narcolepsy treatments. By focusing on the orexin system’s role in sleep/wake regulation, TPM-1116 holds the promise of providing a new, targeted therapy option for patients grappling with the debilitating effects of narcolepsy and other sleep disorders. As the development of TPM-1116 progresses, its potential to improve the lives of those affected by these conditions remains a beacon of hope in the field of sleep medicine.

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