Harmony Biosciences licenses narcolepsy drug

Plymouth Meeting-based Harmony Biosciences Holdings, a company developing treatments for rare neurological diseases, recently signed an exclusive licensing agreement with Bioprojet, a French pharmaceutical company, to develop, manufacture and commercialize TPM-1116.

TPM-1116 is an oral orexin-2 receptor for the treatment of narcolepsy and other sleep/wake disorders.

Under the agreement, Harmony will pay Bioprojet $25.5 million for the exclusive right to develop, manufacture and commercialize TPM-1116 in the United States and Latin America.

Harmony also will pay up to $127.5 million when certain development and regulatory milestones are met, up to $240 million for sales milestones, and a royalty rate on sales in the licensed territories.

“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,” Dr. Jeffrey Dayno Harmony Biosciences president and CEO, said. “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. 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.”