Business
HARMONY BIOSCIENCES REITERATES CONFIDENCE IN WAKIX® (PITOLISANT) PATENTS FOLLOWING FAVORABLE DECISION BY U.S. PATENT AND TRADEMARK OFFICE (USPTO) TO DENY PETITION FOR REEXAMINATION
PLYMOUTH MEETING, Pa., Aug. 28, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"PLYMOUTH MEETING, Pa., Aug. 28, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (\"Harmony\" or the \"Company\") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today commented on the favorable decision by the U.S. Patent and Trademark Office (USPTO) to deny a Petition for Reexamination concerning a patent covering the active ingredient in WAKIX® (pitolisant).\n\n \n \n \n \n \n \n\n \nThe Company issued the following statement:\nWe are pleased that the U.S. Patent and Trademark Office (USPTO) rejected a challenge to the validity of claims within the patent covering the active ingredient in WAKIX® (pitolisant), in line with our expectations. This decision not only underscores our confidence in the strength of the WAKIX patent portfolio but also reinforces our belief in the potential of the WAKIX franchise. We continue to believe that WAKIX represents a billion-dollar plus opportunity in narcolepsy alone, with the potential to contribute up to an additional $1 billion dollars, if approved, in idiopathic hypersomnia and other current lifecycle management programs. We are proud of the work we do every day to address the unmet medical needs of patients living with rare neurological diseases.\nAbout WAKIX® (pitolisant) TabletsWAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.\nINDICATIONS AND USAGEWAKIX is indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.\n...