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Eire-based biopharma Avadel Prescribed drugs (NASDAQ:AVDL) added ~26% on Friday to succeed in the best degree since March, as Needham famous that latest feedback made by the Federal Commerce Fee (FTC) might result in imminent FDA approval for its lead asset Lumryz.
FDA has already granted tentative approval for Lumryz to deal with extreme daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
Nevertheless, the corporate has but to obtain the ultimate approval amid a patent dispute with Jazz Pharma (NASDAQ:JAZZ) which affords the rival remedy Xyrem. The difficulty pertains to U.S. patent No. 8731963 (REMS Patent), listed within the FDA’s Orange Ebook.
In an amicus temporary on Thursday, the FTC argued that patents comparable to ‘963 associated to REMS distribution programs shouldn’t block generic or different competitors.
In response, Needham analyst Ami Fadia famous that FTC’s view signifies that the ‘963 patent “shouldn’t be within the Orange Ebook, which might take away the ultimate hurdle to Lumryz getting FDA approval that might in any other case solely get cleared by patent expiry on June 17, 2023.”
Searching for Alpha contributor Bret Jensen explains how traders ought to tackle the regulatory uncertainty as Avadel (AVDL) seeks full approval for Lumryz.
