AVDL - Avadel at eight-month high as FTC comments raise prospects for lead drug

Ireland-based biopharma Avadel Pharmaceuticals ( NASDAQ: AVDL ) added ~26% on Friday to reach the highest level since March, as Needham noted that recent comments made by the Federal Trade Commission (FTC) could lead to imminent FDA approval for its lead asset Lumryz.

FDA has already granted tentative approval for Lumryz to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

However, the company has yet to receive the final approval amid a patent dispute with Jazz Pharma ( NASDAQ: JAZZ ) which offers the rival therapy Xyrem. The issue relates to U.S. patent No. 8731963 (REMS Patent), which is listed in the FDA’s Orange Book.

In an amicus brief on Thursday, the FTC argued that patents such as ‘963 related to REMS distribution systems should not block generic or other competition.

In reaction, Needham analyst Ami Fadia noted that FTC’s view indicates that the ‘963 patent “should not be in the Orange Book, which would remove the final hurdle to Lumryz getting FDA approval that would otherwise only get cleared by patent expiry on June 17, 2023.”

Seeking Alpha contributor Bret Jensen explains how investors should address the regulatory uncertainty as Avadel ( AVDL ) seeks full approval for Lumryz.

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