AVDL - Avadel gains as judge delays hearing on patent dispute with Jazz Pharma

The shares of Ireland-based biopharma Avadel Pharmaceuticals plc ( NASDAQ: AVDL ) gained more than 9% Thursday after the company announced that a district judge in Delaware postponed a hearing on its patent dispute with Jazz Pharma ( JAZZ ) related to the latter’s narcolepsy therapy Xyrem.

FDA has already granted tentative approval for AVDL’s rival therapy Lumryz to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The final approval depends on resolving a patent dispute over U.S. patent No. 8,731,963 (REMS Patent).

Ahead of a hearing scheduled for Aug. 31, AVDL has filed a renewed motion to have the REMS Patent delisted from the FDA’s Orange Book, expecting a resolution to the dispute.

In a regulatory filing Thursday, AVDL said that a district court judge in Delaware issued an order postponing the hearing and seeking a response from JAZZ on the renewed motion by Aug. 26.

“We continue to believe AVDL’s chances of accelerating final approval are not insignificant,” Needham analyst Ami Fadia with a Buy rating on AVDL, wrote in reaction to the news. According to the analysts, there is an “incrementally higher possibility for a delisting counterclaim ruling to come in the near-term.”

Before the FDA approval of Lumryz, AVDL vowed to “vigorously” defend the company against the allegations of patent violations.

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