Arrowhead files lawsuit against Ionis over plozasiran patent dispute

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) filed a complaint for declaratory judgment in the U.S. District Court for the District of Delaware against Ionis Pharmaceuticals Inc., seeking to declare that Ionis's U.S. Patent No. 9,593,333 is invalid and not infringed by Arrowhead's investigational drug plozasiran.

The legal action follows threats from Ionis regarding potential patent infringement claims related to plozasiran, which is currently under review by the Food and Drug Administration for treating familial chylomicronemia syndrome. Arrowhead stated it believes the infringement allegations are without merit.

Plozasiran is an RNA interference therapeutic designed to reduce production of apolipoprotein C-III, a protein that regulates triglyceride metabolism. The drug has received Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation from the FDA for treating patients with familial chylomicronemia syndrome, a rare disease characterized by extremely high triglyceride levels.

The company is not seeking monetary damages but rather a court declaration that the patent is invalid or not infringed by plozasiran's manufacture, use, sale, or offer for sale. Arrowhead stated it has multiple issued U.S. patents covering plozasiran for familial chylomicronemia syndrome treatment based on internal research.

Plozasiran has demonstrated triglyceride reductions in multiple clinical studies across different patient populations, including those with familial chylomicronemia syndrome, severe hypertriglyceridemia, and mixed hyperlipidemia. The drug has been submitted for marketing authorization to multiple global regulatory authorities but has not been approved to treat any disease.

The information is based on a company press release.

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