Arrowhead Pharmaceuticals, Inc. has filed a complaint for declaratory judgment against Ionis Pharmaceuticals, Inc., seeking to invalidate U.S. Patent No. 9,593,333, which is related to the treatment of lipoprotein lipase deficiency. Arrowhead Pharmaceuticals, Inc. claims that the patent is either invalid, not infringed, or both. The company is seeking a declaration that its investigational therapeutic, plozasiran, will not infringe on the '333 patent.
Arrowhead Pharmaceuticals, Inc., known for its work in RNA interference (RNAi) technology, is focused on developing therapeutics for the treatment of various diseases, including orphan diseases with limited treatment options.
The '333 patent, titled "Modulation of Apolipoprotein C-III (ApoCIII) Expression in Lipoprotein Lipase Deficient (LPLD) Populations," was issued by the U.S. Patent and Trademark Office on March 14, 2017. It aims to disclose methods, compounds, and compositions for reducing expression of apolipoprotein C-III mRNA and protein for treating lipoprotein lipase deficiency in an animal.
Arrowhead's most advanced drug candidate, plozasiran, formerly known as ARO-APOC3, has shown promising results in treating Familial Chylomicronemia Syndrome (FCS). In a pivotal phase 3 clinical trial, plozasiran reduced triglycerides by up to 80% and apolipoprotein C-III levels by up to 94%, while also decreasing the incidence of acute pancreatitis in a statistically significant manner.
The FDA has recognized the potential of plozasiran, granting it fast track designation and breakthrough therapy designation for the treatment of FCS. Arrowhead submitted a new drug application for plozasiran in November 2024, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, for a decision on whether to approve plozasiran.
In December 2024, the FDA approved Ionis Pharmaceuticals, Inc.'s drug, Tryngolza® (olezarsen), for adults with FCS. Tryngolza® requires monthly injections and targets apolipoprotein C-III using a different mechanism compared to plozasiran.
Ionis Pharmaceuticals, Inc. has been accused of attempting to block Arrowhead's plozasiran through threats of litigation, alleging infringement of the '333 patent. Arrowhead, in response, has filed a complaint seeking a declaratory judgment of invalidity of the '333 patent.
The case highlights the competitive landscape in the biopharmaceutical industry, particularly in the development of therapies for rare diseases, and the importance of intellectual property rights in this space. As a result of these announcements, the company's shares have moved 4.18% on the market, and are now trading at a price of $28.89. Check out the company's full 8-K submission here.
