Arrowhead Pharmaceuticals’ subsidiary Visirna Therapeutics has entered an asset purchase agreement with Sanofi for the rights to develop and commercialise plozasiran, a potential treatment for severe hypertriglyceridemia, in Greater China.
The deal involves an upfront payment of $130m to Visirna, which is also eligible for up to $265m in milestone payments on securing approval for plozasiran for different indications in mainland China.
Arrowhead will receive royalties on net commercial sales of the product in Greater China as stipulated in the Arrowhead-Visirna licence, which has been partially assigned to Sanofi.
Arrowhead president and CEO Christopher Anzalone stated: “When we founded Visirna in 2022, we believed that Greater China represented an important potential future market for multiple programmes in Arrowhead’s pipeline of investigational RNAi-based candidates for cardiometabolic diseases.
“The team at Visirna understands the intricacies of China’s clinical, regulatory and commercial environment and has done impressive work moving plozasiran through clinical studies and into the regulatory submission and review process.”
Visirna has concluded a Phase III study of plozasiran in Chinese subjects with familial chylomicronemia syndrome (FCS). The trial achieved its primary efficacy and all key secondary goals.
Following the trial, the company submitted a new drug application for the therapy to China's National Medical Products Administration (NMPA) for the treatment of FCS and obtained official acceptance officially in January 2025.
The investigational RNA interference (RNAi) therapeutic candidate has been designed to reduce apolipoprotein C-III (APOC3) production, a key triglyceride metabolism regulator. It has received priority review designation from the NMPA.
Legal advisors Gibson, Dunn & Crutcher and Sidley Austin are providing counsel to Arrowhead in this transaction.
In January 2025, the US Food and Drug Administration accepted Arrowhead’s NDA for plozasiran in the same indication, a month after the first treatment was approved by the regulator for the treatment of FCS.
