Arrowhead Pharmaceuticals has signed an asset purchase agreement with Sanofi for the rights to develop and commercialize plozasiran, an RNAi therapeutic candidate for treating familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG), in Greater China. Visirna Therapeutics, a majority-owned subsidiary of Arrowhead, has completed a Phase 3 clinical trial of plozasiran, which met its primary efficacy endpoint and all key secondary endpoints. Sanofi will receive an upfront payment of $130 million and is eligible for further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China.
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has announced a significant partnership with Sanofi, with the latter acquiring rights to develop and commercialize plozasiran, an investigational RNA interference (RNAi) therapeutic candidate, in Greater China. The agreement, signed between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead, marks a strategic move to bring plozasiran to patients with familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG) in the region.
Under the terms of the asset purchase agreement, Sanofi will pay an upfront payment of $130 million and is eligible for further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China. Visirna, which has completed a Phase 3 clinical trial of plozasiran in Chinese patients with FCS, successfully meeting its primary and secondary efficacy endpoints, will receive the upfront payment upon closing of the agreement. The trial, identified as CTR20231418/NCT05902598, demonstrated plozasiran's potential to reduce triglycerides and multiple atherogenic lipoproteins in patients with FCS, SHTG, and mixed hyperlipidemia [1].
Sanofi's investment in plozasiran aligns with its strong presence in China's cardiometabolic field and its commitment to addressing unmet medical needs. The company's deep roots in the region and its history of serving people living with various diseases position it well to advance plozasiran. Arrowhead Pharmaceuticals, which develops medicines by silencing genes that cause intractable diseases, is also optimistic about the partnership. The company's President and CEO, Christopher Anzalone, Ph.D., noted that Visirna's understanding of China's clinical, regulatory, and commercial environment has been instrumental in moving plozasiran through clinical studies and regulatory submission [1].
Plozasiran, previously known as ARO-APOC3, is a first-in-class RNAi therapeutic designed to reduce the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism. By inhibiting APOC3, plozasiran aims to reduce triglycerides and restore lipids to more normal levels. The drug has shown promising results in clinical studies, with treatment emergent adverse events generally reflecting the comorbidities and underlying conditions of the study populations [1].
The partnership between Arrowhead and Sanofi underscores the potential of RNAi therapeutics in treating cardiometabolic diseases. With plozasiran's Phase 3 clinical trial results and regulatory acceptance in China, the drug is poised to make a significant impact on the treatment of FCS and SHTG in the region. The collaboration also highlights the growing interest in China's pharmaceutical market, where the demand for innovative treatments is on the rise.
References:
[1] https://www.businesswire.com/news/home/20250801023769/en/Arrowhead-Subsidiary-Visirna-Sells-Rights-to-Hypertriglyceridemia-Candidate-Plozasiran-in-Greater-China-to-Sanofi
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