Sanofi is relinquishing million in upfront payments to use the Chinese rights to a rare metabolic disease treatment, which is in the process of being reviewed by Chinese authorities in the quest to be approved.
The RNAi therapy, known as plozasiran, has already succeeded in a phase 3 trial last year, where it resulted in an 80 percent and 78 percent decrease in triglycerides at the tenth-month mark in patients with familial chylomicronemia syndrome (FCS) at the tested 25 mg and 50 mg doses, respectively.
Since then, its China-based subsidiary Visirna Therapeutics, has filed an approval plan with the Chinese authorities.
Sanofi has since taken an interest-paying Visirna an upfront fee of $130 million with the chance of milestone payments worth up to $265 million in case plozasiran gets approved in China for FCS and other ailments. On its side, Arrowhead will have a share in royalties on the sales made in greater China based on its agreement to license Visirna.
The drug plozasiran is developed to reduce the level of synthesis of apolipoprotein C-III (APOC3), which forms a component of triglyceride-rich lipoproteins and regulates triglyceride metabolism. Treatment with the drug is expected to bring down the levels of APOC3, hence bringing down the levels of triglycerides and bringing the lipids back to normal levels.
In the U.S., Arrowhead had been pipped to the post in a close race with Ionis Pharmaceuticals’ Tryngolza antisense agent, which received FDA approval in FCS at the end of 2024. Nevertheless, Ionis has not made any attempt to gain approval in China.
As we established Visirna in 2022, we recognized that Greater China had the potential to become a sizable future marketplace with respect to a great many programs in the Arrowhead pipeline of RNAi-based investigational medicine candidates in the cardiometabolic disease setting.
“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,” Anzalone added.
Sanofi ended last year scooping up the China rights to Cytokinetics’ hypertrophic cardiomyopathy drug aficamten, which is still awaiting a decision by Chinese regulators. That deal followed a move by the French pharma to establish a $1 billion manufacturing site in the country, marking the company’s largest investment in China to date.
Wayne Shi, president of Sanofi Greater China, put this morning’s deal in the context of the company’s “strong presence in China’s cardiometabolic field.”
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