The Commission claimed that the deal, which could be worth up to $755m, would destroy a startup rival ready to challenge Sanofi's monopoly in the rare disease therapy market
US FTC seeks to block Sanofi’s acquisition of rare disease drug. (Credit: Tingey Injury Law Firm on Unsplash)
The US Federal Trade Commission (FTC) has filed a complaint seeking to block Sanofi’s collaboration and licence agreement with Maze Therapeutics regarding the latter’s MZE001, a therapy in development for the treatment of Pompe disease.
MZE001 is a glycogen synthase 1 (GYS1) inhibitor programme that has completed the Phase 1 stage. It is being developed for Pompe disease treatment and other possible indications.
The proposed licence agreement was originally announced in May this year.
US FTC has authorised a lawsuit in federal court and issued an administrative complaint.
The Commission claimed that the deal, which could be worth up to $755m, would destroy a startup rival ready to challenge Sanofi’s monopoly in the rare disease therapy market.
Sanofi is a monopoly supplier of US Food and Drug Administration (FDA)-licenced drugs to treat this disease.
The complaint alleged that Maze’s Phase 2-ready developing medicine threatens to challenge this monopoly as the first oral treatment of Pompe disease.
The complaint also names Genzyme, a Sanofi subsidiary that is attempting to licence the drug from Maze.
According to the lawsuit, the transaction would protect Sanofi’s monopoly and prevent Maze and Sanofi from competing to develop new Pompe drugs.
This will deny patients and doctors the advantages of competition, including lower prices and more innovation.
FTC bureau of competition acting deputy director Nate Soderstrom said: “Sanofi’s acquisition of Maze’s Pompe disease drug threatens to deprive patients of a new, innovative treatment and maintain a status quo of exorbitant pricing for essential life-saving medicines.
“The FTC is challenging Sanofi’s deal with Maze because it’s critical that patients and doctors have access to innovative, affordable treatment options.”
As per the FTC complaint, Sanofi pointed to MZE001 as a significant threat to its Pompe monopoly. It followed Maze’s development plans which were revealed in 2021.
The FTC has also given its staff permission to file a preliminary injunction and temporary restraining order requests in federal district court to stop Sanofi from purchasing the drug asset.