FTC Seeks to Block Sanofi’s Acquisition of Rare Disease Drug that Threatens Sanofi’s Monopoly

The Federal Trade Commission is seeking to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics Inc.’s therapy in development for treatment of Pompe disease.

The Commission today issued an administrative complaint and authorized a lawsuit in federal court alleging the deal, valued at up to $755 million, would eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market.

Pompe disease is a debilitating and potentially fatal genetic disorder. Sanofi is a monopoly supplier of Food and Drug Administration (FDA) approved drugs to treat the disease. According to the FTC’s complaint, Maze’s Phase 2-ready developmental drug—a glycogen synthase 1 inhibitor called MZE001—threatens to undermine this monopoly as the first oral medication available for Pompe disease patients.

The complaint, which also names Genzyme Corporation, the Sanofi subsidiary seeking to license the drug from Maze, alleges the transaction would protect Sanofi’s monopoly and eliminate competition between Sanofi and Maze to develop new Pompe drugs, denying patients and doctors the benefits of competition, including lower prices and greater innovation.

“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,” said Nate Soderstrom, Acting Deputy Director of the FTC’s Bureau of Competition. “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 a monopolist, Sanofi charges hundreds of thousands of dollars for an annual course of treatment on its Pompe therapies. Sanofi’s drugs are administered via lengthy, biweekly intravenous infusions, whereas Maze’s MZE001, as an oral tablet taken twice daily, would significantly reduce patients’ treatment burden.

According to the FTC’s complaint, Sanofi singled out MZE001 as a significant threat to its lucrative Pompe monopoly shortly after Maze publicly revealed its development plans in 2021. MZE001 threatens to not only capture substantial market share from Sanofi, but also potentially replace Sanofi’s treatments as the standard of care for Pompe disease altogether. The complaint alleges that the proposed acquisition would both extend Sanofi’s monopoly power over Pompe disease treatments and reduce innovation competition to develop new Pompe drugs.

In addition to the administrative complaint, the Commission has authorized FTC staff to seek a temporary restraining order and preliminary injunction in federal district court to prevent Sanofi from acquiring MZE001, pending the agency’s administrative proceeding. The Commission’s federal court complaint will be filed in the U.S. District Court for the District of Massachusetts. A public version of the complaint will be made available at a later time.

The Commission vote to issue an administrative complaint and authorize staff to seek a temporary restraining order and preliminary injunction in federal district court was 3-0.

The Mergers I Division of the FTC’s Bureau of Competition was responsible for this matter.

NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The issuance of the administrative complaint marks the beginning of a proceeding in which the allegations will be tried in a formal hearing before an administrative law judge.