Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

On Dec. 11, 2023, Sanofi announced that it will be terminating its licensing agreement with Maze Therapeutics for the development of a rare disease drug candidate. Sanofi released a statement expressing its disappointment with the Federal Trade Commission’s (FTC’s) same-day announcement that the agency is seeking a preliminary injunction against the proposed licensing agreement between Sanofi and Maze. Sanofi had announced the licensing agreement on May 1, 2023 for MZE001, Maze’s glycogen synthase 1 (GYS1) inhibitor program, which completed Phase I and is in development for Pompe Disease, a rare, inherited disorder that disables the heart and skeletal muscles and is often fatal.

In its statement, Sanofi said, “We respectfully disagree with the action by the FTC which also delays potential advancements that could impact the lives of patients. The Maze partnership was designed to apply Sanofi’s resources, knowledge, and expertise to accelerate the development of MZE001, with the hope of addressing unmet medical needs for this devastating condition. The delay associated with a long litigation has led Sanofi to conclude that it would not be in the best interests of patients to contest this litigation, and Sanofi will therefore be terminating the agreement with Maze in accordance with its terms. Sanofi remains committed to address the Pompe patient community’s unmet needs.”

FTC sought to block the proposed deal, issuing an administrative complaint and authorizing a lawsuit in federal court that alleged the deal, valued at up to $755 million, would eliminate a competitor that could challenge Sanofi’s monopoly in the Pompe disease therapy market. FTC stated in its press release that “Sanofi is a monopoly supplier of Food and Drug Administration (FDA) approved drugs to treat the disease.”

According to FTC’s complaint, MZE001 “threatens to undermine this monopoly as the first oral medication available for Pompe disease patients.” The complaint also names Genzyme, Sanofi’s subsidiary, which was seeking to license the drug from Maze. In its complaint, FTC alleges that the transaction would protect Sanofi’s monopoly and eliminate competition between Sanofi and Maze to develop new Pompe drugs. FTC cautioned in its complaint that this deal would deny 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 FTC’s Bureau of Competition, in the agency press release. “The FTC is challenging Sanofi’s deal with Maze because it’s critical that patients and doctors have access to innovative, affordable treatment options.”

In its complaint, FTC also pointed out that “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.”

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

Source: Sanofi and Federal Trade Commission