FTC Challenges Sanofi’s Deal for Pompe Disease Treatment, Citing Monopoly Concerns

The Federal Trade Commission (FTC) is challenging Sanofi’s proposed $755 million deal to license Maze Therapeutics’ clinical-stage Pompe disease treatment. The FTC argues this deal would end competition and maintain Sanofi’s monopoly in the Pompe disease therapy market. Sanofi already markets Nexviazyme, a treatment for Pompe disease. The FTC’s move to block this deal highlights its increased scrutiny of pharmaceutical mergers and acquisitions, including those involving nascent or potential competitors.

This approach by the FTC reflects concerns raised at a June 2022 workshop, where experts advocated for a broader examination of biopharma deals, including those involving early-stage treatments. The FTC’s action against the Sanofi-Maze deal is based on the belief that the acquisition could prevent a new treatment from entering the market and keep prices high for essential medicines.

Sanofi has decided not to contest the FTC’s decision and will terminate the agreement with Maze. This decision was made despite Maze CEO Jason Coloma expressing disappointment, noting that this is the first time the FTC has challenged a Phase I investigational medicine license. The deal, announced in May, would have given Sanofi access to Maze’s Phase II-ready MZE001 and other related programs. MZE001 has the potential to be the first oral treatment for Pompe disease. Maze is now considering alternative options for developing MZE001.

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[Source: Endpoints, December 11th, 2023]