The Federal Trade Commission (FTC) has scuttled Sanofi’s licensing deal with Maze Therapeutics. With the FTC moving to block the deal, the Big Pharma is pulling out rather than working through the antitrust maze that has sprung up between it and the asset.
In May, Maze and Sanofi revealed a deal for the Pompe disease program MZE001. Sanofi agreed to pay $130 million in upfront cash, plus up to $605 million in milestones, for worldwide rights to a drug candidate that could treat Pompe by stopping the buildup of glycogen. The asset would have slotted into a Pompe portfolio that features the enzyme replacement therapy Nexviazyme.
The FTC sees that as a problem. In a statement to disclose its plans to block the deal, the agency said the agreement would “eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market.” The FTC expanded on the point in a heavily redacted complaint.
In response, Sanofi said it respectfully disagrees with the FTC’s action, making the case that the deal with Maze would have leveraged its “resources, knowledge and expertise to accelerate the development of MZE001.” Sanofi said the FTC action “delays potential advancements that could impact the lives of patients.”
However, the French drugmaker has opted against contesting the move to block the deal. Sanofi said it is terminating the agreement because the “delay associated with a long litigation has led [it] to conclude that it would not be in the best interests of patients to contest this litigation.”
The case marks a shift in the types of deals targeted by the FTC. Previously, companies typically only had to worry about antitrust issues blocking large acquisitions, as threatened to happen when Amgen inked its $27.8 billion takeover of Horizon Therapeutics. Comparatively small acquisitions and licensing deals, a key source of income for biotechs and exits for VCs, have faced far less scrutiny from the FTC.
As the FTC sees things, “Sanofi is now trying to buy out Maze rather than compete with it” because it recognizes that the biotech’s “innovative products risk dislodging its own dominance.” Redacted sections of the complaint discuss Sanofi’s forecasts for the market share MZE001 could capture in the hands of a rival and the extent to which Amicus Therapeutics’ recently approved Pompe drug is a threat.
Maze said it is “evaluating [its] legal and business options.” The FTC complaint revealed that Sanofi had agreed to make a $20 million investment in Maze when it completes an IPO. Maze raised a $190 million financing round at the start of last year.