Sanofi abandons Maze Pompe deal after FTC lawsuit

red light

Signs that the Federal Trade Commission (FTC) in the US may be softening its stance on pharma deals seem to have been misread, as the regulator has now sued to block Sanofi’s planned takeover of a Maze Therapeutics drug – even though it is still in early clinical development.

The FTC said Sanofi’s $755 million deal to acquire Maze’s MZE001 for rare inherited disorder Pompe disease “would eliminate a nascent competitor” to Sanofi’s current Pompe drugs Nexviazyme and Myozyme/Lumizyme and could “stall innovation and deprive patients of lower drug prices.”

“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.”

Sanofi agreed to pay $150 million upfront earlier this year for rights to glycogen synthase 1 (GYS1) inhibitor MZE001, which recently cleared a phase 1 trial, as well as backup compounds in the same class. It is vying to become the first oral therapy for the disease. Rather than go through a lengthy litigation process, Sanofi has opted to abandon the deal altogether.

There’s no doubt that Sanofi, via its Genzyme unit, is one of the leading providers of drug therapies for Pompe disease, a glycogen storage disorder caused by a deficiency in the enzyme acid alfa glucosidase (GAA) that results in progressive weakness in the heart and skeletal muscles. The company made around $1.3 billion in sales of Myozyme (alglucosidase alfa) and Nexviazyme (avalglucosidase alfa) – which are both enzyme replacement therapies (ERTs) – in 2022.

According to the FTC complaint, which also cites Genzyme, that makes it a “monopoly supplier” of FDA-approved drugs to treat the disease and it is seeking a preliminary injunction to prevent the deal going through.

MZE001 works in a different way, inhibiting the formation of glycogen, which has to be broken down in the body by GAA to prevent toxic effects. Maze has said that can result in a more complete blockade of glycogen accumulation than ERT, which should translate to increased efficacy. It was due to start phase 2 testing in the coming months.

In a statement, Sanofi said it “respectfully disagrees” with the FTC action, claiming that it “delays potential advancements that could impact the lives of patients.”

There has been a lot of talk in the industry in the past year of an increasingly interventionist stance taken by the FTC on pharma M&A deals, thrust into the spotlight by its blockade of Amgen’s $28 billion takeover of Horizon Therapeutics earlier this year and an order to dismantle Illumina’s already-completed acquisition of cancer diagnostic company Grail.

The Amgen/Horizon deal was eventually allowed through after a settlement was reached in September that prevented the case from going to trial, with Amgen prohibited from bundling any of its medicines with either of Horizon’s two marketed products when reaching formulary access agreements with insurers and pharmacies.

The Illumina/Grail verdict is being challenged in the courts, while Pfizer’s recently announced $43 billion acquisition of Seagen still remains under scrutiny. The Sanofi/Maze action is notable because it is small and involves an early-stage project, suggesting the FTC may now be casting its net wider.