French Pharma Giant Sanofi Drops Rare Disease Drug Pact As Federal Trade Commission Puts Antitrust Obstacle

Sanofi SA (NASDAQ:SNY) said it is terminating the licensing agreement for Maze Therapeutics Inc.'s treatment for a rare genetic disorder after the Federal Trade Commission (FTC) sued to block the deal.

In May, Maze and Sanofi announced a deal for the Pompe disease program MZE001. Sanofi agreed to pay $150 million in upfront cash, plus up to $600 million in milestones, for worldwide rights to a drug candidate targeting glycogen buildup. 

In a statement, Sanofi says that it was disappointed with the FTC's actions, which would also delay potential advancements for Maze's drug for Pompe disease to the market.

"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," the company said in a statement. "Sanofi will, therefore, be terminating the agreement with Maze."

Pompe disease causes severe muscle weakness and wasting.

In a complaint filed, the FTC said the $755 million deal would maintain Sanofi's monopoly over treatments for Pompe disease, eliminating a nascent competitor poised to challenge Sanofi's monopoly in the Pompe disease therapy market.

The agency noted that Sanofi is a monopoly supplier of FDA-approved drugs to treat the disease. 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, an oral tablet taken twice daily, would significantly reduce patients' treatment burden, FTC said.

Maze has advanced MZE001 through Phase 1 development. In the first-in-human, double-blind, placebo-controlled, single, and multiple ascending dose clinical trial, MZE001 was well-tolerated at doses up to 720 mg twice daily.

Price Action: SNY shares are up 1.06% at $47.65 during the premarket session on the last check Tuesday.