Sanofi (NASDAQ: SNY) has withdrawn from an agreement announced earlier this year to in-license the glycogen synthase 1 (GYS1) inhibitor MZE001 from Maze Therapeutics, following an administrative complaint by the Federal Trade Commission (FTC), the US antitrust agency. The FTC sought a temporary restraining order and preliminary injunction in federal court to block the deal, arguing that the transaction could eliminate Maze’s potential to challenge Sanofi’s dominance in the Pompe disease market, with MZE001 being applauded as a Phase II-ready candidate and the first oral medication for the genetic disorder.
The FTC stated that Sanofi charges hundreds of thousands of dollars per patient annually for its biweekly intravenous Pompe therapies, viewing Maze’s twice-daily oral pill as a “significant threat to its lucrative Pompe monopoly,” due to its potential to become the standard of care.
In a statement, Sanofi expressed its “disappointment” with the FTC’s announcement and “respectful disagreement,” noting that it had originally intended to accelerate the development of MZE001. However, the company acknowledged that a protracted legal process would only delay the potential benefits to patients with Pompe disease.- Flcube.com