Sanofi Ends Licensing Agreement with Maze after FTC Sues

Rare Daily Staff

Drug giant Sanofi said it was terminating a licensing agreement with Maze Therapeutics for its phase 1 program in the rare and fatal lysosomal storage disorder Pompe disease after the U.S. Federal Trade Commission sued to block the deal.

In May the two companies announced Maze would grant an exclusive worldwide license to Sanofi worth up to $750 million for Maze’s glycogen synthase 1 (GYS1) program, including clinical candidate MZE001, which is in development for the treatment of Pompe disease and other potential indications. The agreement consisted of a $150 million upfront payment and potential milestones of $600 million.

Pompe disease is a rare, inherited disorder caused by mutations in the gene coding for acid alpha-glucosidase (GAA), which lead to the buildup of glycogen in skeletal muscle, respiratory muscle and cardiac muscle tissues resulting in progressive weakness and respiratory compromise. MZE001, designed and developed by Maze, is an oral GYS1 inhibitor that aims to address Pompe disease by limiting disease-causing glycogen accumulation.

“The Maze partnership was designed to apply Sanofi’s resources, knowledge, and expertise to accelerate the development of MZE001, with the hope of addressing unmet medical needs for this devastating condition,” Sanofi said in a statement. “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 and Sanofi will therefore be terminating the agreement with Maze in accordance with its terms.”

Maze said it will continue to advance its lead programs addressing common diseases, including MZE829, an APOL1 inhibitor for APOL1-mediated kidney disease, which largely impacts individuals in the black community and is on track to enter clinical development by the end of this year. Maze’s second undisclosed program in chronic kidney disease is scheduled to commence clinical trials in the second half of 2024.