Sanofi bows to FTC demands and ends Maze licensing deal

After being contested by the US Federal Trade Commission (FTC), Sanofi will abide by FTC demands and terminate its licensing agreement with Maze Therapeutics.

The agreement, signed earlier in May, would have seen Sanofi paying $150m upfront and pledging $600m in milestone payments for Maze’s glycogen synthase 1 (GYS1) programme which included the latter’s oral substrate reduction therapy candidate MZE-001 for Pompe disease. MZE-001 is said to have a refined route of administration and subsequently reduce treatment burden.

As per the 11 December FTC complaint, Sanofi is already a monopoly supplier of US Food and Drug Administration (FDA)-approved therapies in the Pompe disease. A potential deal with Maze would maintain Sanofi’s monopoly and hamper any competitive efforts, as per the FTC.  

“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,” acting deputy director of the FTC’s Bureau of Competition Nate Soderstrom commented in the complaint.

MZE-001 is a twice-daily oral tablet glycogen synthase (GSY1) inhibitor designed to limit glycogen accumulation in lysosomes, thereby preventing muscle damage that leads to symptomatic onset of the disease. Maze successfully completed a Phase I study (NCT05249621) of MZE-001 demonstrating that the drug was well tolerated in twice-daily administrations at up to 720 mg doses. The drug also received FDA orphan drug status for the treatment of Pompe in September 2022, and is Phase II-ready as per the company.

The now-terminated agreement would have strengthened Sanofi’s hold in the Pompe disease treatment market. Of the four currently approved Pompe therapies, the pharmaceutical giant markets three; Lumzyme and Nexviazyme, and Myozyme. All three treatments are administered over lengthy biweekly intravenous infusions.

Sanofi is currently evaluating Nexviazyme (avalglucosidase alfa), originally approved in August 2021, in a Phase III study (NCT04910776) as a treatment for infantile onset Pompe disease. GlobalData expects avalglucosidase alfa to bring in $1.07bn by 2029.

Holding a smaller share of the Pompe market is Amicus Therapeutics’ Pombiliti (cipaglucosidase alfa-atga)/Opfolda (miglustat) combination therapy, which was awarded FDA approval earlier in September.

GlobalData is the parent company of Pharmaceutical Technology.

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