In a significant move aimed at safeguarding competition and affordable treatment options for patients, the Federal Trade Commission (FTC) has announced its intention to block Sanofi's proposed acquisition of an exclusive license to Maze Therapeutics Inc.'s therapy for Pompe disease. The deal, valued at up to $755 million, has raised concerns about stifling innovation and maintaining Sanofi's monopoly in the market.

Pompe disease, a debilitating genetic disorder, currently relies on drugs supplied exclusively by Sanofi, which has been the sole provider of Food and Drug Administration (FDA) approved treatments. However, Maze Therapeutics' developmental drug, MZE001, stands as a potential challenger to Sanofi's monopoly, emerging as the first oral medication for Pompe disease patients.

According to the FTC's administrative complaint, the acquisition threatens to eliminate competition and protect Sanofi's monopoly status. By acquiring MZE001, Sanofi would effectively stall innovation in the field and prevent the advent of lower-priced alternatives, depriving patients and doctors of the benefits of competition.

Nate Soderstrom, Acting Deputy Director of the FTC's Bureau of Competition, emphasized the significance of maintaining access to innovative and cost-effective treatments for patients. Soderstrom expressed concerns that the acquisition could obstruct patients' access to new, lifesaving treatments, perpetuating exorbitant pricing for essential medicines.

Sanofi's existing Pompe disease treatments come with a substantial cost, charging patients hundreds of thousands of dollars for an annual course of treatment. In contrast, Maze's MZE001 offers an oral tablet taken twice daily, significantly easing the treatment burden for patients.

The FTC's complaint alleges that Sanofi identified MZE001 as a serious threat to its lucrative Pompe disease monopoly upon learning of Maze's development plans in 2021. Not only does MZE001 pose a risk to Sanofi's market share, but it also has the potential to replace Sanofi's treatments as the standard of care for Pompe disease entirely. The complaint asserts that the acquisition would only serve to enhance Sanofi's monopoly power and hinder competition in the development of new Pompe disease drugs.

In addition to the administrative complaint, the FTC has authorized its staff to seek a temporary restraining order and preliminary injunction from the federal district court to prevent Sanofi from acquiring MZE001 while the agency's administrative proceeding takes place. The Commission's federal court complaint will be filed in the U.S. District Court for the District of Massachusetts.

The FTC's decision to issue an administrative complaint and pursue legal actions underscores its commitment to promoting competition and safeguarding patient access to affordable and innovative treatments. As the proceedings unfold, the agency will diligently examine the allegations in a formal hearing before an administrative law judge.

The FTC's efforts reflect its mandate to encourage competition and prioritize consumer welfare. For more information on antitrust regulations or to file a complaint, individuals can visit the FTC's website. Stay updated on the latest news and resources by following the FTC on social media, subscribing to their press releases, and reading their blog.