After FTC Block, Shionogi Buys Maze's Pompe Drug for $150M

In a notable shift in the pharmaceutical landscape, Japan's Shionogi has successfully acquired Maze Therapeutics’ promising Pompe disease program, MZE001. This development comes after Sanofi's thwarted attempt to secure the same asset, which was blocked by the Federal Trade Commission (FTC).

Earlier in May 2023, Maze and Sanofi had announced a licensing deal for MZE001, with Sanofi agreeing to pay $150 million upfront and potentially an additional $605 million in milestone payments. MZE001, a drug candidate designed to treat Pompe disease by preventing glycogen buildup, seemed like an excellent addition to Sanofi’s pipeline, complementing its enzyme replacement therapy, Nexviazyme.

However, the FTC intervened, expressing concerns that the acquisition would eliminate a potential competitor and reinforce Sanofi’s dominance in the Pompe disease treatment market. Despite Sanofi's objections, they did not formally challenge the FTC's decision. By December 2023, Sanofi had officially terminated the agreement.

Shionogi has now stepped in, acquiring MZE001 for the same upfront payment of $150 million. Although milestones are also part of the deal, the specific amounts were not disclosed in Shionogi’s announcement on May 10. This acquisition stands in stark contrast to Shionogi's previous licensing deal in March, which involved a significantly lower payment of 300 million Japanese yen ($1.9 million) for an anti-IgE antibody-induced peptide developed by FunPep, another Japanese biotech company.

Shionogi’s CEO, Isao Teshirogi, Ph.D., emphasized that MZE001 is a "strong strategic fit" for Shionogi. He highlighted that the acquisition would significantly advance the company’s mission to develop innovative medicines that address unmet medical needs. It also complements Shionogi's expanding pipeline, aligning with the focus areas outlined in its medium-term business plan.

Shionogi is particularly optimistic about MZE001's potential to become the first oral treatment for Pompe disease. If approved, the GYS1 inhibitor could be used both as a standalone therapy and as an adjunct to the current standard of care, enzyme replacement therapy. This dual potential could mark a significant advancement in the treatment of Pompe disease.

Sanofi's CEO, Paul Hudson, might also find some consolation in MZE001 finding a new home. Previously, Hudson had voiced concerns about the future of the drug program following the FTC's decision. At the J.P. Morgan Healthcare Conference in January, Hudson expressed disappointment, noting the risk that the program might not continue due to challenges smaller companies face, such as securing capital and expertise.

In summary, Shionogi's acquisition of MZE001 not only fills a gap left by Sanofi but also strengthens its strategic position in the pharmaceutical market. The deal underscores Shionogi's commitment to addressing unmet medical needs and expanding its innovative treatment offerings. As the first potential oral treatment for Pompe disease, MZE001 represents a significant step forward in improving patient outcomes and diversifying therapeutic options.

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