Sanofi pays J&J $175M for late-phase E. coli shot, pushing deeper into vaccines as partner retreats

As Johnson & Johnson retreats from the vaccine sector, Sanofi is gambling $175 million on the healthcare giant's late-phase E. coli vaccine.

J&J has kept studying the candidate while pulling back from vaccines, positioning Sanofi to swoop in and put its commercial heft behind a product designed to prevent life-threatening bloodstream infections.

The vaccine candidate, ExPEC9V, entered phase 3 in 2021. Since then, J&J has reassessed its vaccine unit, informing employees of an overhaul of its infectious disease unit, dropping programs against respiratory syncytial virus (RSV) and other pathogens, and closing an R&D site. Amid the turbulence, J&J has kept moving its 18,500-subject phase 3 E. coli vaccine trial toward its targeted primary completion date in May 2025.

Now, Sanofi is stepping in to support the program. The French drugmaker is paying $175 million upfront and co-funding current and future R&D costs. In return for the outlay, plus undisclosed development and commercial milestones, Sanofi has secured commercialization rights.

The partners will share profits in the U.S., France, Germany, Italy, Spain and the U.K. Outside of those countries, Sanofi will pay J&J tiered royalties and sales milestones. The French drugmaker framed the deal as a way to put its worldwide manufacturing footprint and expertise in launching vaccines behind the candidate.

While J&J was advancing vaccines against pathogens such as RSV, the E. coli candidate could have slotted into a portfolio of prophylactics, including multiple products targeting older adults. However, the E. coli candidate became an outlier as J&J retreated from infectious diseases.

At Sanofi, the candidate will slot into an existing portfolio of vaccines that target older adults. The phase 3 trial is enrolling people aged 60 years and up with a history of urinary tract infection to assess whether the nine-valent vaccine candidate can prevent invasive extraintestinal pathogenic E. coli disease, a leading bacterial cause of sepsis. 

The vaccine could tackle a top cause of death in seniors while cutting the burdens the pathogen imposes on healthcare systems and reducing the use of antibiotics, some of which are being rendered ineffective by the evolution of the bacterium.