Sanofi licences vaccine against bacterial sepsis

Extraintestinal pathogenic E. coli (ExPEC) is a leading bacterial cause of sepsis, causing approximately 10 million cases of invasive E. coli disease (IED) annually, worldwide. Janssen’s nine-valent first-in-class Phase III vaccine is expected to complement existing older adult vaccines. The agreement merges Janssen’s robust science with Sanofi’s worldwide manufacturing and marketing footprint.

Under the terms of the agreement, both companies will co-fund current and future research and development costs. Sanofi will pay US$175m upfront to Janssen, followed by development and commercial milestones. There will be a profit-share arrangement in the US, France, Germany, Italy, Spain, and the UK. In the rest of the world, Janssen will receive tiered royalties and sales milestones. Closing of the deal is subject to customary regulatory clearance.

Janssen’s ongoing Phase III E.mbrace trial is designed to evaluate the efficacy of the 9-valent extraintestinal pathogenic E. coli vaccine (ExPEC9V) compared to placebo in the prevention of IED caused by ExPEC9V O-serotypes. The study was started in 2021 by Janssen and continues to enroll patients.