Sanofi has entered into an agreement with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, to develop and commercialize the Phase 3 vaccine candidate for extraintestinal pathogenic E.coli (9-valent) developed by Janssen. The agreement combines Janssen’s science behind this potential first-in-class product and Sanofi’s worldwide manufacturing footprint and expertise in launching vaccines.
 
Both parties will co-fund current and future R&D costs. Janssen will receive $175 million upfront, followed by development and commercial milestones. There will be a profit-share arrangement in the U.S., EU4 (France, Germany, Italy, Spain), and the UK. In the rest of the world (ROW), Janssen will receive royalties and sales milestones.
 
Extraintestinal pathogenic E. coli is a leading cause of sepsis, particularly in older adults. Sepsis is a life-threatening bloodstream infection accompanied by severe illness and widespread organ damage, generated by the body’s self-destructive response to the infection. Antimicrobial resistant (AMR) E. coli strains are an ongoing healthcare concern, with extraintestinal pathogenic E. coli a major driver behind the global AMR crisis.
 
The ongoing Phase 3 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 invasive E. coli disease (IED) caused by ExPEC9V O-serotypes. 
 
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, said, “E. coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages. In line with our commitment to design and deliver first- or best-in-class medicines and vaccines, this agreementwith Janssenaims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPECandhelp older adults around the world to live longer, healthier lives.”