Full Press Release Details
Sanofi announces agreement for potential
first-in-class vaccine against extraintestinal pathogenic E. coli
Paris, October 3, 2023. Sanofi announces today that it has entered into an agreement
with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize the vaccine candidate for extraintestinal pathogenic E. coli (9-valent) developed by
Janssen, currently in Phase 3. The agreement brings together Janssen s robust science behind this potential first-in-class product and Sanofi s worldwide
manufacturing footprint and recognized world-class expertise in launching innovative vaccines.
Executive Vice President, Vaccines, Sanofi
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
agreement with Janssen aims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives.
Under the terms of the agreement, both parties will co-fund current and future research and development costs.
Sanofi will pay USD 175M upfront to Janssen, 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 tiered royalties and sales milestones. Closing is subject to customary regulatory clearance.
Extraintestinal pathogenic E. coli is a
leading cause of sepsis, particularly in older adults3. 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. The main risk factors include age, especially 60+, and chronic illnesses (e.g., diabetes, cancer, or kidney disease). Antimicrobial resistant (AMR) E. coli strains are an ongoing healthcare concern,
with extraintestinal pathogenic E. coli a major driver behind the global AMR crisis4.
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. The study was started in 2021 by Janssen and continues
1 Russo TA and Johnson JR. Medical and economic impact of extraintestinal infections due to Escherichia coli: focus
on an increasingly important endemic problem. Microbes Infect. 2003;5:449 456.
2 Rudd KE, Johnson SC, Agesa
KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020;395(10219):200-211.
doi:10.1016/S0140-6736(19)32989-7
3 Rhee C, et al. Prevalence of
Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated with Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA Netw Open. 2020;3(4): e202899.
4 O Neill J. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. Review on
Antimicrobial Resistance. Available at: https://amr-review.org/sites/default/files/AMR%20Review%20Pa
per%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf. Last accessed: October 2022.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science
to improve people s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving
vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
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Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 |
Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Del pine | + 33 6 73 69 36 93 |
Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 |
+ 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
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