Sanofi announces agreement for potential
first-in-class vaccine against extraintestinal pathogenic E.
coli
- Extraintestinal pathogenic E. coli
(ExPEC) is a leading bacterial cause of sepsis, causing
approximately 10 million cases of invasive ExPEC disease (IED)
annually, worldwide1,2
- Phase 3 clinical trial of vaccine
candidate ongoing. Novel ExPEC vaccine expected to complement
existing older adult vaccine portfolio
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.
Thomas TriompheExecutive 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 to enroll
patients. Learn more:
https://classic.clinicaltrials.gov/ct2/show/NCT04899336
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)32989-73 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.
About SanofiWe 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. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.comEvan
Berland | +1 215 432 0234 |
evan.berland@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40
56 92 21 | corentine.driancourt@sanofi.comFelix
Lauscher | +
1 908 612 7239 |
felix.lauscher@sanofi.comTarik
Elgoutni| + 1 617 710 3587 |
tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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