Update on extraintestinal pathogenic E. coli
vaccine phase 3 clinical study
- Independent interim analysis of the
E.mbrace phase 3 study finds that the vaccine candidate didn’t
demonstrate sufficient efficacy in preventing invasive E. coli
disease
- No safety signals related to the
vaccine candidate were identified
Paris, February 13, 2025. A
scheduled review of the E.mbrace phase 3 study (clinical trial
identifier: NCT04899336) conducted by an independent data
monitoring committee (IDMC) determined that Sanofi and Johnson
& Johnson’s vaccine candidate for extraintestinal pathogenic E.
coli was not sufficiently effective at preventing invasive E. coli
disease (IED) compared to placebo. No safety signals related to the
vaccine candidate were identified and, throughout the study,
investigators ensured that participants who developed IED received
prompt treatment and care. As a result of the IDMC’s determination,
the E.mbrace study is being discontinued.
Jean-François Toussaint Global
Head of Research and Development Vaccines, Sanofi “E. coli sepsis
is a devastating disease and there are no preventative measures
available to date. Driven by our ambition to transform the practice
of medicine, we entered this ambitious although challenging field.
We are disappointed to see that the vaccine was not associated with
sufficient efficacy to support the trial continuation, and we will
work tirelessly to understand the factors behind the IDMC’s finding
and to share further analysis once available. We are grateful to
the participants, families and healthcare professionals involved in
this development program. While disappointed by this outcome, we
remain steadfast in our commitment to drive innovation in R&D
by developing first and best-in-class vaccines in areas of high
unmet need.”
In October 2023, Sanofi entered into an agreement
with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson &
Johnson company to develop and commercialize the vaccine candidate.
Under the terms of the agreement, both parties agreed to co-fund
current and future research and development costs. Sanofi paid $250
million in upfront and development milestones to be followed by
commercial milestones.
The E.mbrace study is a randomized, double-blind,
placebo-controlled, multicenter, interventional phase 3 study
evaluating the efficacy, safety, and immunogenicity of a single
dose of the vaccine candidate compared to a placebo in the
prevention of IED, which includes sepsis and bacteremia (blood
infections).
The study was initiated in June 2021 enrolling
adults aged 60 years or older in stable health with a history of
urinary tract infection in the past two years. The study was
conducted at over 250 sites across five continents. Janssen
Research & Development, LLC, is the trial sponsor and
responsible party and will continue appropriate safety follow up
for the currently enrolled participants.
Financial considerationsAs a result of the
discontinuation, Sanofi has recorded an impairment charge before
tax of $250 million in the Q4 2024 IFRS results. This adjustment
impacts negatively the full-year IFRS EPS reported in the Q4 2024
results press release on January 30, 2025, by €0.15 from €4.59
previously to €4.44 now. This adjustment will be
included in Sanofi’s Form 20-F for 2024 to be filed with the
US Securities and Exchange Commission. However, there is no impact
to the business net income / business EPS remaining unchanged
respectively at €8,912 million / €7.12 (non-IFRS). There is no
change to the financial guidance for 2025
About Sanofi 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 the world, 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.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.comNicolas Obrist |
+33 6 77 21 27 55 | nicolas.obrist@sanofi.comLéo Le
Bourhis | +33 6 75 06 43 81 |
leo.lebourhis@sanofi.comVictor Rouault | +33 6 70
93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+44 7545 513 693 |
thomas.larsen@sanofi.comAlizé Kaisserian | +33 6
47 04 12 11 | alize.kaisserian@sanofi.comFelix
Lauscher | +1 908 612 7239 |
felix.lauscher@sanofi.comKeita Browne | +1 781 249
1766 | keita.browne@sanofi.comNathalie Pham | +33
7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | +1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | +33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
Sanofi forward-looking
statementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions, and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
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“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that pandemics or other
global crises may have on us, our customers, suppliers, vendors,
and other business partners, and the financial condition of any one
of them, as well as on our employees and on the global economy as a
whole. The risks and uncertainties also include the
uncertainties discussed or identified in the public filings with
the SEC and the AMF made by Sanofi, including those listed under
“Risk Factors” and “Cautionary Statement Regarding Forward-Looking
Statements” in Sanofi’s annual report on Form 20-F for the year
ended December 31, 2023. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
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are the property of the Sanofi group.
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