Sanofi/Johnson & Johnson Partnered Vaccine Against Bacterial Sepsis Flunks Late-Stage Study

Zinger Key Points

Sanofi and J&J discontinued E.mbrace phase 3 study after the vaccine showed insufficient efficacy in preventing invasive E. coli disease.
Sanofi recorded a $250M impairment charge, lowering Q4 2024 IFRS EPS by €0.15 to €4.44, while business net income and EPS remain unchanged.
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Sanofi SA SNY and Johnson & Johnson JNJ have discontinued the E.mbrace phase 3 study evaluating a vaccine candidate for extraintestinal pathogenic E. coli.

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).

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An independent data monitoring committee (IDMC) conducted a scheduled review of the E.mbrace phase 3 study.

The companies determined that the vaccine candidate 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.

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 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.

As a result of the discontinuation, Sanofi has recorded an impairment charge before tax of $250 million in the Q4 2024 IFRS results. This adjustment negatively impacts the full-year IFRS EPS reported in the Q4 2024 results press release on January 30, 2025, by 15 cents, from 4.59 euros previously to 4.44 euros now.

However, there is no impact on the business net income/EPS, which remain unchanged, respectively, at 8.91 billion euros/ 7.12 euros (non-IFRS).

Price Action: As of Thursday, SNY stock was up 0.18% at $54.66 during the premarket session.

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