France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared to placebo in the E.mbrace study. The study was subsequently terminated.
Financial Impact
Safety signals related to the vaccine candidate were identified, leading Sanofi to record an impairment charge before tax of USD250 million in the Q4 2024 IFRS results.
Vaccine Background
The vaccine was designed to prevent invasive extraintestinal pathogenic Escherichia coli disease, a major bacterial cause of sepsis in elderly people. Sanofi and J&J agreed to jointly develop and commercialize the vaccine candidate in a USD175 million deal in October 2023, with research and development costs shared by both companies.-Fineline Info & Tech
