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Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots:

  • Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax
  • The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive E. coli diseases incl. sepsis & bacteremia
  • Sanofi and J&J jointly developed ExPEC9V under an agreement (Oct 2023), with Sanofi paying $250M upfront with potential development & commercial milestones, while R&D costs were co-funded

Ref: Sanofi | Image: Sanofi and J&J

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