Pharma BD Deal Intelligence
Sanofi entered an October 3, 2023 agreement with Janssen (Johnson & Johnson) to co-develop and commercialize ExPEC9V (VAC52416), a Phase 3 9-valent bioconjugate vaccine against invasive extraintestinal pathogenic E. coli disease (IED). Sanofi paid $175M upfront plus undisclosed development/commercial milestones, with a US/EU4/UK profit share and tiered royalties + sales milestones to Janssen in ex-major markets; the deal closed November 9, 2023. On February 13, 2025, the partners DISCONTINUED the pivotal Phase 3 E.mbrace study after an independent data monitoring committee found ExPEC9V did not demonstrate sufficient efficacy versus placebo in preventing IED (no safety concerns identified). Sanofi recorded a ~$250M impairment in Q4 2024 covering the upfront and development milestones paid to Janssen, reducing FY2024 IFRS EPS by EUR 0.15 while maintaining 2025 guidance. The licensed lead asset has effectively failed; the original commercialization thesis no longer holds. Upfront-only disclosed total was $175M; included under the Top-25 buyer rule.