According to the agreement, both firms will co-fund current and future research and development expenditures with Sanofi paying $175m upfront to Janssen, followed by development and commercial milestones

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Sanofi and Janssen to develop and market E. coli vaccine. (Credit: Micha from Pixabay)

Sanofi has partnered with Janssen Pharmaceuticals, a Johnson & Johnson company, to develop and commercialise the latter’s potential first-in-class vaccine, 9-valent, against extraintestinal pathogenic Escherichia coli (ExPEC).

The 9-valent extraintestinal pathogenic E. coli vaccine (ExPEC9V) is part of Janssen’s extraintestinal pathogenic ExPEC investigational vaccine programme.

According to the agreement, both firms will co-fund current and future research and development expenditures.

Sanofi will pay $175m upfront to Janssen, followed by development and commercial milestones.

The deal includes a profit-share arrangement in the US, EU4 (France, Germany, Italy, Spain) and the UK. For the rest of the world (ROW), Janssen will receive tiered royalties and sales milestones.

Sanofi vaccines EVP Thomas Triomphe said: “E. coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages.

“In line with our commitment to design and deliver first- or best-in-class medicines and vaccines, this agreement with Janssen aims to positively impact public health by reducing hospitalisation costs and the burden on health systems associated with ExPEC and help older adults around the world to live longer, healthier lives.”

ExPEC9V is currently in Phase 3 E.mbrace study for the prevention of invasive E. coli disease (IED) in adults aged 60 or older.

The late-stage trial is designed to assess the efficacy of the vaccine compared to placebo in the prevention of IED. It was initiated in 2021 by Johnson & Johnson’s company and continues to recruit patients.

When approved, the potential first-in-class vaccine will complement the current older adult vaccine portfolio, Sanofi said.

Janssen Research & Development infectious diseases & vaccines global therapeutic area head Penny Heaton said: “We’re committed to addressing the unmet need for a vaccine to protect against IED, which affects nearly 10 million adults each year, has only limited therapeutic options available and can cause life-threatening infections.

“This agreement will enable us to accelerate the development and potential commercialisation of this important preventive option.”