In October 2023 Sanofi announced that it has joined forces with Janssen Pharmaceuticals to develop and commercialise the vaccine candidate for extra-intestinal pathogenic E. coli, developed by Janssen. The vaccine is currently at Phase III. The agreement will unite Janssen’s “robust science” and Sanofi’s “worldwide manufacturing footprint” and recognised world-class expertise” in launching innovative vaccines.  

Escherichia coli  

Escherichia coli, or E. coli, are bacteria that live in the “environment, foods, and intestines of people and animals”. The group is “large and diverse”, with most strains being harmless, but some can cause illness, including diarrhoea, urinary tract infections, respiratory illness, and other illness. Sanofi’s Executive Vice President, Vaccines, commented that “E. Coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults”.  

“In line with our commitment to design and deliver first or best-in-class medicines and vaccines, this agreement with Janssen aims to positively public health by reducing hospitalisation costs and the burden on health systems.”  
The agreement and vaccine  

Under the terms of the agreement both parties co-fund current and future research and development costs; Sanofi will contribute $175 million to Janssen upfront, followed by “development and commercial milestones”. In the US, EU4 (France, Germany, Italy, and Spain), and the UK there will be a “profit-share arrangement”. For the rest of the world, Janssen will receive “tiered royalties and sales milestones”.  

The Phase III trial, E.mbrace, is designed to evaluate the efficacy of the 9-valent extra-intestinal pathogenic E. coli vaccine (ExPEC9V) in comparison with a placebo in the prevention of invasive E. coli disease (IED) caused by ExPEC9V O-serotypes. The study began in 2021 and continues to enrol patients.  

Dr Penny Heaton, Global Therapeutic Area Head, Infectious Diseases and Vaccines at Janssen, stated that the companies are “committed to addressing the unmet need for a vaccine to protect against IED”. IED affects “nearly 10 million adults each year”, with “limited therapeutic options”.  

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

For more details on the trial click here.  

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