Sanofi Announces Agreement for Potential First-in-Class Vaccine Against Extraintestinal Pathogenic E. coli


Paris, October 3, 2023 – In a significant development for public health, Sanofi, a global leader in healthcare, has announced an agreement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, to develop and commercialize a novel vaccine candidate for extraintestinal pathogenic E. coli (ExPEC).

This promising vaccine, currently in Phase 3 clinical trials, could mark a major breakthrough in combating a leading bacterial cause of sepsis. Extraintestinal pathogenic E. coli causes approximately 10 million cases of invasive ExPEC disease (IED) annually worldwide, making this vaccine an urgent medical need.

Understanding the ExPEC Challenge

Extraintestinal pathogenic E. coli (ExPEC) is a formidable pathogen responsible for a significant number of sepsis cases, especially among older adults. Sepsis is a life-threatening condition characterized by a severe bloodstream infection that triggers a systemic inflammatory response, often leading to organ failure. This bacterium poses a significant global health threat due to its role in causing sepsis and its association with antimicrobial resistance (AMR), contributing to the ongoing global AMR crisis.

E. coli-related sepsis is particularly concerning for older adults, who are more vulnerable to its effects. Factors such as age, chronic illnesses (such as diabetes, cancer, or kidney disease), and weakened immune systems increase the risk of ExPEC infection. As the global population ages, the incidence of ExPEC-related sepsis is on the rise, putting additional strain on healthcare systems and increasing the cost of hospitalization.

The Promise of the ExPEC Vaccine

The groundbreaking agreement between Sanofi and Janssen aims to address this critical public health issue by developing a first-in-class vaccine specifically designed to combat ExPEC. The vaccine candidate, known as ExPEC9V, is currently undergoing Phase 3 clinical trials in the E.mbrace trial. This trial seeks to evaluate the vaccine’s efficacy in preventing invasive E. coli disease (IED) caused by ExPEC9V O-serotypes.

ExPEC9V has the potential to offer a game-changing solution to prevent ExPEC-related sepsis and reduce the burden on healthcare systems worldwide. By targeting the specific O-serotypes associated with ExPEC, the vaccine could significantly decrease the incidence of ExPEC infections in older adults and, consequently, the associated mortality rates. Additionally, it has the potential to reduce the development of antimicrobial resistance linked to ExPEC strains, which is a growing concern in the healthcare community.

Collaborative Efforts and Agreements

The collaboration between Sanofi and Janssen signifies the merging of scientific expertise and global resources to address a pressing public health issue. Sanofi, renowned for its worldwide manufacturing capabilities and expertise in vaccine development, is ideally positioned to bring ExPEC9V to market effectively.

Under the terms of the agreement, both companies will jointly fund ongoing and future research and development efforts related to ExPEC9V. Sanofi will make an upfront payment of USD 175 million to Janssen, followed by additional payments upon reaching development and commercialization milestones.

The agreement includes a profit-sharing arrangement in the United States, European Union countries (France, Germany, Italy, Spain), and the United Kingdom. In the rest of the world, Janssen will receive tiered royalties and sales milestones. The deal is contingent on customary regulatory clearance, as is common in agreements of this nature.

A Hopeful Future for Public Health

The partnership between Sanofi and Janssen represents a pivotal step forward in the fight against ExPEC-related sepsis and antimicrobial resistance. This vaccine could potentially save countless lives, reduce hospitalization costs, and alleviate the strain on healthcare systems. With an aging global population and the ongoing threat of antimicrobial resistance, the development of novel vaccines like ExPEC9V is essential to address these significant health challenges.

Public health officials, healthcare providers, and researchers around the world are closely watching the progress of the Phase 3 clinical trial of ExPEC9V, eagerly awaiting the potential benefits this vaccine may bring to older adults and society as a whole. If successful, it could set a precedent for the development of innovative vaccines targeting other life-threatening infections, improving the overall quality of healthcare and extending healthy lifespans for people worldwide.

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