Johnson & Johnson and Sanofi Announce Strategic Collaboration to Co-Develop and Commercialize a First-in-Class ExPEC Vaccine for Invasive E. coli Disease in Adults Aged 60+

On October 3, Johnson & Johnson announced that it had reached a development and commercialization agreement with Sanofi regarding a potential first-in-class extraintestinal pathogenic Escherichia coli (ExPEC) vaccine candidate. The vaccine candidate is currently undergoing the Phase III E.mbrace study for the prevention of invasive Escherichia coli disease (IED) in adults aged 60 years and above.

IED occurs when bacteria that normally live in the intestines leave the gut and infect other parts of the body. Particularly for adults over 60 years old, severe infections such as bacteremia (blood infection) and sepsis can occur, which may even be life-threatening. ExPEC is the main bacterial type responsible for causing sepsis.

This strategic agreement will leverage Johnson & Johnson's R&D capabilities and Sanofi's global commercial vaccine expertise to jointly advance the ExPEC vaccine program. Under the terms of the agreement, both parties will share current and future R&D costs. Sanofi will pay Johnson & Johnson an upfront payment of $175 million and make additional payments upon achieving certain development and commercial milestones. In the United States, four EU countries (France, Germany, Italy, Spain), and the United Kingdom, the two companies will equally share profits. In the rest of the world (ROW), Johnson & Johnson will receive tiered royalties and sales milestone payments.

Penny Heaton, M.D., Global Therapeutic Area Head of Infectious Diseases and Vaccines at Johnson & Johnson, said: "We are committed to addressing the unmet need for an IED vaccine, a disease that affects nearly 10 million adults each year and can lead to life-threatening infections, with currently very limited treatment options. This agreement will enable us to accelerate the development and potential commercialization of this important preventive solution."

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