Features / Comment / Insight / Analysis / Facts 
November 2023  Vol 25 Issue 10

Karuna Therapeutics’ NDA submitted to FDA for schizophrenia treatment
Karuna Therapeutics has announced that it has submitted an NDA to the FDA for KarXT for the treatment of schizophrenia, page 4
Moderna announces clinical trial results for combination flu and COVID-19
Moderna shares positive results from the phase 1/2 trial of its investigational combination vaccine against flu and COVID-19, page 7
Sanofi and Teva announce partnership for development of IBD treatment
Sanofi and Teva have announced that they will collaborate for the development and commercialisation of TEV’574, page 10

Janssen and Sanofi partner for E. coli vaccine programme

Janssen Pharmaceuticals, a Johnson & Johnson company, has announced a development and commercialisation agreement with Sanofi for Janssen’s extraintestinal pathogenic Escherichia coli (ExPEC) investigational vaccine programme.
The lead vaccine candidate is currently being assessed in the phase 3 E.mbrace study, evaluating the vaccine for the prevention of invasive E. coli disease (IED) in adults over the age of 60.
The collaboration is intended to combine the research and development strengths of Janssen with Sanofi’s global commercial vaccine expertise to advance the ExPEC programme.
The two companies will co-fund current and future research and development costs, though Sanofi will pay Janssen an upfront payment of $175m followed by various milestone payments.
Penny Heaton MD, global therapeutic area head of Infectious Diseases and Vaccines at Janssen Research and Development, commented: “We’re committed to addressing the unmet need for a vaccine to protect against IED, which affects nearly ten 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.”
The agreement is still subject to certain customary closing conditions.