JNJ-78901563

Bengaluru: Johnson & Johnson said on Thursday it will discontinue a late-stage study of an experimental E.coli vaccine it was developing in partnership with Sanofi . The drugmaker said its decision was based on the recommendation of an independent committee that found the vaccine candidate may not be sufficiently effective compared with a placebo in preventing infections caused by a group of bacteria commonly found in the gut. No safety signals related to the experimental vaccine were identified, J&J said, adding that it was conducting follow-ups for participants currently enrolled in the trial. The study was testing the safety and efficacy of a single dose of the experimental shot, ExPEC9V, in preventing E.coli disease, including sepsis and blood infections. (Reporting by Bhanvi Satija in Bengaluru; Editing by Savio D'Souza and Krishna Chandra Eluri)

Dive Brief:Sanofi and Johnson & Johnson are ending a Phase 3 study of an experimental E. coli vaccine after it failed to show a significant benefit over placebo in a review by an independent monitoring board.J&J began the study in 2021 and planned to test the vaccine in almost 20,000 adults aged 60 and over at hundreds of locations around the world. The vaccine was designed to fight extraintestinal pathogenic E. coli, a leading cause of sepsis in older adults.But the vaccine was not sufficiently effective at preventing invasive E. coli disease based on the pre-planned interim analysis, Sanofi said Thursday. The research found no concerns with safety, and further analyses will be shared in the future, the company said.Dive Insight:The study failure offers a disappointing end to Sanofis collaboration of a little more than a year with J&J. The two companies were co-funding research and development and planned to share profits in major markets including the U.S. Sanofi had high hopes for the vaccine, at one point telling investors it could bring in between 2 billion and 5 billion euros, or as much as about $5.2 billion,in peak sales.As part of the October 2023 deal, Sanofi paid J&J $175 million up front and agreed to future payments based on development and commercial milestones. On Thursday, Sanofi said the payments to J&J during the partnership totaled $250 million.As a result, the French drugmaker recorded an impairment charge before tax of $250 million in the fourth quarter and will adjust earnings reported on Jan. 30. Sanofi said the study outcome wont affect its full-year guidance for 2025.Sanofi and J&J were trying to introduce the first vaccine to fight a strain of E. coli thats responsible for most urinary tract infections and can also cause meningitis and pneumonia. The need for a vaccine has grown as more patients become resistant to the antibiotics that would normally be used to treat those conditions. '