Sanofi and Johnson & JohnsonOn Thursday, they terminated their research on invasive Escherichia coli (E. coli) Phase III E.mbrace study of the disease vaccine, due to disappointing study data.According to Sanofi's press release, due to the termination of the partnership, Sanofi will record a $250 million impairment charge in its Q4 2024 balance sheet.
During the periodic review of the trial, an independent data monitoring committee found that the vaccine candidate "had insufficient efficacy in preventing disease" compared to the placebo. Overall, the vaccine showed a good safety profile, with no concerning signals related to the vaccine identified throughout the study.According to the announcement on Thursday, patients who contracted invasive E. coli have received adequate treatment.Sanofi's Global Head of Vaccine Research and Development, Jean-François Toussaint, said in a statement that the vaccine candidate "did not show sufficient efficacy to warrant the continuation of the trial" and expressed "disappointment" with the findings. Toussaint added that Sanofi will "spare no effort" to investigate the reasons for the failure and plans to share the results with the broader medical community once they are available.Sanofi and Johnson & Johnson signed a vaccine cooperation agreement in October 2023, with Sanofi paying an upfront fee of $175 million at the time – but according to Thursday's announcement, Sanofi has so far paid a total of $250 million in this deal, including certain milestone payments.The two partners have set their sights on invasive Escherichia coli disease (IED), which occurs when bacteria that normally reside in the intestines invade and infect other parts of the body. Patients with IED can develop various infections, some of which may become severe and even life-threatening, particularly for the elderly. To combat IED and its related complications, Sanofi and Johnson & Johnson have agreed to jointly fund the research and development activities associated with this vaccine candidate.Following the termination of the collaboration on Thursday, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and the study sponsor, will be responsible for continuing appropriate safety follow-up with participants involved in the trial.Sanofi's setback on the _E. coli_ project came just days after tensions arose in another major collaboration. Last week, Dupixent partner Regeneron Pharmaceuticals sued Sanofi, accusing it of failing to provide "complete information" about the blockbuster drug’s sales and claiming that Sanofi "obstructed in every possible way" when asked to provide relevant data.For Johnson & Johnson, the termination of the partnership came last month after it acquired neurology specialist Intra-Cellular for $14.6 billion. A week later, during the company’s fourth-quarter and full-year earnings call, CEO Joaquin Duato told investors that the company would focus on "smaller opportunities" for the remainder of the year.Reference Source:Sanofi Hit With $250M Impairment After Scrapping J&J-Partnered E. coli Vaccine - BioSpaceScan the WeChat QR code, add the editor of the Biological Products Circle, and those who meet the requirements can join.
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