MRC -- Sanofi has entered into an agreement with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, to develop and commercialize the vaccine candidate for extraintestinal pathogenic E. coli (9-valent) developed by Janssen, a potential first-in-class product currently in Phase 3, said Chemanager.
Under the terms of the agreement, both companies will co-fund current and future research and development costs. Sanofi said it will pay $175 million upfront to Janssen, followed by development and commercial milestones. There will be a profit-share arrangement in the US, France, Germany, Italy, Spain as well as the UK. In the rest of the world, Janssen will receive tiered royalties and sales milestones. Closing of the deal is subject to customary regulatory clearance.
Thomas Triomphe, Sanofi’s executive vice president Vaccines, said: “E. coli is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages.”
Extraintestinal pathogenic E. coli is a leading cause of sepsis, particularly in older adults. The main risk factors, Sanofi said, include age, especially 60+, and chronic illnesses (e.g., diabetes, cancer, or kidney disease). Antimicrobial resistant (AMR) E. coli strains are an ongoing healthcare concern, with extraintestinal pathogenic E. coli a major driver behind the global AMR crisis.
In separate news, Sanofi and Teva Pharmaceuticals announced a collaboration to co-develop and co-commercialize lead candidate TEV’574, currently in Phase 2b clinical trials for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease.
Under the terms of the agreement, Teva will receive an upfront payment of €469 million ($500 million) and up to €940 million ($1 billion) in development and launch milestones. Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement, with Sanofi leading the development of the Phase 3 program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. The transaction is subject to customary closing conditions. The partners expect initial program results to be available in 2024.
Paul Hudson, CEO of Sanofi, said: “Anti-TL1As are a promising class of therapies, and we believe that TEV’574 could emerge as a best-in-class option for people living with serious gastrointestinal diseases. This collaboration strengthens our commitment to advancing innovative treatment options for inflammatory conditions with a high unmet need and bolsters our goal to be an industry leader in immunology.”
Teva’s president and CEO, Richard Francis, added: “This is a new era for Teva, and our robust, innovative pipeline is key to our Pivot to Growth strategy. This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A.”
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