In a bold move that could challenge industry giants like Merck and Pfizer, French pharmaceutical powerhouse Sanofi made waves on Wednesday by announcing a strategic partnership with Israel-based Teva Pharmaceuticals. The collaboration aims to co-develop an anti-TL1A therapeutic designed to combat inflammatory bowel disease (IBD), and it comes with a staggering price tag of up to $1.5 billion.
Teva’s asset, known as TEV ‘574, is already in the midst of Phase IIb clinical trials for two distinct types of IBD: ulcerative colitis and Crohn’s disease. This groundbreaking therapy belongs to a newer class of treatments targeting TL1A, a member of the tumor necrosis factor family that exhibits abnormal expression in autoimmune conditions such as IBD, rheumatoid arthritis, psoriasis, and more. Recent studies have unveiled TL1A’s critical role in both the development and progression of these debilitating diseases.
Sanofi is making an initial payment of $500 million to Teva to kickstart their collaborative efforts in co-developing and co-commercializing TEV ‘574. Sanofi’s CEO, Paul Hudson, expressed confidence in the therapy, believing it has the potential to become a “best-in-class option” for individuals grappling with serious gastrointestinal disorders.
But the deal doesn’t stop there. Teva stands to earn an additional $1 billion in potential development and launch milestones if the therapy progresses as expected. In the event that TEV ‘574 advances to Phase III, Sanofi will take the lead in its development, a pivotal stage where the therapy’s true potential will be put to the test. The industry eagerly awaits interim results from the ongoing Phase II study, set to be unveiled in September 2024.
Competition in the IBD space is reaching a boiling point, with major pharmaceutical players zeroing in on therapies targeting TL1A. Merck, for instance, recently solidified its position by acquiring Prometheus Biosciences for a hefty $10.8 billion, gaining access to a suite of immune-mediated disease assets.
Their lead candidate, an anti-TL1A monoclonal antibody (mAb), is on the cusp of entering a Phase III study for Crohn’s and ulcerative colitis. Early data from a Phase II trial showed remarkable response rates, sparking excitement in the medical community.
Meanwhile, Pfizer and Roivant Sciences have also entered the fray, collaborating on RVT-3101, another TL1A-targeting mAb tailored for ulcerative colitis. Encouraging results from a Phase II chronic period study have set the stage for further exploration of this promising therapy.
Sanofi’s partnership with Teva marks their second major collaboration this week. Just a day prior, they revealed plans to team up with J&J’s Janssen to develop and commercialize a Phase III vaccine candidate for E. coli, demonstrating their commitment to pioneering advancements in healthcare. The upfront investment of $175 million, along with undisclosed future milestone payments, underscores Sanofi’s dedication to tackling pressing medical challenges on multiple fronts.