Sanofi pays Teva $500M to join Merck, Roivant in red-hot bowel disease race

Sanofi is splashing the cash. One day after inking a $175 million vaccine deal, the French drugmaker has splurged another 469 million euros ($500 million) on a Teva program to secure the chance to challenge Merck & Co. and Roivant for an emerging inflammatory bowel disease opportunity.

The upfront fee, which is backed by up to 940 million euros ($986 million) in development and launch milestones, has landed Sanofi rights to co-develop and co-commercialize the anti-TL1A therapy TEV’574. Teva has taken the drug candidate into phase 2b clinical trials in ulcerative colitis and Crohn’s disease, keeping it tucked in behind the front-runners in the race to bring treatments aimed at TL1A to market.

Interest in TL1A has taken off over the past year as the leading candidates have delivered midphase data. In December, Pfizer worked with Roivant to spin off its TL1A drug. Fears that the move reflected doubts about the mechanism evaporated over the following weeks, when Prometheus Biosciences released data that sent its stock up 170% and Roivant hit back with results it called best in class. Merck then paid $10.8 billion for Prometheus, while Roche reportedly mulled a $7 billion deal with Roivant.  

Amid the explosion in activity, Teva has stepped up investment in a candidate that is behind the leading candidates in the race to market but, according to the company, has a best-in-class preclinical profile. Work to show whether the preclinical profile translates into clinical differentiation is underway. 

Teva originally moved the candidate into phase 2 as an asthma treatment but terminated that study after it met pre-specified criteria for futility at an interim analysis. Over the past 14 months, Teva has pivoted to Crohn’s and ulcerative colitis, starting a phase 2 trial in patients with moderate to severe forms of the inflammatory bowel diseases in August 2022 and adding a long-term study at the start of 2023. 

On its second-quarter result conference call in August, Teva said (PDF) interim phase 2 results are due in the back half of next year. Eric Hughes, M.D., Ph.D., head of R&D at Teva, added (PDF) that the plan was to move into phase 3 in 2025. The timeline puts Teva and Sanofi well behind the front-runners. Merck plans to start a phase 3 trial this month. Telavant, a Roivant subsidiary, is also preparing to enter phase 3.  

Sanofi will throw its weight behind work to close the gap, taking the lead on the planned phase 3 trials and leading commercialization outside of Europe, Israel and “specified other countries” that will remain the responsibility of Teva. The partners will split profits and losses in major markets and pay royalties in the rest of the world.