Roche entered into a definitive agreement to acquire Telavant Holdings, a Roivant company owned by Roivant Sciences Ltd. and Pfizer, for $7.1 billion upfront and a near-term milestone payment of $150 million. Upon closing, Roche will have full rights to further develop and manufacture RVT-3101, a novel TL1A directed antibody, and commercialize it in the U.S. and Japan.
 
RVT-3101 is a promising new therapy in development for inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Given the antibody’s novel mode of action targeting both inflammation and fibrosis, it has potential to be applied in multiple other diseases.
 
RVT-3101 has been investigated a phase 2b study in patients with moderate to severe ulcerative colitis. The global trial delivered the first long-term, dose finding data in a large number of patients. The maintenance treatment phase following induction resulted in improved clinical remission and endoscopic improvement at the proposed Phase 3 dose administered subcutaneously every month. 
 
“We strongly believe this novel TL1A directed antibody has the transformational potential to make a significant difference for patients living with inflammatory bowel disease and potentially other diseases,” said Thomas Schinecker, CEO Roche Group. “We are excited to add this promising new therapy in development to our portfolio and to make it available to patients as quickly as possible.”
 
“The recent Phase 2b for RVT-3101 delivered the first long-term, robust dataset demonstrating improved clinical remission in the maintenance treatment phase,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Given this promising data, we believe that RVT-3101 has the potential to be the first therapy that offers both high efficacy and safety for people with inflammatory bowel disease and the convenience of an at-home, subcutaneous administration.”
 
Following the closing of the transaction, Roche will also have an option to enter into a global collaboration with Pfizer on a next-generation p40/ TL1A directed bispecific antibody, currently in Phase 1. Telavant was jointly formed by Roivant and Pfizer in 2022 to develop and commercialize RVT-3101 in the US and Japan. Roivant owns 75% of stock of Telavant and Pfizer owns the remaining 25%.
 
The transaction is subject to customary closing conditions and is currently expected to take place 4Q23 or in 1Q24.