Roche to acquire Telavant from Roivant Sciences for $7.1B upfront

Roivant (ROIV) announced the entry into a definitive agreement with Roche (RHHBY) to acquire Telavant, a Roivant company, owned by Roivant Sciences and Pfizer (PFE). The agreement includes the development, manufacturing and commercialization rights in the U.S. and Japan for RVT-3101, a novel TL1A directed antibody. RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. RVT-3101 has been investigated in the TUSCANY-2 phase 2b study in patients with moderate to severe ulcerative colitis. The global, randomized, double-blinded, placebo controlled 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. Beyond the efficacy results, the maintenance dosing period of RVT-3101 also showed a favorable safety profile across all patients. Under the terms of the agreement, Roche will pay a purchase price of $7.1B upfront and a near-term milestone payment of $150M. Upon closing of the transaction, Roche will have full rights to further develop and manufacture RVT-3101 and commercialize it in the U.S. and in Japan pending clinical and regulatory success. Roche is committed to starting a global Phase 3 trial for RVT-3101 as soon as possible to bring this promising therapy to the patients suffering from inflammatory bowel disease. Outside of the US and Japan, Pfizer holds commercialization rights. In addition, 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 the issued and outstanding shares of common stock and preferred stock of Telavant and Pfizer owns the remaining 25%. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions. The closing of the transaction is currently expected to take place in Q4 or in Q1 .