Roivant recently announced the entry into a definitive agreement with Roche to acquire Telavant Holdings (owned by Roivant Sciences Ltd. and Pfizer). The deal includes developing, manufacturing, and commercializing rights in the US and Japan for RVT-3101, a novel TL1A-directed antibody. And RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.
Inflammatory bowel disease is a group of chronic gastrointestinal disorders with nearly 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission. And given the antibody’s novel mode of action targeting both inflammation and fibrosis, it has the potential to be applied in multiple other diseases.
RVT-3101 was 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 (n=245). And the maintenance treatment phase following induction resulted in improved clinical remission (36% at week 56) and endoscopic improvement (50% at week 56) 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 deal, Roche will pay a purchase price of $7.1 billion upfront and a near-term milestone payment of $150 million. And upon the closing of the deal, Roche will have full rights to further develop and manufacture RVT-3101 and commercialize it in the US and in Japan pending clinical and regulatory success. Plus, 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.
Following the closing of the deal, 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. And 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 deal 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 deal is currently expected to take place in Q4 2023 or in Q1 2024.
“It has been a great privilege to work on and meaningfully progress RVT-3101, and we are convinced that Roche will be able to build on these efforts and maximize patient impact with this important program going forward. We would like to thank Pfizer for their partnership in enabling creative collaborations for the benefit of patients, and for their ongoing support. This is one of many examples of Roivant furthering its mission to accelerate the development and commercialization of medicines that matter while delivering value to patients and shareholders alike.”
— Matt Gline, CEO of Roivant
“We are eager to see RVT-3101 rapidly advance with Roche’s resources and commitment to this program. I would like to thank everyone who played a critical role in advancing the RVT-3101 program thus far, including the Telavant team, our colleagues at Pfizer and Roivant, and the program’s dedicated investigators and patients.”
— Frank Torti, M.D, Chairman and CEO of Telavant and Vant Chair at Roivant
“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. 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.”
— Thomas Schinecker, CEO Roche Group