[Ad hoc announcement pursuant to Art. 53 LR] Roche enters into a definitive agreement to acquire Telavant including rights to novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant - Seite 2

“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,” says 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."

Terms of the acquisition
Under the terms of the agreement, Roche will pay a purchase price of US$ 7.1 billion upfront and a near-term milestone payment of US$ 150 million. Upon closing of the transaction, Roche will have full rights to further develop and manufacture RVT-3101 and commercialise it in the US 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 commercialisation 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 commercialise 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 2023 or in Q1 2024.

Citi is acting as the exclusive financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel to Roche. Freshfields Bruckhaus Deringer LLP is acting as legal counsel for Roivant.

About RVT-3101
RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting TL1A. It has been shown to modulate the severity of inflammation and fibrosis by stimulating the TH1 and TH17 pathways, in addition to activating fibroblasts. As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory and fibrotic pathways.