[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

• Roche will gain the rights to develop, manufacture and commercialise RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially multiple other diseases
• RVT-3101 is a Phase 3-ready antibody with first-in-class and best-in-disease potential, a novel mode of action and strong Phase 2b data in ulcerative colitis
• Roche will also obtain an option to enter into a global collaboration with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1
• 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

Basel, 23 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive agreement to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc.. The agreement includes the development, manufacturing and commercialisation rights in the US and Japan for Televant’s 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. Inflammatory bowel disease is a group of chronic gastrointestinal disorders with almost 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission.¹ 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 in the TUSCANY-2 phase 2b study in patients with moderate to severe ulcerative colitis. The global, randomised, double-blinded, placebo controlled trial delivered the first long-term, dose finding data in a large number of patients (n=245). 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 favourable safety profile across all patients.