Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
Roche has agreed to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc for $7.1 billion. Roche will also pay a near-term milestone payment of $150 million.
The arrangement includes the development, manufacturing and commercialisation rights in the US and Japan for Telavant’s potential first-in-class agent RVT-3101. The antibody has a novel mode of action, targeting both inflammation and fibrosis. This gives it potential as a treatment for multiple other diseases, according to Roche.
Clinical evidence for RVT-3101
RVT-3101 has been investigated in the TUSCANY-2 Phase IIb study in patients with moderate to severe ulcerative colitis. Data showed that the maintenance treatment phase following induction resulted in improved clinical remission (36 percent at week 56). Endoscopic improvement of 50 percent at week 56 was also observed with the proposed Phase III dose administered subcutaneously every month. RVT-3101 also demonstrated a favourable safety profile for all patients.
“RVT-3101 has the potential to be the first therapy that offers both high efficacy and safety for people with IBD and the convenience of an at-home, subcutaneous administration”
A Phase II clinical trial in Crohn’s disease is ongoing.
“The recent Phase IIb for RVT-3101 delivered the first long-term, robust dataset demonstrating improved clinical remission in the maintenance treatment phase,” stated Dr 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 IBD and the convenience of an at-home, subcutaneous administration.”
Additional details about Roche’s acquisition agreement with Telavant
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. Pfizer has commercialisation rights outside of the US and Japan.
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. At present, this is being evaluated in Phase I studies.
Roche and Telavant’s acquisition deal is subject to certain customary closing conditions. The transaction is expected to be completed in Q4 2023 or in Q1 2024, Roche noted.