Swiss pharma giant Roche has entered an agreement to purchase Telavant Holdings, a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc., in a transaction valued at $7.1 billion, the company announced on Monday. The deal encompasses the rights for the development, manufacturing, and commercialization of a novel TL1A directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant.
Thomas Schinecker, CEO Roche Group said:
“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.”
RVT-3101 is a cutting-edge therapy in the developmental pipeline, intended to offer relief to individuals grappling with inflammatory bowel disease, which includes conditions like ulcerative colitis and Crohn’s disease. Inflammatory bowel disease is a group of persistent gastrointestinal disorders affecting nearly 8 million people across the globe, with a staggering 80% of patients failing to achieve lasting remission. This sobering statistic underscores the urgent need for innovative treatments in this domain.
RVT-3101 is a potential First-in-class Agent that Targets Both Inflammatory and Fibrotic Pathways by Inhibiting TL1A
What sets RVT-3101 apart is its unique mechanism of action, targeting both inflammation and fibrosis, making it potentially applicable to various other medical conditions beyond just inflammatory bowel disease.
The antibody has already undergone investigation in the TUSCANY-2 phase 2b study, where it was administered to patients with moderate to severe ulcerative colitis. This global, randomized, double-blinded, placebo-controlled trial yielded crucial data, providing insights into long-term effectiveness and dosage requirements for a substantial patient cohort (n=245). Notably, the maintenance treatment phase following induction demonstrated improved clinical remission (36% at week 56) and endoscopic improvement (50% at week 56) when RVT-3101 was administered subcutaneously on a monthly basis at the proposed Phase 3 dose. Besides its efficacy, RVT-3101 exhibited a favorable safety profile throughout the maintenance dosing period, offering reassurance to patients and clinicians alike.
Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development stated:
“The recent Phase 2b for RVT-3101 delivered the first long-term, robust dataset demonstrating improved clinical remission in the maintenance treatment phase. 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.”
Roche’s strategic move to acquire Telavant Holdings, along with the rights to RVT-3101, is poised to reshape the landscape of inflammatory bowel disease treatment. With regulatory approvals and finalization procedures underway, the company’s dedication to advancing healthcare solutions and providing hope to millions of patients worldwide is stronger than ever. This pivotal acquisition reaffirms Roche’s commitment to pioneering groundbreaking therapies in the ever-evolving pharmaceutical industry.
Roche to Make an Initial Payment of $7.1 Billion
In accordance with the acquisition terms, Roche will make an initial payment of $7.1 billion, along with a near-term milestone payment of $150 million. Upon the completion of the transaction, Roche will gain exclusive rights to continue the development, manufacturing, and commercialization of RVT-3101 in the United States and Japan, contingent on successful clinical and regulatory outcomes. Roche is dedicated to initiating a global Phase 3 clinical trial for RVT-3101 at the earliest opportunity to benefit patients with inflammatory bowel disease. Outside of the United States and Japan, Pfizer will retain commercialization rights.
Moreover, following the transaction’s closure, Roche will have the option to engage in a global collaboration with Pfizer concerning a next-generation p40/TL1A-directed bispecific antibody, currently in Phase 1 development. Telavant, jointly established by Roivant and Pfizer in 2022 for the development and commercialization of RVT-3101 in the United States and Japan, is majority-owned by Roivant (75%), with Pfizer owning the remaining 25%.
The completion of this transaction is contingent upon the expiration or termination of the waiting period specified in the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other standard closing conditions. The closing is currently anticipated to occur in either the fourth quarter of 2023 or the first quarter of 2024.
RVT-3101 at a Glance
RVT-3101 is a groundbreaking agent that uniquely tackles inflammation and fibrosis by inhibiting TL1A. This dual-action approach influences TH1, TH17 pathways, and fibroblasts, potentially offering superior results by addressing multiple pathways simultaneously.
Clinical evaluation included a Phase 2 study with 50 patients and a larger global Phase 2b trial (TUSCANY-2) involving 245 adults with ulcerative colitis. Notable findings emerged at week 14 (induction) and week 56 (maintenance), with patients continuing either the same or a lower dose. Positive data was reported for the induction phase in January 2023, followed by equally favorable results in June 2023 for the maintenance phase. Ongoing research explores RVT-3101’s potential in Crohn’s disease.
Original Source: © 2023 F. Hoffmann-La Roche Ltd, Press Release, Basel, 23 October 2023