ROIVW - 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 | Benzinga
- Roche will gain the rights to develop, manufacture and commercialize 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 $7.1 billion upfront and a near-term milestone payment of $150 million
- Roivant will host an investor call at 8AM ET on Monday, October 23, 2023, to discuss this transaction
BASEL, Switzerland and LONDON and NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) announced today the entry into a definitive agreement with Roche ((SIX: RO, ROG, OTCQX:RHHBY) to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc. The agreement includes the development, manufacturing and commercialization rights in the US and Japan for 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, randomized, 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 favorable safety profile across all patients.
"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," said Matt Gline, CEO of Roivant.
Frank Torti, M.D, Chairman and CEO of Telavant and Vant Chair at Roivant, added: "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."
"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."
Terms of the Acquisition
Under the terms of the agreement, Roche will pay a purchase price of $7.1 billion upfront and a near-term milestone payment of $150 million. Upon closing of the transaction, Roche will have full rights to further ...