The Swiss drugmaker will make an upfront of $7.1bn and a near-term milestone payment of $150m, for rights to Telavant’s TL1A-directed antibody RVT-3101 in the US and Japan, and will also conduct a global Phase 3 clinical trial for RVT-3101

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Roche administration and R&D buildings. (Credit: F. Hoffmann-La Roche Ltd)

Swiss pharmaceutical company Roche has agreed to acquire Telavant, a commercial-stage biopharmaceutical company owned by Roivant Sciences and Pfizer, for a total of $7.2bn.

Under the terms of the agreement, the Swiss drugmaker will make an upfront of $7.1bn and a near-term milestone payment of $150m.

Roche will obtain rights to develop, manufacture and market Telavant’s TL1A-directed antibody RVT-3101 in the US and Japan, while Pfizer will hold the rights outside the US and Japan.

It will also conduct a global Phase 3 clinical trial for RVT-3101 soon, to bring the promising therapy to patients suffering from inflammatory bowel disease.

In addition, Roche can also form a global collaboration with Pfizer on a new-generation p40/ TL1A-directed bispecific antibody, which is currently in Phase 1.

The acquisition is expected to be completed in the last quarter of this year or in the first quarter of 2024, subject to certain customary closing conditions.

Roche CEO Thomas Schinecker 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.

Roche global product development head and chief medical officer Levi Garraway said: “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.”

Telavant was jointly established by Roivant and Pfizer last year, to develop and commercialise RVT-3101 in the US and Japan.

RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

It is a potential first-in-class agent that works by stimulating the TH1 and TH17 pathways, in addition to activating fibroblasts, to modulate the severity of inflammation and fibrosis.

The RVT-3101 is being evaluated in a Phase 2 TUSCANY study in 50 patients and in a large global Phase 2b TUSCANY-2 study in 245 adults with moderate to severe ulcerative colitis.

TUSCANY-2 study was designed to investigate the efficacy, safety, and pharmacokinetics of RVT-3101, administered monthly subcutaneously in adult patients.

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

Roivant CEO Matt Gline said: “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.”