Switzerland-based Roche has officially declared its acquisition agreement for Telavant Holdings, Inc., a Roivant company collaboratively owned by Roivant Sciences Ltd. and Pfizer Inc. The spotlight of this $7.1 billion deal is on RVT-3101, a novel TL1A directed antibody, poised as a potential game-changer for nearly 8 million global inflammatory bowel disease patients, including those with ulcerative colitis and Crohn’s disease.

RVT-3101: A Hopeful Breakthrough:

Roche’s newly acquired RVT-3101 is undergoing extensive research and has exhibited significant potential in the TUSCANY-2 phase 2b study. This global, double-blinded, placebo-controlled trial showcased promising long-term results for moderate to severe ulcerative colitis patients. Indications of 36% clinical remission and 50% endoscopic improvement at week 56 were observed.

Roche Group’s CEO, Thomas Schinecker, commented, “We strongly believe this novel TL1A directed antibody has the transformational potential… We are excited to add this promising new therapy in development to our portfolio.”

Roche’s Chief Medical Officer, Levi Garraway, further elucidated, “The recent Phase 2b for RVT-3101 delivered the first long-term, robust dataset… 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.”

Deal Specifics and Future Collaborations:

Beyond the $7.1 billion upfront payment, Roche’s terms include a near-term milestone payment of $150 million. Following the acquisition, Roche will hold exclusive rights to develop, manufacture, and introduce RVT-3101 in the US and Japan, contingent upon clinical success and regulatory approvals. Meanwhile, outside these regions, Pfizer retains commercialization rights.

Additionally, Roche retains the option for a global partnership with Pfizer on a next-generation p40/ TL1A directed bispecific antibody, currently in Phase 1 trials. The expected transaction completion ranges between Q4 2023 and Q1 2024, subject to regulatory conditions.

Financial and Legal Advisory:

For this monumental deal, Citi is serving as Roche’s exclusive financial advisor, with legal counsel from Davis Polk & Wardwell LLP. On the other hand, Roivant’s legal interests are represented by Freshfields Bruckhaus Deringer LLP.

About RVT-3101:

RVT-3101, potentially a first-of-its-kind agent, targets both inflammatory and fibrotic pathways via TL1A inhibition. The compound promises enhanced efficacy by targeting diverse inflammatory and fibrotic pathways, as demonstrated in the extensive TUSCANY and TUSCANY-2 studies.

  Levi Garraway, Pfizer, Pharma acquisition news, Roche, RVT-3101, Telavant Holdings, Thomas Schinecker, USA