USA — Roche, a leading Swiss pharmaceutical company, has announced a significant acquisition that solidifies its position in the inflammatory bowel disease market.

The deal, valued at US$7.1 billion, involves the acquisition of Roivant’s subsidiary, Televant Holdings, and its investigational anti-TL1A antibody, RVT-3101.

This acquisition is poised to make a significant impact on the landscape of therapies for conditions like ulcerative colitis and Crohn’s disease.

This acquisition also positions Roche for head-to-head competition with Merck, as both companies are racing to develop innovative treatments for inflammatory bowel diseases.

The agreement encompasses a substantial upfront payment of US$7.1 billion, along with a near-term milestone payment of US$150 million, highlighting the pharmaceutical industry’s fervor for more effective drugs targeting immune system conditions.

The anticipated closing of the deal is slated for either the fourth quarter of this year or the first quarter of 2024.

Roche gains comprehensive rights to develop, manufacture, and commercialize RVT-3101, contingent upon successful clinical trials and regulatory approvals in the United States and Japan.

Outside of these regions, Pfizer retains the commercial rights to RVT-3101, as the company had collaborated with Roivant on advancing this promising candidate.

Around a year ago, Roivant Sciences established a subsidiary, Televant, to focus on the development of a promising treatment for inflammatory diseases.

This deal comes on the heels of other notable pharmaceutical collaborations and acquisitions, such as Sanofi’s partnership with Teva Pharmaceutical, Merck & Co.’s acquisition of Prometheus Biosciences, and Takeda’s purchase of a psoriasis medicine from Nimbus Therapeutics.

Merck’s investment of US$10.8 billion in Prometheus and its investigational antibody, PRA023, adds to the excitement of this competitive field.

PRA023, like RVT-3101, targets TL1A and is undergoing late-stage studies for ulcerative colitis and Crohn’s disease.

RVT-3101, the codename for Roivant’s investigational treatment, has shown promise in mid-stage trials for ulcerative colitis, with approximately 30% of patients experiencing improvements after 14 weeks of treatment.

Additionally, more than one-third of participants showed enhancements in imaging exams. Recent data released by Roivant in June has only heightened expectations among industry analysts regarding the blockbuster potential of this drug.

Roche’s CEO, Thomas Schinecker, expressed confidence in the transformative potential of RVT-3101, stating, “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.”

The company plans to advance the drug into a global Phase 3 clinical trial for inflammatory bowel disease at the earliest opportunity, with the deal expected to close in the coming quarters.

This rapid transition of RVT-3101 from Pfizer to Roivant and subsequently to Roche, along with its substantial increase in value, is a notable occurrence in the pharmaceutical industry.

Moreover, Roche holds an option to collaborate with Pfizer on a “next-generation” version of the drug that targets both TL1A and another therapeutic target called p40, which is currently in Phase 1 testing.

For Roivant, this deal underscores the success of its business model, characterized by the development or licensing of experimental medicines placed within subsidiaries, known as “Vants,” which can be spun off or sold.

One such Vant, Dermavant, secured U.S. approval for a plaque psoriasis cream, while another, Priovant, is working on a Pfizer drug for an inflammatory skin condition and for lupus.

Immunovant, a third Vant, recently released promising trial data for an experimental autoimmune disease drug, a development that likely played a role in Roivant’s deal with Roche.

However, Roivant has also faced challenges, as exemplified by its early Vant, Axovant, which initially garnered attention for licensing a shelved GSK drug for Alzheimer’s but ultimately failed in late-stage testing, resulting in a name change and eventual closure.

Vivek Ramaswamy, the founder of Roivant and a U.S. presidential candidate, resigned as chairman of Roivant’s board, entrusting leadership to current CEO Matthew Gline in 2021.

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