SWITZERLAND —Roche, the Swiss pharmaceutical giant, is reportedly in advanced discussions with Roivant for the acquisition of potential inflammatory bowel disease (IBD) therapy in a deal that could be valued at up to US$7 billion.
According to media reports, the negotiations are in their final stages, with the Wall Street Journal indicating that Roche is poised to assume control of Roivant’s RVT-3101, a monoclonal antibody designed to target tumor necrosis factor-like ligand 1A (TL1A).
This therapy holds significant promise as a potential first-in-class treatment for Crohn’s disease and ulcerative colitis.
Roivant’s pipeline reveals that RVT-3101, administered subcutaneously, has initiated phase 3 clinical trials for ulcerative colitis and is currently in a phase 2 trial for Crohn’s disease, with results expected to be available next year.
In June, Roivant reported promising preliminary efficacy data from the phase 2b TUSCANY-2 trial, showcasing notable improvements in clinical and endoscopic remission rates at 56 weeks. The therapy demonstrated a favorable safety profile, as it was well-tolerated by patients.
Insiders cited by the Wall Street Journal anticipate that an agreement between Roche and Roivant will be officially announced in the coming days.
This news led to a surge in Roivant’s share price, rising approximately 17% in after-hours trading following a 1.6% increase during regular trading hours.
However, the report suggests that other potential buyers may emerge with competing offers for RVT-3101.
Last December, Roivant established Telavant as a joint venture with Pfizer, which initially developed RVT-3101 under the name PF-06480605 and initiated the TUSCANY-2 trial.
Pfizer holds a 25% stake in Telavant and has a similar arrangement with Roivant for the autoimmune disease subsidiary Priovant.
The decision to form this joint venture raised eyebrows at the time, as Pfizer is already involved in ulcerative colitis treatment with its JAK inhibitor, Xeljanz (tofacitinib), and offers biosimilars of older TNF-alpha inhibitors, which are commonly used in the biological treatment of IBD.
Approximately one-third of patients treated with current TNF-alpha drugs, such as AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab), experience treatment failure.
Analysts have speculated that RVT-3101 could potentially address this issue and become a blockbuster therapy in the future.
One advantage of RVT-3101 is its less frequent dosing requirement, administered only once per month, compared to TNF antibodies.
The therapy also holds theoretical potential for broader activity against TNF. Telavant additionally holds an option on a follow-up anti-TL1A candidate developed by Pfizer, currently in early clinical development.
If the deal with Roche materializes, it would mark the largest transaction for the Swiss company under the leadership of its new CEO, Thomas Schinecker, who assumed the role in March.
The reported value of the deal would approach Roivant’s entire market capitalization, which currently stands at approximately US$8.9 billion.
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