Buoyed by uveitis drug data, Roivant launches massive buyback
2024-04-02
临床3期临床2期上市批准并购临床结果
Roivant announced a $1.5-billion share repurchase programme on Tuesday, including the acquisition of Sumitomo Pharma's entire stake for $648 million. Coinciding with the buyback news, Priovant Therapeutics, a venture between Roivant and Pfizer, revealed that its experimental drug brepocitinib helped reduce symptoms of non-infectious uveitis in a mid-stage study.
In the 26-patient NEPTUNE study, 29% of participants (5/17) on the higher brepocitinib dose of 45mg experienced treatment failure at 24 weeks, the primary endpoint, while the same was true for 44% in the 15mg arm (4/9). By comparison, a failure rate of 62% was seen in a previous trial of AbbVie 's Humira (adalimumab), currently the only FDA-approved therapy for non-infectious uveitis, though it lost key patents last year.
Analyst David Risinger of Leerink Partners called the results "extremely positive," adding that brepocitinib could become the first oral therapy for the potentially blinding eye condition if it succeeds and is eventually approved.
Roivant CEO Matt Gline said the NEPTUNE data highlights the company's commitment to developing treatments for underserved conditions with high unmet needs.
"This transaction along with further potential buybacks reduces shareholder concentration and efficiently retires shares, increasing our continuing shareholders' exposure to developments in [non-infectious uveitis] and to the rest of our upcoming clinical data and company progress," he said.
Roivant's buyback and pipeline updates come after its $7.1-billion sale of rights to an experimental anti-TL1A antibody to Roche last year, providing substantial financial flexibility.
Formed through a 2022 deal with Pfizer, Priovant is steering brepocitinib's development across multiple autoimmune indications, positioning it as a "potential multi-blockbuster franchise," according to Roivant. As a dual inhibitor of TYK2 and JAK1, the drug is designed to suppress key cytokines linked to autoimmunity.
A Phase III trial is ongoing in dermatomyositis, with results expected next year. Plans are also underway to initiate a late-stage programme for non-infectious uveitis in the second half of 2024. However, brepocitinib failed a Phase II study in lupus last year, prompting Roivant to scrap that programme.
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