Roivant reveals positive immune drug data, share buyback plans

2024-04-02

临床结果临床3期并购临床2期免疫疗法

Dive Brief:

An experimental drug being developed by a subsidiary of Roivant Sciences succeeded in a Phase 2 trial testing it for a type of inflammatory eye condition called non-infectious uveitis, Roivant said Tuesday.

Patients who received the drug, known as brepocitinib and licensed from Pfizer, had a meaningfully lower rate of “treatment failure,” a mixed measure of eye inflammation and other disease markers, than did those given placebo. Roivant claimed the findings surpass results for Humira, the only non-steroid treatment approved for the condition. No new safety concerns were reported, the company said.

Roivant simultaneously revealed plans to buy back up to $1.5 billion of its shares, including $648 million worth of stock held by Sumitomo Pharma. The Japanese drugmaker has invested in, or acquired, multiple Roivant subsidiaries in recent years.

Dive Insight:

Roivant is a so-called hub-and-spoke biotech, with a web of subsidiaries custom-built to advance specific drug candidates in different therapeutic areas. In Roivant’s case, those prospects are typically plucked from the shelves of pharmaceutical companies.

The strategy hasn’t always worked out. One of its subsidiaries, the Alzheimer’s drug developer Axovant Sciences, collapsed several years ago. But the company has had a recent run of success, highlighted by the $7 billion sale of Televant last year. The trial data released Tuesday are the latest example.

The results come from Roivant subsidiary Priovant Therapeutics, which the company formed with Pfizer two years ago. Priovant’s pipeline centered on two drugs, one of which was brepocitinib, a medicine Pfizer had developed for inflammatory conditions.

Brepocitinib blocks two targets, TYK2 and JAK1, that are implicated in a variety of autoimmune disorders. TYK2 and JAK1-targeting drugs have typically been positioned as treatments for common skin conditions like eczema and psoriasis. But Priovant started trials in non-infectious uveitis and a rare condition called dermatomyositis.

A Phase 3 study in dermatomyositis is ongoing, with results expected in 2025. But the study results achieved in uveitis are “extremely impressive” and “compare very favorably” to what was seen with Humira, wrote Leerink Partners analyst David Risinger, in a Tuesday note to clients.

Specifically, 29% of the patients treated with a 45 milligram dose met the study’s criteria for treatment failure after 24 weeks. Though comparing drugs across trials is difficult, Risinger noted that Humira had a 62% treatment failure rate at 25 weeks in a larger trial.

A Phase 3 study in non-infectious uveitis should begin in the second half of 2024, Roivant said.

The share repurchase deal, meanwhile, will see Roivant acquire Sumitomo’s 71.3 million shares at $9.10 apiece. The deal will reduce Roivant’s total number of outstanding shares by 9%.

Sumitomo paid $3 billion for stakes in five Roivant subsidiaries in 2019. It’s since taken control of another Roivant unit, Urovant, and acquired Myovant for $3 billion in 2022.

Shares for Roivant rose by about 5% in Tuesday trading.

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