Nearly a year after agreeing to a $7 billion-plus sale for an inflammatory bowel disease drug candidate, Roivant Sciences is pitching big potential in another drug from the back of a drugmaker’s closet.
On Tuesday, Roivant said it has licensed global rights to mosliciguat, an inhaled lung drug previously discovered and developed by Bayer. The German pharma giant discontinued work in 2022 when it largely exited respiratory research. Roivant paid $14 million upfront, along with up to $280 million in potential milestone payments and possible tiered royalties in the high-single digits. The drug will be under a new subsidiary called Pulmovant.
Bayer and Roivant agreed to the deal in July 2023, but Roivant has kept it under wraps for competitive reasons and to flesh out the clinical strategy, CEO Matt Gline told Endpoints News. A Phase 2 study testing mosliciguat against a placebo group in patients with pulmonary hypertension associated with interstitial lung disease, or PH-ILD, will start “imminently,” Gline added.
Roivant will also present Phase 1 data Tuesday for the drug at the European Respiratory Society Congress in Vienna. The company expects Phase 2 results in the second half of 2026, although that “certainly could be earlier” if patient enrollment goes faster, Gline added. If Phase 2 is successful, Roivant believes one registrational Phase 3 study could then support approval.
Roivant is still enjoying its windfall from the Roche sale, and ended June with $5.69 billion in cash and equivalents. True to its nature, the company remains on the hunt for even more deals, especially as many pharma giants prepare for their own patent cliffs ahead.
“Lots of capacity, lots of enthusiasm, lots of opportunity,” Gline said. “It’s a great moment to do what we do well. This program has no impact either on our capacity or our enthusiasm to do more.”
One approved competitor
Compared to the TL1A drug licensed from Pfizer and sold to Roche, the mosliciguat program is earlier in development. But Gline said the drug’s opportunity is on the same size and scale, with a potential market opportunity of over $6 billion and little competition, according to a corporate presentation.
The only fully approved PH-ILD treatment is United Therapeutics’ Tyvaso, which won FDA clearance in 2021. Patients with the disease have high blood pressure in their lungs, causing shortness of breath and limiting their activities. It’s ultimately associated with a higher risk of hospitalization or death.
The deal could pit Roivant in a fierce market battle with United, a longtime pioneer of pulmonary hypertension treatments. Roivant’s leaders said Tyvaso’s safety and tolerability profile leaves room for improvement, particularly with its four-times-daily dosing regimen. About 44% of patients reported cough as a side effect in United’s Phase 3 study.
Mayukh SukhatmeMayukh Sukhatme, Roivant’s chief investment officer who received an $80.6 million bonus after the Roche deal, led deal talks for mosliciguat. The drug had three key features making it attractive, he said: Phase 1 data showing it lowered the resistance of blood vessels in the lung; once-daily dosing; and its safety and tolerability profile.
“Any one of those attributes would make this really interesting,” Sukhatme said in an interview. “The fact it’s all in one, that we’re actually hitting all three of those, is remarkable.”
Wall Street has been making guesses about what drug or disease Roivant would pick for its next program after the TL1A sale to Roche. Jefferies analyst Dennis Ding had listed roughly 50 possible drugs with targets like NLRP3, IRAK4, and ANGPTL3 as potential fits for the undisclosed program in an August research note. Mosliciguat is an activator of sGC, a key enzyme involved with controlling oxidative stress in cells — but didn’t make Ding’s shortlist.