Roivant Sciences, a prolific creator of biotechnology startups, said Thursday it is establishing a new company to develop and commercialize one of Pfizer’s experimental drugs for inflammatory diseases.
The drug, which is now called RVT-3101, blocks a protein that helps regulate inflammation and fibrosis. Pfizer has already ushered RVT-3101 into mid-stage testing as a treatment for moderate-to-severe ulcerative colitis. A 50-person study of the drug wrapped up in 2018, while a nearly 250-person study is still running. Pfizer has said early results from the induction period of that larger trial were positive, and data from a maintenance period will be made available sometime this year.
Should RVT-3101 succeed in testing, it could become the first approved therapy to target that protein, called TL1A. But it isn’t alone in that race. By the end of the year, Prometheus Biosciences, a San Diego-based company, expects to have results from a pair of Phase 2 studies evaluating its own TL1A-inhibiting drug against ulcerative colitis and Crohn’s disease. The generics manufacturer Teva Pharmaceutical is also going after those same two diseases through a recently started mid-stage trial of its experimental medicine TEV-48574.
To some, Pfizer’s decision to offload RVT-3101 came as a surprise, especially given how, just this year, company leadership talked up the drug’s benefits and touted a “precision biomarker” that could be used to gauge its effects.
In a note to clients, Evercore ISI analyst Umer Raffat wrote that the deal is “really confusing.”
Meanwhile, shares of Prometheus fell more than 6% in early Thursday morning trading.
Pfizer hasn’t cut all ties with its asset, however. Deal terms give it a 25% equity position as well as board representation in the new Roivant company. Pfizer will also retain commercial rights to RVT-3101 outside of the U.S. and Japan.
“We are very excited about the preliminary data from the [larger mid-stage] study and for this new [company] to drive the advancement of this asset,” Pfizer’s Chief Scientific Officer Mikael Dolsten said in a statement. “At the same time, it enables Pfizer to bring additional innovative breakthrough medicines and vaccines to patients in need more quickly, allowing us to serve more people.”
In addition to developing RVT-3101, the new Roivant company has an exclusive option to collaborate with Pfizer on a next-generation antibody drug that targets TL1A and recently entered early-stage human testing. Specifically, the new company can enter into an agreement for global development of the drug before it reaches Phase 2, which, according to Roivant, is expected in 2025. In that agreement, costs would be split evenly.
The creation of this new company is similar to another recent deal between Pfizer and Roivant that led to the formation of Priovant Therapeutics. Pfizer holds a 25% equity stake in Priovant, which is developing two of the big pharma’s treatments for autoimmune conditions.
In their statement, Pfizer and Roivant said it’s estimated that up to 2 million adults in the U.S. have inflammatory bowel diseases like ulcerative colitis and Crohn’s disease. They also said the commercial market opportunity for advanced therapies for these diseases is $15 billion per year in the U.S.