Roivant Sciences, Pfizer create new business for inflammatory disease drug

Roivant Sciences, a US healthcare company, and Pfizer have established a new Vant to develop and commercialize PF-06480605 (now RVT-3101) for inflammatory and fibrotic bowel diseases.

Pfizer-developed RVT-3101 is a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A (TL1A), which has been shown to modulate the place and harshness of inflammation and fibrosis by stimulating TH1 and TH17 pathways, apart from activating fibroblasts.

TL1A is currently in phase 2b development in ulcerative colitis (UC).

A new Vant or Roivant Sciences subsidiary will finance the development of RVT-3101 in UC and other inflammatory and fibrotic diseases.

Pfizer will have a 25% equity in the new unit and Roivant Sciences will own the majority stake.

Roivant Sciences, Pfizer create new business for inflammatory disease drug. Photo courtesy of Lauri Silvennoinen/Wikimedia Commons.

The Roivant Sciences subsidiary will hold commercial rights in the US and Japan while Pfizer will have commercial rights outside of the US and Japan, apart from a seat on the company’s Board of Directors.

The Vant will also have the exclusive option to work with Pfizer on a next-generation TL1A directed antibody which recently entered phase 1.

The new business can enter into an agreement for global development with a 50/50 cost share and co-commercialization rights with Pfizer prior to Phase 2, which is anticipated in 2025.

Mikael Dolsten — Pfizer Chief Scientific Officer and Worldwide Research, Development and Medical President said: “We are very excited about the preliminary data from the TUSCANY-2 study and for this new Vant to drive the advancement of this asset.

“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.”

The commercial market for advanced inflammatory bowel diseases therapies is estimated to be approximately $15bn a year in the US alone, stated the Nasdaq-listed Roivant Sciences.

Mayukh Sukhatme — Roivant Sciences President and Chief Investment Officer said: “We believe in RVT-3101’s potential to transform the inflammatory bowel disease landscape, which has long been in need of new, innovative therapies with greater efficacy.

“We are excited about this collaboration with Pfizer on a potential first-in-class program, which we intend to pursue in both ulcerative colitis and in additional inflammatory and fibrotic diseases.

“TUSCANY-2 builds on the earlier TUSCANY data with many firsts for the class – TUSCANY-2 is the first study with subcutaneous efficacy data and the first dose-ranging study – and is among the largest Phase 2b studies ever conducted in the indication.”