Galapagos Assumes Responsibility Of Late-Stage Filgotinib Trial In Crohn's Disease

Galapagos NV GLPG has randomized the last patient into the DIVERSITY Phase 3 study of filgotinib in the induction and maintenance of remission in patients with Crohn's Disease (CD). The DIVERSITY study enrolled 1,374 participants.
The study evaluates the safety and efficacy of 100mg and 200mg filgotinib versus placebo on clinical remission and endoscopic response in a 10-week induction phase, followed by a 47-week maintenance phase.
Topline results of the DIVERSITY study are anticipated in H1 2023.
Gilead Sciences Inc GILD and Galapagos NV are partners in a global collaboration to develop and commercialize filgotinib.
Galapagos will assume operational and financial responsibility for the DIVERSITY study and its long-term extension study.
The parties intend to complete the transfer by June 30, 2022. Upon completing the transfer, Gilead will make a one-time payment of $15 million to Galapagos.
Related: Galapagos' Long-Serving CEO Onno Van De Stolpe To Exit After R&D Setbacks.
From April 1, 2022, Galapagos will also be solely responsible for all development costs for the DIVERSITY clinical study.
In addition, on EMA approval of filgotinib for CD based on DIVERSITY trial data, then royalties payable by Galapagos to Gilead will be reduced by 30% across all filgotinib indications and will become 5.6 to 10.5% of net sales in Europe.
These royalties are payable as of 2024. Gilead remains responsible for commercial activities outside of Europe.
Price Action: GLPG stock is down 3.55% at $51.69 during the premarket session on Monday's last check, while GILD closed 1.85% lower at $68.56 on Friday.

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