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

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  • Galapagos NV (NASDAQ: 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 (NASDAQ: 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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