Galapagos NV (NASDAQ:GLPG) saw its shares decrease in price Monday on developments out of the lab. The company announced Monday it 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.
Meantime, Gilead Sciences Inc (NASDAQ:GILD) is partnering with Galapagos 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 the end of next June. Upon completing the transfer, Gilead will make a one-time payment of $15 million to Galapagos.
From April 1, 2022, Galapagos will also be solely responsible for all development costs for the DIVERSITY clinical study. In addition, if the European Medicines Agency grants regulatory approval of filgotinib for the treatment of CD based on data from the DIVERSITY trial, 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.
Shares in GLPG were down $2.06, or 3.8%, to $51.53, while those for GILD gained five cents to $68.61.
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