Gilead and Galapagos announce new commercialization and development agreement for Jyseleca.

Gilead Sciences, Inc. and Galapagos NV announced that the companies have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the FDA to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA. Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in RA in the United States and that the 200 mg dose is unlikely to achieve approval for RA in the U.S. without conducting substantial additional clinical studies. Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib. This is an acceleration of the commercial strategy in place for products under the separate ten-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialization. Through a phased transition including the transfer of filgotinib’s marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved, and is co-marketed with Eisai. Filgotinib Development: Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA. Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-infectious uveitis following receipt of the CRL and, without a viable path forward in the United States, the companies no longer believe it is feasible to continue the current global development program for filgotinib in these indications. As a result, these trials will be stopped over the coming months. Week 26 data from the MANTA and MANTA-RAy studies, including primary and key secondary endpoints, will be available by mid-2021 and the parties expect to submit the data to regulatory authorities shortly thereafter. In order to complete their review of filgotinib in RA or other future indications,the FDA has requested up to Week 52 follow-up data for patients who show greater than 50% decrease in semen parameters by Week 26 and do not recover in the ongoing MANTA and MANTA-RAy studies.. Gilead and Galapagos will continue to investigate the potential for filgotinib to support patients living with Inflammatory Bowel Disease (IBD). Gilead will retain operational responsibility for the current trials in Crohn’s disease while Galapagos will assume operational responsibility for ongoing trials in UC. Filgotinib is currently under review by the European Medicines Agency (EMA) for the treatment of UC and is expected to be submitted to the Japanese Ministry of Health, Labour and Welfare in the first half of 2021. Gilead and Galapagos expect to have further clarity on the potential U.S. filing of filgotinib in IBD, after consultation with FDA, including on the results of the MANTA and MANTA-RAy studies as described above.