Our inflammation franchise
Our filgotinib franchise
We have a collaboration agreement with Gilead to develop and commercialize filgotinib in multiple diseases. Filgotinib is approved for use in RA in Europe and Japan in September 2020. Gilead decided not to advance the approval application in RA in the U.S. following receipt of a CRL from and subsequent discussions with the U.S. FDA in 2020. Filgotinib was submitted for approval in UC in Europe in 2020 and is in a Phase 3 clinical trial in CD. Gilead expects to submit filgotinib for approval in UC in Japan in H1 2021. A regulatory path for approval in UC and CD in the U.S. is pending review of the MANTA and MANTA-RAy data by the FDA.
At the end of 2020, we and Gilead entered into a binding term sheet pursuant to which we agreed to amend the existing arrangement for the commercialization and development of filgotinib. We will assume sole commercial, operational, and development responsibility in Europe for filgotinib in RA. Gilead will retain commercial rights and remain marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib is approved and is co-marketed with Eisai. Gilead and we 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 we will assume operational responsibility for ongoing trials in UC. We will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe, and Gilead will receive royalties from European sales of filgotinib, starting in 2024. Please see the Notes to the consolidated financial statements for financial details of the revised agreement.
The European market for drugs that treat inflammatory diseases is considerable: we estimate that the inflammation market today in the five largest European markets is approximately €5.7 billion, with about 60% of the current market going to RA therapies and about 40% to UC and CD combined:
EU5 inflammation market today, €B
RA: rheumatoid arthritis CD: Crohn’s disease UC: ulcerative colitis
Source: IQVIA Analytic Link (MAT to Q2 2020) – estimated value by disease at ex-manufacturer list prices. Estimates include all biologics and tsDMARDs.1tsDMARDs: targeted synthetic disease-modifying antirheumatic drugs
We have the ambition to achieve peak commercial sales of approximately €500 million in RA, UC, and CD in Europe in the latter half of this decade, targeting an 8-12% share of the total estimated market for RA, UC, and CD in the five largest markets in Europe.