Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 1,600 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and favorable findings on safety and tolerability. From a regulatory perspective, filgotinib is an investigational agent and its safety and efficacy have not been established.
Phase 3 programs with filgotinib in rheumatoid arthritis, Crohn's disease and ulcerative colitis (UC) were initiated in 2016, as well as Phase 2 studies in small bowel CD, fistulizing CD, Sjögren’s syndrome, ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus (CLE), lupus membranous nephropathy and uveitis in 2017.
In December 2015, Galapagos entered into a global collaboration agreement with Gilead to develop and commercialize filgotinib for the treatment of inflammatory indications. Galapagos received an upfront payment of $725 million consisting of a one-time license fee in the amount of $300 million and a $425 million equity investment. In addition, Galapagos will be eligible to receive development and regulatory milestone-based payments of up to $755 million, of which Galapagos has already received $70 million, and sales-based milestone payments of up to $600 million. Galapagos will be eligible to receive tiered royalty percentages ranging from 20% to 30% on global net sales of licensed products. Galapagos will assume a portion of the co-promotion effort in Germany, France, Italy, Spain, the United Kingdom, the Netherlands, Belgium, and Luxembourg and will share equally in the net profits and net losses in these territories instead of receiving royalties in those territories during the period of co-promotion. Under the terms of the collaboration, Gilead is primarily responsible for development and for seeking regulatory approval of the licensed product. Galapagos is responsible for co-funding 20% of development costs through to regulatory approval.