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 nethropathy and uveitis in 2017.
In December 2015, Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory diseases. Pursuant to the agreement, the companies collaborate jointly on the global development of filgotinib starting with the initiation of Phase 3 trials in RA and Crohn's disease. Galapagos co-funds 20 percent of global development activities and Gilead is responsible for manufacturing and worldwide marketing and sales activities. Galapagos has the option to co-promote filgotinib in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg, in which case the companies will share profits equally. If Galapagos exercises its option to co-promote in Belgium, the Netherlands or Luxembourg, it will also book sales in these countries. Galapagos received an upfront license fee of $300 million and Gilead made a $425 million equity investment in Galapagos. Galapagos is eligible to receive further development, regulatory and commercial milestone payments up to $1.35 billion, plus tiered royalties on global sales starting at 20%, with the exception of the co-promotion territories, where profits will be shared equally.