- Following a recent setback, Gilead has decided to mostly back away from a drug at the center of its $5 billion research partnership with Galapagos, a Belgian biotech.
- The companies have been co-developing the drug, known as filgotinib, since 2015, testing it in a variety of immune-related diseases before asking the Food and Drug Administration for approval in rheumatoid arthritis. But in August, the FDA surprisingly rejected filgotinib due to concerns about the safety of its high dose. Gilead says the high dose is crucial for filgotinib to compete in the U.S. rheumatoid arthritis market.
- Based on FDA feedback, Gilead said Tuesday it will not pursue U.S. approval of filgotinib in rheumatoid arthritis. What's more, it has renegotiated terms of its partnership so that Galapagos regains all the rights to develop, manufacture and commercialize the drug in Europe. Galapagos will also be solely responsible for running ongoing rheumatoid arthritis studies, while Gilead will retain commercial rights to filgotinib outside of Europe, including in Japan, where the drug was recently approved.
Gilead is best known for antiviral medicines. But as its hepatitis C business started to erode, the company looked for other areas of drug research that could offset the declines. Under CEO Daniel O'Day, who arrived in early 2019 after leading Roche's pharmaceutical division, the search has turned to several high-profile deals — the first of which was with Galapagos.
The companies had already worked together for years, first linking up in 2015 to develop filgotinib across a range of inflammatory diseases. Yet, Gilead had come to see Galapagos' work as an entry point to the larger world of immunology, and by mid-2019, the partners agreed to enter a 10-year, $5 billion research deal that would hand Gilead certain rights to more than two dozen of Galapagos' drug programs.
Even with the larger deal, filgotinib remained the crown jewel of the partnership and an important litmus test for Galapagos' research and development capabilities. A so-called JAK inhibitor, filgotinib blocks a type of inflammatory protein in a similar way to Pfizer's Xeljanz, Eli Lilly's Olumiant and AbbVie's Rinvoq.
While JAK drugs had raised safety concerns before, Gilead and Galapagos were confident theirs would come to market unburdened by such issues. The companies were met with a major surprise in August, when FDA reviewers rejected filgotinib's approval filing and asked to see more safety data.
Now, Gilead seems convinced the high-dose of filgotinib won't be approved for rheumatoid arthritis in the U.S. Without that dose, which was shown to be more effective in clinical testing, the company doesn't see a way for filgotinib to compete. Filgotinib has received approvals in Japan and Europe, where it's sold under the brand name Jyseleca.
Before, deal terms terms held that Gilead was responsible for filgotinib in the U.S., while in Europe, Gilead and Galapagos would co-commercialize the drug in France, Germany, Italy, Spain and the United Kingdom and split profits 50-50 in those countries.
Now, Galapagos is on its own with filgotinib in Europe. The Belgian biotech will receive payments from Gilead in related to this change in responsibility, whereas Gilead will receive royalties from European sales of the drug.
Gilead also said that "without a viable plan forward" in the U.S., the companies will be stopping clinical trials testing filgotinib as a treatment for psoriatic arthritis, ankylosing spondylitis, and non-infectious uveitis. The companies had recently paused these studies following the FDA rejection.
Studies in Crohn's disease will still be run by Gilead, while Galapagos will handle trials testing filgotinib in ulcerative colitis. The companies also plan to continue developing the drug of inflammatory bowel disease, and expect to soon learn more from the FDA about a possible approval application.
Galapagos shares were down about 20% Wednesday morning, whereas Gilead's were largely unchanged.