Gilead and Eisai Announce Collaboration to Co-Promote Investigational JAK1 Inhibitor Filgotinib for Rheumatoid Arthritis in Japan

TOKYO, Jan. 29, 2020 /PRNewswire/ -- Gilead Sciences, Inc. (NASDAQ: GILD) and Eisai Co., Ltd. (Tokyo, Japan) recently announced that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have reached an agreement for the distribution and co-promotion in Japan of filgotinib, an investigational oral selective JAK1 inhibitor for the treatment of rheumatoid arthritis, pending regulatory approval. Under this collaboration, Gilead Japan will be responsible for the manufacturing and marketing authorization of filgotinib, while Eisai will handle the distribution of the product in Japan for the treatment of rheumatoid arthritis and potentially other indications in the future. Upon approval, the two companies will jointly commercialize the drug.

Japan has approximately 60To1 Million People Suffer from Rheumatoid Arthritis^[1], despite the availability of various treatment options, many patients continue to experience unremitted disease. In the global Phase 3 FINCH study, filgotinib demonstrated sustained efficacy and safety across multiple rheumatoid arthritis patient populations, including those with prior inadequate response to methotrexate therapy(MTX)Patients with inadequate response, those intolerant to one or more biologic therapies, and patients receiving methotrexate (MTX) for the first time.

Luc Hermans, M.D., President and Representative Director of Gilead Sciences Japan, stated, “We are delighted to announce this important partnership with Eisai, which brings together our complementary expertise and commitment in inflammation to provide new treatment options for patients with inflammatory conditions in Japan.”

Hidenori Yabune, Senior Vice President of Eisai and President of Eisai Co., Ltd. in Japan, stated: “We have extensive clinical development and commercialization experience in the field of rheumatoid arthritis and hold a strong rheumatoid arthritis drug franchise in Japan.” He added, “Based on this agreement, we look forward to benefiting more patients with rheumatoid arthritis by adding filgotinib to our product portfolio.”

Global studies on the application of filgotinib in other diseases are also underway, including the Phase 3 SELECT trial for ulcerative colitis, the Phase 3 DIVERSITY trial for Crohn’s disease, the Phase 3 PENGUIN trial for psoriatic arthritis, and Phase 2 studies for uveitis and small bowel and fistulizing Crohn’s disease.

Gilead and Galapagos NV (Mechelen, Belgium) have entered into a global collaboration for the development and commercialization of filgotinib for the treatment of inflammatory conditions. Filgotinib is an investigational drug, and its efficacy and safety have not yet been established. Approval of filgotinib is pending from regulatory authorities in Japan, Europe, and the United States, based on the evaluation results of global Phase 3 trials assessing the efficacy and tolerability of filgotinib.

References

[1] March 26, 2018, Ministry of Health, Labour and Welfare, Health Science Council, Working Group on Disease Control, Committee on Rheumatoid Arthritis Research: “Current Status of Rheumatoid Arthritis from an Internal Medicine Perspective.” (Japanese only)