Eisai, Gilead Enter Exclusive Agreement for JAK Inhibitor Filgotinib in Asia

Eisai Co., Ltd. entered into an agreement with Gilead Sciences, Inc. for the commercialization and distribution of filgotinib (Jyseleca), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn's disease in Asia (South Korea, Taiwan, China, Hong Kong, S.A.R., China and Singapore). In December 2019, Eisai signed a partnership agreement with Gilead Sciences K.K., a Japanese subsidiary of Gilead, for the distribution and co-promotion of filgotinib in Japan.
Under the terms of the new agreement, Eisai will obtain an exclusive marketing right for filgotinib in South Korea, Taiwan, China, Hong Kong, S.A.R., China and Singapore from Gilead. Gilead has received approval for the treatment of RA in Taiwan, China and has applied for approval of filgotinib for the treatment of RA in South Korea. Following approvals, Eisai will take over the manufacturing and marketing licenses for filgotinib from Gilead in South Korea and Taiwan, China. In Hong Kong, S.A.R., China and Singapore, Eisai will apply for approval for filgotinib. With this agreement, Eisai will pay Gilead a contractual up-front payment, as well as regulatory milestones and sales milestones.
Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.