24 December 2019 - - US-based biopharmaceutical company Gilead Sciences, Inc.'s (NASDAQ: GILD) Japan-based Gilead Sciences K.K. business and Japanese pharmaceutical company Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis, the companies said.

Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.

Approximately 600,000 to 1m people are living with RA across Japan, and despite available options, many still do not experience disease remission. In the global Phase 3 FINCH studies, filgotinib demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment, those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve.

Global studies investigating filgotinib in additional diseases are also underway, including the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn's disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in 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 in inflammatory indications. Filgotinib is an investigational drug whose efficacy and safety have not been established.

Filgotinib is pending regulatory approval in Japan, Europe and the United States, based on global Phase 3 trials evaluating its efficacy and tolerability.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.

The company has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

Eisai Co., Ltd. is a global research and development-based pharmaceutical company headquartered in Japan.