Dec 24, 2019 17:22 JST

Source: Eisai

Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

- Agreement Extends to Additional Potential Indications for Filgotinib, Including Ulcerative Colitis, Crohn's Disease and Psoriatic Arthritis -

TOKYO, Dec 24, 2019 - (JCN Newswire) - Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences K.K. (Tokyo, Japan) and 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 (RA). 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 1 million people are living with RA across Japan(1), 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 (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-naive.

"We are very pleased to announce this important new partnership with Eisai, which brings together our complementary expertise and commitment in inflammation, to deliver this important new option to patients living with inflammatory diseases in Japan," said Luc Hermans, M.D., President and Representative Director, Gilead Japan.

"We have extensive clinical development and commercialization experience spanning more than 20 years in RA and have established a solid RA franchise in Japan," said Hidenori Yabune, President of Eisai Japan, Senior Vice President of Eisai. "With this agreement, we look forward to contributing more to patients living with RA by adding filgotinib to our product line-up."

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.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit www.eisai.com/.

(1) "Status of RA from the Point of View of Internal Medicine," Study Committee on RA, Working Group on Disease Control, Health Sciences Council, Ministry of Health, Labour and Welfare, March 26, 2018

Source: Eisai
Sectors: BioTech

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