PIII Clinical Study Data on Chronic Constipation Treatment“GOOFICE® 5mg Tablet”
Will Be Presented at DDW2018
This material is an English translation of the press release issued on May 28, 2018 in Japanese,and the Japanese release is given priority regarding content and interpretation.
May 28, 2018
Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd.
Eisai Co., Ltd.
Mochida Pharmaceutical Co., Ltd. (President: Naoyuki Mochida; Headquarters: Tokyo, Japan) (hereinafter“Mochida”) and Eisai Co., Ltd. (CEO: Haruo Naito; Headquarters: Tokyo, Japan) (hereinafter "Eisai"),
Eisai’s subsidiary for gastrointestinal diseases EA Pharma Co., Ltd. (President & CEO: Yuji Matsue;
Headquarters: Tokyo, Japan) (hereinafter “EA Pharma”) announce that an oral presentation on PIII clinicalstudy data on “GOOFICE® 5mg Tablet” (nonproprietary name: elobixibat hydrate; development code:AJG533, hereinafter “elobixibat”), a bile acid transporter inhibitor launched in Japan on April 19, 2018, will
be given at Digestive Disease Week (DDW) 2018, June 2nd – 5th in Washington D.C., USA.
Elobixibat is a once-daily, orally available constipation treatment1) with a novel action mechanism.
EA Pharma in-licensed this product from Albireo AB (Sweden). Elobixibat inhibits the bile acidtransporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to thecolon. The dual action of moisture secretion and bowel movement promotion by bile acids canfacilitate defecation. Elobixibat is the world’s first pharmaceutical product approved for marketingwith the above action mechanism. At DDW2018, safety results obtained from a PIII clinical study
and a long-term dosing study will be presented.
■DDW 2018 Presentation Title
Presentation
Product/CompoundPresentation Title

Date/Time(local time)

Elobixibat【Abstract No.:744】(GOOFICE® Tablet) MEDIUM-TERM EFFICACY AND LONG-TERM SAFETY OF ILEAL BILEMondayJune 4thACID TRANSPORTER INHIBITOR, ELOBIXIBAT, IN CHRONIC

16:48-17:04

CONSTIPATION

Oral presentation

Elobixibat was jointly developed by Mochida and EA Pharma. Mochida and EA Pharma distribute
elobixibat under the same brand name “GOOFICE® 5mg Tablet”, respectively, in Japan. EA Pharmaand Eisai jointly provide proper use information of “GOOFICE® 5mg Tablet” under a co-promotion
agreement.
Mochida, EA Pharma and Eisai strive to make a further contribution to improve QOL for patientswith chronic constipation through maximization of product value of “GOOFICE® 5mg Tablet”.
1) Excluding structural disease-caused constipation
EndMore Information
1. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has been committed to research and development ofinnovative pharmaceutical products since its establishment thereby providing distinctive
medicines to the medical field. Currently, the core pharmaceutical business focuses resources on
the targeted areas of cardiovascular, obstetrics and gynecology, dermatology, psychiatry andgastroenterology, while also providing medicine for intractable disease as well as generics
including biosimilars, to meet medical needs.
For more information on Mochida Pharmaceutical Co., Ltd., please see
http://www.mochida.co.jp/english/
2. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was establishedin April 2016 by integration of the gastrointestinal business unit with more than 60 years’ history of theEisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its
business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D,
logistics and sales & marketing.
For more information on EA Pharma Co., Ltd., please see http://www.eapharma.co.jp/en/
3. 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 andtheir families and to increasing the benefits health care provides," which we call our human healthcare (hhc) philosophy. With approximately 10,000 employees working across our global networkof 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 particularfocus in our strategic areas of Neurology and Oncology.
For more information on Eisai Co., Ltd., please see https://www.eisai.com/