World’s First Bile Acid Transporter Inhibitor “GOOFICE® 5mg Tablet” Launched inJapan
This material is an English translation of the press release issued on April 19, 2018 in Japanese,and the Japanese release is given priority regarding content and interpretation.
April 19, 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”) today announced that the bile acidtransporter inhibitor “GOOFICE® 5mg Tablet” (nonproprietary name: Elobixibat Hydrate; development
code: AJG533) (hereinafter “GOOFICE® Tablet”) was listed in Japan’s National Health Insurance Drug
Price List as of April 18, 2018, and Mochida and EA Pharma launched the product onto Japan’s market
today.
GOOFICE® Tablet, which EA Pharma in-licensed from Albireo AB (Sweden), is a once-daily, orally
available constipation treatment with a novel action mechanism. GOOFICE® Tablet inhibits the bile
acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids tothe colon. The dual action of moisture secretion and bowel movement promotion is expected toenhance natural defecation. GOOFICE® Tablet is the first ileal bile acid transporter inhibitor
approved anywhere in the world.
Constipation is a very common disease. The prevalence is high in young women and both elderly
men and women. In Japan, the number of patients with subjective symptoms of constipation isestimated to be about 4.5 million1). In constipation, symptoms such as sensation of incomplete
evacuation and hard stools appear in addition to reduction of bowel movement frequency. Whensuch symptoms become chronic, many patients suffer a decline in QOL (quality of life). In a placebocontrolled, double-blind Phase 3 clinical study conducted in Japan, which was the basis for marketing
approval, there were statistically significant improvements observed in changes in spontaneous
bowel movement2) (primary endpoint), complete spontaneous bowel movement3) (secondaryendpoint), time to first spontaneous bowel movement, stool consistency and other parameters for
the GOOFICE® Tablet-treated group compared to the placebo group. No serious adverse eventswere observed.
GOOFICE® Tablet was jointly developed by Mochida and EA Pharma. Mochida and EA Pharma will
distribute the product under the same brand name, respectively. EA Pharma and Eisai have signed
a co-promotion agreement and will jointly provide information for proper use of the product.
By providing GOOFICE® Tablet with its novel mechanism of action, Mochida, EA Pharma and Eisaistrive to broaden treatment options for patients with chronic constipation to make a further
contribution to improve patients’ QOL.
1) Estimation based on the Comprehensive Survey of Living Conditions 2016 conducted by Ministry ofHealth, Labour and Welfare2) Defecation without use of laxative, enema or manual disimpaction3) Spontaneous defecation without sensation of incomplete evacuation

EndMore Information
1. “GOOFICE® 5 mg Tablet”
Brand name

GOOFICE® 5 mg Tablet

Nonproprietary nameElobixibat Hydrate

Dosage form

A film-coated tablet containing 5 mg of elobixibatIndication

Chronic constipation(excluding structural disease-induced constipation)

Dosage andThe normal adult dose is 10 mg of elobixibat once daily orally before

administrationa meal. The dose can be increased or reduced depending on thesymptoms. The maximal dose should be 15 mg per day.

Package

100 tablets (blister pack), 500 tablets (blister pack)

National Health
Insurance (NHI) Drug¥105.80 per tablet of GOOFICE® 5 mg Tablet

Price
Date of marketing
approval
Listing in NHI Drug
Price List
Date of launch
Manufacturer anddistributor
Promotion alliance withEA Pharma Co., Ltd.
Distributor

January 19, 2018
April 18, 2018
April 19, 2018
EA Pharma Co., Ltd.
Eisai Co., Ltd.
Mochida Pharmaceutical Co., Ltd.

■Product photos

A tabletA blister pack

2. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has been committed to research and development ofinnovative pharmaceutical products since its establishment thereby providing distinctivemedicines 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/
3. 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 http://www.eapharma.co.jp/en/
4. 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/