New drug approval of bile acid transporter inhibitor “GOOFICE® 5mg Tablet”
for chronic constipation was obtained in Japan
This material is an English translation of the press release issued on January 19, 2018 inJapanese, and the Japanese release is given priority regarding content and interpretation.
January 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 disease area EA Pharma Co., Ltd.
(President & CEO: Yuji Matsue; Headquarters: Tokyo, Japan) (hereinafter “EA Pharma”) today
announced that EA Pharma has obtained new drug approval for bile acid transporter inhibitor“GOOFICE® 5mg Tablet” (nonproprietary name: Elobixibat Hydrate; development code: AJG533)(hereinafter “GOOFICE® Tablet”) for chronic constipation (excluding structural disease-inducedconstipation) in Japan.
GOOFICE® Tablet was jointly developed by Mochida and EA Pharma. After inclusion in theNational Health Insurance drug price list, the two companies will respectively market the productunder the same brand name in Japan. EA Pharma and Eisai concluded a co-promotion agreement
and jointly provide proper use information of this product.
GOOFICE® Tablet, which EA Pharma in-licensed from Albireo AB (Headquarters: Sweden), is aonce-daily, orally available constipation treatment with a novel mechanism of action. GOOFICE®
Tablet inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing
the flow of bile acids to the colon, which is expected to enhance natural defecation.
Constipation is a very common disease, and the prevalence is particularly high in women and theelderly. In constipation, symptoms such as sensation of incomplete evacuation and hard stools
appear in addition to reduction of bowel movement frequency. When such symptoms become
chronic, many patients suffer from decline of QOL (quality of life).
The above new drug approval was mainly based on the results of a placebo-controlled, doubleblind Phase III clinical study in patients with chronic constipation conducted in Japan. As a result oforal administration of GOOFICE® Tablet or placebo once daily for 14 days, statistically significant
improvements were observed in the GOOFICE® Tablet group as compared to the placebo group in
the primary endpoint of spontaneous bowel movement1) frequency change and also in thesecondary endpoints including complete spontaneous bowel movement2) frequency change andstool consistency. There were no serious adverse events in the study.
By providing GOOFICE® Tablet with its novel mechanism of action, Mochida, EA Pharma and Eisai
strive to broaden treatment options for patients with chronic constipation to make a further
contribution to improve patients’ QOL.
1) defecation without use of laxative, enema or manual disimpaction2) spontaneous defecation without sensation of incomplete evacuation

More information
1.“GOOFICE® 5 mg Tablet” Product outline
Brand name

GOOFICE® 5 mg Tablet

Nonproprietary nameElobixibat Hydrate

Date of new drug
approval
Manufacturer
and distributor
Promotion alliance withEA Pharma Co., Ltd.
Distributor
Indication
Dosageand administration

January 19, 2018
EA Pharma Co., Ltd.
Eisai Co., Ltd.
Mochida Pharmaceutical Co., Ltd.
Chronic constipation (excluding structural disease-inducedconstipation)
The normal adult dose is 10 mg of elobixibat once daily orally
before a meal. The dose can be increased or reduced dependingon the symptoms. The maximal dose should be 15 mg per day.

2. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has been committed to research and development of innovative
pharmaceutical products since its establishment thereby providing distinctive medicines to themedical field. Currently, the core pharmaceutical business focuses resources on the targeted areasof cardiovascular medicine, obstetrics and gynecology, dermatology, emergency medicine andpsychiatry, 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 established inApril 2016 by integration of the gastrointestinal business unit with at least 60 years’ history of the Eisai
Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its businesscore. 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/
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 network ofR&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.
For more information on Eisai Co., Ltd., please see http:// www.eisai.com/