Application for Marketing and Manufacturing Approval of Chronic Constipation
Treatment AJG555 Was Filed in Japan
This material is an English translation of the press release issued on November 27, 2017 inJapanese, and the Japanese release is given priority regarding content and interpretation.
November 27, 2017Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd.
EA Pharma Co., Ltd. (President, Yuji Matsue; Headquarters, Tokyo, Japan) (hereinafter “EAPharma”), a subsidiary of Eisai Co., Ltd. for the gastrointestinal disease area, and MochidaPharmaceutical Co., Ltd. (President, Naoyuki Mochida; Headquarters, Tokyo, Japan) (hereinafter“Mochida”) announced today that EA Pharma has filed an application for marketing andmanufacturing approval of chronic constipation treatment AJG555 (polyethylene glycolpreparation), which EA Pharma and Mochida have developed for the Japanese market.
AJG555 is an oral chronic constipation treatment that EA Pharma in-licensed from Norgine B.V.
(Headquarters, the Netherlands). AJG555 controls osmotic pressures in the intestinal tract andpromotes bowel movement. This product has been mainly marketed in Europe and in othermarkets, under the brand name MOVICOL, and widely used for treatment of chronic constipation inpediatric and adult patients. The guidelines of NICE (National Institute for Health and CareExcellence) UK endorse the use of polyethylene glycol preparations for treatment of pediatricchronic constipation, and so do the guidelines of World Gastroenterology Organisation fortreatment in adults.
Constipation is a very common disease. The prevalence is particularly high in women and in theelderly, and the symptoms can become severe in pediatric patients. The symptoms of constipation
are reduced bowel movements, feeling of incomplete evacuation, hard stools and others. When thesymptoms become chronic, many patients suffer from a decline of QOL (Quality of Life).
Once EA Pharma has obtained the marketing and manufacturing approval of AJG555, EA Pharma
and Mochida will distribute the product in Japan respectively under a same brand name. The twocompanies have jointly developed another chronic constipation treatment AJG533 of a different
action mechanism from that of AJG555 (AJG533 is now being reviewed by the regulatory
authorities for marketing and manufacturing approval). By providing AJG555 and AJG533, EA
Pharma and Mochida desire to add treatment options for patients suffering from chronic
constipation with different disease histories to make a contribution to fulfillment of various needs
and increase of benefits of patients with chronic constipation, their families and medical
practitioners.

More information
1. About AJG555 (polyethylene glycol preparation)
In Japan, polyethylene glycol preparation for chronic constipation was designated as a drugwith high medical needs by the Evaluation Committee on Unapproved or Off-Labeled Drugs
with High Medical Needs* in April 2015. Upon request from the Ministry of Health, Labour andWelfare, Ajinomoto Pharmaceuticals Co., Ltd. (now EA Pharma) has developed AJG555 fortreatment of chronic constipation in pediatric and adult patients in Japan. As of September 29,
2017, EA Pharma and Mochida signed a joint development and marketing agreement for
AJG555.
*The Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs
This committee was organized in the Ministry of Health, Labour and Welfare to evaluate the medical needs of thedrugs and indications that are not approved in Japan (“unapproved or off-labeled drugs”) and the appropriateness offiling the public knowledge-based application and requirement of additional studies for filing the marketing andmanufacturing application to promote development of unapproved or off-labeled drugs by pharmaceuticalcompanies.

2. About AJG533 （nonproprietary name: elobixibat hydrate）
AJG533, which EA Pharma in-licensed from Albireo AB (Headquarters, Sweden), is an orally
available chronic constipation treatment having a novel mechanism of action. AJG533 inhibits
the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow ofbile acids to the colon, which is expected to enhance colonic motility. EA Pharma and Mochidahave a joint development and marketing agreement for AJG533. EA Pharma filed theapplication for marketing and manufacturing approval as of February 1, 2017. Once EA
Pharma has obtained the approval, the two companies will distribute AJG533 respectively
under a same brand name in Japan.
3. About Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has 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 targetedareas of cardiovascular medicine, obstetrics and gynecology, dermatology, emergency
medicine and psychiatry, while also providing medicine for intractable disease as well asgenerics including biosimilars, to meet medical needs.
For more information on Mochida Pharmaceutical Co., Ltd.,
please see http://www.mochida.co.jp/english/
4. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, wasestablished in April 2016 by integration of the gastrointestinal business unit with at least 60years history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Grouphaving amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma witha full value chain covering R&D, logistics and sales & marketing.
For more information on EA Pharma Co., Ltd., please see https://www.eapharma.co.jp/en/