Joint Development and Marketing Agreement for Chronic Constipation Treatment
AJG555 in Japan Was Signed
This material is an English translation of the press release issued on September 29, 2017 inJapanese, and the Japanese release is given priority regarding content and interpretation.
September 29, 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 the two companies have signed a joint development andmarketing agreement for chronic constipation treatment AJG555 (polyethylene glycol preparation),
which EA Pharma has been developing 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, under the brandname MOVICOL® and is widely used for treatment of chronic constipation in pediatric and adultpatients. In Japan, polyethylene glycol preparation for chronic constipation was designated as adrug with high medical needs by the Evaluation Committee on Unapproved or Off-Labeled Drugs
with High Medical Needs*1 in April 2015, and the Ministry of Health, Labour and Welfare requested
that Ajinomoto Pharmaceuticals Co., Ltd. (now EA Pharma) develop the product for the Japanesemarket. At this moment, the PIII clinical study of AJG555 in pediatric and adult patients with chronic
constipation is ongoing.
Constipation is a very common disease. The prevalence is particularly high in women and in theelderly, and 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).
EA Pharma and Mochida have a joint development and marketing agreement for another chronic
constipation treatment AJG533*2 which has a different action mechanism from that of AJG555. The
application for the new drug approval for AJG533 has already been filed and is now underregulatory review. With these two types of chronic constipation treatments, EA Pharma andMochida desire to add treatment options for patients with chronic constipation to make acontribution to increase patients’ QOL, and the two companies’ have found a consistency in theirportfolio strategy which has led to the execution of above-captioned agreement.
Under this agreement, EA Pharma and Mochida will jointly distribute AJG555 under the same brandname in Japan after EA Pharma has obtained the marketing and manufacturing approval. WithAJG533 and AJG555, EA Pharma and Mochida strive together to make a further contribution toincrease of QOL of patients with chronic constipation.

*1 The Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs:
This committee is a ministerial council that was organized in the Ministry of Health, Labour and Welfare with the purposeof evaluating the medical needs of the drugs or indications that have not been approved yet in Japan (hereinafter“unapproved or off-labeled drugs”) and confirming the appropriateness of filing new drug applications for such drugs aswell as the adequate additional studies required for filing such applications to accelerate the development of unapproved
or off-labeled drugs by pharmaceutical companies.
*2 Chronic constipation treatment AJG533:
AJG533 (nonproprietary name: elobixibat hydrate) has a novel action mechanism which inhibits the transporter that
regulates reabsorption of bile acids. It is currently under development.

More information
1. 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. Please see http://www.mochida.co.jp/ formore information about Mochida Pharmaceutical Co., Ltd.
2. About EA Pharma Co., Ltd.
EA Pharma Co., Ltd. is a gastrointestinal specialty pharma having a full value chain of researchand development, production and logistics, sales and marketing, established in April 2016 byintegration of the gastrointestinal business unit with more than 60 year-history of the Eisai
Group and the Ajinomoto Group’s gastrointestinal business unit with the core in amino acid.
Please see http://www.eapharma.co.jp/ for more information about EA Pharma Co., Ltd.