Marketing and Manufacturing Approval of Chronic Constipation Treatment“MOVICOL®” Obtained in Japan
This material is an English translation of the press release issued on September 21, 2018 inJapanese, and the Japanese release is given priority regarding content and interpretation.
September 21, 2018
Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd.
EA Pharma Co., Ltd. (President, Yuji Matsue; Headquarters, Tokyo, Japan) (hereinafter“EA Pharma”) and Mochida Pharmaceutical Co., Ltd. (President, Naoyuki Mochida;
Headquarters, Tokyo, Japan) (hereinafter “Mochida”) announced today that EA Pharma hasobtained the marketing and manufacturing approval of chronic constipation treatment“MOVICOL®” (Development code AJG555, hereinafter “MOVICOL®”), which EA Pharma andMochida have jointly developed for the Japanese market.
MOVICOL® increases the moisture in the intestinal tract by osmolality of its main ingredientpolyethylene glycol, which increases fecal moisture, softens feces, increases fecal volume andphysiologically activates the peristaltic movement of the colon to promote bowel movement.
The product has been mainly marketed in Europe and other markets, under the brand name
MOVICOL, and widely used for treatment of chronic constipation in pediatric and adult patients.
The guidelines of NICE (National Institute for Health and Care Excellence) UK recommend theuse of polyethylene glycol preparations for treatment of pediatric chronic constipation, and sodo the guidelines of World Gastroenterology Organisation for treatment in adults.
In Japan, in consideration of the situation that use of polyethylene glycol preparations forchronic constipation was not approved, Japanese Society for Pediatric Gastroenterology,
Hepatology and Nutrition submitted the letter of request for development of polyethylene glycol
preparations for pediatrics to the Evaluation Committee on Unapproved or Off-Labeled Drugs
with High Medical Needs1). In April’s meeting in 2015, the Committee concluded that there
were high unmet medical needs for polyethylene glycol preparations for chronic constipation.
Upon request from the Ministry of Health, Labour and Welfare, Ajinomoto Pharmaceuticals Co.,
Ltd. (now EA Pharma) in-licensed MOVICOL® from Norgine B.V. (Headquarters, theNetherlands), and EA Pharma and Mochida jointly developed the product for orally available
treatment of chronic constipation in pediatric and adult patients in Japan.
The above marketing and manufacturing approval was based on two phase III clinical trials
conducted in Japan. The phase III clinical trial in adults consisted of a confirmatory period ofplacebo-controlled double-blind study and a consecutive arminidtration period of open-label
long-term administration study. In the confirmatory period, 156 patients of the age 15 years orabove with chronic constipation with spontaneous bowel movement 2) frequency less than
3 times a week in average for at least 6 months were given orally 2 to 6 sachets daily ofplacebo or MOVICOL® depending on symptoms for 2 weeks. As a result, the spontaneousbowel movement frequency (the primary endpoint) statistically significantly increased in
the MOVICOL® group as compared with the placebo group. In the subsequent 52-weekconsecutive administration period, the spontaneous bowel movement frequency was steadily
maintained in most cases.
In the phase III clinical trial (a baseline-controlled open-label study) in pediatric patients,
39 patients of the age between 2-14 years with spontaneous bowel movement frequency lessthan 2 times a week in average for at least 2 months were given orally MOVICOL® 1-4 sachetsfor patients with the age between 2-6 years, 2-4 sachets for those between 7-11 years and2-6 sachets for those between 12-14 years daily depending on symptoms for 12 weeks. Asa result, the spontaneous bowel movement frequency (the primary endpoint) statisticallysignificantly increased as compared with the baseline.
The major side effects in the above trials were mild diarrhea and abdominal pain. No serious
side effects were observed.
The prevalence of constipation is high in women in the young and both men and women in
the elderly, and the symptoms can become severe particularly in pediatric patients.
The symptoms of constipation are reduced bowel movements, feeling of incomplete
evacuation, hard stools and others. When the symptoms become chronic, many patients sufferfrom a decline of QOL (Quality of Life).
EA Pharma and Mochida have respectively distributed “GOOFICE® 5 mg Tablet”, bile acidtransporter inhibitor for chronic constipation treatment, under the same brand name since its
launch in Japan in April 2018. Likewise, EA Pharma and Mochida distribute MOVICOL ®
respectively under the same brand name after inclusion of MOVICOL® in the National Health
Insurance drug price list. With the new treatment MOVICOL®, EA Pharma and Mochida strive
to increase treatment options for patients with chronic constipation with various diseasehistories to contribute to fulfillment of varied needs of patients with chronic constipation,
their families and healthcare providers to increase their benefits.
1) 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 the drugs and indications that are not approved in Japan (“unapprovedor off-labeled drugs”) and the appropriateness of filing the public knowledge -based
application and requirement of additional studies for filing the marketing and manufacturing
application to promote development of unapproved or off-labeled drugs by pharmaceuticalcompanies.
2) Defecation without use of laxative, enema or manual disimpactionEndMore Information
1. “MOVICOL®” Product Outline
Brand name

MOVICOL®

Nonproprietary

macrogol 4000, sodium chloride, sodium bicarbonate,

namepotassium chlorideMarketing andmanufacturing

September 21, 2018

approval date
Manufacturer anddistributor
Distributor
Indication

EA Pharma Co., Ltd.
Mochida Pharmaceutical Co., Ltd.
Chronic constipation(excluding structural disease-induced constipation)
Dissolve this medicine in water and drink.
For children of the age between 2 and 6 years, normally 1 sachet
should be orally given at once per day for the initial dose. Then,the dose can be increased or decreased depending on symptoms,
orally given 1-3 times per day. The maximum daily dose is 4 sachets(up to 2 sachets at once). At least a 2-day interval is needed forevery dose escalation, and the dose should not be increased
exceeding1 sachet per day.
For children of the age between 7 and 11 years, normally 2 sachets

Dosageand administration

should be orally given at once per day for the initial dose. Then,the dose can be increased or decreased depending on symptoms,
orally given 1-3 times per day. The maximum daily dose is 4 sachets(up to 2 sachets at once). At least a 2-day interval is needed for every
dose escalation, and the dose should not be increased exceeding
1 sachet per day.
For adults and children of the age 12 years and above, normally
2 sachets should be orally given at once per day for the initial dose.
Then, the dose can be increased or decreased depending on
symptoms, orally given 1-3 times per day. The maximum daily doseis 6 sachets (up to 4 sachets at once). At least a 2-day interval isneeded for every dose escalation, and the dose should not beincreased exceeding 2 sachets per day.

2. About “GOOFICE® 5 mg Tablet”“GOOFICE® 5 mg Tablet”, which EA Pharma in-licensed from Albireo AB (Headquarters,Sweden), is an orally available chronic constipation* treatment having a novel mechanism ofaction. “GOOFICE® 5 mg Tablet” inhibits the bile acid transporter that regulates reabsorptionof bile acids thereby increasing the flow of bile acids to the colon, which is expected to enhancecolonic motility. EA Pharma and Mochida have a joint development and marketing agreementfor “GOOFICE® 5 mg Tablet”. After EA Pharma obtained the marketing and manufacturing
approval on January 19, 2018, EA Pharma and Mochida started distribution of “GOOFICE®
5 mg Tablet” respectively under the same brand name on April 19, 2018 in Japan. EA Pharma
also has a co-promotion agreement with Eisai Co., Ltd. EA Pharma and Eisai Co., Ltd. jointly
provide the proper use information of “GOOFICE® 5 mg Tablet”.
*Excluding mechanical disorder-induced constipation
3. 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 resourceson the targeted areas of cardiovascular medicine, obstetrics and gynecology, dermatology,psychiatry and gastroenterology, while also providing medicine for intractable disease as wellas generics 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 more than
60 years history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group
having 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/*「MOVICOL」 is a registered trademark of the Norgine group.
(In this document, MOVICOL means the product marketed in non-Japan countries.)