May 28, 2021
EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
(Code 4574, Tokyo Stock Exchange 1st Section)

EA Pharma Filed Marketing Approval Application for
AJM300 (Nonproprietary Name: Carotegrast Methyl)
Indicated for Treatment of Ulcerative Colitis
EA Pharma Co., Ltd. (President, Yuji Matsue; Headquarters, Chuo-ku, Tokyo, Japan; “EAPharma”) and Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman
and CEO: Mutsuo Kanzawa; "Kissei") announced that EA Pharma has filed the marketing
approval application in Japan for AJM300 (nonproprietary name: carotegrast methyl), which
the two companies have developed for treatment of ulcerative colitis. The application was filed
based on the results of Phase III clinical study (AJM300/CT3) and other studies conducted inJapan. Detailed data of AJM300/CT3 will be presented at an upcoming major medical
conference this year.
AJM300 is an orally available small molecule α4 integrin antagonist that was originated by EA
Pharma (formerly known as Ajinomoto Pharmaceuticals Co., Ltd.). EA Pharma and Kissei havejointly developed AJM300 since 2015, aiming to launch the world-first orally available α4integrin antagonist onto the market.
In ulcerative colitis, lymphocytes and other inflammatory cells excessively aggregate andinvade into the inflamed site in the colonic mucosa. AJM300 can antagonize both α4β1 and
α4β7 integrins expressed on the surface of inflammatory cells and inhibit the cell adhesion
mediated by binding to adhesion molecules excessively expressed on the vascular endotherial
cells in the colonic mucosa, which suppresses invasion of lymphocytes into the inflamed site
to exert anti-inflammation effects.
EA Pharma and Kissei strive to quickly provide AJM300 for clinical use to increase treatment
options for ulcerative colitis to contribute to QOL of patiens and their families.

Media Inquiries
EA Pharma Co., Ltd.

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Corporate Planning Dept.
TEL： +81(0)3-6280-9802

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《More information》
1．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 60year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group
having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty
pharmaceutical company with a full value chain covering R&D, production & logistics and sales &marketing.
For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/en/
2．Kissei Pharmaceutical Co., Ltd.
Under the management philosophy “contribute to society through high-quality, innovative
pharmaceutical products” and “serve society through our employees”, Kissei PharmaceuticalCo., Ltd. provides unique innovative pharmaceutical products as a drug discovery and R&Doriented company for patients in the world with a special focus on urology, renal diseases,dialysis, diabetes, gastroenterology and rare diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/
3. Ulcerative Colitis
Ulcerative colitis is an inflammatory disease that causes ulcers and erosions in the colonicmucosa. The major symptoms are abdominal pain, diarrhea, bloody stools and so on. In
many cases, the “remission” stage where the symptoms improve and the “relapse” stage where
the symptoms deteriorate repeat over time, and patients suffer from the decline of QOL (qualityof life). The mechanism of onset is unknown up to the present. In Japan, ulcerative colitis is
one of the “designated intractable disease” by Ministry of Health, Labour and Welfare. The
registered patient number in Japan was nearly 220,000 in 2019, and the patient number hasa tendency to increase in recent years.1)
1) “Basic treatment guidance for patients with ulcerative colitis” (revised March 2020), Research group for
intractable inflammatory bowel diseases, Research project on rare and intractable diseases, Health and Labour
Sciences Research Grants.

4. AJM300/CT3 Study
The study was a randomized, double blind, pracebo controlled study in 203 patients withmoderately active ulcerateive colitits who had inadequate response or intorelance to the basic
treatment with 5-aminosalicylic acid in 82 medical facilities in Japan. The patients wererandomized to the groups treated with AJM300 or pracebo and received oral administration 3times daily for 8 weeks to investigate the efficacy and safety of AJM300.