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March 31, 2015

Kissei and Ajinomoto Pharmaceuticals announce partnership for joint development and marketing of AJM300 and AJG511 for treatment of ulcerative colitis in Japan

Kissei Pharmaceutical Co., Ltd.
Ajinomoto Pharmaceuticals Co., Ltd.



Kissei Pharmaceutical Co., Ltd. ("Kissei") (Chairman & CEO, Mutsuo Kanzawa; Headquarters, Nagano, Japan) and Ajinomoto Pharmaceuticals Co., Ltd. ("Ajinomoto Pharmaceuticals") (President, Takashi Nagamachi; Headquarters, Tokyo, Japan) announced a partnership for the joint development and marketing of Phase 3 stage projects AJM300 α4 integrin antagonist and AJG511 budesonide rectal foam, both which Ajinomoto Pharmaceuticals has been developing for the treatment of ulcerative colitis in Japan.

AJM300 is a novel α4 integrin antagonist that was originated by Ajinomoto Pharmaceuticals. AJM300 has a new action mechanism of suppressing excessive invasion of lymphocytes into the inflamed site. The Phase 2 clinical study demonstrated for the first time in the world that an orally-available α4 integrin antagonist was effective in ulcerative colitis. AJM300 is expected to be a new choice that can contribute to those patients who have inadequate response to the existing treatments of 5-aminosalicylic acid preparations or steroids.

AJG511 is the first rectal foam product in Japan containing budesonide as active ingredient, to which Ajinomoto Pharmaceuticals obtained license from Dr. Falk Pharma (Germany). Budesonide is a locally-active steroid and, thus, is expected to reduce systemic side effects. In addition, AJG511 is a foam type product that can reach the inflamed sites of rectum and sigmoid colon by rectal administration, and has a characteristic feature of preventing leakage after administration. Budesonide rectal foam is already available on the market in Europe, and prescriptions have been increasing. AJG511 will be a new treatment option for ulcerative colitis in Japan.

Ulcerative colitis is one of inflammatory bowel diseases, and is a government-designated intractable disease. It is reported that there are more than 160,000 patients with ulcerative colitis in Japan. In ulcerative colitis, ulcers develop in the colonic mucosa. Abdominal pain, diarrhea and rectal bleeding strongly decrease the patients' QOL (quality of life). The cause of disease remains unknown, and there exist merely limited treatments up to the present. Intention of Ajinomoto Pharmaceuticals to concentrate on GI disease area and aim to improve QOL of as many as patients matched Kissei's portfolio strategy, and the two companies have decided to go into partnership.

Kissei and Ajinomoto Pharmaceuticals will jointly develop AJM300 and AJG511. Ajinomoto Pharmaceuticals will file applications for manufacturing and marketing authorizations. Kissei and Ajinomoto Pharmaceuticals will jointly market the products under the same brand names in Japan. Kissei and Ajinomoto Pharmaceuticals strive to contribute to increasing QOL of patients through providing new treatment options by pharmaceuticals of novel action mechanisms and formulations that were not available in conventional pharmaceuticals.