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We will startmarketing Predonema Enema 20mg , a therapeutic drug for ulcerative colitis and regional enterocolitis

September 9, 2002

Kyorin Pharmaceutical Co., Ltd. (Headquarters; Tokyo, President; Mr. Ikuo Ogihara) and Nisshin Kyorin Pharmaceutical Co., Ltd. (Headquarters; Tokyo, President; Mr. Hiroyuki Yoshigai) will release Predonema Enema 20mg, a therapeutic drug for ulcerative colitis and regional enterocolitis tomorrow, September 10. Predonema Enema 20 mg, manufacturing approval was obtained by Nisshin Kyorin Pharmaceutical Co., Ltd, will be sold by both Kyorin Pharmaceutical Co., Ltd. and Nisshin Kyorin Pharmaceutical Co., Ltd.

The steroid enema on the market as a therapeutic drug for inflammatory bowel disease (IBD): one of the orphan diseases designated by the Ministry of Health, Welfare and Labor (MHWL), is a drug mainly composed of betamethasone sodium phosphate. However, according to the therapeutic guidelines prepared by the research group of the MHWL, 20 mg of prednisolone is recommended to be administered once or twice a day as steroid enemas. Thus specialists have also called for development of enemas mainly composed of prednisolone.

Predonema Enema 20 mg, the first enema mainly composed of prednisolone sodium phosphate in Japan, is expected to have the effect of inducing rapid disappearance of distal lesions of ulcerative colitis and regional enterocolitis (Crohn disease) developed in distal lesions (rectum or sigmoid colon). Moreover, the dosage form is miniaturized to be convenient to carry or to store, and the enema-container is easy to insert.

The number of patients with IBD, although which is a designated orphan disease, has been increasing over recent years, so an appropriate method of treatment for IBD urgently needs to be established. We marketed Pentasa Tablets 250 mg as a therapeutic drug for IBD since 1996. In addition, we will start marketing Predonema Enema 20 mg, which can improve the treatment and the Quality of life (QOL) of patients with IBD.

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