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December 11th, 2009 PRESS RELEASE Zeria Pharmaceutical Co., Ltd. (Code 4559 Tokyo stock exchange) Kyowa Hakko Kirin Co., Ltd. (Code 4151 Tokyo stock exchange) Launch of “Asacol® Tablets 400 mg”, Agent for Ulcerative Colitis We would like to announce that Zeria Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President and Chief Executive Officer: Sachiaki Ibe; “Zeria”) and Kyowa Hakko Kirin Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President and Chief Executive Officer: Yuzuru Matsuda; “Kyowa Hakko Kirin”) launch “Asacol® Tablets 400 mg” (“Asacol®”; pH dependent controlled release mesalazine) on December 16th, 2009. Zeria obtained the marketing approval for Asacol® on October 16th, 2009, and its National Health Insurance price was listed today. Under the Agreement with Kyowa Hakko Kogyo Co., Ltd. (currently Kyowa Hakko Kirin) for co-development and co-marketing concluded in January 2007, Asacol® is manufactured by Zeria, and marketed by both companies with a single brand through two channels. Clinical development for ulcerative colitis*1 was conducted by Zeria alone, but for Crohn’s disease*2, co-development is carried out. Asacol® was developed for the treatment of inflammatory bowel disease (IBD) by Tillotts Pharma AG (Headquarters: Switzerland; Chief Executive Officer: Thomas A. Tóth von Kiskér) which became a subsidiary of Zeria as of September 1st, 2009. Asacol® has become available in over 60 countries worldwide including various countries where the rights to Asacol® have been divested (such as, but not limited to the United States, Canada and the United Kingdom). This mainstay product has secured an approximately 50% market share in the United States, the world’s largest market for IBD treatment agents, and also commands the top global pharma market share in this field. –1– Asacol® is an enteric-coated tablet with pH-dependent release that enables the delivery of mesalazine to the lower gastrointestinal tract (from the distal end of ileum to colon), and it is expected to improve the inflammation of the lower gastrointestinal tract in patients with IBD. *1 Ulcerative colitis is an intractable disease where inflammation occurs on the mucosa of the colon, and lesions and erosions continually occur from the anus and spreading upwards through the digestive tract. It is common for this disease to alternate between an “active phase” characterized by severe abdominal pain and diarrhea, and a “remission phase” during which symptoms are mostly absent. A number of factors have been suggested to cause the disease such as genetic factors, abnormalities of the immune system and environmental factors including diet, however the real cause of disease is still not fully understood. The number of patients with ulcerative colitis in Japan is gradually increasing. *2 Crohn’s disease develops mainly in younger people, and inflammations or lesions (loss of mucosa) occur everywhere from the oral cavity to the anus. Such pathological changes are frequently observed in the distal end of the small intestine, and are characterized by discontinuous inflammations (existence of normal areas next to inflamed areas). Those pathological changes produce abdominal pain, diarrhea, bloody stool and loss of body weight. Zeria and Kyowa Hakko Kirin aim a fast market penetration with Asacol®, and to provide more alternatives of drug therapies for ulcerative colitis as well as improvement of patients’ quality of life. Contacts for inquiries Zeria Pharmaceutical Co., Ltd. Kyowa Hakko Kirin Co., Ltd. Public Relations Corporate Communications Tel.: 03-3661-1039 Tel.: 03-3282-1903 –2– Outline of Asacol® Tablets 400 mg [Brand name] Asacol® Tablets 400mg [Generic name of active ingredient] Mesalazine [Dosage form] Film-coated tablet [Indication] Ulcerative colitis (excluding severe case) [Administration and dosage] Generally, to adults, mesalazine 2,400 mg/day is orally administered by dividing into 3 times after meal, but in active phase, 3,600 mg/day is orally administered by dividing into 3 times after meal. Dependent on patient’s condition, the dosage may be decreased. [Main features] • An oral mesalazine (5-ASA) product approved and used in over 60 countries worldwide (as of January 2009) • A pH-dependent enteric-coated tablet that enables to release and deliver mesalazine at pH 7 or higher, and mainly from the distal end of ileum to colon • In the induction of remission therapy in patients with ulcerative colitis, the efficacy was demonstrated in the types of pancolitis, left-sided colitis and proctitis. • In the maintenance of remission therapy (48 weeks), percentage of patients without bloody stool was 76.9 % (50/65 cases), and percentage of non-relapse was 80.0 % (52/65 cases) • Percentage of adverse drug reactions observed in clinical trials in Japan was 48.5 % (116/239 cases) [Packaging] PTP 100 tablets (10 tablets × 10), 500 tablets (10 tablets × 10 × 5) [NHI price] 400 mg 1 tablet: 89.1 Japanese yen [Approval date] October 16th, 2009 [Date of NHI price listing] [Launch date] December 11th, 2009 December 16th, 2009 [Marketing authorization holder] [Distributor] Zeria Pharmaceutical Co., Ltd. Kyowa Hakko Kirin Co., Ltd. –3–