Results of the Pharmaceutical Affairs Subcommittee Regarding the Application of Epogin for Chemotherapy-Induced Anemia
September 30, 2011 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama (hereafter, Chugai)] announced today the result of the review conducted at the Pharmaceutical Affairs Subcommittee, Pharmaceutical Affairs and Food Sanitation Council (hereafter, “the Subcommittee"), convened yesterday to discuss on its application for the approval of an additional indication, dosage and administration, and formulation for treatment of “chemotherapy-induced anemia in solid tumor patients who are not eligible for curative surgery” for the recombinant human erythropoietin, "[generic name: epoetin beta (genetic recombination)], which had been submitted to the Japanese Ministry of Health, Labour and Welfare in November, 2009. The Subcommittee has concluded that it is not appropriate to approve Epogin® for this indication. Chugai will consider future action regarding this indication for Epogin®.
There shall be no change in the outlook for fiscal year 2011, ending Dec. 31, 2011.
Name of listed company: Chugai Pharmaceutical Co., Ltd.
Code number: 4519 (1st Section of Tokyo Stock Exchange)
Head office: 1-1, Nihonbashi-Muromachi, 2-Chome, Chuo-ku, Tokyo
President & CEO: Osamu Nagayama
Inquiries to: Nobuyuki Chiba, General Manager, Corporate Communications Dept.
Posted: September 2011