Primary Endpoint Achieved in Phase III Clinical Trial of Epogin in Chemotherapy Induced Anemia
TOKYO, June 30, 2009 - Chugai Pharmaceutical Co., Ltd. ("Chugai") [Head Office: Chuo-ku, Tokyo; President: Osamu Nagayama] announced today that Phase III study of the recombinant human erythropoietin "Epogin® Injection" [generic name: epoetin beta (recombinant)] achieved the primary endpoint by significantly reducing the theoretical transfusion rate* in patients with chemotherapy induced anemia.
In the double-blind study, patients with chemotherapy-induced anemia were randomized to receive a weekly dosage of epoetin beta (recombinant) 36000IU or placebo for 12 weeks to examine efficacy and safety of epoetin beta (recombinant) treatment. As a result, the study met its primary endpoint with patients who received epoetin beta (recombinant) demonstrating a statistically significant reduction in theoretical transfusion rate compared with those who received placebo. Most common adverse effects observed in patients who received epoetin beta (recombinant) included increased blood pressure, hypertension, constipation and diarrhea.
Oncology is one of the strategic focus areas for Chugai. Patients receiving cancer chemotherapy may experience anemia resulting from various adverse reactions including bone-marrow suppression. Nonetheless, blood transfusion has been the only treatment option for such anemia in Japan. Chugai will continue to focus on obtaining marketing approval for Epogin® in this setting to make a new treatment option available for patients and medical professionals. Regulatory filing is planned by the end of 2009.
* The percentage of patients who received blood cell transfusion or had hemoglobin level under 8.0g/dL between four weeks after taking the first dose of treatment and the end of the study.<!-- ???????? -->
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: Mamoru Togashi
General Manager, Corporate Communications Dept.
Posted: June 2009