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Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks
Date:10/19/2007

neous (SC) MIRCERA at extended administration intervals. MIRCERA has a longer half-life than any commercially available erythropoiesis-stimulating agent (ESA). In clinical trials MIRCERA corrected anemia in chronic kidney disease (CKD) patients with dosing once every two weeks and maintained hemoglobin levels in CKD patients with dosing intervals up to once monthly. In the U.S., the FDA is completing its review and MIRCERA is anticipated to be approved mid-November.

Safety Information

MIRCERA has a demonstrated safety profile comparable to other erythropoietic agents. The most commonly reported adverse events in the MIRCERA Phase II/III clinical program were hypertension, nasopharyngitis, diarrhea, headache, and upper respiratory tract infection.

Erythropoietic therapies increase the risk of death and serious cardiovascular and thromboembolic events when administered to a hemoglobin of greater than 12 g/dL. A rate of Hb rise of >1 g/dL over 2 weeks may also contribute to these risks.

Erythropoiesis stimulating agents, when administered to target a hemoglobin of greater than 12 g/dL, have shortened the time to tumor progression, shortened survival and increased the risk of death in cancer patients.

Pure Red Cell Aplasia (PRCA) has been observed in patients treated with erythropoietin therapy. However, PRCA has not been observed with MIRCERA in clinical trials to date.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by Med Ad News and one of
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