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Data Analyses Outline Efficacy and Safety of Mircera for the,Treatment of Renal Anemia Associated With Chronic Kidney Disease

ORLANDO, Fla. and NUTLEY, N.J., April 12, 2007 /PRNewswire-FirstCall/ -- Data analyses from the largest initial registration clinical trial program ever undertaken in the renal anemia arena provide efficacy and safety information on the investigational anemia therapy MIRCERA(TM) for the treatment of renal anemia associated with chronic kidney disease (CKD) in patients on dialysis and not on dialysis. Three data analyses were presented at the National Kidney Foundation 2007 Spring Clinical Meetings in Orlando, Florida.

According to these analyses, MIRCERA with extended dosing up to once every four weeks: (1) corrected and maintained hemoglobin (Hb) levels in patients with CKD, on dialysis and not on dialysis; (2) maintained Hb levels in dialysis patients, regardless of congestive heart failure (CHF) status as shown in a post-hoc analysis; and (3) exhibited a safety profile that is consistent with that of commercially available erythropoiesis stimulating agents (ESAs) and typical of those associated with this patient population.

"The goal in treating renal anemia is to safely maintain target hemoglobin levels," said Steven Fishbane, MD, Associate Director of Nephrology, Associate Chairman of the Department of Medicine, and Director of End-Stage Renal Disease research at Winthrop University Hospital. "These data analyses clearly demonstrate that MIRCERA corrected low hemoglobin levels, and maintained target hemoglobin levels with the added convenience of up to once- monthly dosing."

About the Studies

Safety and Tolerability of C.E.R.A. In Patients With Chronic Kidney Disease: Pooled Data From Ten Phase II-III Trials

Pooled data from four Phase II and six Phase III studies evaluated the safety and tolerability of MIRCERA (intravenous (IV) and subcutaneous (SC)) in patients not previously treated with commercially available ESAs and those previously treated with commercially availa
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