BioTrends Release: ESAs and a New Class of Late Stage Oral HIF-PH Inhibitors May be Impacted by the Fact That Nephrologists Report Initiating ESAs at Lower Hemoglobins

EXTON, Pa., April 4, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that, compared to just one year ago, the mean hemoglobin at erythropoiesis-stimulating agent (ESA) initiation has significantly declined and is nearing levels at which a blood transfusion may be required. In addition, nephrologists tend to overestimate the percent of stage 3 chronic kidney disease (CKD) patients on an ESA, but accurately assess the percent of patients being treated with an ESA in stage 4 and stage 5 non-dialysis. Amgen's Aranesp has a slightly higher share of late-stage CKD patients than do the other available ESAs, including Procrit (manufactured by Amgen and distributed by Janssen) and Amgen's Epogen.

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The ChartTrends^®: Renal Anemia in CKD-ND 2012 (U.S.) report also covers the use of oral iron and IV iron in CKD-ND patients. AMAG Pharmaceutical's Feraheme, in number two share position behind Venofer, recently announced FDA acceptance of supplemental new drug application for label expansion to include iron deficiency anemia patients who cannot take oral iron. In addition, this study found that Feraheme patient share has declined directionally from 2011 with directional increases of the use of Sanofi's Ferrlecit.

"In this study, nearly half of physicians report initiating ESAs in CKD-ND at lower hemoglobin levels in the past year, something evident in the patient audit portion of this study as well," said BioTrends Research Group Director of Nephrology Rob Dubman. "This report could also have implications for the late-stage oral HIF-PH inhibitors in development, for example Akebia Therapeutics' AKB-6548 or FibroGen's/Astellas's FG-4592/ASP1517."

The BioTrends' TreatmentTrends: Nephrology (US) Q4 2012 report, found that over 20 percent of nephrologists expect to use AKB-6548 and FG-4592/ASP1517 products after ESA failures, respectively. Late stage oral HIF-PH inhibitors manufacturers must be considering when and how these agents will be used, especially when physicians are waiting longer to initiate ESAs.

ChartTrends^®: Renal Anemia in CKD-ND 2012 (U.S.) is a syndicated report series, in which 226 U.S. nephrologists provide patient chart data on 1,130 CKD-ND patients in the U.S. to uncover the actual management related to renal anemia. Through an in-depth review of patient charts, details such as product dosing and titration, switching, concomitant medications, and a host of laboratory and patient demographic variables help define patient types and identify therapy triggers.

TreatmentTrends^®: Nephrology (U.S.) is a syndicated quarterly report series, based on primary market research that provides a comprehensive view of the current and expected future management of renal anemia and bone and mineral metabolism in patients with kidney disease. The Q1 2013 wave published in March 2013 and the Q2 2013 wave will publish in June with survey comments due April 10, 2013.

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SOURCE BioTrends Research Group