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Affymax And Takeda Announce Analyses From OMONTYS® (peginesatide) Injection Phase 3 Dialysis Studies Presented At 2012 American Society Of Nephrology Meeting

“Anemia management is multi-faceted and given the interdependence of irons and ESAs in red blood cell production, it’s important to evaluate utilization of these agents in dialysis patients who are being treated for the condition,” said Robert Provenzano, MD, Chair, Division of Nephrology, St. John Hospital & Medical Center, Detroit, and presenter of these EMERALD analyses. “The observations of these post-hoc analyses from the EMERALD studies may warrant further scientific evaluation.”

According to the OMONTYS prescribing information, healthcare professionals should correct or exclude other causes of anemia, including iron deficiency, before initiating treatment. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Evaluate transferrin saturation and serum ferritin prior to and during treatment, and administer supplemental iron when serum ferritin is less than 100 mcg/L or when serum ferritin saturation is less than 20%. For lack or loss of response to OMONTYS, initiate a search for causative factors, including iron deficiency. Please see full prescribing information, available at www.omontys.com.

About the EMERALD Studies

Evaluating approximately 1,600 dialysis patients across 172 sites in the U.S. and Europe, the primary efficacy endpoint of the EMERALD 1 and 2 studies was a mean change in Hb between the baseline and evaluation period (between weeks 29 through 36) following study entry. In these trials, CKD patients on dialysis who were stable on epoetin were randomized to receive OMONTYS either once monthly or to continue treatment with epoetin (according to its labeling), with dose adjustments to maintain Hb levels within the study-specified range (between 10.0-12.0 g/dL). Current Prescribing Information recommends reducing or interrupting the dose as Hb levels approach or exceed 11 g/dL.

The EMERALD studies were part of the first Phase 3 program to prospectively evaluate the cardiovascular (CV) safety of different ESAs based on a composite cardiovascular safety endpoint (CSE). The CSE was adjudicated by a blinded and independent committee.

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