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Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting
Date:11/7/2008

PHILADELPHIA, Nov. 7 /PRNewswire/ -- Data from an investigational, open-label, randomized study assessing extended dosing regimens of PROCRIT(R) (Epoetin alfa) in treating anemia in subjects with Stages 3 - 4 chronic kidney disease (CKD) were presented today at the American Society of Nephrology 41st Annual Meeting.

All three dosing groups, including the FDA-approved three-times-per-week (TIW) regimen, plus once-a-week (QW) and once-every-two-weeks (Q2W) investigational regimens, achieved a mean final hemoglobin (Hb) within the range of 11.0 - 11.9 g/dL. Based on the increases in Hb, the QW and Q2W investigational regimens were statistically non-inferior to the TIW regimen (lower limits of 95 percent confidence intervals [CIs] within the non-inferiority margin of -1 g/dL).

The percent of subjects with Hb exceeding 11.9 g/dL during the first 22 weeks of treatment was higher in the TIW group (86.2 percent) than in the QW (78.4 percent) and Q2W (71.2 percent) groups; the median per-subject frequency of Hb exceeding 11.9 g/dL was 6, 4 and 3 times for the TIW, QW and Q2W groups, respectively.

In the first 22 weeks of treatment, the proportion of subjects experiencing serious adverse events (SAEs) was 15 percent in the TIW group, compared with 22 percent in both the QW and Q2W groups. During the entire 44 weeks of treatment, the proportion of subjects experiencing SAEs was 29, 33 and 33 percent in the TIW, QW and Q2W groups, respectively. The number of subjects with investigator-confirmed thromboembolic vascular events (TVEs) over the first 22 weeks was 2 in the TIW, 2 in the QW and 3 in the Q2W groups; over 44 weeks, these numbers were 2, 5 and 8 in the TIW, QW and Q2W groups, respectively. The number of subjects who died during the first 22 weeks was 0 in the TIW, 6 in the QW and 3 in the Q2W groups. Over 44 weeks, 4, 6 and 4 subjects died, respectively. None of the deaths were considered related to the study drug.

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SOURCE Ortho Biotech Products, L.P.
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