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Keryx Biopharmaceuticals Announces Positive Final Data from Zerenex™ Short-Term Phase 3 Study
Date:4/28/2011

oint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).

Additional efficacy results are as follows: Mean Serum Phosphorus (mg/dL) ITT (n=146)1g/Day
(n=50)6g/Day
(n=51)8g/Day
(n=45)Baseline (End of Washout)

7.3

7.6

7.5Day 28/LOCF* (End of Treatment)

7.4

5.6

5.3Change from Baseline at Day 28

P-Value

0.1-2.0

<0.0001

-2.2

<0.0001% Change from Baseline at Day 28

0.5%

-25.7%

-29.6%* Last observation carried forward was used for missing data.

Additional highlights from Dr. Goldfarb's presentation on Zerenex are as follows:

  • Statistically significant dose response increase in serum bicarbonate suggests potential to address metabolic acidosis
  • Statistically significant dose response reduction in calcium x phosphorus product
  • Modest upward trends in Ferritin and TSAT in 6 grams/day and 8 grams/day dose groups further supports theory that Zerenex could reduce the need for intravenous iron and erythropoiesis-stimulating agent (ESA) use
  • Zerenex appeared to be safe and well-tolerated in the study
  • GI adverse events were mostly mild and transient in nature
  • No SAEs were deemed to be drug-related by the Data Safety Monitoring Committee

  • Dr. Goldfarb concluded that Zerenex has the potential to become a viable alternative to the currently approved phosphate binders used to treat ESRD patients.

    Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are encouraged by the final efficacy and safety data from the Phase 3 short term study presented earlier today, which confirm the top-line data previously reported."  Mr. Bentsur continued, "We thank Dr. Goldfarb for his time and effort in preparing for and delivering this morning's presentation."

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    SOURCE Keryx Biopharmaceuticals, Inc.
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