DGAP-News

Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology - Seite 2

health care professionals and the healthcare system.'

The Company's New Drug Application (NDA) for Zerenex is currently under review
by the U.S. Food and Drug Administration (FDA).

Ron Bentsur, Chief Executive Officer of Keryx, commented, 'We are very pleased
with the publication of the Phase 3 PERFECTED study results in a premier
peer-reviewed nephrology journal and are encouraged by Zerenex's potential
differentiated product profile.' Mr. Bentsur added, 'We thank the investigators
and patients who participated in this study and look forward to potentially
bringing Zerenex to market in the U.S.'

Phosphorus Control is Necessary for Most ESRD Patients on Dialysis

In the United States, according to data from the U.S. Renal Data System, there
are currently approximately 600,000 ESRD patients, with the number of ESRD
patients projected to rise in the future. The majority of ESRD patients in the
United States, more than 400,000, require dialysis. Phosphate retention and the
resulting hyperphosphatemia in patients with ESRD on dialysis are associated
with secondary hyperparathyroidism, renal osteodystrophy, soft tissue
mineralization and an increase in adverse cardiovascular events.
Hyperphosphatemia is ubiquitous in ESRD, with the majority of the patients
requiring chronic treatment with phosphate-binding agents to lower and maintain
serum phosphorus at acceptable levels.

Zerenex Administration Over 52 Weeks Increased Iron Stores

In addition, approximately seventy percent of dialysis patients are truly or
functionally iron depleted, suffer from anemia and require treatment with IV
iron and/or ESA injections. The newly published clinical trial results show
that, in addition to its efficacy as a phosphate binder, Zerenex also
significantly raises iron stores as measured by serum ferritin and TSAT.

The results showed Zerenex demonstrated a statistically significant treatment
difference versus the active control group in mean change in serum ferritin
(+306 ng/mL vs. +19 ng/mL) and TSAT (+8% vs -1.2%) from baseline (day 0) to
week 52. In the PERFECTED study, subjects randomized to receive Zerenex
required significantly lower dosages of IV iron and ESA; and hemoglobin levels
were higher in Zerenex treated patients than in those receiving active control.

The investigators cited an analysis of the trial results that indicated that
the projected reduction in the need for IV iron and ESA use would result in
significant pharmaco-economic benefits. In addition, the investigators wrote,
'one would postulate that decreased IV iron and ESA usage could result in