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Advanced Magnetics Announces Positive Results from Two Additional,Phase III Studies of Ferumoxytol as an Intravenous Iron Replacement,Therapeutic

The primary safety analysis was the descriptive comparison of adverse events (AEs) experienced during ferumoxytol and placebo administration. Treatment related AEs occurred in 37 patients (5.2%) after ferumoxytol treatment and in 30 patients (4.2%) after placebo treatment. Treatment related serious adverse events (SAEs), as determined by the investigator, occurred in one patient (0.1%) after ferumoxytol treatment and in one patient (0.1%) after placebo treatment.

"The data from these studies are very promising because they demonstrate a statistically significant improvement in hemoglobin levels for non-dialysis dependent CKD patients undergoing ferumoxytol therapy as compared to oral iron therapy. In my opinion, the results from these two new studies, in conjunction with previous clinical trials, support an attractive profile for ferumoxytol," stated Allen Nissenson, MD, Professor of Medicine and Director of the Dialysis Program at David Geffen School of Medicine at UCLA and Chair of the Ferumoxytol Scientific Advisory Board.

"We are very pleased with the results that we are presenting today at the National Kidney Foundation meeting," stated Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics. "We have now presented data from three of the four studies in the pivotal program for ferumoxytol. These new results are encouraging, and we remain on track to file our NDA for ferumoxytol in the fourth calendar quarter of 2007."

Efficacy and Safety Study in Non-Dialysis Dependent CKD Poster

The first poster shows results from the second of two efficacy and safety studies in non-dialysis dependent CKD patients (Protocol 62,745-7; ClinicalTrials.gov identifier NCT00255437). Efficacy results in the intent to treat (ITT) and efficacy evaluable populations were similar. Efficacy results from the ITT analysis showed:

      * For the primary endpoint, which is change in hemoglobin from baseline

        at Day 35, patients receiving
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