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Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Date:10/27/2008

s respectively. The infusion reaction

experience in the GOUT 3 study was consistent and similar in nature and

pattern to that observed in the GOUT 1 and GOUT 2 studies and was

easily managed utilizing the methods specified in the study protocols.

As previously reported in GOUT 1, GOUT 2 and GOUT 3, there were a total

of seven patient deaths in the clinical program: 5 (5/169 or 3%) in

pegloticase treatment groups and two (2/44 or 4.5%) in the placebo

groups.

- Of these seven deaths, 3 were attributed to cardiac events. Two of

the events occurred in the pegloticase arms and one in the placebo

group as previously reported by the Company and not believed to be

drug related.

Cardiovascular Serious Adverse Events (SAEs) in patients on pegloticase

GOUT 1 and GOUT 2 were as follows:

- There were two reported cardiac SAEs which were included among the

seven deaths indicated above.

- A third patient who was on pegloticase every 4 weeks, following a

placebo dose had an SAE relating to congestive heart failure which

was resolved after hospitalization. However, as previously

reported, this patient died of renal failure after voluntarily

withdrawing from renal dialysis.

- The remaining five patients with cardiac SAEs continued to receive

pegloticase in the trials. It is important to note that all five

patients continued treatment successfully despite their

cardiovascular event.

None of these cardiovascular events, including the patient deaths were

thought to be causally related to pegloticase treatment by the

Investigators and Sponsor.

We believe the overall safety profile of pegloticase in the clinical

program indicates that long-term administration of 8 mg pegloticase in<
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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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