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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

ition amounting to a severe gout syndrome, in a synthesis of data derived from five studies: the pegloticase Phase 2 study, GOUT 1, 2, and 3, and a 12-month non-interventional natural history study in treatment-failure gout patients. This was the first time that the data from these studies was presented in a scientific forum.

New Results presented at ACR:

-- The GOUT 3 study data demonstrated the continuing efficacy of

pegloticase in normalizing PUA to less than 6 mg/dL. It also

demonstrated the ability to maintain control of PUA for up to 18

months with continuous treatment in both the every 2 weeks and every 4

weeks treatment groups, in a proportion of patients similar to that

demonstrated in GOUT 1 and 2.

-- Gout Tophi: As previously reported by the Company, the superiority of

pegloticase administered every 2 weeks as compared to placebo in

attaining a gout tophus Complete Response was statistically significant

and clinically meaningful in the pegloticase 8mg every 2 weeks group

within 6 months of therapy, in the pre-specified pooled analysis.

Moreover, the tophus Complete Response was attained for the every 2

weeks group in both the GOUT 1 and GOUT 2 pivotal trials individually,

as well as in the pooled analysis. The pegloticase every 4 weeks group

attained statistical significance for tophus Complete Response in the

pre-specified pooled analysis. The analyses of secondary efficacy

endpoints for the individual studies as well as for the pooled data

across the two studies, has been included in the BLA submission for FDA

review.

The GOUT 3 data presented at ACR provided continued evidence of the

increase in pegloticase's favorable effect on achieving a Complete

Response for tophus resolution that was demonstrated in the initial 6

months of treatmen
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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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