Savient Pharmaceuticals, Inc. (SVNT) Announces Publication in Annals of the Rheumatic Diseases, Posters Presented at the ACR/AHRP Annual Meeting

Today, Savient Pharmaceuticals announced that the safety and efficacy profile of KRYSTEXXA (pegloticase) for long-term treatment of refractory chronic gout (RCG) has been reinforced by new data from an open-label extension (OLE) study published in the Annals of the Rheumatic Diseases.

The OLE data agreed with outcomes that were seen in the KRYSTEXXA pivotal Phase III clinical trials, with no new safety signals identified. As evidenced by flare and tophus reduction first initiated in participants treated by KRYSTEXXA in the Phase III trial, who maintained goal range urate-lowering responses, improvements in clinical status were sustained or advanced during the trial and over the course of up to two-and-a-half years of additional treatment.

In addition to being published in the international peer-reviewed journal, two posters are being presented through Nov. 14 at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/AHRP) Annual Meeting, further demonstrating the safety and efficacy seen in the OLE study.

Confirming both the long-term safety of KRYSTEXXA and the durable and progressive response to treatment, the data are encouraging and signal good news for patients suffering with RCG, as treatment options are currently limited for this severe, debilitating, and progressive form of gout.

In all, 151 patients were enrolled in the study and completed one of the two Phase III randomized, double-blind, placebo-controlled registration trials. For the management of RCG, patients received either 8 mg of KRYSTEXXA every two weeks or the same dose every four weeks. Consistent with Phase III trials, gout flares and injection reactions were the most frequently reported adverse events, with 71 percent of patients reporting gout flares and 44 percent of patients reporting injection reactions. These adverse events were least common in patients with a sustained response to KRYSTEXXA, as well as those receiving treatments every two weeks. In most patients defined as KRYSTEXXA responders in the Phase III trials, plasma and serum uric acid levels remained less than 6 mg/dL, and sustained and progressive improvements in tophus resolution and flare incidence were seen throughout the period of the study.

Savient Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and commercialization of KRYSTEXXA (pegloticase) for treating chronic gout in adult patients refractory to conventional therapy. The company has exclusively licensed the global rights to the technology related to KRYSTEXXA and its uses from Duke University and Mountain View Pharmaceuticals, Inc. Duke developed the recombinant uricase enzyme and Mountain View Pharmaceuticals developed the PEGylation technology used in the manufacture of KRYSTEXXA. These two entities have received U.S. and foreign patents disclosing and claiming the licensed technology. Additionally, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents that cover the composition, manufacture, and methods of use and administration of KRYSTEXXA. Savient additionally supplies Oxandrin (oxandrolone tablets, USP) CIII in United States.

For more information, visit www.savient.com

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