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Disability and Poor Quality of Life Associated With Treatment Failure Gout Patients

Posted on: Tuesday, 5 May 2009, 08:00 CDT

New Study Published in the Journal of Rheumatology Examines Quality of Life and Disability in Treatment Failure Gout Patients

EAST BRUNSWICK, N.J., May 5 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced today the print publication of the Savient-supported longitudinal observational (non-interventional) study of patients with treatment failure gout (TFG). The objective of the study was to determine the baseline characteristics and natural history of the disease in these patients, who are without treatment options, when under the care of a Board Certified Rheumatologist.

The study is the first to evaluate the quality of life in patients with treatment failure gout and appears in the May issue of the Journal of Rheumatology. TFG is defined as advanced gout in patients where conventional therapy is contraindicated or has been ineffective.

"Our study examined some of the most difficult to treat gout patients, many of whom regularly experience excruciating pain and struggle with co-morbid health disorders like metabolic and cardiovascular disease," said John S. Sundy, MD, PhD, Division of Rheumatology at Duke University Medical Center. "The results from the study provides clear evidence that despite today's best practice, treatment failure gout has a significant impact on health-related quality of life and disability. Many everyday activities even walking, are virtually impossible for many of these patients."

Treatment failure gout was shown to be associated with poor health-related quality of life and significant disability. Validated survey instruments for the assessment of patient-reported quality of life were used in this study which included Health Assessment Questionnaire-Disability Index and the SF-36. The TFG patients that were studied averaged 59 years in age. However, due to the poor quality of life associated with the disease, the reported results were more typical of Americans 74 years or older without TFG. Additionally, patient-reported perceptions of their gout-related pain and functioning were even more severe and more consistent than assessments of these same metrics reported by physicians.

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader specialty markets. Savient's product development candidate, KRYSTEXXA(TM) (pegloticase) for treatment failure gout, has reported positive Phase 1, 2 and 3 clinical data. Patient dosing in the Phase 3 clinical studies began in June 2006; patient enrollment was completed in March 2007; and the Phase 3 clinical studies were completed in October 2007. The BLA was filed with the FDA in October 2008; granted priority review status in December 2008; and the review period was extended by three months in February 2009. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Further information on Savient can be accessed by visiting: http://www.savient.com. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the efficacy and safety of KRYSTEXXA(TM) (pegloticase), our BLA filing with the FDA, the Advisory Committee, approval of the BLA, preparation for commercialization of KRYSTEXXA, and the market for KRYSTEXXA, are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, our Phase 3 clinical data and on current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, the delay or failure in completing development of KRYSTEXXA and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and CMC data by the FDA; delay achieving or failure to achieve FDA approval of KRYSTEXXA; inability to manufacture commercial quantities of our products; inability to gain market acceptance sufficient to justify development and commercialization costs if our products are approved for marketing; our continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in ongoing or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak only as of the date of publication of this press release to shareholders. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.

SVNT - G

SOURCE Savient Pharmaceuticals, Inc.

Source: PR Newswire

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