EAST BRUNSWICK, N.J., Sept. 22, 2008 (GLOBE NEWSWIRE) -- Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) announced today that four scientific abstracts on pegloticase and two scientific abstracts based on Treatment Failure Gout (TFG) will be presented at the American College of Rheumatology (ACR) 72nd Annual Scientific Meeting in San Francisco from October 24 - 29, 2008. For complete information on all six abstracts, please visit the ACR website at www.rheumatology.org.
About the Phase 3 Study Oral Presentations
New clinical data on pegloticase from two replicate Phase 3 randomized, double blind, and placebo-controlled studies, Gout Outcomes and Urate Therapy 1 and 2 (GOUT1 and GOUT2) will be featured in an ACR plenary session, presented by John Sundy, MD on Sunday, October 26. In both Phase 3 studies, pegloticase was shown to rapidly reduce and maintain plasma uric acid level less than 6mg/dL during the study period in the TFG population whose hyperuricemia and severe gout symptoms were inadequately managed with current urate lowering therapy. The most commonly reported adverse events included gout flares induced by uric acid lowering, and infusion-related reactions.
* #635: J Sundy. Efficacy and Safety of Intravenous (IV)
Pegloticase (PGL) in Subjects with Treatment Failure Gout
(TFG): Phase 3 Results from GOUT1 and GOUT2.
11:15 AM - 11:30 AM, October 26th
Also to be presented in concurrent oral sessions on Tuesday, October 28 by Michael Becker, MD, will be an analysis of GOUT1 and GOUT 2 results which describe the immune response to pegloticase treatment, and the association of immunoreactivity and treatment effect. Pegloticase treated patients with the highest anti-pegloticase antibody titers failed to maintain normalization of plasma uric acid. Additionally, pegloticase treated patients with the high anti-pegloticase antibody titers had a higher incidence of infusion-related reactions. No clinically relevant elevations of anti-pegloticase IgE, and no neutralizing antibodies were identified.
* #1945: M Becker. Immunoreactivity and Clinical Response to
Pegloticase (PGL): Pooled Data from GOUT1 and GOUT2, PGL Phase
3 Randomized, Double Blind, Placebo-controlled Trials.
3:30 PM - 3:45 PM, October 28th
About the Phase 3 Study Poster Presentations
Clinical outcomes centered on improvements of tophus response and Health-related Quality of Life from both Phase 3 studies will be presented during a poster session on October 26.
In GOUT 1 and GOUT 2, tophi were assessed with standardized digital photography, image analysis, and a Central Reader, blinded to treatment assignment. More than 70% of patients who enrolled in the two GOUT studies had gout tophi at baseline. Patients treated with pegloticase infusion every 2 weeks showed statistically significant "complete response," or resolution of at least one tophus without worsening or development of any new tophi as compared to placebo, in both GOUT 1 and GOUT 2, whereas the "complete response" did not attain significance in the pegloticase every 4 week group.
* #22: H Baraf. Tophus Response to Pegloticase (PGL) Therapy:
Pooled Results from GOUT1 and GOUT2, PGL Phase 3 Randomized,
Double Blind, Placebo-controlled Trials. 9 AM - 11 AM, October
26th
In another poster presentation, results will be discussed showing that patients treated with pegloticase had significant improvements in physical component summary score as assessed by SF-36 and physical function as assessed by HAQ-DI, in comparison with placebo control patients.
* #27: N Edwards. Improvement in Health-related Quality of Life
(HRQL) and Disability Index in Treatment Failure Gout (TFG)
after Pegloticase (PGL) Therapy: Pooled Results from GOUT1 and
GOUT2, Phase 3, Randomized, Double Blind, Placebo
(PBO)-Controlled Trials. 9 AM - 11 AM, October 26th
About the Treatment Failure Gout Poster Presentations
Also to be presented during the poster session on October 26 are results from a one-year, multi-center, prospective observational Natural History Study (NHS) highlighting the impact of work productivity loss due to flares in patients with TFG; and results from four independent cohorts (NHS, Phase 2, GOUT1 and GOUT2) describing the similarity of clinical features of TFG.
In the NHS of TFG, the majority of patients who were younger than 65 years of age reported at least one work day lost due to a gout flare during the year with a mean work day loss of approximately 25 days per year.
* #1363/#85: F Pan. Work Productivity Loss Due to Flares in
Treatment-Failure Gout (TFG). 9 AM - 11 AM, October 26th
The clinical features of TFG were found to have similar demographics, physical characteristics, co-morbidities, and clinical symptoms of severe gout in all four independent studies.
* #34: R Yood. Clinical Homogeneity and Syndromic
Characteristics of Treatment Failure Gout (TFG) in Four
Independent Cohorts. 9 AM - 11 AM, October 26th
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals is a biopharmaceutical company engaged in developing and distributing pharmaceutical products that target unmet medical needs in both niche and broader markets. The company's product development candidate, Puricase(r) (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. Savient has exclusively licensed worldwide rights to the technology related to Puricase from Duke University and Mountain View Pharmaceuticals, Inc. Savient's experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late-stage compounds and exploring co-promotion and co-development opportunities that fit the Company's expertise in specialty pharmaceuticals and biopharmaceuticals with an initial focus in rheumatology. Savient also manufactures and supplies Oxandrin(r) (oxandrolone tablets, USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on Savient can be accessed by visiting: http://www.savient.com.
FORWARD-LOOKING LANGUAGE
We may from time to time make written or oral forward-looking statements, including statements contained herein, in our filings with the Securities and Exchange Commission, in our press releases and in our reports to stockholders within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts included in this press release regarding our strategy, strategic alliances, competitive position, plans and objectives of management 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 clinical results of the Phase 3 clinical trials and the ongoing Open Label Extension (OLE) for Puricase(r) (pegloticase), the filing, based on those results, of a BLA with the FDA, the filing of a Marketing Authorization Application with the EMEA, the results of the pre-BLA meeting with the FDA and its potential impacts on the BLA submission, the timing of approval of the BLA and launch of pegloticase, the market for pegloticase, and the absence of other therapies for treatment-failure gout patients, are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our current assessment of the 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 pegloticase 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 pegloticase, difficulties of expanding our product portfolio through in-licensing or acquisition; 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 technologies 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.
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