EAST BRUNSWICK, N.J., May 29, 2009 (GLOBE NEWSWIRE) -- Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) announced today that six abstracts (two oral presentations and four posters) about the Company's product candidate KRYSTEXXA(tm) (pegloticase) will be presented at the European League Against Rheumatism (EULAR) 2009 Annual Congress June 10-13 in Copenhagen, Denmark addressing various aspects of treatment failure gout. Treatment failure gout occurs in patients with gout who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with urate-lowering therapy at the maximum medically appropriate dose or for whom those drugs are contraindicated.
The first oral presentation will discuss complete tophus resolution with KRYSTEXXA defined as a 100 percent decrease in measured tophus area, as observed during Savient's two replicate Phase 3 Gout Outcomes and Urate Lowering Therapy (GOUT 1 and GOUT 2) clinical trials. The second oral presentation will address data suggesting that the health-related quality of life in patients with treatment failure gout is significantly compromised and is comparable to other severe chronic conditions.
The four poster presentations will address data from Savient's Phase 3 clinical trial of KRYSTEXXA for treatment failure gout. Data on patients' quality of life following KRYSTEXXA treatment, results of a global internet-based quantitative market research survey in hyperuricemia and gout and clinical practice patterns will be presented.
Oral presentation details are as follows:
-- Reduction of Tophus Size with Pegloticase (PGL) in Treatment
Failure Gout (TFG): Results from GOUT1 and GOUT2 (HSB Baraf
et al, Abstract #OP-0047, June 11, 2009, 10:15 a.m., Auditorium 2)
-- Health Related Quality-of-Life (HRQOL) of Patients with
Treatment Failure Gout (TFG) is Poor and Comparable to that
in Other Severe Chronic Conditions (V Strand, Abstract
#OP-0291, June 13, 2009, 8:45 a.m., Hall A3)
Poster presentation details are as follows:
-- Efficacy and Safety of Intravenous Pegloticase (PGL) in
Treatment Failure Gout (TFG): Results from GOUT1 and GOUT2
(J Sundy et al, Abstract #THU0446, June 11, 2009, 11:45 a.m.,
Bella Center)
-- Clinical Manifestations of Treatment Failure Gout (TFG) in
Four independent Cohorts Abstract. (R. Yood et al, Abstract
#THU0462, June 11, 2009, 11:45 a.m., Bella Center)
-- Health-Related Quality of Life (HRQOL) and Disability Index:
Results from GOUT1 and GOUT2 (NL Edwards, Abstract #FRI0544,
June 12, 2009, 11:45 a.m., Bella Center)
-- Global Internet-Based Quantitative Market Research Survey in
Hyperuricemia and Gout (FD Ottery et al, Abstract #THU0538,
June 11, 2009, 11:45 a.m., Bella Center)
ABOUT KRYSTEXXA
KRYSTEXXA(tm) (pegloticase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of KRYSTEXXA therapy in patients with treatment failure gout, under the auspices of an SPA from the FDA. KRYSTEXXA was granted orphan drug designation by the FDA in 2001. Savient's KRYSTEXXA BLA filing includes data from both the six-month placebo-controlled Phase 3 pivotal trials, as well as data from an open label extension study.
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. The KRYSTEXXA Phase 3 clinical studies were completed in October 2007; the BLA was filed with the FDA in October 2008 and the FDA granted priority review status in December 2008. The Company submitted amendments to the BLA to the FDA in January 2009 and the FDA extended the review period by three months, revising the PDUFA date to August 1, 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 LANGUAGE
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.
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