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OVERVIEW |
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We are a specialty biopharmaceutical company focused on developing pegloticase (KRYSTEXXA™) for the treatment of chronic gout in patients refractory to conventional therapy.
Chronic gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. Pegloticase is not meant for the treatment of asymptomatic hyperuricemia.
In our two replicate randomized, double-blind, placebo-controlled Phase 3 clinical trials, pegloticase, a biologic PEGylated uricase enzyme, demonstrated the normalization of uric acid in patients with chronic gout refractory to conventional therapy. There is no drug or biologic approved for this patient population.
We believe that if approved, pegloticase will offer physicians and patients a new treatment option for those patients with contraindication to or who have failed to achieve therapeutic success at the maximum medically appropriate dose of xanthine oxidase inhibitors or allopurinol. It is for these patients with refractory chronic gout that pegloticase potentially offers a benefit and for which the compound has been granted orphan drug designation in the United States.
Savient has licensed worldwide rights to the technology related to pegloticase from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. Oxandrin is a registered trademark of Savient Pharmaceuticals, Inc. KRYSTEXXA is a trademark of Savient Pharmaceuticals, Inc.
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Stock Information (Time Delayed)
SVNT - (NASDAQ)
$14.92
- 0.08
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09-03-10
4:00 PM ET |
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Recent Releases
08-03-10
Savient Pharmaceuticals Reports Second Quarter 2010 Financial Results
07-28-10
Savient Pharmaceuticals to Hold Second Quarter 2010 Results Conference Call on Wednesday, August 4, 2010
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Events
08-04-10
Savient Pharmaceuticals 2010 2nd Quarter Earnings Conference Call
05-06-10
Savient Pharmaceuticals 2010 1st Quarter Earnings Conference Call
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Savient Pharmaceuticals, Inc. (the "Company") believes that the information included in the Investor Relations section of this website was correct at the time it was added to the website. However, the Company expressly disclaims any duty to update the information on the website and makes no representation or warranty as to accuracy and completeness of the contents of this Investor Relations section of the website or any other section of the website. Access to and use of the information on this website is at the user's own risk. The Company assumes no responsibility for any errors or omissions in the content of this website and disclaims any liability for damages of any kind (whether direct, consequential or punitive) arising out of the use of this website or the information contained on the website or on links to or from this website.
The Investor Relations section of this website contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts included in the website 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 identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding whether our KRYSTEXXA BLA resubmission, combined with the submissions made and planned by our third party contract manufacturer, fully addresses the deficiencies and observations raised and provides the additional materials requested in the Complete Response Letter that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009, the timing of FDA action with respect to the BLA resubmission, potential FDA marketing approval for KRYSTEXXA™, the efficacy and safety of KRYSTEXXA and the potential regulatory filings outside the United States and the potential for marketing approval in those jurisdictions 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 and Open Label Extension Study clinical data, our current understanding of the Complete Response Letter 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 possibility that the FDA may raise further issues regarding the BLA for KRYSTEXXA, our third party contract manufacturer or require that we conduct additional clinical trials; our reliance on third parties to manufacture, market and distribute many of our products; our ability to commercialize and market acceptance of KRYSTEXXA; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in 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 website 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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Copyright © 2010 Savient Pharmaceuticals, Inc. All rights reserved. |
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