Savient Pharmaceuticals, Inc. Presents Results of Puricase Phase I Studies at American College of Rheumatology Annual Scientific Meeting.

EAST BRUNSWICK, N.J. -- Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) today presented results from its two Phase 1 clinical studies of Puricase(R) (PEGylated uricase) in severe gout in three poster presentations at the 68th Annual Scientific Meeting of the American College of Rheumatology in San Antonio, Texas.

The two Phase 1 clinical studies were conducted at Duke University Medical Center, under lead investigator John S. Sundy, M.D. Each study was designed to evaluate the safety, tolerability, and pharmacokinetics of a range of single doses of Puricase in subjects with hyperuricemia associated with severe refractory gout. At the time of enrollment in the study, the overall quality of life and functional status in the study subjects were found to be substantially impaired in comparison to persons of the same age and sex in the general population. Study subjects were selected either because they could not tolerate allopurinol, the most common conventional drug therapy for treatment of hyperuricemia, or because their hyperuricemia was inadequately controlled by allopurinol.

Puricase was administered by subcutaneous injection in the first study, which resulted in injection site reactions and drug intolerance in some patients. These findings were not observed in the second study, in which Puricase was administered intravenously. Both studies showed a dose-related, sustained reduction in plasma uric acid to normal levels.

Based on Phase 1 results, Savient is now conducting a Phase 2 multi-center dose-ranging safety and efficacy study of repeated intravenous administration of Puricase in patients with severe refractory gout. It is Savient's goal to complete the Phase 2 study this year and, if successful, enter Phase 3 trials in 2005. No FDA-approved therapy is available today to treat these refractory patients.

Uric acid is a breakdown product that is normally excreted by the kidneys. However, if excess uric acid accumulates, it will crystallize in the joints and eventually cause symptoms of gout. The disease causes severe pain and damage to the joints and may lead to kidney stones, as well. Current treatments for gout are sometimes ineffective and may even cause life-threatening allergic reactions.

Uricase, an enzyme produced by most animals, though not by humans, converts uric acid into allantoin, a highly water-soluble and easily excreted product. Puricase is a chemically modified form of recombinant uricase, based on mammalian sequences, that is being developed by Savient for individuals with severe gout who cannot be treated by conventional therapies.

In February 2001, Savient received FDA Orphan Drug designation for Puricase in the treatment of gout patients for whom conventional therapy is contraindicated or has been ineffective. It is estimated that in the United States, there are approximately 32,000 patients who suffer from severe, untreatable gout.

Savient licensed worldwide rights to the Puricase technology from Duke University, which developed the recombinant uricase enzyme, and California-based Mountain View Pharmaceuticals, Inc., which designed and synthesized PEG conjugates of uricase to prolong the activity and enhance the safety of Puricase by reducing its potential immunogenicity.

For further information on the ongoing Phase 2 Puricase study, visit www.clinicaltrials.gov.

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc. is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and wider markets. Products marketed by Savient in the United States are Oxandrin(R) (oxandrolone, USP) and Delatestryl(R) (testosterone enanthate). The Company's subsidiary, Rosemont Pharmaceuticals Limited, develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market. The Company's Israeli subsidiary, Bio-Technology General (Israel) Ltd., manufactures and markets in Israel Bio-Tropin(TM) (recombinant human growth hormone), BioLon(R) (sodium hyaluronate), Bio-Hep-B(R) (hepatitis B vaccine), and Arthrease(TM) (sodium hyaluronate for osteoarthritis). Products marketed by Savient's licensees are Mircette(R) (oral contraceptive), and BioLon(R) in the United States, and Bio-Tropin(TM), BioLon(R), Bio-Hep-B(R), Silkis(R) (vitamin D derivative), and recombinant human insulin, in international markets. Savient's news releases and other information are available on the Company's website at www.savientpharma.com.

Arthrease is a trademark of DePuy Orthopaedics, Inc., except in Israel, where it is owned by Bio-Technology General (Israel) Ltd., Savient's wholly owned subsidiary; Mircette is a registered trademark of Organon, Inc.; Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.; Silkis is a registered trademark of Galderma S.A.

This news release 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 this report regarding the Company's strategy, expected future financial position, results of operations, cash flows, financing plans, discovery and development of products, strategic alliances, competitive position, plans and objectives of management are forward-looking statements. 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, the statements regarding the Company's new strategic direction and its potential effects on the Company's business are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company's business and the biopharmaceutical and specialty pharmaceutical industries in which the Company operates. Such risks and uncertainties include, but are not limited to, delay or failure in developing Prosaptide, Puricase and other product candidates; difficulties of expanding the Company's product portfolio through in-licensing; disruption of management and costs associated with the divestiture of the Company's operations in Israel; introduction of generic competition for Oxandrin; fluctuations in buying patterns of wholesalers; potential future returns of Oxandrin or other products; 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 the Company's products; economic, political and other risks associated with foreign operations; risks of maintaining protection for the Company's intellectual property; risks of an adverse determination in on-going or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. The Company's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that the Company may make. The Company does not assume any obligation to update any forward-looking statements.