Savient and FDA Agree on Phase 3 Protocol SPA; Puricase(R) (PEG-uricase) on Track to Enter Phase 3

Savient Pharmaceuticals Inc. (NASDAQ: SVNT), an emergingspecialty pharmaceuticals company focused on developing, manufacturingand marketing novel therapeutic products for unmet medical needs,announced today that the Company has received written response fromthe U.S. Food and Drug Administration (FDA) that the Agency is inagreement with the Company's proposed Phase 3 protocol(s), submittedas a Special Protocol Assessment (SPA) for its lead drug candidatePuricase (PEG-uricase). The Company plans to implement the protocolsin support of a marketing application for the orphan drug indicationof the control of hyperuricemia in patients with symptomatic gout inwhom conventional therapy is contraindicated or has been ineffective.The Company has scheduled the Phase 3 Investigators meeting for March31 - April 2, 2006, with patient recruitment expected to be completedtoward the end of 2006 or early 2007. An NDA filing with the FDA isanticipated in late 2007.

The FDA asked for minor changes in the proposed statisticalanalysis of the secondary efficacy endpoints, and then re-submissionof the Special Protocol Assessment for final approval prior toenrollment of patients in the clinical program. Savient believes ithas complied with FDA requests and has filed its SPA re-submission onMarch 17. These steps are part of the formal process delineated in FDAregulations (Guidance for Industry: Special Protocol Assessment) andwill mean that patient dosing could start in May.

Christopher G. Clement, President and Chief Executive Officer ofSavient commented, "The written FDA response is a key development forSavient and means that we are on track with our stated strategy toachieve a NDA submission by late 2007. As previously announced, theCompany is devoting its efforts and resources towards the clinicaldevelopment program and commercialization for Puricase (PEG-uricase).We are excited about the prospect of beginning our Phase 3 trials andadvancing this drug toward registration for the orphan gout populationthat today has no safe and effective therapy. If we are able todemonstrate adequate safety and efficacy in the initial, we believe wewill be able to explore other gout-related indications, and todetermine whether Puricase has the potential to be a disease modifyingtherapy for patients who suffer from gout."

The Phase 3 program is designed to compare the safety and efficacyof Puricase (PEG-uricase) administered by two-hour intravenousinfusion every two weeks or every four weeks versus placebo infusion,over a six month period. The program design consists of two replicatesix-month placebo-controlled trials of approximately 100 randomizedpatients each. All patients who complete the placebo controlled trialswill be invited to participate in a long-term open label extension,which the FDA suggested to continue for two years. Therefore, patientswho are randomized to the placebo arms will be eligible to receivePuricase (PEG-uricase) treatment in an open label extension trialfollowing completion of the six-month controlled registration trial.

Each of the two trials is independently powered for the primaryefficacy (or key registration) endpoint, a responder analysisassessing the proportion of patients who have normalized plasma uricacid at month 3 and month 6. Secondary efficacy endpoints will beassessed in a population pooled from the two trials. These endpointswill include an assessment of the reduction in burden of gout tophiusing digital photography, reduction in the frequency of gout flares,improvement in the count of swollen and tender joints, andimprovements in patient reported outcomes using the Short Form 36(SF-36) and the Health Assessment Questionnaire-Disability Index(HAQ-DI).

Zeb Horowitz, MD, Chief Medical Officer said, "The SPA process hasafforded Savient the opportunity to interact extensively with thereviewing Division of the FDA. We believe this process has beeninvaluable and may facilitate the FDA review of our Phase 3 data afterwe submit our NDA. The FDA response to our SPA submission is oftremendous importance to Savient, as it indicates agreement with theFDA on the key safety and efficacy endpoints, methodologies, and thestatistical analysis plan in this innovative clinical program whichexplores new territory for the treatment of gout patients. Thenormalization of plasma uric acid remains the key registrationendpoint, as it has been for all other drugs indicated to treat gout.However, the Savient program will also determine the effect ofPuricase (PEG-uricase) on clinical outcomes of vital importance tosymptomatic gout patients, not successfully achieved in any other goutdrug development program. Since the Savient study population is onefor which conventional therapy has already failed or iscontraindicated, the potential benefit of Puricase treatment for thesepatients is uniquely important. We look forward with enthusiasm toimplementation of the Phase 3 clinical program in the near future,with patient recruitment pending finalization of the formal SPAprocess."

Savient licensed exclusive, worldwide rights to the technologiesrelated to Puricase (PEG-uricase) from Duke University ("Duke") ofNorth Carolina and Mountain View Pharmaceuticals, Inc. ("MVP"), aCalifornia corporation. Duke developed the recombinant porcine uricaseenzyme and MVP developed the PEGylation technology. MVP and Duke weregranted U.S. and foreign patents covering the licensed technology.Puricase is a registered trademark of Mountain View Pharmaceuticals,Inc.

ABOUT SAVIENT

Based in East Brunswick, New Jersey, Savient Pharmaceuticals,Inc., is an emerging specialty pharmaceuticals company and is engagedin developing, manufacturing and marketing pharmaceutical productsthat address unmet medical needs in both niche and broader markets.The Company's lead product development candidate, Puricase(R)(PEG-uricase), for the treatment of refractory gout has reportedpositive Phase 1 and 2 clinical data. Savient's experienced managementteam is committed to advancing its pipeline and expanding its productportfolio by in-licensing late stage compounds and exploringco-promotion and co-development opportunities that fit the Company'sexpertise in specialty pharmaceuticals and initial focus inrheumatology. Savient markets its product Oxandrin(R) (oxandrolone,USP) in the United States. The Company's subsidiary, RosemontPharmaceuticals Ltd., develops, manufactures, and markets through itsown sales force oral liquid formulations of prescription products forthe UK pharmaceutical market. Rosemont's product portfolio includesover 100 liquid formulations primarily targeting the geriatricpopulation. Puricase is a registered trademark of Mountain ViewPharmaceuticals, Inc. Further information on the Company can beaccessed by visiting: www.savientpharma.com

FORWARD LOOKING LANGUAGE

This news release contains forward-looking statements within themeaning of Section 21E of the Securities Exchange Act of 1934. Allstatements, other than statements of historical facts, included inthis report regarding the Company's strategy, expected futurefinancial position, results of operations, cash flows, financingplans, discovery and development of products, strategic alliances,competitive position, plans and objectives of management areforward-looking statements. Words such as "anticipate," "believe,""estimate," "expect," "intend," "plan," "will" and other similarexpressions help identify forward-looking statements, although not allforward-looking statements contain these identifying words. Inparticular, the statements regarding the clinical development ofPuricase (PEG-uricase), commencement of the Phase 3 clinical trial forPuricase (PEG-uricase), time for completion of patient recruitment andtiming for the filing of an NDA for Puricase (PEG-uricase) areforward-looking statements. These forward-looking statements involvesubstantial risks and uncertainties and are based on currentexpectations, assumptions, estimates and projections about theCompany's business and the biopharmaceutical and specialtypharmaceutical industries in which the Company operates. Such risksand uncertainties include, but are not limited to, the Company'sability to find a buyer for Rosemont Pharmaceuticals and to negotiateand consummate a sale of Rosemont at an attractive price; delay orfailure in developing Puricase and other product candidates;difficulties of expanding the Company's product portfolio throughin-licensing; introduction of generic competition for Oxandrin;fluctuations in buying patterns of wholesalers; potential futurereturns of Oxandrin or other products; the Company's continuing toincur substantial net losses for the foreseeable future; difficultiesin obtaining financing; potential development of alternativetechnologies or more effective products by competitors; reliance onthird-parties to manufacture, market and distribute many of theCompany's products; economic, political and other risks associatedwith foreign operations; risks of maintaining protection for theCompany's intellectual property; risks of an adverse determination inon-going or future intellectual property litigation; and risksassociated with stringent government regulation of thebiopharmaceutical and specialty pharmaceutical industries. The Companymay not actually achieve the plans, intentions or expectationsdisclosed in its forward-looking statements, and you should not placeundue reliance on the Company's forward-looking statements. Actualresults or events could differ materially from the plans, intentionsand expectations disclosed in the forward-looking statements that theCompany makes. The Company's forward-looking statements do not reflectthe 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 anyforward-looking statements.