Savient Pharmaceuticals, Inc. Receives FDA Approval To Market Soltamox(R); The First Oral Liquid Tamoxifen In U.S.; U.K.-Based Liquids Manufacturing Facility Meets The FDA's Current Good Manufacturing Practices

EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Oct. 31, 2005--Savient Pharmaceuticals, Inc. (NASDAQ: SVNTE), an emerging specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Soltamox(TM) (tamoxifen oral solution) for the treatment of breast cancer in adjuvant and metastatic settings and to reduce risks of breast cancer in women with ductal carcinoma in situ (DCIS) and reduction of breast cancer incidence in women with high risk of breast cancer. Soltamox is the product of Savient's wholly-owned subsidiary, Rosemont Pharmaceuticals Ltd. located in Leeds, U.K.

Soltamox represents the first oral liquid product entry into the U.S. from Savient's wholly-owned U.K. subsidiary and it will be the first oral solution of tamoxifen available in the United States. Soltamox is currently sold in the U.K., Ireland and Germany.

The Company is currently in discussions with potential partners to form an alliance to market Soltamox in the United States and expects to conclude negotiations early in 2006.

Christopher Clement, Savient's President and Chief Executive Officers, said, "The approval of Soltamox marks a significant milestone for Savient and represents a major step in the advancement of our strategic plan to position the Company as an emerging pharmaceutical company. Soltamox is the first of Rosemont's products to be introduced into the United States as we seek to expand the geographic reach of our oral liquids pharmaceutical business. This approval follows the FDA review of our U.K. manufacturing facility and establishes the regulatory pathway for additional Rosemont products to follow into the U.S. market as we continue to enhance the value of this asset."

Tamoxifen is a cytostatic estrogen receptor antagonist used extensively for the treatment and prevention of breast cancer. Soltamox is the only oral liquid presentation licensed in the U.K., Ireland, Germany and now in the U.S. Rosemont Pharmaceuticals, Ltd. holds a global portfolio of patents covering this product.

Important safety information for Soltamox

Use of Soltamox in risk reduction setting (women at high risk for cancer and women with DCIS) has shown to cause cancer of the uterus, stroke, and blood clots. The benefits of Soltamox outweigh its risks in women already diagnosed with breast cancer. Soltamox should not be used in women who require concomitant use of coumarin-type anticoagulant, or in women with history of deep vein thrombosis or pulmonary embolus. Women who are pregnant or plan to become pregnant should not take Soltamox. Cataracts and cataract surgery can also occur more frequently with Soltamox. The most frequently reported adverse reactions with Soltamox were hot flashes and vaginal discharge.

About Savient Pharmaceuticals, Inc.

Based in East Brunswick, New Jersey, Savient Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to developing, manufacturing and marketing novel therapeutic products that address unmet medical needs. The Company's lead product development candidate, Puricase(R), for the treatment of refractory gout has reported positive Phase 1 and 2 clinical data. 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 initial focus in rheumatology. The Company's operations also include a wholly-owned U.K. subsidiary, Rosemont Pharmaceuticals Ltd., which develops, manufactures and markets liquid formulations of prescription pharmaceutical products. Rosemont's product portfolio includes over 90 liquid formulations primarily targeting the geriatric population. Further information on the Company can be accessed by visiting www.savientpharma.com.

Safe Harbor Statement

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, 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, statements as the timing of the completion of a potential partnering alliance in the U.S. and the launch of Soltamox 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, delisting of the Company's common stock from The Nasdaq Stock Market, delay or failure in developing Prosaptide(TM), Puricase(R) and other product candidates; difficulties of expanding the Company's product portfolio through in-licensing; introduction of generic competition for Oxandrin(R); fluctuations in buying patterns of wholesalers; potential future returns of Oxandrin or other products; 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 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.

Contacts

Savient Pharmaceuticals, Inc. Jenene Thomas, 732-565-4716 jdthomas@savientpharma.com

or

Investors: The Ruth Group Francesca DeMartino, 646-536-7024 fdemartino@theruthgroup.com

or

Media: The Ruth Group Janine McCargo, 646-536-7033 jmccargo@theruthgroup.com

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