Savient Pharmaceuticals, Inc. Submits New Drug Application for Soltamo

    Pharmaceutical Writers/Business Editors

    EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Jan. 6, 2005--Savient Pharmaceuticals, Inc. (NASDAQ: SVNT), an emerging specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address unmet medical needs is pleased to announce the submission of a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") of Soltamox(R) (tamoxifen oral liquid solution) for the treatment of hormonally sensitive breast cancer. Soltamox is the product of Savient's wholly-owned subsidiary, Rosemont Pharmaceuticals Ltd. located in Leeds, U.K.
    Soltamox was filed with the FDA on December 23, 2004. It represents the first potential product entry into the U.S. from Savient's U.K. subsidiary. Soltamox is currently sold in the U.K. and will be marketed in Germany under a recently announced collaboration with O.R.C.H.A.PHARM GmbH. Rosemont Pharmaceuticals recently completed a series of modifications to its U.K.-based liquids manufacturing facility to meet the U.S. FDA's Current Good Manufacturing Practices (cGMP).
    "The U.S. filing of Soltamox is a significant milestone for Savient as we look to expand the geographic reach of our oral liquids pharmaceutical business model," said Christopher Clement, Savient's CEO and President. "Following FDA review of our manufacturing facility, we will look to move forward with additional oral liquid filings in 2005 and beyond. We will also seek to form a broad strategic alliance for marketing and distribution of those products in the United States."
    Tamoxifen is a cytostatic oestrogen receptor antagonist used extensively for the treatment of hormonally sensitive breast cancer. Soltamox is the only oral liquid presentation licensed in the U.K. Rosemont holds a worldwide patent covering this product.

    About Rosemont Pharmaceuticals

    Rosemont Pharmaceuticals is the leading developer, manufacturer and marketer of high quality oral liquid medicines in the UK. Rosemont's products are effectively marketed by a very highly trained and focused sales force comprised primarily of nursing specialists.
    With over 90 oral liquid formulations, Rosemont is the U.K. Specialists in Oral Liquid Medicines, supplying both licensed and special (named patient basis) products covering a broad range of therapeutic areas, including cardiovascular, CNS, anti-infectives and oncology.

    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). Savient'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. Savient's Israeli subsidiary, Bio-Technology General (Israel) Ltd., manufactures and markets in Israel Bio-Tropin(TM) (recombinant human growth hormone), BioLon(R) (sodium hyaluronate for ophthalmic surgery), 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 Savient'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 Savient's expected timing of revenues and results of operations 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. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about Savient's business and the biopharmaceutical and specialty pharmaceutical industries in which Savient 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 Savient's product portfolio through in-licensing; disruption of management and costs associated with the divestiture of Savient'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 Savient's products; economic, political and other risks associated with foreign operations; risks of maintaining protection for Savient's intellectual property; risks of an adverse determination in on-going or future intellectual property or other litigation; and risks associated with stringent government regulation of the biopharmaceutical and specialty pharmaceutical industries. Savient may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on Savient's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Savient makes. Savient's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that Savient may make. Savient does not assume any obligation to update any forward-looking statements.

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CONTACT: Wolfe Axelrod Weinberger Associates: Don Weinberger, 212-370-4500 or Savient Pharmaceuticals, Inc.: Jenene Thomas, 732-565-4716

KEYWORD: NEW JERSEY INDUSTRY KEYWORD: PHARMACEUTICAL PRODUCT SOURCE: Savient Pharmaceuticals, Inc.

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