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Soltamox

Generic name: tamoxifen
Treatment for: Breast Cancer

Savient Pharmaceuticals, Inc. Submits New Drug Application for Soltamox to the U.S. Food and Drug Administration

EAST BRUNSWICK, N.J., January 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 (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 (oxandrolone, USP) and Delatestryl (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 (recombinant human growth hormone), BioLon (sodium hyaluronate for ophthalmic surgery), Bio-Hep-B (hepatitis B vaccine), and Arthrease (sodium hyaluronate for osteoarthritis). Products marketed by Savient's licensees are Mircette (oral contraceptive), and BioLon in the United States, and Bio-Tropin, BioLon, Bio-Hep-B, Silkis (vitamin D derivative), and recombinant human insulin, in international markets.

Posted: January 2005

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Soltamox (tamoxifen) FDA Approval History

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