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Savient Pharmaceuticals, Inc. Provides Update on Its Process for the Potential Divestiture of Its Israeli Operations and Subsidiary.


EAST BRUNSWICK, N.J. -- Company to Focus Resources on Advancing Clinical Development of Its Two Phase II Products, Prosaptide and Puricase; Seeks to Enhance Clinical Pipeline

Savient Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SVNT) today announced that its management, together with its advisors, UBS UBS Union Bank of Switzerland
UBS United Bible Societies
UBS United Blood Services
UBS United Buying Service
UBS Used Bookstore
UBS University Business Services
UBS Universal Building Society (UK)
UBS Ulaanbaatar Broadcasting System
 Investment Bank, is proceeding with the process for exploring a potential divestiture of its Israeli business operations including its subsidiary, Bio-Technology General (Israel) Ltd. Early in the fourth quarter of 2004, a confidential information memorandum is expected to be made available to prospective acquirers. If a satisfactory offer is received and approved by the Company's board of directors, management expects that, subject to the receipt of required regulatory approvals, the transaction could complete in the first half of 2005.

The potential divestiture is expected to include existing biopharmaceutical product licensing arrangements outside of Israel such as the human growth hormone human growth hormone (HGH): see growth hormone. , Tev-Tropin(TM), licensed in the United States to Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in , Ltd. The potential divestiture would also include products currently manufactured in Israel such as the sodium hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee.  (HA) based product out-licensing candidates Nuflexxa(TM) (pending final FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval) in the United States, Euflexxa(TM) in Europe and BioLon(TM) in the United States.

"We are very pleased to be moving forward with the execution of our previously announced plans to reposition the Company to focus on the development of our product pipeline. A successful divestment of our Israeli business would streamline our operations and provide the financial resources to advance our two primary drug candidates currently in Phase II clinical development," said Christopher Clement, President and Chief Executive Officer of Savient. He continued, "Ultimately, we believe these actions will increase the likelihood that the full value of our assets will be realized by our shareholders."

The Company is conducting a Phase II multi-center dose-ranging safety and efficacy study of repeated intravenous administration of Puricase(R), assessing uric acid uric acid (yr`ĭk), white, odorless, tasteless crystalline substance formed as a result of purine degradation in man, other primates, dalmatians, birds, snakes, and lizards.  levels in patients with severe refractory gout gout, condition that manifests itself as recurrent attacks of acute arthritis, which may become chronic and deforming. It results from deposits of uric acid crystals in connective tissue or joints. . Today, there is no FDA-approved therapy for these patients. The Company's goal is to complete the study this year and, if successful, enter Phase III trials in 2005.

The Company is also conducting a Phase II clinical safety and dose-ranging study of Prosaptide in the treatment of neuropathic pain associated with HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome . The Company's goal is to complete this study by the third quarter of next year.

In July, the Company conducted a Scientific Advisory Panel review of its monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  technology (referred to as BTG-271) to consider progress and the possibilities for its development in several potential indications. The Company will complete pre-clinical experiments in two indications leading to a decision to proceed or terminate development of the technology by year-end.

The Company is also stepping up efforts to in-license and develop novel compounds in early- to mid-stage clinical development.

The Company continues to market Oxandrin(R) for involuntary weight loss in the United States. In addition, the Company's U.K. subsidiary, Rosemont Pharmaceuticals Limited, continues to develop, manufacture and market oral liquid pharmaceuticals primarily in the United Kingdom. However, modification of the Rosemont facility is under way with a view toward attaining U.S. FDA approval and the introduction of Rosemont's oral liquid products in the United States. The Company plans to submit its first FDA filing of an oral liquid product, Soltamox(TM) (oral liquid tamoxifen tamoxifen (təmŏk`sĭfĕn'), synthetic hormone used in the treatment of breast cancer. Introduced in 1978, tamoxifen is used to prevent recurrences of cancer in women who have already undergone surgery to remove their tumors. ), later this year. The Company is also seeking a marketing partner for Soltamox in Germany where it has already received regulatory approval.

Several developments anticipated in the near-term related to Savient's human growth hormone and sodium hyaluronate products are expected to enhance the value of the Company's assets to be included in the confidential information memorandum. The Company is proceeding with its plans to bring its FDA approved recombinant human growth hormone to market in the United States late in the fourth quarter of this year. The product is licensed to and will be marketed by Teva under the trade name Tev-Tropin(TM). The U.S. pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 market for recombinant human growth hormones is approximately $500 million and currently growing at an annual rate of 12%.

The Company is also seeking marketing partners for its sodium hyaluronate (HA) injectable, Nuflexxa(TM) (U.S. - approvable, pending final FDA approval) or Euflexxa(TM) (Europe - approved), for the treatment of pain associated with osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
 of the knee. The U.S. market alone for this indication is about $350 million and growing at a double-digit rate.

In addition, the Company is seeking a new marketing partner in the United States for BioLon(TM), its HA-based, high-viscosity gel used in ophthalmic surgery procedures such as cataract removal and intraocular lens Intraocular lens
Lens made of silicone or plastic placed within the eye; can be corrective.

Mentioned in: Cataract Surgery
 implantation. The global market for this niche product is about $130 million with only minimal growth expected.

Mr. Clement continued, "We are acting upon our stated plan by taking the steps to best position the Company to focus on its development pipeline, build a new senior management team, eliminate non-strategic spending and redirect our resources to the areas of highest potential return. As progress is made on each of these fronts, we will keep our stakeholders advised."

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 USP - unique sales point ) and Delatestryl(R) (testosterone enanthate testosterone enanthate Warning - Hazardous drug!

Delatestryl

Pharmacologic class: Hormone

Therapeutic class: Androgenic and anabolic steroid, antineoplastic

). 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 hepatitis B vaccine
n. Abbr. HB
A vaccine prepared from the inactivated surface antigen of the hepatitis B virus and used to immunize against hepatitis B.
), and Arthrease(TM) (sodium hyaluronate for osteoarthritis). Products marketed by Savient's licensees are Mircette(R) (oral contraceptive oral contraceptive
n.
A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill.
), and BioLon(R) in the United States, and Bio-Tropin(TM), BioLon(R), Bio-Hep-B(R), Silkis(R) (vitamin D vitamin D

Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin.
 derivative), and recombinant human insulin Noun 1. recombinant human insulin - a form of insulin (trade name Humulin) made from recombinant DNA that is identical to human insulin; used to treat diabetics who are allergic to preparations made from beef or pork insulin
Humulin
, 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 Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
; Mircette is a registered trademark of Organon or·ga·non or or·ga·num
n. pl. or·ga·nons or or·ga·nums or or·ga·na
1. An organ.

2. A set of principles for use in scientific investigation.



organon

pl. organa [Gr.] organ.
, 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 23, 2004
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