722104--3/2/2009--SAVIENT_PHARMACEUTICALS

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Risks Relating to Development of K and Our Ability to Accomplish Our Future Business Objectives Our business depends on our success in completing development of and commercializing K . If we are unable to commercialize K , or experience significant delays in doing so, our business will be materially harmed. Unless we are successful in consummating a significant collaboration to commercialize K or a broader strategic transaction, we expect that we will need to raise substantial additional capital to develop and commercialize K uch financing may only be available on terms unacceptable to us, or not at all. If we are unable to obtain financing on favorable terms, our business, results of operations and financial condition may be materially adversely affected. We may not be able to commercialize K if our clinical trials do not demonstrate safety or efficacy, or if we are required to conduct additional clinical trials. One of the elements of the FDA approval process of K is our ability to successfully defend our BLA before a meeting of the FDA Arthritis Advisory Committee, which we expect to occur in mid-2009. If we do not receive a favorable vote of the Arthritis Advisory Committee, this could place in jeopardy, or delay, the FDA s ultimate approval for marketing of K Even if the FDA approves the sale of K , it may only be approved for indications that are not as broad as we intend, and the FDA may require us to conduct supplemental post-marketing clinical trials. In addition, we may elect to perform additional clinical trials for other indications or in support of applications for regulatory marketing approval in jurisdictions outside the United States. These supplemental trials could be costly and could result in findings inconsistent with or contrary to our historic United States clinical trials. We have limited marketing and sales capabilities. If we are unable to expand our sales and marketing capabilities or enter into sales and marketing agreements with third parties, we may be unable to generate product sales revenue from sales to customers. The commercial success of K will depend upon the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community. Our business may be harmed if we do not adequately predict the market size or customer demand for K We face substantial competition, and our competitors may develop or commercialize alternative technologies or products more successfully than we do. If we fail to attract and retain senior management and other key personnel, we may not be able to successfully develop or commercialize K , particularly in light of the recent resignation of our president and chief executive officer and the termination of our chief financial officer. The manufacture and packaging of pharmaceutical products such as K are subject to the requirements of the FDA and similar foreign regulatory bodies. If we or our third-party manufacturers fail to satisfy these requirements, our product development and commercialization efforts may be materially harmed. If it is approved for sale, K could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with the product. If we are unable to obtain adequate reimbursement from third-party payors, or acceptable prices, for K , our revenues and prospects for profitability will suffer. Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products abroad. Foreign governments tend to impose strict price controls, which may adversely affect our revenues. Product liability lawsuits could cause us to incur substantial liabilities. Risks Relating to Our Reliance on Third Parties We have no manufacturing capabilities and limited manufacturing personnel. We depend on third parties to manufacture K . If these manufacturers fail to meet our requirements at acceptable quality levels and at acceptable cost, and if we are unable to identify suitable replacements, our product development and commercialization efforts may be materially harmed. If the company on which we plan to rely for fill and finish services for K is unable to perform these services for us, our business may suffer. We rely on third parties to conduct our clinical development activities for K and those third parties may not perform satisfactorily. We are seeking a partner for the further development and commercialization of K , and we expect to continue to depend on collaborations with third parties. If we are not successful in these efforts, we may fail to meet our business objectives. Risks Relating to Intellectual Property If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business. If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, the value of our technology and products will be adversely affected. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. If we infringe or are alleged to infringe intellectual property rights of third parties, our business may be adversely affected. In the future we may be involved in costly legal proceedings to enforce or protect our intellectual property rights or to defend against claims that we infringe the intellectual property rights of others. Risks Relating to Our Results of Operations and Your Investment in Our Common Stock We may not be able to achieve profitability. We have incurred operating losses from continuing operations since 2004 and anticipate that we will incur operating losses from continuing operations for the foreseeable future, particularly as a result of increasing expenses related to our development and, if our BLA is approved by the FDA commercialization of K We expect sales of Oxandrin and oxandrolone to continue to decrease. Our stock price is volatile, which could adversely affect your investment. We expect our quarterly results to fluctuate, which may cause volatility in our stock price. Effecting a change of control of our company could be difficult, which may discourage offers for shares of our common stock. We are a party to a shareholder lawsuit regarding the adequacy of our public disclosure, which could have a material adverse affect on our business, results of operations and financial condition.

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722104--3/2/2009--SAVIENT_PHARMACEUTICALS_INC