722104--3/14/2008--SAVIENT_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{property, intellectual, protect}
{product, liability, claim}
{stock, price, operating}
{acquisition, growth, future}
{regulation, government, change}
{financial, litigation, operation}
{provision, law, control}
{control, financial, internal}
{personnel, key, retain}
{product, market, service}
{stock, price, share}
{regulation, change, law}
Pegloticase, and any other product candidate that we may develop in the future, must satisfy rigorous standards of safety and efficacy before it can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy clinical trials and extensive manufacturing quality assessments to obtain regulatory approval. We may not be successful in establishing strategic alliances, which could adversely affect the implementation of our strategic business plan. Our strategic business plan includes a licensing initiative to collaborate with a partner for the development and commercialization of pegloticase outside the United States and Canada. If we are not successful in our efforts to partner pegloticase, then the full potential of pegloticase may not be realized. If we do not successfully recruit and train qualified sales and marketing personnel and build a marketing and sales infrastructure, our ability to independently launch and market pegloticase will be impaired. We will be required to incur significant costs and devote significant efforts to establish a direct sales force. Our strategic business plan includes an initiative to in-license or partner other novel compounds to build our development portfolio. We may not be successful in our efforts to expand our product portfolio in this manner. The full development and commercialization of pegloticase and execution of our strategic business plan will require substantial capital, and we may be unable to obtain such capital. If we are unable to obtain additional financing, our business, results of operations and financial condition may be adversely affected. We incurred an operating loss from continuing operations for the year ended December 31, 2007 and anticipate that we may incur operating losses from continuing operations for the foreseeable future, particularly as a result of decreasing Oxandrin sales, which in the past accounted for a significant portion of our revenues. If we are unable to obtain regulatory approval for or commercialize pegloticase or any other product candidates we may pursue, we may never achieve operating profitability. If third parties on which we rely for distribution of our generic version of oxandrolone do not perform as contractually required or as we expect, our results of operations may be harmed. We rely on third parties to conduct our clinical development activities for pegloticase and those third parties may not perform satisfactorily. Manufacturing our products requires us to meet stringent quality control and quality assurance standards. In addition, we depend on third parties to manufacture pegloticase and intend to rely on third parties to manufacture and supply any future products. If these third-party manufacturers and suppliers, and particularly our sole source supplier for pegloticase, fail to meet applicable regulatory requirements or to supply us for any reason, our revenues and product development efforts may be materially adversely affected. We operate in a highly competitive market. Our competitors may develop alternative technologies or safer or more effective products before we are able to do so. The manufacture and packaging of pharmaceutical products are subject to the requirements of the FDA and similar foreign regulatory bodies. If we or our third-party suppliers fail to satisfy these requirements, our business operations may be materially harmed. Our sales depend on payment and reimbursement from third-party payers and a reduction in the payment or reimbursement rate could result in decreased use or sales of our products. If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop or commercialize our product candidates. We may incur substantial costs related to product liability. The ultimate outcome of pending securities litigation is uncertain. Tax requirements and audits could impact our results of operations. 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. We, our contract manufacturers, suppliers and contract research organizations, are subject to stringent governmental regulation, and our or their failure to comply with applicable regulations could adversely affect our ability to conduct our business. Recently enacted legislation may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute products after approval. Risks Relating to an Investment in Our Common Stock 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.

Full 10-K form ▸

related documents
722104--3/16/2007--SAVIENT_PHARMACEUTICALS_INC
1162192--3/31/2009--AVALON_PHARMACEUTICALS_INC
920947--8/14/2007--NORTHFIELD_LABORATORIES_INC_/DE/
1000694--3/16/2007--NOVAVAX_INC
920947--8/14/2008--NORTHFIELD_LABORATORIES_INC_/DE/
932903--3/16/2007--AVIGEN_INC_\DE
932903--3/17/2008--AVIGEN_INC_\DE
877902--3/8/2006--NEOSE_TECHNOLOGIES_INC
932903--3/16/2009--AVIGEN_INC_\DE
944522--3/23/2009--VION_PHARMACEUTICALS_INC
1029142--3/16/2006--DYNAVAX_TECHNOLOGIES_CORP
1029142--3/16/2007--DYNAVAX_TECHNOLOGIES_CORP
1066833--3/15/2006--DOV_PHARMACEUTICAL_INC
1123979--2/4/2010--SENOMYX_INC
1033025--3/17/2006--PRAECIS_PHARMACEUTICALS_INC
1123979--2/12/2009--SENOMYX_INC
886744--2/28/2008--GERON_CORP
886744--3/16/2007--GERON_CORP
722104--3/28/2006--SAVIENT_PHARMACEUTICALS_INC
730272--6/9/2006--REPLIGEN_CORP
1029142--3/17/2008--DYNAVAX_TECHNOLOGIES_CORP
1273013--3/19/2007--PHARMACOPEIA_DRUG_DISCOVERY_INC
1274563--3/30/2009--HELICOS_BIOSCIENCES_CORP
1123979--2/14/2008--SENOMYX_INC
1099215--7/31/2007--PROTALEX_INC
1274563--3/17/2008--HELICOS_BIOSCIENCES_CORP
729922--2/24/2010--OSI_PHARMACEUTICALS_INC
884731--3/14/2007--ARIAD_PHARMACEUTICALS_INC
819050--3/10/2006--VICAL_INC
1023024--3/30/2010--BIOSANTE_PHARMACEUTICALS_INC