831547--3/14/2008--SPECTRUM_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{product, market, service}

{regulation, government, change}

{stock, price, operating}

{provision, law, control}

{control, financial, internal}

{personnel, key, retain}

{cost, regulation, environmental}

{cost, operation, labor}

{operation, international, foreign}

If we are unable to establish sales and marketing capabilities, we may be unable to successfully commercialize LEVOleucovorin. We may need a third party to assist us with the marketing of LEVOleucovorin. If required, and we are not able to secure a favorable arrangement with a third party, our business and financial condition could be harmed, including the successful commercialization of LEVOleucovorin. We are dependent on a third party to market, sell and distribute our generic product sumatriptan injection and they may not be successful in doing so. The development of our drug product, ozarelix, may be adversely affected if the development efforts of Aeterna Zentaris who retained certain rights to the product, are not successful. The development of our drug product, satraplatin, depends on the efforts of a third party and, therefore, its eventual success or commercial viability is largely beyond our control. The inability to retain and attract key personnel could significantly hinder our growth strategy and might cause our business to fail. As we evolve from a company primarily involved in development to a company also involved in commercialization, we may encounter difficulties in managing our growth and expanding our operations successfully. Our collaborations with outside scientists may be subject to change, which could limit our access to their expertise. We may rely on contract research organizations and other third parties to conduct clinical trials and, in such cases, we are unable to directly control the timing, conduct and expense of our clinical trials. We are subject to risks associated with doing business internationally. We may have conflicts with our partners that could delay or prevent the development or commercialization of our drug products. Our efforts to acquire or in-license and develop additional drug products may fail, which might limit our ability to grow our business. From time to time we may need to license patents, intellectual property and proprietary technologies from third parties, which may be difficult or expensive to obtain. We are a small company relative to our principal competitors, and our limited financial resources may limit our ability to develop and market our drug products. Our supply of drug products will be dependent upon the production capabilities of contract manufacturing organizations, or CMOs, and component and packaging supply sources, and, if such CMOs are not able to meet our demands, we may be limited in our ability to meet demand for our products, ensure regulatory compliance or maximize profit on the sale of our products. We may not be successful in establishing additional active pharmaceutical ingredient or finished dose drug supply relationships, which would limit our ability to develop and market our drug products. Our drug products may not be more effective, safer or more cost-efficient than a competing drug and otherwise may not have any competitive advantage, which could hinder our ability to successfully commercialize our drug products. Our drug product LEVOleucovorin may not be more cost efficient than competing drugs and otherwise may not have any competitive advantage, which could hinder our ability to successfully commercialize it. The marketing and sale of our drug product LEVOleucovorin, may be adversely affected by the marketing and sales efforts of third parties who sell LEVOleucovorin outside North America. The size of the market for our potential products is uncertain. Intense competition from a large number of generic companies may make the marketing and sale of our sumatriptan injection product and any of our other generic drugs not commercially feasible and not profitable. Risks Related to Our Industry If third-party payors do not adequately reimburse providers for any of our product candidates, if approved for marketing, we may not be successful in selling them. Rapid bio-technological advancement may render our drug products obsolete before we are able to recover expenses incurred in connection with their development. As a result, our drug products may never become profitable. Competition for patients in conducting clinical trials may prevent or delay product development and strain our limited financial resources. We may not be successful in obtaining regulatory approval to market and sell our drug products. Failure to obtain regulatory approval outside the United States will prevent us from marketing our product candidates abroad. Even after we receive regulatory approval to market our drug products, the market may not be receptive to our drug products upon their commercial introduction, which would negatively affect our ability to achieve profitability. Our failure to comply with governmental regulations may delay or prevent approval of our drug products and/or subject us to penalties. The discovery of previously unknown problems with drug products approved to go to market may raise costs or prevent us from marketing such product. Our failure to comply with advertising regulations enforced by the FDA and the Federal Trade Commission may subject us to sanctions, damage our reputation and adversely affect our business condition. Legislative or regulatory reform of the healthcare system and pharmaceutical industry may hurt our ability to sell our products profitably or at all. If we market products in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties. If we are unable to adequately protect our technology or enforce our patent rights, our business could suffer. Intellectual property rights are complex and uncertain and therefore may subject us to infringement claims. Intellectual property litigation is increasingly common and increasingly expensive and may result in restrictions on our business and substantial costs, even if we prevail. We may be subject to damages resulting from claims that we, or our employees, have wrongfully used or disclosed alleged trade secrets of our employees former employers. We may be subject to product liability claims, and may not have sufficient product liability insurance to cover any such claims, which may expose us to substantial liabilities. The use of hazardous materials in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials. Risks Related to Our Stock There are a substantial number of shares of our common stock eligible for future sale in the public market. The sale of these shares could cause the market price of our common stock to fall. Any future equity issuances by us may have dilutive and other effects on our existing stockholders. The market price and volume of our common stock fluctuate significantly and could result in substantial losses for individual investors. Provisions of our charter, bylaws and stockholder rights plan may make it more difficult for someone to acquire control of us or replace current management even if doing so would benefit our stockholders, which may lower the price an acquirer or investor would pay for our stock.

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831547--3/14/2008--SPECTRUM_PHARMACEUTICALS_INC