911326--3/13/2009--TRIMERIS_INC

related topics
{product, candidate, development}
{property, intellectual, protect}
{product, liability, claim}
{control, financial, internal}
{gas, price, oil}
{product, market, service}
{interest, director, officer}
{acquisition, growth, future}
{stock, price, operating}
{stock, price, share}
{regulation, government, change}
We face intense competition in our efforts to increase sales of FUZEON as a commercially successful drug. If we are unable to compete successfully, our business will suffer. If FUZEON does not maintain or increase its market acceptance, our business will be materially harmed. We do not control the manufacturing and production schedule at Roche s Boulder facility where FUZEON is manufactured and we cannot ensure that significant costs associated with scheduling decisions will not be incurred. We have been named as defendants in a lawsuit in which Novartis Vaccines and Diagnostics, Inc. has alleged infringement of a patent in connection with the manufacture and sale of FUZEON. If we cannot resolve this lawsuit on favorable terms and at a reasonable expense, our business may be materially harmed. In order to remain profitable we will need to maintain arrangements with third parties for the sale, marketing and distribution of FUZEON or expend significant resources to develop these capabilities. If sufficient amounts of FUZEON, cannot be manufactured on a cost-effective basis, our financial condition and results of operations will be materially and adversely affected. HIV is likely to develop resistance to FUZEON and our future drug candidate, which could adversely affect demand for FUZEON or our drug candidate TRI-1144 and harm our competitive position. Our business is based on a novel technology called fusion inhibition, and unexpected side effects or other characteristics of this technology may delay or otherwise adversely affect the development, regulatory approval and/or commercialization of our drug candidate TRI-1144. In order to move forward with the development and commercialization of TRI-1144 we would need to partner with a company that has the requisite expertise and capabilities related to the development, sale, marketing and distribution of drugs. If we cannot maintain commercial manufacturing arrangements with third parties on acceptable terms, or if these third parties do not perform as agreed, the commercial development of FUZEON or our drug candidate TRI-1144 could be delayed or otherwise materially and adversely affected. If Roche or our manufacturing partners do not maintain good manufacturing practices, it could negatively impact our ability to obtain regulatory approvals and commercialize our drug candidate. We depend on patents and proprietary rights, which may offer only limited exclusive protection and do not protect against infringement. If we are unable to protect our patents and proprietary rights, our assets and business could be materially harmed. The intellectual property of our competitors or other third parties may prevent us from developing or commercializing our drug candidate TRI-1144. Uncertainties relating to third-party reimbursement and health care reform measures could limit the amount we will be able to charge for our drugs and adversely affect our results of operations. If the testing or use of FUZEON or our drug candidate TRI-1144 harms people, we could face costly and damaging product liability claims far in excess of our liability and indemnification coverage. Our quarterly operating results are subject to fluctuations. If our operating results for a particular period deviate from the levels expected by securities analysts and investors, it could adversely affect the market price of our common stock. If we are unable to meet or maintain the standards for maintaining internal control over financial reporting as required by the Sarbanes-Oxley Act of 2002, our stock price could be materially harmed. We rely on our collaborative partner Roche to timely deliver important financial information relating to FUZEON sales and expenses. In the event that this information is inaccurate, incomplete or not timely we will not be able to meet our financial reporting obligations as required by the SEC. Our charter requires us to indemnify our officers and directors to the fullest extent permitted by law, which obligates us to make substantial payments and to incur significant insurance-related expenses. Any additional financing we obtain may result in dilution to our stockholders, restrictions on our operating flexibility or the transfer of particular rights to technologies or drug candidates. The Nasdaq Global Market may delist our securities, which could limit investors ability to trade in our securities.

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