1018710--3/17/2008--INTROGEN_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, operating}

{product, market, service}

{regulation, change, law}

{customer, product, revenue}

{cost, regulation, environmental}

{control, financial, internal}

{personnel, key, retain}

{acquisition, growth, future}

{provision, law, control}

{stock, price, share}

{investment, property, distribution}

Even if our products are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market. Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs could prevent us from selling our products in foreign markets, which may adversely affect our operating results and financial conditions. We have a history of operating losses, expect to incur significant additional operating losses and may never become profitable. If we continue to incur operating losses for a period longer than we anticipate and fail to obtain the capital necessary to fund our operations, we will be unable to advance our development program and complete our clinical trials. If we cannot maintain our existing corporate and academic arrangements and enter into new arrangements, we may be unable to develop products effectively, or at all. If we do not continue to receive grant funding from federal agencies and others we may be unable to continue our research and development programs for certain of our product candidates at current levels or in the manner we have planned for the future. If we are not able to create effective collaborative marketing relationships, we may be unable to market our products successfully or in a cost-effective manner. Serious and unexpected side effects attributable to molecular therapies may result in governmental authorities imposing additional regulatory requirements or a negative public perception of our products. Patient enrollment may be slow and patients may discontinue their participation in clinical studies, which may negatively impact the results of these studies and extend the timeline for completion of our and our collaborators development programs for our product candidates. We cannot predict the safety profile of the use of ADVEXIN therapy when used in combination with other therapies. If we fail to adequately protect our intellectual property rights our competitors may be able to take advantage of our research and development efforts to develop competing drugs. Third party claims of infringement of intellectual property could require us to spend time and money to address the claims and could limit our intellectual property rights. We may be subject to litigation and infringement claims that may be costly, divert management s attention and materially harm our business. If we fail to meet our obligations under license agreements, we may lose our rights to key technologies on which our business depends. Competition and technological change may make our product candidates and technologies less attractive or obsolete. Even if we receive regulatory approval to market our ADVEXIN therapy, INGN 241, INGN 225 or other product candidates, we may not be able to commercialize them profitably. We must achieve significant market share and obtain high per-patient prices for our products to achieve profitability. If we are unable to obtain adequate reimbursement from governments or third-party payors for any products that we may develop or if we are unable to obtain acceptable prices for those products, they may not be purchased or used and our revenues and prospects for profitability will suffer. Governments outside the United States may impose strict price controls, which may adversely affect our revenues, if any. If we are unable to manufacture our products in sufficient quantities or obtain regulatory approvals for our manufacturing facilities, or if our manufacturing process is found to infringe a valid patented process or processes of another company, then we may be unable to meet demand for our products and lose potential revenue. We rely on a limited number of suppliers for some of our manufacturing materials. Any problems experienced by such suppliers could negatively affect our operations. If product liability lawsuits are brought against us, we may incur substantial expenses and damages and demand for our product candidates may be reduced. We use hazardous materials in our business. Any claims relating to improper handling, storage, use or disposal of these materials could significantly harm our business. Our stock price may fluctuate substantially. If we do not progress in our programs as anticipated, our stock price could decrease. Our research and development efforts may not result in additional product candidates being discovered on anticipated timelines, if at all, which could limit our ability to generate revenues. 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 our existing products. Any acquisition we might make may be costly and difficult to integrate, divert management resources or dilute stockholder value. If we lose key personnel or are unable to attract and retain additional, highly skilled personnel required to develop our products or obtain new collaborations, our business will suffer. Future changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected financial reporting fluctuations and affect our reported results of operations. Our corporate governance structure, including provisions in our certificate of incorporation and by-laws, and Delaware law, may prevent a change in control or management that stockholders may consider desirable. Our executive officers, directors and principal stockholders will maintain the ability to control all matters submitted to stockholders for approval. Some of our insiders are parties to transactions with us that may cause conflicting obligations.

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1018710--3/17/2008--INTROGEN_THERAPEUTICS_INC