1173657--3/14/2006--BARRIER_THERAPEUTICS

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{regulation, government, change}

{personnel, key, retain}

{customer, product, revenue}

{system, service, information}

{stock, price, share}

{stock, price, operating}

{acquisition, growth, future}

Our revenues, operating results and cash flows may fluctuate in future periods and we may fail to meet investor expectations, which may cause the price of our common stock to decline Risks Related to Development of Product Candidates We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results or if our clinical trials do not demonstrate safety and efficacy in humans. If our clinical trials for our product candidates are delayed, we would be unable to commercialize our product candidates on a timely basis, which would materially harm our business. If we are wrong in our assessment of the stages of clinical development of our initial product candidates, we may need to perform preclinical studies or clinical trials that we did not anticipate, which would result in additional product development costs for us and delays in filing for regulatory approval for our product candidates. Risks Related to Regulatory Approval of Our Product Candidates We may not receive regulatory approvals for our product candidates or approvals may be delayed, either of which could materially harm our business. If we fail to comply with regulatory requirements, regulatory agencies may take action against us, which could significantly harm our business. Some of our product candidates are based on new technologies that have not been extensively tested in humans, which may affect our ability or the time we require to obtain necessary regulatory approvals. If we fail to obtain regulatory approval in foreign jurisdictions, we would not be able to market our products abroad, and the growth of our revenues, if any, would be limited. If our products and product candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited. If we are unable to expand our domestic sales and marketing infrastructure or enter into agreements with third parties to perform these functions in territories outside the United States and Canada, we will not be able to commercialize our product candidates. If we fail to comply with the laws governing the marketing and sale of our products regulatory agencies may take action against us, which could significantly harm our business. We rely on third parties to perform many necessary commercial services for our products, including services related to the distribution, storage, and transportation of our products We depend on three wholesalers for the vast majority of our product revenues in the United States, and the loss of any of these wholesalers would decrease our revenues. We may acquire additional products, product candidates and businesses in the future and any difficulties from integrating such acquisitions could damage our ability to attain profitability. Risks Related to Our Dependence on Third Parties for Manufacturing, Research and Development and Marketing and Distribution Activities Because we have no manufacturing capabilities, we will contract with third-party contract manufacturers whose performance may be substandard or not in compliance with regulatory requirements, which could increase the risk that we will not have adequate supplies of our product candidates and harm our ability to commercialize our product candidates. We rely on a single source supplier for the manufacture of our marketed products and the active ingredients contained in those products and the loss of these suppliers could disrupt our business. If third parties on whom we rely do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products and product candidates. We are dependent upon distribution arrangements and marketing alliances to commercialize our product candidates outside the United States and Canada. These distribution arrangements and marketing alliances place the marketing and sale of our product candidates in these regions outside our control. Risks Related to Intellectual Property There are limitations on our patent rights relating to our products and product candidates that may affect our ability to exclude third parties from competing against us. If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business. Various aspects of our Johnson Johnson license agreements may adversely affect our business. If we are unable to obtain and maintain patent protection for our intellectual property, our competitors could develop and market products similar or identical to ours, which may reduce demand for our product candidates. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology may be adversely affected. If the development of our product candidates infringes the intellectual property of our competitors or other third parties, we may be required to pay license fees or cease our development activities and pay damages, which could significantly harm our business. Risks Related to Employees and Growth If we are not able to retain our current senior management team or attract and retain qualified scientific, technical and business personnel, our business will suffer. We will need to hire additional employees as we grow. Any inability to manage future growth could harm our ability to commercialize our product candidates, increase our costs and adversely impact our ability to compete effectively. Risk Related to Our Industry If third-party payors do not reimburse customers for any of our products candidates, they might not be used or purchased, and our revenues and profits will not develop or grow. New federal legislation will increase the pressure to reduce the price of pharmaceutical products paid for by Medicare, which will adversely affect our revenues. Foreign governments tend to impose strict price controls, which may adversely affect our revenues. We face potential product liability exposure, and, if successful claims are brought against us, we may incur substantial liability for a product and may have to limit its commercialization. If our competitors develop and market products faster than we do or if the products of our competitors are considered more desirable than ours, revenues for any of our products and product candidates that are approved for marketing will not develop or grow. Risks Related to Our Common Stock Our stock price is volatile, and the market price of our common stock may drop below the price you pay.

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1173657--3/14/2006--BARRIER_THERAPEUTICS_INC