1008848--2/26/2010--ACORDA_THERAPEUTICS_INC

related topics
{product, liability, claim}
{product, candidate, development}
{property, intellectual, protect}
{stock, price, share}
{stock, price, operating}
{acquisition, growth, future}
{provision, law, control}
{control, financial, internal}
{financial, litigation, operation}
{regulation, government, change}
{personnel, key, retain}
{customer, product, revenue}
{cost, regulation, environmental}
{regulation, change, law}
Risks related to our business We have a history of operating losses and we expect to continue to incur losses and may never be profitable. We will be highly dependent on the commercial success of Ampyra in the U.S. for the foreseeable future; we may be unable to meet our expectations with respect to Ampyra sales and/or attain profitability and positive cash flow from operations. Our recently expanded sales, managed markets and marketing organization may not be successful in effectively marketing Ampyra, which could in turn materially adversely affect our cash flow and prospects for achieving profitability. We have no manufacturing capabilities and are dependent upon Elan and other third party suppliers to manufacture Ampyra, Zanaflex Capsules and Zanaflex tablets. Even though we have obtained marketing approval for Ampyra, the approval is subject to a REMS and post-marketing commitments, which may affect the success of Ampyra The FDA-approved product labeling for Ampyra is limited and may adversely affect market acceptance of Ampyra. If we or others identify previously unknown side effects of Ampyra, or known side effects are more frequent or severe than in the past, our business would be adversely affected and could lead to a significant decrease in sales of Ampyra or to the FDA's withdrawal of marketing approval. If the specialty pharmacies that we rely upon to sell Ampyra in the U.S. fail to perform, our business may be adversely affected. We may incur significant liability if it is determined that we are promoting the "off-label" use of Ampyra or any other marketed drug. We are dependent on our collaboration with Biogen Idec to commercialize Ampyra outside of the U.S. Our collaboration partner, Biogen Idec, will need to obtain regulatory approval in foreign jurisdictions where we seek to market Ampyra. Our drug development programs are in early stages of development and may never be commercialized. Our other drug development products must undergo rigorous clinical testing, the results of which are uncertain and could substantially delay or prevent us from bringing them to market. If third-party contract research organizations do not perform in an acceptable and timely manner, our preclinical testing or clinical trials could be delayed or unsuccessful. The pharmaceutical industry is subject to stringent regulation and failure to obtain regulatory approval will prevent commercialization of our product candidates and, if we do not comply with FDA regulations if we obtain regulatory approval, approved products could be withdrawn from the market. Our products and product candidates may not gain market acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenue. If we market products in a manner that violates healthcare fraud and abuse laws, or if we violate false claims laws or fail to comply with our reporting and payment obligations under the Medicaid rebate program or other governmental pricing programs, we may be subject to civil or criminal penalties or additional reimbursement requirements and sanctions, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects. Our potential products may not be commercially viable if we fail to obtain an adequate level of reimbursement for these products by Medicaid, Medicare or other third-party payers. If our competitors develop and market products that are more effective, safer or more convenient than our approved products, or obtain marketing approval before we obtain approval of future products, our commercial opportunity will be reduced or eliminated. We may expand our business through the acquisition of companies or businesses or in-licensing product candidates that could disrupt our business and harm our financial condition. We face an inherent risk of liability in the event that the use or misuse of our products results in personal injury or death. The approval of Zanaflex Capsules and Zanaflex tablets and any other products for which we may receive marketing approval in the future are subject to post-approval regulatory requirements, and we may be subject to penalties if we fail to comply with these requirements and our products could be subject to restrictions or withdrawal from the market. State pharmaceutical compliance and reporting requirements may expose us to regulatory and legal action by state governments or other government authorities. Our operations could be curtailed if we are unable to obtain any necessary additional financing on favorable terms or at all. Under our financing arrangement with the Paul Royalty Fund, or PRF, upon the occurrence of certain events, PRF may require us to repurchase the right to receive revenues that we assigned to it or may foreclose on the Zanaflex assets that secure our obligations to PRF. Any exercise by PRF of its right to cause us to repurchase the assigned right or any foreclosure by PRF could adversely affect our results of operations and our financial condition. The loss of our key management and scientific personnel may hinder our ability to execute our business plan. If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages. Fulfilling our obligations pursuant to compliance with the Sarbanes-Oxley Act of 2002 is expensive and time consuming. Risks related to our intellectual property If we cannot protect, maintain and, if necessary, enforce our intellectual property, our ability to develop and commercialize our products will be severely limited. If third parties successfully claim that we infringed their patents or proprietary rights, our ability to continue to develop and successfully commercialize our product candidates could be delayed. We are dependent on our license agreements and if we fail to meet our obligations under these license agreements, or our agreements are terminated for any reason, we may lose our rights to our in-licensed patents and technologies. Risks relating to our common stock Our stock price may be volatile and you may lose all or a part of your investment. Future sales of our common stock could cause our stock price to decline. If our officers, directors and largest stockholders choose to act together, they may be able to control the outcome of stockholder vote. Certain provisions of Delaware law, our certificate of incorporation and our bylaws may delay or prevent an acquisition of us that stockholders may consider favorable or may prevent efforts by our stockholders to change our directors or our management, which could decrease the value of your shares. Because we do not intend to pay dividends in the foreseeable future, you will benefit from an investment in our common stock only if it appreciates in value.

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