792977--2/27/2009--AMAG_PHARMACEUTICALS_INC.

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{product, liability, claim}
{product, candidate, development}
{acquisition, growth, future}
{customer, product, revenue}
{stock, price, operating}
{regulation, change, law}
{condition, economic, financial}
{personnel, key, retain}
{cost, regulation, environmental}
{property, intellectual, protect}
{loan, real, estate}
{loss, insurance, financial}
We are solely dependent on the success of Feraheme. We may experience significant delays in our efforts to obtain approval for Feraheme or we may never receive regulatory approval for the marketing and commercial sale of Feraheme in the U.S. or elsewhere. We may not be able to adequately address the deficiencies identified by the FDA during the recent inspection of our manufacturing facility or operate our manufacturing facility in compliance with current good manufacturing practices and other FDA regulations, which could result in a substantial delay in the approval of Feraheme, a suspension of our ability to manufacture Feraheme, the loss of our existing Feraheme inventory, or other unanticipated compliance costs. We need to maintain, and possibly increase our manufacturing capabilities or establish and qualify second source manufacturing facilities in order to successfully commercialize Feraheme. Our inability to obtain raw materials and our reliance on sole source suppliers could adversely impact our ability to manufacture sufficient quantities of Feraheme, which would have a severe adverse impact on our business. The commercial success of Feraheme will depend upon the degree of its market acceptance among physicians, patients, healthcare payors, and the two major operators of dialysis clinics in the U.S. Our ability to generate future revenues from Feraheme will depend heavily on our ability to obtain and maintain satisfactory insurance coverage, coding, and reimbursement for Feraheme. We have limited marketing and sales experience, and any failure on our part to effectively execute our Feraheme commercial plans would have a severe adverse impact on our business. Competition in the pharmaceutical and biopharmaceutical industries is intense. If our competitors are able to develop and market products that are or are perceived to be more effective, safer, more convenient or have more favorable pricing, insurance coverage, coding and reimbursement than Feraheme, our commercial opportunity for Feraheme will be adversely impacted. Feraheme, if approved, will remain subject to ongoing regulatory review, and if we fail to comply with such continuing regulations we could be subject to penalties up to and including the suspension of the manufacturing, marketing and sale of Feraheme. Significant safety or drug interaction problems could arise for Feraheme even after FDA approval, resulting in recalls, restrictions in Feraheme's label, or withdrawal of Feraheme from the market. Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly. The current credit and financial market conditions may exacerbate certain risks affecting our business. Our ability to generate and grow revenues from the sale of Feraheme will be limited if we do not obtain approval or if we experience significant delays in our efforts to obtain approval to market Feraheme for additional indications in the U.S. or if we do not obtain approval to market Feraheme in countries outside of the U.S. We rely on third parties in the conduct of our clinical trials, and if they fail to fulfill their obligations, our development plans may be adversely affected. The investment of our cash is subject to risks, which may cause losses or adversely affect the liquidity of these investments. Our corporate compliance program cannot ensure that we are in compliance with all applicable laws and regulations, and our failure to comply with such laws and regulations could harm our business. Legislative or regulatory changes may adversely impact our business. Our operating results will likely fluctuate so you should not rely on the results of any single quarter to predict how we will perform over time. Our success depends on our ability to attract and retain key employees. If we do not effectively manage our growth, our ability to commercialize Feraheme, pursue opportunities and expand our business could be adversely affected. We may enter into collaborations, in-licensing arrangements, or acquisition agreements that could disrupt our business, decrease our profitability, result in dilution to stockholders or cause us to incur debt or significant additional expense. We may need additional capital to achieve our business objectives. Our success depends on our ability to maintain the proprietary nature of our technology. We are exposed to a number of different potential liability claims, and we may not be able to maintain or obtain sufficient insurance coverage to protect our cash and other assets. We are subject to environmental laws and potential exposure to environmental liabilities. If securities analysts downgrade our stock or cease coverage of us, the price of our stock could decline.

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