318154--3/10/2006--AMGEN_INC

related topics
{product, candidate, development}
{product, liability, claim}
{customer, product, revenue}
{acquisition, growth, future}
{stock, price, operating}
{regulation, government, change}
{property, intellectual, protect}
{regulation, change, law}
{cost, contract, operation}
{financial, litigation, operation}
If our intellectual property positions are challenged, invalidated, circumvented or expire, or if we fail to prevail in present and future intellectual property litigation, our business could be adversely affected. Before we commercialize and sell any of our product candidates, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected. Our product development efforts may not result in commercial products. Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products. Certain of our raw materials, medical devices and components are single-sourced from third parties; third-party supply failures could adversely affect our ability to supply our products. Our current products and products in development cannot be sold if we do not maintain regulatory approval and comply with manufacturing regulations. We formulate, fill, and finish substantially all our products at our Puerto Rico manufacturing facility; if significant natural disasters or production failures occur at this facility, we may not be able to supply these products. Difficulties, disruptions or delays in manufacturing may limit supply of our products and limit our product sales. We are dependent on third parties for a significant portion of our bulk supply and the formulation, fill, and finish of ENBREL. We have grown rapidly, and if we fail to adequately manage that growth our business could be adversely impacted. Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do. Concentration of sales at certain of our wholesaler distributors and consolidation of freestanding dialysis clinic businesses may negatively impact our bargaining power and profit margins. Our marketing of ENBREL will be dependent in part upon Wyeth. Our business may be impacted by government investigations or litigation. We may be required to defend lawsuits or pay damages for product liability claims. We may be required to perform additional clinical trials or change the labeling of our products if we or others identify side effects after our products are on the market. Guidelines and recommendations published by various organizations can reduce the use of our products. Our stock price is volatile, which could adversely affect your investment. Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable U.S. federal and state regulations and all potentially applicable foreign regulations. Our revenues may fluctuate, and this fluctuation could cause financial results to be below expectations. We may not realize all of the anticipated benefits of our merger with Abgenix, Inc. Continual manufacturing process improvement efforts may result in the carrying value of certain existing manufacturing facilities or other assets becoming impaired.

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