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ViroPharma Incorporated Reports Fourth Quarter and Full Year 2010 Financial Results
Date:2/24/2011

size of the market, future growth potential and market share for Cinryze in the United States, Europe and other territories;
  • the availability of third party payer reimbursement for Cinryze patients;
  • fluctuations in wholesaler order patterns and inventory levels;
  • competition from the approval of products which are currently marketed for other indications by other companies or new pharmaceuticals and technological advances to treat the conditions addressed by Cinryze;
  • changes in prescribing or procedural practices of physicians, including off-label prescribing of products competitive with Vancocin and Cinryze;
  • the timing of regulatory submissions and approvals, including the timing of the EMEA's review of our MAA for Cinryze;
  • the impact of recent healthcare reform legislation;
  • actions by the FDA, EMEA and the Internal Revenue Service or other government regulatory agencies;
  • decreases in the rate of infections for which Vancocin is prescribed or decreases in the sensitivity of the relevant bacteria to Vancocin;
  • the timing and results of anticipated events in our clinical development programs including studies with Cinryze subcutaneous formulation, Cinryze for antibody mediated rejection and delayed graft function, as well as VP20621 for recurrence of C. difficile; and
  • the timing and nature of potential business development activities related to our efforts to expand our current portfolio through in-licensing or other means of acquiring products in clinical development or marketed products.

  • There can be no assurance that we will conduct additional studies or that we will be successful in gaining regulatory approval of Cinryze for additional indications, formulations or in additional territories, including in Europe. In addition, approval of a competing product which has been granted orphan drug designation in Europe could prevent Cinryze from reaching the market
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    SOURCE ViroPharma Incorporated
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