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ViroPharma Announces First Quarter 2013 Financial Results
Date:5/1/2013

or other indications by other companies or new pharmaceuticals and technological advances to treat the conditions addressed by Cinryze,  Buccolam and Plenadren;
  • changes in prescribing or procedural practices of physicians, including off-label prescribing of products competitive with Cinryze, Buccolam and Plenadren;
  • manufacturing, supply or distribution interruptions, including but not limited to our ability to acquire adequate supplies of Cinryze and our other products in order to meet demand for each product;
  • our ability to receive regulatory approval for the use of Cinryze for additional indications and routes of administration and in additional territories in the timeframes we anticipate or at all;
  • the impact of healthcare reform legislation in the United States;
  • actions by the FDA and EMA or other government regulatory agencies;
  • the timing and results of anticipated events in our clinical development programs including studies with Cinryze subcutaneous formulations, Cinryze for antibody mediated rejection, and maribavir for treatment of CMV infections in transplant recipients;
  • whether we pursue regulatory approval of Plenadren in the United States; 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 and our efforts to find a partner for VP20621.
  • 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, routes of administration or in additional territories.  The entry of competing generic products following FDA approval in April 2012 has and will continue to significantly affect our sales of Vancocin and our financial performance.  Biologics such as Cinryze require processing steps
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    SOURCE ViroPharma Incorporated
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