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Talecris Biotherapeutics Announces First Quarter 2011 Results
Date:4/27/2011

nation by the European Commission for the development of the company's direct-acting thrombolytic, Plasmin (Human), to treat acute peripheral arterial occlusion (aPAO).  Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot. Through the orphan drug designation, the European Medicines Agency (EMA) will provide Talecris with ten years of marketing exclusivity if the product is the first to be approved in the European Union.  In addition, under this designation, EMA will provide the company with clinical development assistance and reduced regulatory fees.  Talecris received orphan drug designation for Plasmin for aPAO from the U.S. Food and Drug Administration (FDA) in 2009; and
  • During the first quarter, Talecris converted all U.S. sales from Gamunex IGIV labeled product to Gamunex-C IGIV labeled product.  Gamunex-C IGIV is the first and only immune globulin to provide both the intravenous route of administration and a new subcutaneous route of administration.  The intravenous delivery mode is approved to treat primary immune deficiency (PI), chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP).  The subcutaneous mode is approved to treat only PI.  A required post-marketing study will be initiated in the second half of 2011.

  • Use of Non-GAAP Financial MeasuresThis press release and the accompanying tables include non-GAAP financial measures including adjusted net income, adjusted diluted EPS, EBITDA, adjusted EBITDA, and Consolidated Cash Flow.  For a description of these non-GAAP financial measures, including the reasons management uses these measures and reconciliations of these non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with U.S.
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    SOURCE Talecris Biotherapeutics Holdings Corp.
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