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

are reform legislation, legal proceedings or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare and the Public Health Service Program and additional legislation and regulatory action now under consideration; legislation or regulations in markets outside of the U.S. affecting product pricing, reimbursement, access, or distribution channels; Talecris' ability to procure adequate quantities of plasma and other materials which are acceptable for use in manufacturing processes from the company's own plasma collection centers or from third-party vendors; Talecris' ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; Talecris' ability to identify growth opportunities for existing products and Talecris' ability to identify and develop new product candidates through the company's research and development activities; timing of, and Talecris' ability to obtain and/or maintain, regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of the company's products; unexpected shut-downs of Talecris' manufacturing and storage facilities or delays in opening new planned facilities; Talecris and Talecris suppliers' ability to adhere to cGMP; potential sanctions, if any, that the Department of Justice (DOJ) or other federal agencies may impose on the company as a result of Talecris' internal FCPA investigation; the impact of Talecris' appeal of the Plasma Centers of America, LLC (PCA) judgment; Talecris' ability to manufacture at appropriate scale to meet the markets demand for the company's products; ability to resume or replace sales to countries affected by the company's internal Foreign Corrupt Practices Act (FCPA) investigation; impact of geographic and product mix on the company's sales and gross profit; foreign currency exchange rate
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SOURCE Talecris Biotherapeutics Holdings Corp.
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