Biotest AG / Key word(s): Regulatory Approval 20.12.2012 10:33 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Ad-hoc RELEASE Announcement according to § 15 Sec. 1 Securities Trading Act (WpHG) Dreieich, Germany and Boca Raton, Florida December 20, 2012: Biotest AG announced today that Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of the listed Biotest AG, received approval for BIVIGAM(TM) for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA) yesterday evening. Bivigam(TM) is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest Pharmaceuticals Corporation (BPC) at its Boca Raton, Florida facility. This product is being produced for patients in the United States and the company plans to begin commercial shipments shortly. Biotest Aktiengesellschaft The Executive Management Board Biotest AG Landsteinerstr. 5 D-63303 Dreieich www.biotest.de Disclaimer This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so. About Biotest Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of immunology and haematology. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange. Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 Securities' ID No., ISIN preference shares: 522723, DE0005227235 Listing: Prime Standard Open market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart 20.12.2012 DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Biotest AG LandsteinerstraÃe 5 63303 Dreieich Germany Phone: 0 61 03 - 8 01-0 Fax: 0 61 03 - 8 01-150 E-mail: investor_relations@biotest.de Internet: http://www.biotest.de ISIN: DE0005227235, DE0005227201 WKN: 522723, 522720 Indices: SDAX Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart End of Announcement DGAP News-Service ---------------------------------------------------------------------------
DGAP-Adhoc: Biotest AG: FDA Approves Bivigam TM
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