Biotest AG  / Key word(s): Regulatory Approval

20.12.2012 10:33

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
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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


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

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

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Language:     English
Company:      Biotest AG
              Landsteinerstraße 5
              63303 Dreieich
Phone:        0 61 03 - 8 01-0
Fax:          0 61 03 - 8 01-150
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