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BIVIGAM™ [Immune Globulin Intravenous (Human), 10% Liquid] is the First New IVIG Product Approved with a Validated and FDA



 BIVIGAM™ [Immune Globulin Intravenous (Human), 10% Liquid] is the First New
 IVIG Product Approved with a Validated and FDA Approved Thrombin Generation
                               Assay (TGA) Test

PR Newswire

BOCA RATON, Fla. and DREIEICH, Germany, Jan. 31, 2013

BOCA RATON, Fla. and DREIEICH, Germany, Jan. 31, 2013 /PRNewswire/ -- Biotest
Pharmaceuticals Corporation (BPC), a wholly owned U.S. subsidiary of Biotest
AG, recently announced the U.S. Food and Drug Administration's (FDA) approval
of BIVIGAM™, its new intravenous immune globulin, for the treatment of
patients with Primary Humoral Immunodeficiency (PI). BIVIGAM is the first new
intravenous immune globulin (IVIG) to be approved by the FDA with a validated
assay for measuring potential thrombogenic activity. Thrombin generation tests
are utilized to detect procoagulant activity. BPC plans to begin shipments of
the product shortly.

To reduce the risk of thromboembolic events that PI patients have experienced
in the past with alternative products, BPC initiated the development and
validation of a TGA test in close cooperation with the FDA. Every lot of BPC's
BIVIGAM will be screened before release to assure the product fulfills the
stringent release criteria pertaining to the threshold levels of Factor XIa.
Increased Factor XIa has been identified as one of the risk factors associated
with thromboembolic events following immune globulin intravenous therapy.

BIVIGAM is a sugar-free, glycine stabilized intravenous immune globulin that
was approved by the FDA on December 19, 2012 and is available in 50 mL (5
gram) and 100 mL (10 gram) tamper-evident vials. The product uses a label with
an integrated hanger and the packaging material is latex free. It is
manufactured in a state-of-the-art US facility and will be available
exclusively for patients and healthcare professionals in the USA. For Full
Prescribing Information and more information about the product, the indication
and additional services, please visit www.BIVIGAM.com.

For ordering information, please contact our customer support at
1.800.458.4244 and select Option 1.

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 AG
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 clinical immunology, haematology and intensive medicine. 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.

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Dusseldorf, Frankfurt, Hamburg, Hannover, Munchen,
Stuttgart

About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation was created as a wholly-owned US
subsidiary of Biotest AG in December 2007. Innovative technologies and a sharp
focus on safety are incorporated into every facet of the business. From plasma
collection to product manufacturing and distribution – from nature for life –
Biotest Pharmaceuticals Corporation is committed to maintaining high standards
of excellence.
With further questions, please contact the Customer Support at 1-800-458-4244

SOURCE Biotest Pharmaceuticals Corporation

Website: http://www.biotestpharma.com
Contact: Dr. Monika Buttkereit, +49(0)6103-801-4406,
investor_relations@biotest.de, fax: +49(0)6103-801-347
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