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DGAP-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: FDA Approves Biotest's BIVIGAM(TM), an Intravenous Immune
Globulin (Human), 10% liquid

20.12.2012 / 10:45


FDA Approves Biotest's BIVIGAM(TM), an Intravenous Immune Globulin (Human),
10% liquid

Dreieich, Germany and Boca Raton, Florida December 20 2012: Biotest AG
announced today that Biotest Pharmaceuticals Corporation 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. BivigamTM 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.

Prof. Dr. Gregor Schulz, CEO of Biotest AG said: 'Biotest has made a
significant commitment in the U.S. to bring a new immune globulin to
individuals with primary immunodeficiency. We have invested over $50
million to create a state-of-the-art facility and have expanded our U.S.
capabilities from plasma collection to protein purification and product
distribution. BPC will eventually produce up to 1.5 million grams (= 1.5
tons) of BivigamTM in the U.S. facility. We look forward to providing this
therapy to patients in the U.S. This will be another milestone in Biotest's
long legacy of providing immune globulin products to patients around the

The U.S. IVIG market is the largest in the world and Biotest's entry into
this market fulfills the company's longstanding vision of being a
significant global participant. Biotest formed BPC as a U.S. subsidiary in
2007, with the purchase of Nabi Biopharmaceuticals biologics strategic
business unit which included a plasma protein plant and plasma collection
centers. Today's approval represents a sales potential of$100 million for

Marcia Boyle, President & Founder of the Immune Deficiency Foundation, the
national patient organization for persons with primary immunodeficiency
diseases, commented, 'We commend Biotest for its significant commitment and
investment in the development of BivigamTM. Its launch provides a new
product to our community, helping to assure continued access to this
lifesaving therapy for people who live with primary immunodeficiency
diseases. We welcome BivigamTM as a valuable option to help members of our
community live healthy and productive lives.'

The BivigamTM pivotal clinical study successfully achieved its primary
endpoints for safety, efficacy and tolerability and the results were
recently published in the Journal of Clinical Immunology (Wassermann RL,
Church JA, Stein M, et al. Safety, efficacy and pharmacokinetics of a new
10% liquid intravenous immunoglobulin (IVIG) in patients with primary
immunodeficiency. Journal of Clinical Immunology. (See Open access at

BivigamTM 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.
For Full Prescribing Information and more information about the product,
the indication and additional services, please visit
For ordering information, please contact customer support at 1.800.458.4244
and select Option 1.


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 clinical immunology, haematology and intensive medicine. In
its Plasma Protein portfolio 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. Biotest also
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

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 these same high standards of excellence. For inquiries about
the US market, please contact Biotest Pharmaceuticals, 561-989-5800

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich,
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
fax: +49 (0) 6103 801-347

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

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