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

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

PR Newswire

DREIEICH, Germany and BOCA RATON, Fla., Dec. 20, 2012

DREIEICH, Germany and BOCA RATON, Fla., Dec.20, 2012 /PRNewswire/ --Biotest
AG  announced  today that Biotest Pharmaceuticals Corporation received
approval for BIVIGAM™ for the treatment of patients with Primary Humoral
Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA).
BIVIGAM 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 BIVIGAM 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 globe."

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 BPC.

Marcia Boyle, President & Founder of the Immune Deficiency Foundation, a
national patient organization for persons with primary immunodeficiency
diseases, commented, "We commend Biotest for its significant commitment and
investment in the development of BIVIGAM. 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 BIVIGAM
as a valuable option to help members of our community live healthy and
productive lives."

The BIVIGAM 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 http://dx.doi.org/10.1007/s10875-012-9656-5).

BIVIGAM is a sugar-free, glycine stabilized intravenous immune globulin that
was approved by the FDA 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 www.BIVIGAM.com.

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 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 specialized 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 exchange.


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

Contact: Dr. Monika Buttkereit, +49 (0) 6103 801-4406,
investor_relations@biotest.de, fax: +49 (0) 6103 801-347
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