Press Detail





Biotest AG: Clinical Data on Efficacy and Safety of Bivigam(TM) accepted by FDA. Sales and profit guidance confirmed despite delays in US registration.


Biotest AG / Key word(s): Regulatory Admission

07.08.2012 / 17:06


/
PRESS RELEASE

Clinical Data on Efficacy and Safety of BivigamTM accepted by FDA.
Sales and profit guidance confirmed despite delays in US registration.

Dreieich, Germany, 7 August 2012: In an official statement by the United States Food and Drug Administration, FDA, received on August 6, 2012 no questions were raised on the clinical efficacy and safety of the newly developed investigational polyspecific immunoglobulin preparation by Biotest Pharmaceuticals Corp., Boca Raton, Florida, USA. However, yesterday's letter did not grant the preparation's approval in the US because FDA has requested a new and additional validated test system for detection of thrombogenic activity. Such a test system has not historically incorporated in the routine batch release process of immunoglobulins, but is now required by the FDA for the approval of our newly developed preparation. An elevated content of thrombogenic factors led to the temporary withdrawal of a competitor's product in Europe and the US. As consequence, new test methods have been developed over the past months but still require validation.

In a co-operation with a reference laboratory, Biotest is currently working on the validation of such a test. The development will presumably need several months. Biotest then expects the FDA marketing approval in the US. Despite the delay, Biotest confirms its given guidance for sales and profit in 2012. The half-year report, to be published on August 13, 2012, will contain more details.

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 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 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 these same high standards of excellence. For inquiries about the US market, please contact Douglas Loock at +1 561 989 5732.

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
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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180726  07.08.2012