Biotest AG: Biotest submits BivigamTM dossier for regulatory approval to US Food and Drug Administration
Biotest AG / Key word(s): Regulatory Admission
03.11.2010 16:57
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Biotest submits BivigamTM dossier for regulatory approval to US Food and
Drug Administration
Important step to expand US market position
Annual sales potential of around USD 100 Mio.
Biotest expects approval for end of 2011
Dreieich, 3 November 2010. Biotest Pharmaceutiocals Corp., Boca Raton/ USA
has submitted today the dossier for regulatory approval of the polyspecific
immunoglobulin BivigamTM to the US regulatory agency FDA (US Food and Drug
Administration).
Bivigam TM is a polyspecific immunoglobulin for the treatment of antibody
deficiencies. The product is a ready for use 10% solution, stabilised by
glycin and therefore sugarfree. This is a considerable advantage for the
clinical application. This preparation was developed exclusively for the US
market. In Europe and other global markets, Intratect(R) will continue to
be marketed.
The submission of the dossier for regulatory approval of BivigamTM to the
FDA marks an important step for the expansion of the US presence of
Biotest. The US market is the worldwide largest single market for
polyspecific immunoglobulins, with high and stable prices. The expected
demand in the US of 44 tons of immunoglobulins in 2010 represents approx.
44% of the worldwide consumption. Biotest expects the approval of Bivigam
TM for the end of 2011. As of today, the expected annual sales potential is
approx. USD 100 Mio.
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 as well as
reagents and systems for microbiology. 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. The products of the
Microbiological Monitoring segment are primarily used in hygiene
monitoring. Biotest has more than 1,900 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
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/Regulated market
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
03.11.2010 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Deutschland
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Hamburg, Berlin, Düsseldorf, Stuttgart
End of Announcement DGAP News-Service
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