Biotest AG: Biotest: US approval increases potential of diagnostic business
Biotest AG / Miscellaneous
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Biotest: US approval increases potential of diagnostic business
· FDA authorises marketing of manual reagents for blood group typing
· Biotest consequently consolidates its position in the world’s largest
and most attractive market
· Objective: annual sales of around US$50 million within five years
Dreieich, 18 August 2008. Biotest has made significant progress in the
internationalisation of its business operations driven forward as part of
its strategic corporate development. Last Friday the US Food and Drug
Administration (FDA) granted approval for 37 products for manual blood
group typing (immunohaematological diagnostics). The products may now be
marketed with immediate effect in the United States.
As a result, Biotest can now operate as a full service provider in the area
of immunohaematology as one of only three companies to do so in the USA.
The system developed by Biotest for automated blood group typing in blood
banks and hospitals, TANGO® optimo, including the associated test
substances, was granted FDA approval as early as 2005.
The distribution licence which has now been granted for the reagents for
the manual procedure carries dual potential. First, the USA is the world’s
largest and most attractive market for blood group typing products. The
annual market volume amounts to approximately US$250 million, of which
around three quarters are currently still attributable to manual
diagnostics. The FDA’s stringent quality requirements restrict the number
of approved suppliers, which is why unlike in Europe, there has not been a
drop in prices or margins here.
Second, sales opportunities for the TANGO® optimo system are also
improving, as US clinics and blood banks can now cover the entire test
spectrum – whether manual or automated – with products from Biotest. It is
widely believed that automated blood group typing will gain considerably in
importance in the coming years. When deciding on a supplier, clients set
great store by the fact that they can source the products needed for both
procedures from under one roof.
Biotest already stepped up its sales and marketing activities in the USA
last year and realigned its structures to realise the higher sales
potential. Over the next five years, the company intends to achieve a
market share of 20% which, based on the current market volume, would
correspond to annual sales of around US$50 million.
Disclaimer
This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and asset
situation 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
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 AG, Dreieich, Germany, is a company that researches and
manufactures pharmaceutical, biotherapeutic and diagnostic products and has
specialised in immunology and haematology. In its Pharmaceutical segment,
Biotest develops immunoglobulins, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In the Biotherapeutic segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and blood cancer. The Diagnostic
segment spans reagents and immunological diagnostics which are used, for
example, in blood transfusions and transplants. Biotest has around 1,850
employees worldwide and its shares are listed in the Frankfurt Stock
Exchange's Prime Standard.
Biotest AG:
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Michael Ramroth
Tel: +49 (0)6103 801-338
Fax: +49 (0)6103 801-347
e-mail: michael_ramroth@biotest.de
WKN, ISIN ordinary share: 522720, DE0005227201
WKN, ISIN preference share: 522723, DE0005227235
Listed: Prime Standard/official trading
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
18.08.2008 Financial News transmitted by DGAP
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Language: English
Issuer: 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: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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