Biotest AG: Biotest: Successful launch of plasma protein business in the USA
Biotest AG / Miscellaneous
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Biotest: Successful launch of plasma protein business in the USA
· Work to integrate the activities acquired from Nabi Biologics
in December 2007 is on schedule
· Preparations for a capacity expansion have been completed
· Sales and income in the first quarter match expectations
Dreieich, 7 April 2008. The Biotest Group has successfully completed its
first quarter as a plasma protein provider in the USA. Sales of plasma and
the Nabi HB® immunoglobulin, which is used in the prevention of hepatitis
B, have matched expectations. When the company acquired the plasma protein
activities from Nabi Biopharmaceuticals, Biotest also took over Nabi HB® as
part of the asset deal. In addition, two promising development projects
have been transferred to the ownership of BPC. These are a polyvalent
immunoglobulin (IVIG) in clinical Phase III and a hyperimmunoglobulin used
in the prevention of hepatitis C (Civacir®), which is currently in clinical
Phase IIb.
The integration into the Group of the assets acquired in December 2007 as
part of an asset deal is progressing according to schedule. All activities
have been transferred to Biotest Pharmaceuticals Corp. (BPC), with
registered office in Boca Raton, Florida. Headed by CEO Dr. Rainer Pabst,
the management team is complete. The authorities of the US federal state of
Florida have agreed to the transfer of the product licence to BPC, and the
process of pooling all US activities relating to the development and
approval of plasma proteins in Boca Raton is nearing conclusion. This
involves relocating the departments of Clinical Development, Regulatory
Affairs and Drug Safety, which were previously based in Rockville,
Maryland, to the headquarters of BPC.
Preparations for the planned expansion of production at the Boca Raton site
are also virtually complete. Biotest will expand the plasma fractionation
facility to a capacity of 400,000 litres per year, while increasing the
annual production capacity for immunoglobulins to 1.6 tons. This work is
scheduled for completion in the second quarter of 2009. Furthermore, plans
are in place to integrate the Boca Raton facility into the production of
monoclonal antibodies being developed by Biotest. A total of USD 13.5
million is to be invested in the BPC facility in the next two years.
Together with the capacity in Dreieich, which will also be expanded,
Biotest will be in a position to produce around 6.0 tons of immunoglobulins
per annum from 2009 onwards. Compared with the status quo, this represents
an almost three-fold increase on the current potential production volume.
The Orphan Drug Designation (ODD) issued by the FDA for the US market in
respect of the hepatitis B immunoglobulin of another manufacturer in the
indication of prevention of reinfection with hepatitis B following liver
transplantation is unlikely to have a major impact on expected sales of
Nabi HB®. Since the late 1990s, Nabi HB® has been the standard preparation
used in the USA for the prevention of infection with hepatitis B after
inadvertent exposure.
Biotest has confirmed its target of achieving sales with the US plasma
protein activities amounting to approximately USD 100 million in the
current year.
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 1,800
employees worldwide and its shares are listed in the Frankfurt Stock
Exchange's Prime Standard and S-DAX.
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
07.04.2008 Financial News transmitted by DGAP
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Language: English
Issuer: Biotest AG
Landsteinerstr. 5
63303 Dreieich
Deutschland
Phone: +49 - 6103 / 801 - 0
Fax: +49 - 6103 / 801 - 150
E-mail: mail@biotest.de
Internet: www.biotest.de
ISIN: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices: SDAX
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