Biotest AG: Biotest achieves major milestones in the development of biotherapeutics
Biotest AG / Research Update
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Biotest achieves major milestones in the development of biotherapeutics
· Orphan drug designation granted for monoclonal antibody, BT-062,
in the USA
· Up to seven years’ market exclusivity from approval
· Clinical testing for indication multiple myeloma anticipated to start
in the first six months of 2008
Dreieich, 11 March 2008. Biotest has achieved some further major milestones
in its biotherapeutical development projects. The FDA granted monoclonal
antibody, BT-062, Orphan Drug designation for the indication multiple
myeloma. In principle, this grants market exclusivity in the USA for drugs
developed to treat rare and serious diseases for a period of up to seven
years from granting of approval. The decision was made on the basis of
pre-clinical development, which produced positive data on the effectiveness
of the antibody.
As planned, in february Biotest has submitted an FDA application for
approval of the first clinical study (Investigational New Drug, IND) and is
confident that it will be able to begin testing the antibody on humans in
the first half of the current year.
Subject to approval being granted, Biotest are of the opinion that BT-062
has the potential to capture a significant share of the market for biotech
drugs for the treatment of multiple myeloma. The estimated market volume in
2009 is forecast by experts to be in the region of around 3 billion US
dollars.
Multiple myeloma is an aggressive malignant disease of the bone marrow, for
which there is no cure as yet. Biotest has developed BT-062 as a highly
potent immunoconjugate, which is a combination of a monoclonal antibody and
an effective cell toxin. This is a concept which differs markedly from
chemotherapy, the predominant method of treating the disease up to now.
While chemotherapy attacks healthy tissue as well, BT-062 attaches itself
selectively to a protein found in high densities in malignant cells. Only
when this has occurred, does the cell toxin begin to target and then
destroy the fast growing cancer cells. Cell system tests and animal trials
have repeatedly confirmed the precision targeting and effectiveness of the
process.
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
11.03.2008 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
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart
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