Biotest AG: Enhanced property rights for BT-062
Biotest AG / Miscellaneous
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Enhanced property rights for BT-062
- European Commission grants Orphan Drug designation to the monoclonal
antibody
- Designation ensures ten years’ market exclusivity in the EU from
approval of the drug for the treatment of multiple myeloma
- Phase I clinical trials underway
Dreieich, 15 December 2008. The European Commission has granted Biotest’s
monoclonal antibody BT-062 Orphan Drug designation in principle for the
indication of multiple myeloma. The decision was made on the basis of the
assessment by the European approval authority, EMEA, that the use of BT-062
promises a significant improvement in terms of efficacy and safety in the
treatment options for this malignant, extremely aggressive and to date
incurable disease of the bone marrow.
Orphan Drug designation also grants market exclusivity for the relevant
drug for ten years within the European Union from approval for the
indication. In addition, the EMEA provides support for the preparation of
clinical trial protocols and fee reductions in the approval process. These
benefits are aimed at promoting the development of drugs for the treatment
of life-threatening or very rare serious diseases for which there is no or
only inadequate treatment at present.
In spring 2008 the US approval authority, the FDA, granted BT-062 Orphan
Drug designation which guarantees market exclusivity in the USA for up to
seven years from approval.
BT-062 is an immunoconjugate, which is an antibody combined with another
substance. It comprises the monoclonal antibody and a highly effective cell
toxin - DM4 - developed by Biotest’s partner ImmunoGen Inc. The antibody
attaches itself to a protein (antigen), which occurs in particularly high
concentrations on the surface of the cancer cells. When the antibody is
absorbed by the target cell, the DM4 is released and effectively destroys
the rapidly growing cancer cells. Through this combination of precision
targeting and high efficacy, BT-062 differs from chemotherapy, the
predominant method of treating multiple myeloma at the moment. Moreover,
the researchers are also expecting considerably fewer side effects.
The monoclonal antibody BT-062 is currently undergoing Phase I clinical
trials at four renowned cancer clinics in the USA to test the safety and
tolerability of the drug for use in humans and provide initial information
on its efficacy. Preparations are being made at present to extent the
clinical development programme to Europe.
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 S-DAX.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Michael Ramroth,
Tel: +49 (0) 6103 801-520,
e-mail: michael_ramroth@biotest.de
Fax: +49 (0) 6103 801-347
WKN, ISIN ordinary share: 522720, DE0005227201
WKN, ISIN preference share: 522723, DE0005227235
Listed: Prime Standard/official trading
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
15.12.2008 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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