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Biotest AG: Major milestones achieved in the development of monoclonal antibodies. – Commencement of clinical development of BT-061.

Biotest AG / Miscellaneous



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Major milestones achieved in the development of monoclonal antibodies. –
Commencement of clinical development of BT-061.

Approval by regulatory authority to begin clinical development with BT-061.
Impressive efficacy of BT-062 in several animal models for Multiple Myeloma
- manufacturing agreement with CMC Biopharmaceuticals to provide antibody
for clinical trials.

Dreieich, December 21, 2006. Biotest AG, Dreieich, has today received the
approval to start with the clinical development of BT-061 by the
Paul-Ehrlich-Institute, Germany.

BT-061 is a monoclonal antibody that is in development for the indications
rheumatoid arthritis and psoriasis. After promising clinical data had been
generated with the precursor antibody of BT-061, during the past two years
Biotest, together with its partners, has successfully completed the
prerequisites to continue the clinical development. In collaboration with
Lonza the production process has been established and performed at large
scale at Lonza Biologics, Slough, UK. The material was successfully used in
preclinical studies that support the safety and efficacy of the compound.
The approval for clinical testing of BT-061 is the latest milestone reached
in the development of this new medical agent.

The other monoclonal antibody programmes conducted by Biotest also recorded
significant progress in 2006. BT-063, which is in development for Systemic
Lupus Erythematosus, has been humanised. Currently the biotechnological
production system, a necessity for the manufacturing of clinical material,
is being established.

For BT-062, the impressive effectiveness observed with the murine precursor
antibody, has recently been confirmed at the renowned Dana-Farber Cancer
Institute, Boston, with the humanised (chimerised) antibody. Research
performed at ImmunoGen Inc., Cambridge also supports these findings. As a
consequence, a manufacturing agreement for the production of clinical grade
material of BT-062 has now been signed with CMC Biopharmaceuticals A/S,
Copenhagen.

By combining BT-062 with ImmunoGen’s proprietary maytansinoid-based TAP
technology, Biotest develops a tumor specific antibody-directed therapeutic
agent for the treatment of multiple myeloma. BT-062 displays a mode of
action that is entirely different from classical chemotherapies. It is
expected that this currently incurable and aggressive bone marrow cancer
can be treated with high efficacy and specificity using this new drug. In
several preclinical experiments, malignant myeloma cells were destroyed
with high effectiveness.


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 immunoglobulines, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In addition, Biotest also researches into the
clinical development of monoclonal antibodies, including in the indications
of rheumatoid arthritis and blood cancer. The Diagnostic segment spans
reagents and serology and microbiology systems which are used, for example,
in blood transfusions. Biotest has around 1,100 employees worldwide and its
shares are listed in the Frankfurt Stock Exchange's Prime Standard.

Biotest AG: Tel. +49 6103 801-338
Fax: +49 6103 801-347, e-mail: michael_ramroth@biotest.de
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de

German Securities Code Number, ISIN ordinary shares: 522720, DE0005227201
German Securities Code Number, ISIN preferred shares: 522723, DE0005227235
Listed: Prime Standard/Official market
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart






DGAP 21.12.2006 
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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
WWW:          www.biotest.de
ISIN:         DE0005227201, DE0005227235
WKN:          522720, 522723
Indices:      
Listed:       Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
              Berlin-Bremen, Düsseldorf, Hamburg, Stuttgart
 
End of News                                     DGAP News-Service
 
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