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Biotest AG / Miscellaneous


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Clinical development of BT-063 started

- Monoclonal antibody for the lead indication systemic lupus erythematosus
- Phase I clinical trial with 24 healthy volunteers started
- All three antibodies in the Biotest pipeline now in clinical development

Dreieich, 30 September 2009. Biotest AG has achieved a further milestone in
the development of monoclonal antibodies (mAb). The antibody BT-063 has
entered clinical development. Following approval of the Phase I clinical
trial by the competent authority and the ethics committee, the antibody has
now been administered to the first healthy volunteer. This means that all
three mAb in Biotest's pipeline are now in clinical development.

BT-063 is being developed for the lead indication of systemic lupus
erythematosus (SLE). The monoclonal antibody specifically neutralises a
cell growth factor which plays an important role in the development and
symptoms of the disease. The monocentric Phase I study will involve 24
healthy volunteers. The aim of this unblinded clinical trial is to evaluate
safety and tolerability of the agent in humans as part of a dosage
escalation scheme.

SLE is an autoimmune disease, which causes chronic connective tissue and
vascular inflammation and potentially affects various organs in the body,
leading to a clinical picture with severe to fatal outcome. For reasons as
yet unknown, in SLE, the immune system identifies the body's own tissue as
foreign and attacks it. As a result, areas of the body can become
chronically inflamed resulting in damage of the tissue. In the medium term,
this might cause serious complications or even death.

The other mAbs in Biotest's pipeline are BT-061 (lead indications are
rheumatoid arthritis and psoriasis) and BT-062 (multiple myeloma). Clinical
trials up to and including Phase II are currently ongoing for these


This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and assets
position 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
significant 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 is a provider of pharmaceutical and biotherapeutic drugs as well as
reagents and systems for diagnostics and microbiology. With a value added
chain that extends from pre-clinical and clinical development to worldwide
sales, Biotest has specialised primarily in the areas of application of
immunology and haematology. In its Plasma Protein segment, Biotest develops
and markets immunoglobulins, coagulation factors and albumins based on
human blood plasma. These are used for diseases of the immune and
haematopoietic systems. In the Biotherapeutic segment, Biotest researches
into the clinical development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and cancer of plasma cells. The
products of the Microbiological Monitoring segment are primarily used in
hygiene monitoring, while those of Medical Diagnostics are used, for
example, in blood transfusions and transplants. Biotest has more than 2,000
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich,
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
fax: +49 (0) 6103 801-347

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard/Official traded
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart

30.09.2009 Financial News transmitted by DGAP

Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, Hamburg, Stuttgart

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