DGAP-News: Biotest AG: Monoclonal antibody BT-061 shows efficacy in the indication psoriasis

ID: 1011472
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(businesspress24) - Biotest AG / Research Update

17.03.2010 11:59

Dissemination of a Corporate News, transmitted by
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Monoclonal antibody BT-061 shows efficacy in the indication psoriasisð§ Final results of Phase I/IIa trial in chronic plaque psoriasis show long-
lasting therapeutic effect after a single administration in the
relevant dose levels
ð§ Good safety confirmed by comprehensive testing
ð§ First patients treated in a new phase II trial with repeated dosing

Dreieich, 17 March 2009. Biotest reached another important milestone in the
development of its monoclonal antibody BT 061. The analysis of the final
unblinded data from a phase I/IIa clinical trial is now available. The
antibody has been tested in an placebo-controlled, single dose,
dose-escalation trial for the treatment of moderate to severe chronic
plaque psoriasis. This clinical trial has focussed on pharmacokinetic
properties of the antibody as well as its safety and efficacy.

In total, 55 patients have been treated of which 75% of the patients
received BT-061 and 25% received placebo. Theantibody was applied as
single dose either intravenous (IV) or subcutaneous (SC) with dose levels
ranging from 0.5 mg up to 25 mg (per dose level 7 or 8 patients).

Highest clinical efficacy, as measured by the PASI score,* was achieved
with subcutaneous application. There was at least 50% improvement in the
PASI (PASI 50) at day 75 in 60% of patients who received 25 mg BT-061 SC,
as compared with 25% of those who received placebo. At the same time, in
this dose group, 20% of patients receiving active drug had an improvement
of at least 75% (PASI 75). In the corresponding placebo group, no PASI 75


was observed.

The clinical response lasted in single patients for up to 90 days. Detailed
results of the trial will be presented at international scientific
congresses.

'We are encouraged to report the final data analysis which showed a very
promising improvement of the PASI score,' stated Dr. Frank Osterroth, Head
of Biotherapeutic segment at Biotest. 'Completion of this phase I/IIa trial
is of particular importance to the further development of BT-061 in the
indication Psoriasis.'

Comprehensive safety assessments were conducted by the Data Safety
Monitoring Board (DSMB) and by Biotest in agreement with
Paul-Ehrlich-Institute. Since no signs of risk became evident, dosage could
be increased to the highest scheduled dosage level.

In order to guarantee the highest level of safety for the patients, the
trial was subject to very strict inclusion and exclusion criteria. As a
consequence, a screening of 950 patients was necessary in order to enrol 55
patients in the trial. 'These high safety requirements were the main
reasons for the long duration of the trial,' said Dr. Osterroth.

Based on the highly promising data achieved after single administration, a
new phase II clinical trial has started in which BT-061 is given in
repeated doses. This trial is a placebo controlled trial in which patients
will be treated weekly for eight consecutive weeks in six different dose
groups. This trial, too, is placebo-controlled. Its aim is to gain more
insight into BT-061's safety andefficacy profile in repeated doses. In
addition, this study is designed to assess the most effectivedose for the
preferred subcutaneous application.

Further information
BT 061:
BT 061 enhances a natural mechanism of down regulating excessive immune
responses and is therefore developed to treat disease conditions that
originate from an overreaction of the immune system.

Currently, three clinical trials are ongoing in order to investigate the
clinical efficacy and safety of BT 061 in the lead indications Rheumatoid
Arthritis and Chronic Plaque Psoriasis. Based on the data obtained so far,
promising efficacy and an overall good safety and tolerability in both lead
indications could be demonstrated.

Plaque psoriasis:
Chronic plaque psoriasis affects 1-3 % of the population in Europe and
North America and is characterised by an excessive stimulation of growth of
the keratinocytes, the most frequent cell type in the epidermis (the top
layer of the skin). The clinical manifestation comprises large scaly and
itchy patches and redness of the skin. It is associated with an increased
prevalence of long-term complications such as psoriatic arthritis,
cardiovascular diseases or diabetes.

*The PASI (Psoriasis Area and Severity Index) is a globally accepted
measure for the assessment of extensive psoriasis. This measures the
average redness, thickness and scaliness of the psoriatic lesions (each
graded on a 0-4 scale), weighted by the area of involvement.

Disclaimer

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 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. Biotest has more than 1,900 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, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations(at)biotest.de
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


17.03.2010 11:59 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------

Language: English
Company: 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(at)biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
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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Date: 03/17/2010 - 06:59
Language: English
News-ID 1011472
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