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Biotest AG: Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe rheumatoide Arthritis did not meet the primary endpoint - potential one time effect of - EUR 30 million

Biotest AG  / Key word(s): Research Update

24.04.2015 09:00

Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
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The issuer is solely responsible for the content of this announcement.

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Ad-hoc RELEASE
Announcement according to § 15 Sec. 1 Securities Trading Act (WpHG)

Biotest Phase IIb study of Tregalizumab (BT-061) in moderate to severe
rheumatoide Arthritis did not meet the primary endpoint  - potential one
time effect of - EUR 30 million

Dreieich, April 24, 2015 - Biotest today announced top line results from
the TREAT 2b study [T cell REgulating Arthritis Trial 2b], evaluating the
efficacy, safety and tolerability of its investigational monoclonal
antibody tregalizumab (BT-061) in patients with moderate to severe
rheumatoide Arthritis. Initial results indicated that none of the three
dosing arms of tregalizumab showed a statistically significant improvement
in ACR 20 scores when compared to placebo, the primary efficacy end point
of the trial at week 12.

Patient safety in the TREAT IIb trial was monitored frequently by an
independent data safety monitoring board (DSMB) and no safety concerns were
noted for the study.

Dr. Ehmer, CEO of Biotest, says that he is disappointed that the Phase IIb
study did not meet the primary endpoint. The entire statistical analysis
will be available until end of May and the data will be evaluated in depth
to fully understand the outcomes of this trial. Over the coming weeks the
results will be discussed with external experts and the collaboration
partner AbbVie.

Biotest is in the process of sharing the data with AbbVie, who will decide
within 90 days whether to continue the co-development on tregalizumab.

More detailed results from the TREAT IIb trial will be submitted for
publication in a peer reviewed journal and for presentation on upcoming
scientific meetings.

If the evaluation leads to a decision to discontinue the development of
tregalizumab, Biotest's earnings would be reduced by EUR 25-30 million in
2015.

Biotest Aktiengesellschaft
The Executive Management Board

Biotest AG
Landsteinerstr. 5
D-63303 Dreieich
www.biotest.de

 
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 plasma proteins and biotherapeutic drugs. With a
value added chain that extends from pre-clinical and clinical development
to worldwide sales, Biotest has specialised primarily in the areas of
clinical immunology, haematology and intensive medicine. 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 addition Biotest develops monoclonal antibodies
in the indications of rheumatoid arthritis and cancer of plasma cells,
which are produced by recombinant technologies. Biotest has more than 2,100
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
München, Stuttgart


24.04.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
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Language:     English
Company:      Biotest AG
              Landsteinerstraße 5
              63303 Dreieich
              Germany
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:         DE0005227235, DE0005227201
WKN:          522723, 522720
Indices:      SDAX
Listed:       Regulated Market in Frankfurt (Prime Standard); Regulated
              Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart
 
End of Announcement                             DGAP News-Service
 
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