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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 up to - EUR 30 million


Biotest AG / Key word(s): Research Update

2015-04-24 / 09:05



PRESS RELEASE

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 up to - EUR 30 million

- No safety concerns were noted for the BT-061 study

- AbbVie, will decide within 90 days whether to continue the co-development on tregalizumab (BT-061)

Dreieich, April 24, 2015 - Biotest today announced topline 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.

"We are disappointed that our Phase IIb study did not meet the primary endpoint" said Dr. Ehmer, CEO of Biotest. "We will receive the entire statistical analysis until end of May and will evaluate the data in depth to fully understand the outcomes of this trial. During the coming weeks we will discuss the results with external experts and our 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.

Conference call
Biotest will conduct a conference call open to analysts and investors today, Friday, April 24 at 11:00 CEST. To participate in the conference call please call one of the following numbers:

Germany: + 49 69 51 70 95 75
UK: + 44 20 3651 8923
USA East Cost: + 1 718 354 1291
USA West Coast: + 1 408 916 0665

Passcode: 391 29 084#

About Treat 2b
The Phase IIb study also known as TREAT 2b (T cell REgulating Arthritis Trial 2b) is a double blind, randomised and placebo-controlled trial with four treatment groups, evaluating the efficacy and safety of tregalizumab (BT-061) in patients with rheumatoid arthritis. In the active treatment groups and the main part of the study tregalizumab (BT-061) is administered at doses of 25, 100 and 200 mg subcutaneously once-weekly for a treatment duration of 24 weeks given in combination with methotrexate. Patients in the control arm receive methotrexate only. In patients who respond to treatment, the therapy can be extended for further six months in an 'extension phase'. More information can be found on clinicaltrials.gov (identifier NCT 01999192).

About Tregalizumab (BT-061)
Tregalizumab (BT-061) is a humanized monoclonal anti-CD4 antibody, which selectively activates regulatory T cells (Tregs). Tregalizumab (BT-061) thereby strengthens a natural function of the body that prevents excessive immune reactions. The antibody is being developed to treat diseases due to an overreaction of the immune system such as autoimmune diseases. Tregalizumab (BT-061) is currently in Phase IIb clinical development for rheumatoid arthritis.

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 biological 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.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany; www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@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
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart





2015-04-24 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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