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
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." 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 Germany: + 49 69 51 70 95 75 Passcode: 391 29 084# About Tregalizumab (BT-061) 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 AG, Landsteinerstr. 5, 63303 Dreieich, Germany; www.biotest.de Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 2015-04-24 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.medientreff.de and www.dgap.de |
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 | |
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