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Biotest to present data from TREAT 2b trial at The American College of Rheumatology (ACR) 2015 Annual Meeting

- Presentation of clinical results from TREAT 2b trial (T cell REgulating Arthritis Trial 2b), evaluating the efficacy, safety and tolerability of its investigational monoclonal antibody, Tregalizumab (BT-061), plus methotrexate combination therapy in patients with moderate to severe rheumatoid arthritis

- Preclinical studies are being performed in additional indication and form the basis for a partnering

Dreieich, 09 November 2015. Biotest announced yesterday that an oral presentation of the abstract for tregalizumab (BT-061) will be presented at the 2015 annual meeting of the American College of Rheumatology (ACR), taking place November 6-11, 2015 in San Francisco, California, USA.

Tregalizumab (BT-061) is an investigational, humanised anti-CD4 monoclonal antibody, inducing selective activation of regulatory T-cells. As announced on April 24, 2015, the phase 2b study (TREAT 2b) of tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis (RA) did not meet its primary endpoint.

Following a detailed analysis of the data, tregalizumab (BT-061) showed a dose-dependent effect on cells in the immune system which did not translate into marked clinical efficacy in rheumatoid arthritis. The good safety and tolerability profile could be confirmed. Pre-clinical studies are currently being performed in model systems to determine whether tregalizumab (BT-061) could be of benefit in other diseases with high medical need.

The abstract can be accessed on the ACR website at: http://www.acrabstracts.org

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy I: Biologics

Abstract 972: A Phase 2b Study Evaluating the Efficacy and Safety of Subcutaneously Administered Tregalizumab in Subjects with Active Rheumatoid Arthritis (RA) Despite Treatment with Methotrexate (MTX).

Oral presentation: November 8, 2015: 2.30 - 4.00 PM (PST)



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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 cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,200 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406
email: investor_relations@biotest.de

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