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Biotest reaches the next milestone in the clinical development of its monoclonal antibody BT-063 by starting the clinical phase IIa trial in the indication systemic lupus erythematosus (SLE)

- First patient included and treated in the multicentric, placebo-controlled phase IIa trial

- SLE is an indication with high medical need

Dreieich, October 6, 2015. The phase IIa clinical study (Nr. 990) with the monoclonal antibody BT-063 in the lead indication systemic lupus erythematosus (SLE) has started with the first patient treated.

SLE is an autoimmune disease which may affect various organs. Chronic inflammation may occur resulting in potentially severe organ damage. Approximately 5 million people worldwide suffer from this autoimmune disease. Within the last 50 years, only one new drug has been approved for the treatment of SLE. Therefore, the medical need for new therapeutic options is high.

The monoclonal antibody BT-063 specifically neutralizes interleukin 10 (IL-10), which plays a crucial role in the development of the disease. With BT-063 Biotest pursues a completely new therapeutic approach to treat SLE patients. The safety of BT-063 has already been evaluated in a monocentric phase I study in healthy volunteers. In the currently initiated phase IIa study SLE patients in several European countries will be treated for three months with BT-063 (or placebo) in addition to their standard therapies. The primary goal of this clinical study is to investigate the safety and tolerability of the antibody in SLE patients. Furthermore, first data on efficacy of BT-063 in SLE patients are expected.

Pharmacological investigations will be conducted in parallel to the clinical study 990 to obtain a more detailed understanding of BT-063's mode of action. Together with the study data these data will provide the basis for the planning of future clinical trials with BT-063 in its lead indication SLE.

Dr. Andrea Wartenberg-Demand, Vice President Corporate Clinical Research at Biotest pointed out: "This is a major milestone in the clinical development of BT-063. In this clinical study with the humanized anti-IL-10 antibody, we hope to confirm the results regarding indications of efficacy and tolerability that were obtained during a previous study. We hope these results will bring us one step further in the development of a new therapeutic option to treat patients suffering from this serious disease."

About Biotest

Biotest AG 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 indication cancer of plasma cells and systemic lupus erythematosus (SLE), 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

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
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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.