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BT-062 demonstrates rapid and complete tumor eradication in preclinical studies

- Pronounced anti-tumor activity against aggressive solid tumors, e.g. human breast, pancreas, bladder and lung cancers in preclinical studies

- Data show efficacy in indications with a particularly high medical need

- Project proposal selected for application to center of excellence cluster CI3, an innovation initiative of the German Federal Ministry of Education and Research

Dreieich, Germany, 22 March 2012. Today Biotest announced pre-clinical data showing the efficacy of the immunoconjugate BT-062 against several types of solid tumors. These data indicate that the immunoconjugate might have a significant potential in the treatment of certain solid tumor types for which there is currently no adequate treatment option.

BT-062 is in clinical development in its lead indication multiple myeloma and two monotherapy clinical trials are ongoing. A third clinical trial investigating BT-062 for this cancer as part of a combination regimen was submitted to the FDA (Food and Drug Administration) in December 2011. In initial clinical testing, BT-062 has been found to provide evidence of clinical efficacy and good tolerability at doses up to 160 mg/m² at three-week intervals and 120 mg/m² given at days 1, 8 and 15 of a 4-week cycle.

In addition to multiple myeloma, many solid tumors over-express CD138, the target antigen (target on the tumor, to which BT-062 binds) of BT-062. Biotest therefore initiated pre-clinical studies to investigate the potential of BT-062 to treat such solid tumors. Within this context, mice implanted with patient derived tumors were treated with BT-062. For the study , Biotest used primary tumors of human origin to obtain the most relevant data on the anti-tumor activity of BT-062. The investigations were performed using human breast, pancreas, bladder, and lung carcinoma material.

The mice received BT-062 once weekly at alternative study doses (between 2 mg/kg to 13 mg/kg). BT-062 caused complete elimination of the tumors in all animals, with no recurrence of the tumors throughout the follow up periods. Especially striking results were obtained for triple negative breast cancer. These tumors do not respond to treatment with estrogen-, progesterone-, or HER2 (Herceptin2)-targeted therapies thus leaving few treatment options. In triple negative breast cancer models, BT-062 completely eradicated the tumor burden in all animals at doses starting well below of the maximum tolerated dose established in the multiple myeloma clinical trials. These results suggest effective treatment of such tumors can be achieved at doses that can be used in patients . Similar responses in comparable tumor model are rarely observed with other compounds, highlighting the potential of BT-062 for the treatment of malignancies with a high medical need.

'These are very exciting pre-clinical results which have not been demonstrated up to now with other compounds in our well characterized mammary cancer model MAXF 1322', said Prof. Heinz-Herbert Fiebig, an oncology expert from the university of Freiburg and CEO of Oncotest. These tumor models provided by Oncotest GmbH can be highly predictive for the clinical effect of the tested compound. Additionally Biotest submitted a project application for BT-062 to the center of excellence cluster CI3 Rhine-Main 'Individualized ImmuneIntervention' and passed the scientific review board successfully. CI3 is a cluster initiative of more than 100 partners of universities, biotechnology start-ups and pharmaceutical industry, which is supported by the German Federal Ministry of Education and Research. The focus of this initiative is a strengthening of innovations in Germany by building bridges between science and business in order to bring new technologies to the market. The CI3 cluster received amongst more than EUR 80 million of BMBF (German Federal Ministry of Education and Research) funding.

Biotest will continue to focus its resources on the development of BT-062 in the lead indication multiple myeloma. For the clinical development in solid tumor indications Biotest intends to collaborate with a strategic partner.

About BT-062:
BT-062 is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen, Inc. The antibody binds specifically to the antigen CD138, which is over-expressed on multiple myeloma cells and a variety of solid tumors.

Once the conjugate is internalized into the target cell, the DM4 is released from the targeting molecule, thereby restoring its original cytotoxic potency. This combination of high efficacy and specificity with low systemic toxicity sets BT-062 apart from most therapies currently used to treat multiple myeloma.

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 pharmaceutical 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 application of clinical immunology, haematology and intensive medicine. In its Plasma Protein segment, 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 the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
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