Press Detail

/
PRESS RELEASE

Biotest AG starts combination therapy study with BT-062 in multiple myeloma

- Antibody-drug conjugate BT-062 continues to show good tolerability in monotherapy

- First patient treated in phase I/IIa combination therapy study (no. 983) in multiple myeloma

- Funding for further activities in solid tumours approved by excellence cluster CI3 Rhine-Main 'Individualized ImmuneIntervention'

Dreieich, Germany, 16 July 2012. Biotest AG is pursuing an innovative therapeutic strategy to treat multiple myeloma using the antibody-drug conjugate (ADC) BT-062.
BT-062 is currently in clinical development for treating patients with relapsed or relapsed/refractory multiple myeloma. Two clinical trials investigating different dose schedules of BT-062 as monotherapy have shown good tolerability and have provided evidence for anti-tumor activity.

Whereas treatment of 32 patients within the first monotherapy study 969 is finished, Biotest continues to investigate BT-062 as monotherapy in study 975. In study 975 about 50 patients with relapsed or relapsed/refractory multiple will be treated at a more frequent dose schedule, receiving intravenous administration of BT-062 on days 1, 8, and 15 every 4 weeks. The patient recruitment of the first seven dose levels has been completed. So far BT-062 continued to be well tolerated. In addition, initial evidence of efficacy was confirmed.

Combination therapies are widely used to treat multiple myeloma and other cancers to improve overall response rates. Preclinical studies using in vitro and in vivo animal models show a strong increase of efficacy when BT-062 is combined with widely used multiple myeloma drugs such as lenalidomide, suggesting an additive or even synergistic anti-tumor effect of such combinations in patients.

Currently, Biotest expands the clinical development of BT-062 into combination therapy. The phase I/IIa study (study no. 983) investigates safety and efficacy of BT-062 when administered on days 1, 8, and 15 every 4 weeks in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.A few days ago the first patient in study 983 started treatment.

Additionally, Biotest will receive funding to evaluate BT-062 in preclinical solid tumor models by the center of excellence cluster CI3 Rhein-Main 'Individualized ImmuneIntervention'. 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.

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

About Multiple Myeloma:
Multiple myeloma is a malignant and aggressive bone marrow disease for which no cure has been developed so far.

About BT-062:
BT-062 is an antibody-drug conjugate that consists of a monoclonal antibody attached by an engineered linker to a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen, Inc, Boston. 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 antibody, thereby restoring its original cytotoxic potency. This combination of 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 portfolio, 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. Biotest also develops monoclonal antibodies, including in the indications of rheumatoid arthritis and multiple myeloma. 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
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