Biotest AG, DE0005227235

Biotest AG, DE0005227235

06.12.2016 - 07:02:39

Biotest AG: Encouraging data of Indatuximab Ravtansine in combination therapy in advanced Multiple Myeloma

/ PRESS RELEASE

Encouraging data of Indatuximab Ravtansine (BT-062) in combination therapy in advanced Multiple Myeloma

- New data from BT-062 in combination therapy presented at 58th annual conference of the American Society of Hematology

- Clinical benefit seen in large majority of patients with advanced multiple myeloma

- Very good response achieved in patients who did not respond adequately to prior therapies

Dreieich, 6 December 2016. Biotest presented new clinical data derived from an ongoing combination study with BT-062 at the 58th annual meeting of the American Society of Hematology (ASH) in San Diego. The Phase I/IIa study (Study 983) is investigating the safety and efficacy of BT-062 in combination with lenalidomide or pomalidomide and dexamethasone in patients with multiple myeloma who have not been responding (any more) to previous treatments. Multiple myeloma is an incurable malignant hematologic disease and despite new treatment options patients finally relapse.

In the study, a total of 64 patients were treated with BT-062, used in combination with lenalidomide and dexamethasone (47 patients) or pomalidomide and dexamethasone (17 patients). Enrollment into the study is completed. Patients are treated until progression of multiple myeloma or intolerance. 11 of the 64 heavily pretreated patients enrolled are currently still on treatment, partly for up to 42 months.

Currently available efficacy data were evaluated from 43 patients treated with BT-062 in combination with lenalidomide and dexamethasone, who had received at least two complete treatment cycles. 77% of these heavily pretreated patients had an objective response, achieving a partial response or better. Even in 13 patients previously treated with both lenalidomide and bortezomib and who did not respond adequately to the last therapy, an objective response rate of 54% was obtained. This patient population, known to usually have a poor response to treatment, was selected for a treatment with BT-062 in combination with pomalidomide and dexamethasone. Among 14 patients having completed at least 2 treatment cycles, 11 patients achieved a partial or very good partial response, resulting in an objective response rate of 79%.

The available data indicates that BT-062 at doses up to 100 mg/m² is well tolerated in both combination regimens.

Data from the study suggests that BT-062 in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone may provide additional treatment options for patients with advanced multiple myeloma. BT-062 in combination with pomalidomide and dexamethasone seems particularly suitable for patients usually known to have a poor outcome. These encouraging data support further investigation in larger clinical studies. Biotest is currently looking for a partner for further development of this promising compound, which is also being investigated in a clinical study in solid tumors.

Further information is available on the Biotest website: http:// www.biotest.de/ww/en/pub/biotherapeutics/publications.cfm

About BT-062 BT-062 (indatuximab ravtansine) is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the ADC 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 releasing it in its fully- potent state. This combination of high efficacy and specificity with low systemic toxicity sets BT-062 apart from most therapies currently used to treat multiple myeloma.

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 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

IR contact Dr. Monika Buttkereit phone: +49-6103-801-4406 email: investor.relations@biotest.com

PR contact Dirk Neumüller phone: +49-6103-801-269 email: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201 Preference shares: securities' ID No. 522723; ISIN DE0005227235 Listing: Prime Standard Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart

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.

06.12.2016 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. Archive at 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, Hanover, Munich, Stuttgart, Tradegate Exchange End of News DGAP News Service

526807 06.12.2016

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