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Biotest AG: Biotest starts clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding

Biotest AG / Key word(s): Miscellaneous

06.12.2012 / 10:40


Biotest starts clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding

- Approval of study protocol to conduct a phase I/II clinical trial

- Treatment of first patient with congenital fibrinogen deficiency is expected shortly

Dreieich, 6. December 2012. After approval of the study protocol Biotest will start clinical development of its new human fibrinogen concentrate with the inclusion of the first patient shortly.

This study investigates whether congenital fibrinogen deficiency can be compensated by the administration of fibrinogen concentrate. Moreover, the study will examine to what extent the administration of fibrinogen concentrate can stop acute bleeding in patients with such a deficiency. Approximately 20 patients in the age between 6 and 75 will be included in this multinational phase I/II study, which will be conducted in several countries.

A follow-up study will examine the efficacy of fibrinogen concentrate in treating serious, acquired bleeding complications, which can occur for example during cardio-surgical interventions and/or atonic bleeding after childbirth.

Only recently diagnostic test methods are available for the determination of fibrinogen deficiency in the surgery and emergency room (point-of-care diagnostics). Thus, for the first time a targeted and prompt administration of clotting factors during surgery is feasible. As a consequence the demand for fibrinogen is increasing tremendously. The global market for fibrinogen for the treatment of serious, acquired bleeding is estimated EUR 530 million. Biotest aims to cover approximately 20% of the global market with its proprietary development, thus generating additional turnover of EUR 100 million.

About fibrinogen and fibrinogen deficiency

Fibrinogen is a clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood's ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. So far, these patients have been treated primarily with fresh frozen plasma (FFP). Fibrinogen administration based on the point-of-cared diganostic data allows for the first time a tailor-made, patient specific and higly effective therapy.

Biotest's fibrinogen concentrate

The recently developed manufacturing process is leading to a high-purity fibrinogen with a high level of viral safety and good solubility.

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 researches into the 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, 63303 Dreieich,
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
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

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