Biotest proceeds into phase III programme in congenital fibrinogen deficiency
- Fibrinogen concentrate shows good efficacy and safety profile based on preliminary data
- Preliminary data on pharmacokinetic profile are comparable to licensed products
- German authority (Paul-Ehrlich-Institut) approved the extension of ongoing study to phase a I/III trial
Dreieich, 1 December 2015. Biotest finalised the phase I part of the ongoing phase I/II study in patients with congenital fibrinogen deficiency in which the distribution of the compound in the human body (pharmacokinetic) was analysed.
In the currently ongoing part II of the study, patients are being treated in case of acute bleeding or as prophylaxis if surgery is planned. So far, preliminary results show a very good therapeutic effect and a favourable safety profile.
The Paul-Ehrlich-Institut recently approved the extension of this study to a phase III trial by keeping the treatment regimen and extending the study to a larger patient population. This study will be the basis for the marketing authorisation application.
The fibrinogen market has continuously been growing in recent years due to a more customised coagulation therapy. This development has been driven by improved and faster bed side diagnostics, enabling physicians to better control bleeding complications.
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). The administration of Fibrinogen is based on the point-of-cared diagnostic data which allows a tailor-made, patient specific and highly effective therapy.
Biotest's fibrinogen concentrate
The recently developed manufacturing process of fibrinogen concentrate is leading to a high-purity fibrinogen with a high level of viral safety and good solubility.
About the study
The study was designed as a prospective, open-label, multicentre, phase I/III study investigating the 14 day single-dose pharmacokinetic properties, efficacy and safety of fibrinogen (BT-524) following intravenous administration in the treatment or prophylaxis of bleeding in patients with congenital fibrinogen deficiency (www.ClinicalTrials.gov: Identifier NCT02065882).
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,
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
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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.
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