Development pipeline

Fibrinogen (BT-524)

Biotest's novel fibrinogen concentrate (BT-524) is purified from human plasma.

Fibrinogen is a plasmatic coagulation protein produced in the liver and is not only essential, but is also one of the most important factors of the clotting cascade. Upon conversion into fibrin it takes on a crucial role in clot formation and haemostasis. In case of fibrinogen deficiency the blood’s ability to form a clot is impaired, which leads to a greatly increased risk of critical bleeding and additionally to a delay in bleeding cessation.

In the case of severecongenital fibrinogen deficiency patients' ability to produce sufficient levels of functional fibrinogen is impaired or absent. These patients require frequent injections of fibrinogen concentrate. In acquired fibrinogen deficiency patients lose endogenous fibrinogen, which can lead to uncontrolled bleeding. A frequent cause is high blood loss during complex surgery but also as a result of severe traumatic injuries. In this case fibrinogen must be administered intravenously to stop the bleeding by increasing fibrinogen above the critical level.

Biotest's fibrinogen concentrate is currently being investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency. A Phase III study in acquired fibrinogen deficiency for patients with high blood loss is in preparation and is estimated to recruit the first patients at the end of 2017.

Press releases

Biotest AG: Annual general meeting approves payout of d...

30.08.2017, News

Biotest AG: Annual general meeting approves payout of dividend - Dividend payout of EUR 0.05 per ordinary share and EUR 0.07 per preference share Dreieich/ Frankfurt a. M., 30 August 2017. At the ... [More]

DGAP-AFR: Biotest AG: Preliminary announcement of the p...

23.08.2017, AFR

Biotest AG hereby announces that the following financial reports shall be disclosed for the business year 2017: Report: Quarterly financial report within the 2nd half-year (Q3) Date of disclosure ... [More]

Biotest reported sales of EUR 247.1 million in the firs...

14.08.2017, News

Biotest reported sales of EUR 247.1 million in the first half of 2017 - Successful building inspection of the new building at Dreieich - Closing of the Public Takeover Offer is subject to the ... [More]

Biotest takes over Cara Plasma s.r.o. with one plasma c...

19.07.2017, News

Biotest takes over Cara Plasma s.r.o. with one plasma collection centre in the Czech Republic - Long-term plasma supplier Cara Plasma was taken over by Biotest - Biotest has now 16 plasma ... [More]

Biotest reaches 2nd milestone in Biotest Next Level exp...

22.06.2017, News

Biotest reaches 2nd milestone in Biotest Next Level expansion project - Authorities grant building approval - Relocation activities of laboratories and offices for production start in June ... [More]

Biotest AG shareholders accept voluntary public tender ...

14.06.2017, News

Biotest AG shareholders accept voluntary public tender offer by CREAT Group Dreieich, 14 June, 2017. The shareholders of Biotest AG have accepted the voluntary public tender offer by Tiancheng ... [More]

Release according to Article 26, Section 1 of the WpHG ...

12.06.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification Acquisition/disposal of shares ... [More]

Biotest sold US therapy business to ADMA Biologics, Inc...

07.06.2017, News

Biotest sold US therapy business to ADMA Biologics, Inc. - Biotest receives 50% minus one share of ADMA - Biotest receives also distribution rights of specified current product and a right of ... [More]

Release according to Article 26, Section 1 of the WpHG ...

06.06.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification Acquisition/disposal of ... [More]

Release according to Article 26, Section 1 of the WpHG ...

01.06.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification Acquisition/disposal of ... [More]

Release according to Article 26, Section 1 of the WpHG ...

01.06.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification Acquisition/disposal of ... [More]

Joint reasoned statement of Biotest AG - Management Boa...

01.06.2017, News

Joint reasoned statement of Biotest AG - Management Board and Supervisory Board recommend to accept tender offer of CREAT Group Dreieich, 1 June, 2017. Today, the Management Board and Supervisory ... [More]

Release according to Article 26, Section 1 of the WpHG ...

24.05.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification Acquisition/disposal of ... [More]

Publication of the offer document on the voluntary publ...

18.05.2017, News

Publication of the offer document on the voluntary public tender for Biotest AG by CREAT Group - Offer document reaffirms the offer announced on April 7, 2017 - The Management Board and the ... [More]

DGAP-AFR: Biotest AG: Preliminary announcement of the p...

17.05.2017, AFR

Biotest AG hereby announces that the following financial reports shall be disclosed : Report: Financial report (half-year/Q2) Date of disclosure / German: August 14, 2017 Date of disclosure / ... [More]

Biotest AG opens seventh plasma collection centre in Hu...

16.05.2017, News

Biotest AG opens seventh plasma collection centre in Hungary - 15 plasma collection centres in Europe and - 22 in the US to ensure long-term plasma supply Dreieich, 16 May 2017. Biotest ... [More]

Biotest reports revenue of EUR 110 million in the first...

10.05.2017, News

Biotest reports revenues of EUR 110.5 million in the first quarter 2017 Dreieich, 10 May 2017. In the first quarter of 2017, the Biotest Group generated sales of EUR 110.5 million, after EUR 133.6 ... [More]

Correction of a release from 07.04.2017, 15:23 CET/CEST...

04.05.2017, PVR

Correction of a notification of Major Holding published on 07.04.2017 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for ... [More]

Release according to Article 26, Section 1 of the WpHG ...

28.04.2017, PVR

Notification of Major Holdings 1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of ... [More]

Voluntary recall of human albumin

26.04.2017, News

Biotest: Voluntary recall of human albumin - Already quarantined batches of human albumin are recalled - Consequences of the one-time effect on Sales and EBIT are currently being evaluated - As ... [More]

Clinical trials

Title

Indication

Status

 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Study ongoing

A prospective, open-label, uncontrolled, single dose phase I/III study investigating pharmacokinetic properties, efficacy, safety, and tolerability of BT524 (fibrinogen concentrate from human plasma) in patients with congenital fibrinogen deficiency

Link clinicaltrials.gov
 
Fibrinogen (Study 995) Congenital fibrinogen deficiency Study ongoing

A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major spine surgery (AdFIrst).

Clinicaltrialsregister.eu