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 severe congenital 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

Large data analysis for DSA after lung transplantation ...

29.05.2018,

/PRESS RELEASELarge data analysis for DSA after lung transplantation confirms impressive therapy outcome with Pentaglobin(R)- The development of donor specific antibodies (DSA) can lead to graft rejec ... [More]

Efficacy and safety of Cytotect(R) CP was demonstrated ...

23.05.2018,

/PRESS RELEASEEfficacy and safety of Cytotect(R) CP was demonstrated in patients after stem cell transplantation- 78% of "difficult-to-treat" patients responded to Cytotect(R) CP administration- 70% o ... [More]

Biotest increases revenues in the first quarter 2018 by...

15.05.2018,

PRESS RELEASEBiotest increases revenues in the first quarter 2018 by 34%- Guidance confirmed- Q1 EBIT totalled to EUR -3.0 million after EUR-33.2 million in Q1 2017Dreieich, 15 May 2018. In the first ... [More]

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

15.05.2018,

PRESS RELEASEBiotest AG: Annual general meeting approves payout of dividend- Dividend payout of EUR 0.04 per preference shareDreieich/ Frankfurt a. M., 15 May 2018. At the annual general meeting (AGM) ... [More]

New data from Biotest's monoclonal antibody-drug-conjug...

03.05.2018,

PRESS RELEASENew data from Biotest's monoclonal antibody-drug-conjugate (ADC) BT-062 in the therapy of solid tumors- Good tolerability and signs of efficacy in phase I/IIa clinical study- Very good ef ... [More]

Biotest reaches 2017 profit guidance

22.03.2018,

PRESS RELEASEBiotest reaches 2017 profit guidance- Adjusted EBIT stable- Five new plasmapheresis centres opened in Europe- Biotest Next Level: building acceptance obtained and successful "Good Manufac ... [More]

First patient with acquired fibrinogen deficiency treat...

15.03.2018,

PRESS RELEASEFirst patient with acquired fibrinogen deficiency treated in clinical phase III study of Biotest AG - Important milestone reached in the clinical development programme of fibrinogen conce ... [More]

Biotest supports a large international registry study t...

13.03.2018,

PRESS RELEASE Biotest supports a large international registry study to record data on use of Pentaglobin(R) in patients with severe bacterial infections- High medical need due to high mortality a ... [More]

Biotest reaches FY 2017 EBIT guidance

27.02.2018,

Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Biotest reaches FY 2017 EBIT guidanceDreieich, 27 February 2018. According to preliminary and unaudited figures ... [More]

Tiancheng intends to enter into a domination and profit...

08.02.2018,

Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Tiancheng intends to enter into a domination and profit and loss transfer agreement with Biotest AGDreieich, 8 ... [More]

Release according to Article 40, Section 1 of the WpHG ...

02.02.2018,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Release according to Article 40, Section 1 of the WpHG ...

01.02.2018,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Creat takeover of Biotest closed

31.01.2018,

/PRESS RELEASE Creat takeover of Biotest closed- Transfer of tendered shares completed- Majority shareholding (approx. 90% of Biotest AG's ordinary shares and voting share capital) of Creat in Bi ... [More]

Biotest AG opens second plasma collection centre in Cze...

24.01.2018,

/PRESS RELEASEBiotest AG opens second plasma collection centre in Czech Republic- 19 plasma collection centres in Europe to ensure long-term plasma supplyDreieich, 24 January 2018. Biotest received an ... [More]

All conditions met for Creat takeover of Biotest

19.01.2018,

/Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)All conditions met for Creat takeover of BiotestDreieich, 19. January 2018. Biotest AG disclosed today that fo ... [More]

Release according to Article 40, Section 1 of the WpHG ...

11.01.2018,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Trimodulin: concept for phase III study successfully co...

20.12.2017,

/PRESS RELEASETrimodulin: concept for phase III study successfully coordinated with the authorities- Clinical concept of the Phase III study is supported by the regulatory authorities- Optimized produ ... [More]

Preliminary announcement of the publication of financia...

06.12.2017,

Biotest AG hereby announces that the following financial reports shall be disclosed : Report: Annual financial report Date of disclosure / German: March 22, 2018 Date of disclosure / English: March ... [More]

Preliminary announcement of the publication of quarterl...

06.12.2017,

Biotest AG hereby announces that the following financial reports shall be disclosed : Report: Quarterly financial report within the 1st half-year (Q1) Date of disclosure / German: May 15, 2018 Date ... [More]

Biotest supports a randomized multicenter controlled tr...

05.12.2017,

/PRESS RELEASEBiotest supports a randomized multicenter controlled trial in peritonitis (PEPPER trial) with Pentaglobin(R) lead by Aachen University- Trial investigates personalized treatment approach ... [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