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

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]

Biotest generates revenues of EUR 377.8 million in the ...

14.11.2017,

PRESS RELEASEBiotest generates revenues of EUR 377.8 million in the first nine months 2017- Successful regulatory inspection and approval of Biotest Next Level in August- Paul-Ehrlich Institute approv ... [More]

Tender Offer by Tiancheng (Germany) Pharmaceutical Hold...

07.11.2017,

/Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Tender Offer by Tiancheng (Germany) Pharmaceutical Holdings AG / Tiancheng withdrawal of application of transa ... [More]

Biotest AG opens eighth plasma collection centre in Hun...

06.11.2017,

/PRESS RELEASEBiotest AG opens eighth plasma collection centre in Hungary- 17 plasma collection centres in Europe and- 22 in the USA to ensure long-term plasma supplyDreieich, 6 November 2017. Biotest ... [More]

Correction of a release from 24.10.2017, 10:28 CET/CEST...

26.10.2017,

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 26, Section 1 of the WpHG ...

24.10.2017,

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 X Acquisition/d ... [More]

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

19.10.2017,

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 X Acquisition/d ... [More]

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

18.10.2017,

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]

Correction of a release from 16.10.2017, 12:50 CET/CEST...

17.10.2017,

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 26, Section 1 of the WpHG ...

16.10.2017,

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 26, Section 1 of the WpHG ...

13.10.2017,

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]

Biotest strengthens its position in the German haemophi...

11.10.2017,

/PRESS RELEASEBiotest strengthens its position in the German haemophilia market with the introduction of new patient support services- Biotest supports home treatment with a team of specialised nurses ... [More]

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

30.08.2017,

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

Preliminary announcement of the publication of quarterl...

23.08.2017,

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,

/PRESS RELEASEBiotest 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 ... [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