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    BIO3   DE0005227235


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PRESS RELEASE : Biotest AG: Biotest accelerates fibrinogen phase III study with additional patient group

04/07/2021 | 01:02am EDT
DGAP-News: Biotest AG / Key word(s): Study 
Biotest AG: Biotest accelerates fibrinogen phase III study with additional patient group 
2021-04-07 / 07:00 
The issuer is solely responsible for the content of this announcement. 
Biotest accelerates fibrinogen phase III study with additional patient group 
- First patient of this group treated successfully 
- Important milestone for acceleration of the clinical development program for Fibrinogen 
- Excellent efficacy and tolerability confirmed 
- Results are the basis for the marketing authorization in Europe 
Dreieich, 7 April 2020. Biotest AG announces today that the first patient with pseudomyxoma peritonei (PMP) has been 
treated as part of the ongoing phase III trial for the treatment of severe bleeding in the case of acquired fibrinogen 
deficiency (AdFIrst study no. 995). PMP is a rare malignant and painful tumor in the abdominal cavity. During a 
surgical procedure, the tumor tissue is removed, which could lead to high blood loss and thus to the loss of the body's 
own fibrinogen. In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has 
developed the fibrinogen concentrate BT524. The efficacy and tolerability of BT524 are investigated in the AdFIrst 
study (Adjusted Fibrinogen Replacement Strategy) in comparison to the standard therapy, consisting of blood plasma 
preparations (frozen fresh plasma and cryoprecipitate). 
The AdFIrst study is a prospective, randomized, active-controlled, multicenter phase III study that investigates the 
efficacy and tolerability of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency. Patients 
who have a high level of blood loss during a planned spinal or abdominal surgery are included. 
With the AdFIrst study in acquired fibrinogen deficiency, Biotest is further expanding its development program for the 
fibrinogen concentrate BT524. The phase I/III study no. 984 for the treatment of patients with congenital fibrinogen 
deficiency was already completed successfully in May 2020. The results of both studies will serve as the basis for the 
marketing authorization of fibrinogen concentrate BT524 for the treatment of patients with congenital and acquired 
fibrinogen deficiency. 
About Biotest's fibrinogen concentrate 
The newly developed manufacturing process of the fibrinogen concentrate leads to high-purity fibrinogen with a defined 
concentration, high level of viral safety and good solubility. 
About study no. 995 / 
The AdFIrst study is a prospective, active-controlled, multicentre phase III study investigating the efficacy and 
safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency. Patients who have high 
blood loss during planned spinal and abdominal surgery are randomised 1:1 to treatment with BT524 or FFP/ 
Cryoprecipitate. To evaluate the efficacy, further blood loss is compared between the both treatment options. Further 
information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). 
About fibrinogen and fibrinogen deficiency 
Fibrinogen is a blood 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. To date, these 
patients have been treated mainly with fresh frozen plasma (FFP), but this contains variable amounts of fibrinogen and 
must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate now allows a 
tailor-made, patient specific and highly effective therapy. 
About Biotest 
Biotest 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 care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin 
based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more 
than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on 
the German stock exchange. 
IR contact 
Dr Monika Buttkereit 
Phone: +49-6103-801-4406 
Mail: investor_relations@biotest.de 
PR contact 
Dirk Neumüller 
Phone: +49-6103-801-269 
Mail: pr@biotest.com 
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com 
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201 
Preference shares: securities' ID No. 522723; ISIN DE0005227235 
Listing: Frankfurt (Prime Standard) 
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate 
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. 
2021-04-07 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
Language:     English 
Company:      Biotest AG 
              Landsteinerstraße 5 
              63303 Dreieich 
Phone:        0 61 03 - 8 01-0 
Fax:          0 61 03 - 8 01-150 
E-mail:       investor_relations@biotest.de 
Internet:     http://www.biotest.de 
ISIN:         DE0005227235, DE0005227201 
WKN:          522723, 522720 
Listed:       Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, 
              Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange 
EQS News ID:  1181473 
End of News   DGAP News Service 

1181473 2021-04-07

(END) Dow Jones Newswires

April 07, 2021 01:01 ET (05:01 GMT)

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