15.03.2018
Biotest AG DE0005227235
DGAP-News: Biotest AG: First patient with acquired fibrinogen deficiency treated in clinical phase III study of Biotest AG
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: First patient with acquired fibrinogen deficiency treated in
clinical phase III study of Biotest AG
15.03.2018 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
First patient with acquired fibrinogen deficiency treated in clinical phase
III study of Biotest AG
- Important milestone reached in the clinical development programme of
fibrinogen concentrate
- Phase III study in acquired fibrinogen deficiency approved by European
regulatory authorities and ethics committees
- The results will be the basis for marketing authorisation in Europe
Dreieich, 15 March 2018. Biotest AG today announces that the first patient
in the pivotal phase III study in patients with acquired fibrinogen
deficiency (study no. 995) has been treated.
The ADFIRST (Adjusted Fibrinogen Replacement Strategy) study recruits
patients who lose the body's own coagulation factor fibrinogen due to major
blood loss during a planned spinal surgery. To compensate this fibrinogen
deficiency and to halt such bleedings effectively Biotest has developed the
fibrinogen concentrate BT524. In ADFIRST, the efficacy and safety of BT524
are being studied and compared with the standard therapy fresh frozen
plasma.
The study design was coordinated with the European Medicines Agency (EMA)
and the study has been approved by European authorities and ethics
committees. It is planned to conduct the study in about 200 patients in a
total of 15 study sites in Germany, Spain, Belgium, Switzerland and Poland.
With the start of the ADFIRST study in acquired fibrinogen deficiency
Biotest is further expanding the development programme of its fibrinogen
concentrate BT524. The ongoing phase I/III study no. 984 in patients with
acquired fibrinogen deficiency is proceeding as planned. Based on the first
preliminary results, the EMA has agreed on the paediatric investigation plan
for treatment of children below 6 years in this study.
The results of both studies will serve as a basis for the marketing
authorisation of fibrinogen concentrate BT524 for treatment of patients with
congenital and acquired fibrinogen deficiency.
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'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 elective spinal surgery are randomised 1:1 to
treatment with BT524 or FFP. To evaluate efficacy, further blood loss is
then compared between the two treatments. Further information about the
study design can be found at www.clinicaltrialsregister.eu (EudraCT number:
2017-001163-20).
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 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
indications of cancer of plasma cells and systemic lupus erythematosus which
are produced by recombinant technologies. Biotest has more than 1,600
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.
IR contact
Dr. Monika Buttkereit
Phone: +49-6103-801-4406
Mail: [email protected]
PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: [email protected]
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
Disclaimer
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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15.03.2018 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.
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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