DGAP-News: Biotest AG: Biotest starts clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Miscellaneous
Biotest AG: Biotest starts clinical development programme of human
fibrinogen concentrate to treat serious, life-threatening bleeding
06.12.2012 / 10:40
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PRESS RELEASE
Biotest starts clinical development programme of human fibrinogen
concentrate to treat serious, life-threatening bleeding
- Approval of study protocol to conduct a phase I/II clinical trial
- Treatment of first patient with congenital fibrinogen deficiency is
expected shortly
Dreieich, 6. December 2012. After approval of the study protocol Biotest
will start clinical development of its new human fibrinogen concentrate
with the inclusion of the first patient shortly.
This study investigates whether congenital fibrinogen deficiency can be
compensated by the administration of fibrinogen concentrate. Moreover, the
study will examine to what extent the administration of fibrinogen
concentrate can stop acute bleeding in patients with such a deficiency.
Approximately 20 patients in the age between 6 and 75 will be included in
this multinational phase I/II study, which will be conducted in several
countries.
A follow-up study will examine the efficacy of fibrinogen concentrate in
treating serious, acquired bleeding complications, which can occur for
example during cardio-surgical interventions and/or atonic bleeding after
childbirth.
Only recently diagnostic test methods are available for the determination
of fibrinogen deficiency in the surgery and emergency room (point-of-care
diagnostics). Thus, for the first time a targeted and prompt administration
of clotting factors during surgery is feasible. As a consequence the demand
for fibrinogen is increasing tremendously. The global market for fibrinogen
for the treatment of serious, acquired bleeding is estimated EUR 530
million. Biotest aims to cover approximately 20% of the global market with
its proprietary development, thus generating additional turnover of EUR 100
million.
About fibrinogen and fibrinogen deficiency
Fibrinogen is a 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. So far, these patients have been treated primarily
with fresh frozen plasma (FFP). Fibrinogen administration based on the
point-of-cared diganostic data allows for the first time a tailor-made,
patient specific and higly effective therapy.
Biotest's fibrinogen concentrate
The recently developed manufacturing process is leading to a high-purity
fibrinogen with a high level of viral safety and good solubility.
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.
Biotestdoes not intend to update the forward-looking statements and
assumes no obligation to do so.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic 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
application of clinical immunology, haematology and intensive medicine. In
its Plasma Protein portfolio 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. Biotest also
researches into the development of monoclonal antibodies, including in the
indications of rheumatoid arthritis and cancer of plasma cells. Biotest has
more than 1.600 employees worldwide. The preference shares of Biotest AG
are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations(at)biotest.de
fax: +49 (0) 6103 801-347
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
München, Stuttgart
End of Corporate News
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06.12.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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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: investor_relations(at)biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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196110 06.12.2012
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Datum: 06.12.2012 - 10:40 Uhr
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News-ID 210218
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