DGAP-News: Biotest AG: First patient treated with CivacirTM after Hepatitis C induced liver transplantation in Biotest's Phase III clinical trial
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: First patient treated with CivacirTM after Hepatitis C
induced liver transplantation in Biotest's Phase III clinical trial
05.08.2013 / 13:00
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PRESS RELEASE
First patient treated with CivacirTM after Hepatitis C induced liver
transplantation in Biotest's Phase III clinical trial
- 50% of liver transplantations are due to Hepatitis C infection
- High unmet medical need: Prevention of Hepatitis C virus recurrence in
liver transplant
- CivacirTM has an orphan drug designation in both the US and the EU
Dreieich, 05 August 2013. Biotest AG has achieved another milestone in the
development of intravenous hyperimmune globulins: After treatment with
virostatics over several weeks the first patient underwent liver
transplantation and subsequently was treated with the Hepatitis C
hyperimmune globulin CivacirTM in the Phase III clinical trial. CivacirTM,
the 10 % Hepatitis C hyperimmune globulin developed and produced at Biotest
Pharmaceuticals Corporation, a fully owned subsidiary of Biotest AG, has
started a clinical trial in North America in patients undergoing liver
transplantation as a consequence of Hepatitis C infection.
End-stage liver disease due to hepatitis C virus (HCV) is a common
indication for liver transplantation. However, newly transplanted livers
are rapidly infected by any Hepatitis C viruses which are still circulating
in the patient's body, resulting in a reinfection rate of around 80 %
within 4 weeks after transplantation. Currently, there is no approved
treatment available to prevent recurrence of the Hepatitis C virus after
surgery since current antiviral regimens can not be safely used after
surgery due to toxicities, tolerability issues and drug-drug interactions
within the first months after transplantation. Approximately 30% of these
patients require a second liver transplantation within 5 years.
The aim of this Phase III clinical trial (Study 988) is to evaluate the
efficacy and safety as well as the pharmacokinetics of the agent in the HCV
transplant population. The study is being conducted in sites in the US and
Canada, with a total up to 90 patients to be enrolled.
Market exclusivity for 7 and 10 years after approval in US and EU
respectively is ensured by the Orphan Drug designation.
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.
About Biotest
Biotest is a provider of plasma proteins 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
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 rheumatoid arthritis and cancer of plasma cells,
which are produced by recombinant technologies. Biotest has about 1.800
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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05.08.2013 Dissemination of a Corporate News, transmitted by DGAP - a
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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: 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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