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Biotest AG: First patient treated with CivacirTM after Hepatitis C induced liver transplantation in Biotest's Phase III clinical trial


Biotest AG / Key word(s): Research Update

05.08.2013 / 13:00



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@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



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