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Biotest AG. (11/10/14). "Press Release: Very Good Results of Civacir (Hepatitis C Immune Globulin) US Phase III Clinical Trial". Dreieich.

Region Region United States (USA)
Organisations Organisation Biotest Pharmaceuticals Corporation
  Group Creat (Group)
  Organisation 2 American Association for the Study of Liver Disease (AASLD)
Products Product Civacir™ (10% Hepatits C hyperimmune globulin)
  Product 2 transplantation
Persons Person Schulz, Gregor (Biotest 201212 CEO)
  Person 2 Buttkereit, Monika (Biotest 201308 Head of Investor Relations)

- Preliminary data presented at the Congress of the American Association for the Study of Liver Disease (AASLD) show prevention of re-infection after liver-transplantation

- More than 50% of study patients have been enrolled in the Civacir Phase III trial

Biotest AG announced yesterday in an oral presentation the efficacy and safety interim results from its ongoing US Phase III study (Study 988) with Civacir at the Congress of the American Association of the Study of Liver Disease (AASLD) in Boston, Massachusetts, USA.

Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG) is the only manufacturer of an investigational Hepatitis C immune globulin (Civacir(R)) worldwide. In the ongoing Phase III trial, Civacir(R) is being investigated in patients who receive a liver transplant due to chronic hepatitis C infection.

End-stage liver disease due to hepatitis C infection is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by hepatitis C viruses which are still circulating in the patient's body.
Currently, there is no approved treatment available to prevent recurrence of the hepatitis C virus after transplant surgery since current antiviral regimens are generally not used due to toxicities, tolerability issues and drug-drug interactions minimum within the first 6 months after transplantation. Approximately 30% of liver transplant patients require a second liver transplant within 5 years.

This randomized, open-label Phase III trial conducted in 24 clinical centers in the United States is to evaluate the efficacy, safety and pharmacokinetics in the hepatitis C positive transplant population. More than half of the planned patient number has been enrolled in the study.

All patients in the study received antiviral treatment prior to transplantation, including new recently approved virostatics. Patients were randomly assigned to the study drug or the control group. Patients who received the study drug received either 200 mg/kg or 300 mg/kg body weight in the peri- and post transplant periods. The control group received no study drug.

To date, none (0%) of the patients in the higher dosage group have experienced HCV recurrence. Control subjects have a 35% HCV recurrence rate. "The current data are very exciting and we hope that after completion of the study the final evaluation will confirm the presented data", said Prof Gregor Schulz, CEO of Biotest AG.

The tolerability of tCivacir(R) was excellent and comparable to the safety profile of other immune globulin products.

About Civacir(R)

Civacir(R) is an intravenous immune globulin preparation with high titer of hepatitis C (HVC) antibodies. It is currently being investigated for the prevention of HCV recurrence in patients undergoing liver transplantation. Civacir(R) is administered during the critical time after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.


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 AG

Biotest AG 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 rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2.000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

About Biotest Pharmaceuticals Corporation

Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, researches, develops and manufactures biotherapeutic products with a specialization in immunology and hematology. BPC is a leader in the collection of source plasma and is currently involved in the development of plasma protein products and various hyperimmune (IG) products. The Company owns and manages sixteen plasmapherisis centers across the United States and a state-of-the-art manufacturing facility in Boca Raton, Florida. The Company employs more than 900 people in the U.S.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich,

Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
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, Hanover, Munich, Stuttgart

Record changed: 2017-04-02


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