First Patient Treated with Civacir® 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
- Civacir has received an Orphan Drug designation in both the US and the EU
BOCA RATON, Fla. and DREIEICH, Germany, Aug. 7, 2013 /PRNewswire/ -- 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 Civacir in the Phase III clinical trial. Civacir, a 10 % hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, is being used in 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 HCV 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 HCV virus after surgery since current antiviral regimens cannot 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 transplant 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. Study 988 is being conducted at sites in the US and Canada, with a total of up to 90 patients to be enrolled.
Market exclusivity for 7 and 10 years after approval in the US and EU, respectively, is ensured by the Orphan Drug designation.
About Biotest AG
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 specialized primarily in the areas of application of clinical immunology, hematology 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 hematopoietic systems. Biotest also researches into the clinical 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.
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 twelve plasmapherisis centers across the United States and a state-of-the-art manufacturing facility in Boca Raton, Florida. The Company employs more than 700 people in the U.S.
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.
SOURCE Biotest Pharmaceuticals Corporation
CONTACT: Nina Johnson, 561-989-5831, www.biotestpharma.com, [email protected]
Web Site: http://www.biotestpharma.com