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Biotest presents new clinical and preclinical results of Civacir^(R) at The 50^th International Liver Congress 2015 in Vienna

- Preliminary clinical results suggest that Civacir^(R) reduces the hepatitis C virus recurrence rate after liver transplantation in an impressive way to 5% (1 out of 21 patients)

- Preclinical data shows activity of Civacir^(R) against different hepatitis C virus variants

Dreieich, 23 April 2015. Biotest announces today clinical and preclinical data on Civacir^(R), presented at The 50^th International Liver Congress 2015 in Vienna, Austria.

Currently, there is no approved treatment available to prevent hepatitis C virus recurrence during and after liver transplant surgery. Although direct acting antivirals (DAAs) have the potential to reduce viral load prior to liver transplantation, hepatitis C virus recurrence is frequent. There is still a very high medical need for treatment options preventing reinfection during the critical time during and immediately after transplantation. Data presented at the congress are phase III clinical study data. The study is a randomized, open-label trial conducted in 24 clinical centers in the United States.

All patients in the study received antiviral treatment prior to transplantation, mainly new recently approved antivirals. Patients who were treated with the study drug Civacir^(R) obtained either 200 mg/kg or 300 mg/kg body weight during and immediately after transplantation. The control group received the standard of care (no antiviral treatment after transplantation).

The clinical data shows that 1 out of 21 (5%) reinfection was observed in the high dose group. In contrast 6 out of 20 (30%) and 7 out of 22 (32%) reinfections occurred in the low dose and control group, respectively. Civacir^(R) has been well tolerated and no serious adverse events were related to the study drug. More than two-thirds of the planned patients have been enrolled in the ongoing clinical trial.

"Civacir^(R) represents a novel prophylactic approach to prevent hepatitis C virus recurrence in liver transplant recipients. If the presented results are also confirmed after the conclusion of the study, this would be a relevant therapy option for the treatment of transplant patients with hepatitis C." said Dr. Bernhard Ehmer, CEO of Biotest AG.

The preclinical study presented demonstrates activity of Civacir^(R) against different hepatitis C virus escape variants. The data shows that Civacir^(R) may potently and dose-dependently neutralize all virus variants tested including variants resistant to neutralizing host antibodies.

"The data supports that the antibody diversity of Civacir^(R) translates into neutralization of all viral variants analysed. Other therapies are limited by rapid viral evasion. This differentiates our polyclonal hepatitis C immune globulin approach from other therapy options." said Dr. Jörg Schüttrumpf, Global Research of Biotest AG.

About Civacir^(R)

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

Civacir^(R) is developed by Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG), the only manufacturer of an investigational Hepatitis C immune globulin worldwide. Civacir^(R) is produced from plasma of hundreds of donors with high titers of anti-HCV antibodies.

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 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 2.100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

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