DGAP-News

Biotest AG: Very good results of Civacir(R) (Hepatitis C Immune Globulin) US Phase III clinical trial

DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Very good results of Civacir(R) (Hepatitis C Immune
Globulin) US Phase III clinical trial

10.11.2014 / 07:00

---------------------------------------------------------------------

/
PRESS RELEASE

Very good results of Civacir(R) (Hepatitis C Immune Globulin) US Phase III
clinical trial

- 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

Dreieich, November 10, 2014. 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