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Hepatitis C Immune Globulin (HCIG)

Hepatitis C Immune Globulin (HCIG)

Biotest Pharmaceuticals’ Hepatitis C Immune Globulin (HCIG) is an investigational human polyclonal antibody product that contains a diverse array of antibodies against the hepatitis C virus (HCV).  Pre-clinical studies confirm that Biotest-HCIG contains a spectrum of antibodies that are indeed neutralizing to HCV. We are developing Biotest-HCIG to prevent hepatitis C recurrence in HCV-positive liver transplant patients, an unmet medical need among these patients. There is currently no effective way to prevent post-transplant HCV recurrence. There is no vaccine available for protection against HCV.

Biotest-HCIG is derived from human plasma enriched with HCV antibodies collected from screened donors at multiple plasma collection centers. After viral inactivation, we use the process of fractionation to concentrate a sterile antibody preparation ready for intravenous administration. The antibodies in Biotest-HCIG have been shown in multiple animal studies and cellular assays to neutralize HCV. It is believed that a large part of the antibody’s mechanism of action against HCV is binding the circulating virus in the blood stream to help the body’s immune system clear virus before they may re-infect critical organs, such as a transplanted liver in an HCV-positive patient.

Market

HCV causes acute hepatitis C and chronic liver disease, including cirrhosis and liver cancer. The World Health Organization, or WHO, estimates that about 180 million people, or 3% of the world’s population are chronically infected with HCV and two to four million people are newly infected each year. The CDC currently estimates that there are approximately 4 million individuals in the US chronically infected with HCV.

HCV has significant social impact because it causes chronic infection in a large percentage of those infected and often results in severe illness and death at the later stages of the disease. Chronic HCV infection is the most frequent cause of end-stage liver disease, or ESLD, in the U.S., often resulting in death or the need for liver transplantation. In the U.S. 40-50% of all liver transplants, or approximately 3,000 liver transplants per year, are due to HCV infections. The proportion of liver transplants due to HCV infection is expected to increase over the next decade as the baby boomer population matures and other reasons for ESLD decline. Currently, during surgery and in the period immediately following, these patients have no treatment options to prevent HCV recurrence as they are under heavy immunosuppression to protect the new liver. Unfortunately, infection of the transplanted liver is certain within days to weeks following surgery and new virus production can occur within hours of transplantation. Post-transplant HCV recurrence also contributes to frequent hospitalizations and failure of the transplanted liver. Very few patients undergo re-transplantation after HCV recurrence.

Regulatory Status

Biotest-HCIG received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and following the favorable opinion of the European Medicines Agency (EMEA) (adopted by the Committee of Orphan Medicinal Products), the European Commission granted Orphan Medicinal Product (OMP) Designation. Both designations were granted, entitling Biotest to seven (U.S.) or ten years (EU) marketing exclusivity post-licensure. Biotest-HCIG was granted Fast Track Status by the U.S. FDA.