GHENT (Belgium), December 11, 2007 - GENimmune, the newly created biopharmaceutical subsidiary of Innogenetics, today announced that its candidate hepatitis C monoclonal antibody has been granted Orphan Medicinal Product Designation by the European Commission. The product is under development for the prevention of hepatitis C virus re-infection after liver transplantation.
It is estimated that over 3% of the world’s population, some 175 million persons worldwide, are chronically infected with the hepatitis C virus (HCV). Three to four million new infections occur each year.
A substantial number of chronically infected HCV patients develop progressive liver disease, which can lead to liver cirrhosis or liver cancer. When liver failure occurs, liver transplantation remains the sole life-saving option. However, following transplantation, hepatitis C liver disease re-occurs in almost 100% of patients, and is characterized by an accelerated disease course.
In the US and Europe combined, approximately 13,000 liver transplantations are carried out annually. Some 40% of these liver transplants are due to complications from HCV infection. The risk for re-infection, the high cost of liver transplantation, and the limitations of current drugs justify the development of new treatments.
As an outcome of its E1 research program, GENimmune has identified a series of HCV monoclonal antibodies that show potent neutralizing properties by blocking the infection of liver cells in vitro. The neutralizing properties were studied in collaboration with Dr. Robert Purcell’s team at the Laboratory for Infectious Diseases, Hepatitis Viruses and Molecular Hepatitis Sections (NIAID, NIH, Bethesda, MD). These monoclonal antibodies provide a possible additional means to counter HCV infection after liver transplantation. Based on the solid preclinical data, GENimmune is developing these antibodies to prevent recurrent HCV-induced liver disease in liver transplant recipients. One antibody has been selected for the Orphan Medicinal Product Designation application.
The validity of GENimmune’s different treatment approach for hepatitis C liver disease has also been recognized by the scientific community. An article describing the new monoclonals co-authored with NIH scientists has been accepted by the peer-reviewed Journal of Virology, and is scheduled for publication January 2008. Posters describing the properties of the monoclonals were also being presented at the annual International HCV Meeting in Glasgow, UK (Sept. 9-13) and at the Liver Meeting of the American Association for the Study of Liver Disease (AASLD) held in Boston, MA (Nov. 2-6).
Based on the criteria laid down in Regulation (EC) N° 141/2000, the European Commission has granted Orphan Medicinal Product Designation for GENimmune’s lead recombinant human hepatitis C monoclonal antibody. The designation resulted from the positive opinion by the Committee for Orphan Medicinal Products (COMP)*.
Orphan Medicinal Products benefit from various advantages, including a 10-year market exclusivity period following Marketing Authorization in the European Community.
Furthermore, GENimmune will be entitled to benefit from free Protocol Assistance to help in product development, which will maximize the chances of success upon Marketing Authorization Application. Orphan Drug designation also results in important fee reductions.
Guy Buyens, CEO of GENimmune commented: "The Orphan Medicinal Product Designation for our neutralizing human monoclonal antibody is an important milestone for GENimmune. It is a clear confirmation that this product offers a innovative solution to meet an urgent medical need. Furthermore, it fully valorizes our previous investment in the HCV E1 program. The decision by the European Medicines Agency (EMEA) provides GENimmune with either an exciting opportunity for streamlined development of this product by ourselves, or as a means to work on this program with an interested partner. In either case, this antibody now becomes an important asset of our expanding pipeline of innovative products that will make us a key player in the field of immune therapeutics.”
It is estimated that over 3% of the world’s population, some 175 million persons worldwide, are chronically infected with the hepatitis C virus (HCV). Three to four million new infections occur each year.
A substantial number of chronically infected HCV patients develop progressive liver disease, which can lead to liver cirrhosis or liver cancer. When liver failure occurs, liver transplantation remains the sole life-saving option. However, following transplantation, hepatitis C liver disease re-occurs in almost 100% of patients, and is characterized by an accelerated disease course.
In the US and Europe combined, approximately 13,000 liver transplantations are carried out annually. Some 40% of these liver transplants are due to complications from HCV infection. The risk for re-infection, the high cost of liver transplantation, and the limitations of current drugs justify the development of new treatments.
As an outcome of its E1 research program, GENimmune has identified a series of HCV monoclonal antibodies that show potent neutralizing properties by blocking the infection of liver cells in vitro. The neutralizing properties were studied in collaboration with Dr. Robert Purcell’s team at the Laboratory for Infectious Diseases, Hepatitis Viruses and Molecular Hepatitis Sections (NIAID, NIH, Bethesda, MD). These monoclonal antibodies provide a possible additional means to counter HCV infection after liver transplantation. Based on the solid preclinical data, GENimmune is developing these antibodies to prevent recurrent HCV-induced liver disease in liver transplant recipients. One antibody has been selected for the Orphan Medicinal Product Designation application.
The validity of GENimmune’s different treatment approach for hepatitis C liver disease has also been recognized by the scientific community. An article describing the new monoclonals co-authored with NIH scientists has been accepted by the peer-reviewed Journal of Virology, and is scheduled for publication January 2008. Posters describing the properties of the monoclonals were also being presented at the annual International HCV Meeting in Glasgow, UK (Sept. 9-13) and at the Liver Meeting of the American Association for the Study of Liver Disease (AASLD) held in Boston, MA (Nov. 2-6).
Based on the criteria laid down in Regulation (EC) N° 141/2000, the European Commission has granted Orphan Medicinal Product Designation for GENimmune’s lead recombinant human hepatitis C monoclonal antibody. The designation resulted from the positive opinion by the Committee for Orphan Medicinal Products (COMP)*.
Orphan Medicinal Products benefit from various advantages, including a 10-year market exclusivity period following Marketing Authorization in the European Community.
Furthermore, GENimmune will be entitled to benefit from free Protocol Assistance to help in product development, which will maximize the chances of success upon Marketing Authorization Application. Orphan Drug designation also results in important fee reductions.
Guy Buyens, CEO of GENimmune commented: "The Orphan Medicinal Product Designation for our neutralizing human monoclonal antibody is an important milestone for GENimmune. It is a clear confirmation that this product offers a innovative solution to meet an urgent medical need. Furthermore, it fully valorizes our previous investment in the HCV E1 program. The decision by the European Medicines Agency (EMEA) provides GENimmune with either an exciting opportunity for streamlined development of this product by ourselves, or as a means to work on this program with an interested partner. In either case, this antibody now becomes an important asset of our expanding pipeline of innovative products that will make us a key player in the field of immune therapeutics.”
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