The company expects to file an investigational new drug application (IND) in late 2005 or early 2006, followed by a biologic license application in the second half of 2007. It hopes to launch a commercial product in 2008. Additional indications will be sought subsequent to the first approval.
Immune globulin intravenous (IGIV) is currently used to treat primary immune deficiency, idiopathic thrombocytopenia purpura, some forms of cancer, certain autoimmune diseases, pediatric AIDS and during organ transplants. Early-stage research has demonstrated that IGIV may also be of importance in the treatment of multiple sclerosis, rheumatoid arthritis and Alzheimer’s disease.
IGIV is comprised of naturally occurring antibodies that are normally produced in the human body. However, in some cases, patients cannot produce sufficient quantities of these antibodies and are required to receive IGIV infusions every three to four weeks to avoid infectious diseases.
The first approvals for an intravenously administered immunoglobulin preparation occurred in the mid-1980s. Since then, several additional IGIV products have been approved for commercial sale in major markets.
“Our decision to go ahead with IGIV as the initial therapeutic product is another important step in our strategic plan to become a leading developer and manufacturer of plasma-derived therapeutic proteins,” said Lee Hartwell, president and CEO of Hemosol.