Cangene Corporation announces that its Varicella zoster immune globulin (VariZIG) has received orphan drug designation from the United States Food and Drug Administration (FDA) for passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella. This designation will give the drug seven years of market exclusivity after marketing approval is obtained. It also means certain regulatory filing fees will be waived.
This designation is another step in our commitment to address the unmet medical need faced by susceptible individuals who are exposed to chickenpox. It builds on the expanded access investigational new drug protocol that was approved in January by the FDA," said Dr. John Langstaff, Cangene's president and chief executive officer.
VariZIG is a purified antibody preparation (hyperimmune) specific for Varicella zoster virus, which causes chickenpox and shingles. The following types of patients are at-risk for serious infection if exposed to the virus: immune compromised paediatric or adult patients, neonates (infants less than one year old), pre-term infants, pregnant women and newborns whose mothers had Varicella zoster infection within five days before or two days after delivery. Cangene manufactures VariZIG(TM) in its Winnipeg, Manitoba facility. The Company has three FDA-approved hyperimmunes that it manufactures using similar processes.
Cangene is one of Canada's largest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and in Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to having four approved products, Cangene has two products that have been submitted for regulatory review and a significant clinical trial programme.