Health Canada Approves Cangene Corporation's Anti-Hepatitis B product
TORONTO and WINNIPEG, Jan. 22 /CNW/ - Cangene today announces that it has
received a Notice of Compliance with conditions ("NOC/c") for its HepaGam
B(TM) hyperimmune product from the Biologics and Genetic Therapies Directorate
of Health Canada. The approved indication is for the prevention of Hepatitis B
recurrence following liver transplantation in adult patients with Hepatitis B
who have no or low levels of hepatitis B virus replication. This NOC/c confers
marketing approval to the drug in Canada while requiring the Company to
continue with a confirmatory clinical study. HepaGam B(TM) is Cangene's
Hepatitis B Immune Globulin (human) Injection, which is a purified antibody or
hyperimmune that is specific for the hepatitis B virus. It is the only
intravenous product licensed in Canada for this indication. An NOC/c is
granted to provide patients who are suffering from serious, life-threatening
or severely debilitating illnesses or conditions, accelerated access to
promising new therapies.