Press Release
SOURCE: InterMune
InterMune Files New Drug Submission for Actimmune(R) in Canada
BURLINGAME, Calif., Jan. 3 /PRNewswire/ -- InterMune (Nasdaq: ITMN - news) announced today that it has filed a New Drug Submission (NDS) with the Therapeutic Products Programme of Health Canada (TPP) to market ACTIMMUNE® (Interferon gamma-1b) in Canada for chronic granulomatous disease (CGD) and severe, malignant osteopetrosis, both life-threatening childhood diseases. The TPP has granted Priority Review status to the NDS, and the Company expects approval within six months, as there are no other effective treatments available for these diseases. ACTIMMUNE® is currently marketed in the United States for CGD and severe, malignant osteopetrosis.
``In the United States, physicians have more than ten years of experience using ACTIMMUNE® in children,'' said W. Scott Harkonen, M.D., CEO and President of InterMune. ``In Canada there is currently no effective treatment approved for CGD or osteopetrosis, and with ACTIMMUNE's strong safety record, we look forward to ACTIMMUNE® being available to Canadian physicians and patients.''
In 1990, the U.S. Food and Drug Administration (FDA) approved ACTIMMUNE® for reducing the frequency and severity of serious infections associated with CGD, a rare, inherited deficiency of the immune system that leaves patients vulnerable to frequent and severe bacterial and fungal infections. These infections often require hospitalization and can be fatal.
In February 2000, the FDA approved ACTIMMUNE® for delaying the time to disease progression in patients with severe, malignant osteopetrosis. Severe, malignant osteopetrosis is a life-threatening congenital disorder in which an overgrowth of bony structures leads to blindness, deafness and increased susceptibility to infection. ACTIMMUNE® is the only FDA-approved treatment for severe, malignant osteopetrosis or CGD.
InterMune Pharmaceuticals, Inc. is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune currently markets ACTIMMUNE® (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. For more information about InterMune and ACTIMMUNE,® please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com. |
