INTERMUNE FILES NDS FOR ACTIMMUNE IN CANADA.InterMune (Nasdaq: ITMN), Burlingame, Calif., has filed a New Drug Submission (NDS See eDirectory. NDS - Netware Directory Services ) with the Therapeutic Products Programme of Health Canada (TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. ) to market ACTIMMUNE(R) (Interferon gamma-1b) in Canada for chronic granulomatous disease Chronic Granulomatous Disease Definition Chronic granulomatous disease (CGD) is an inherited disorder in which white blood cells lose their ability to destroy certain bacteria and fungi. (CGD CGD Chronic granulomatous disease, see there ) 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(R) 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(R) in children," said W. Scott Harkonen, M.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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(R) being available to Canadian physicians and patients." In 1990, the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approved ACTIMMUNE(R) 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(R) 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 overgrowth Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced. of bony structures leads to blindness, deafness and increased susceptibility to infection. ACTIMMUNE(R) 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(R) (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. For more information, visit InterMune's web sites at http://www.intermune.com and http://www.actimmune.com or call 415-433-5381. |
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