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InterMune Pharmaceuticals, Inc. develops and commercializes innovative products for the treatment of serious pulmonary and infectious diseases and congenital disorders. The Company currently markets ACTIMMUNE© (Interferon gamma-1b) Injection in the U.S. for the treatment of Chronic Granulomatous Disease (CGD) and osteopetrosis. Our Business InterMune Pharmaceuticals develops and commercializes innovative products for the treatment of serious pulmonary and infectious diseases and congenital disorders. We have the exclusive license rights in the United States to ACTIMMUNE© (interferon gamma-1b injection) for a range of indications, including chronic granulomatous disease, osteopetrosis, idiopathic pulmonary fibrosis, mycobacterial infections, systemic fungal infections and cystic fibrosis. We currently market ACTIMMUNE for chronic granulomatous disease. We have active development programs underway for the other indications, several of which are in mid- or advanced-stage human testing, known as clinical trials. Idiopathic pulmonary fibrosis, mycobacterial infections and systemic fungal infections are serious and difficult to treat diseases that we believe represent a combined potential market opportunity for ACTIMMUNE of approximately $3.5 billion annually in the United States. Interferon gamma-1b, the active ingredient in ACTIMMUNE, is a human protein which plays a key role in preventing the formation of excessive scar, or fibrotic, tissue and is a potent stimulator of the immune system. Interferon gamma is biologically distinct from interferon alpha and interferon beta, two related proteins that are currently marketed for the treatment of diseases such as hepatitis B infection and multiple sclerosis. Interferon gamma has a superior safety profile as compared to interferon alpha and interferon beta because it results in fewer and less severe adverse side effects. ACTIMMUNE Marketed Indication Chronic Granulomatous Disease. The U.S. Food and Drug Administration has approved ACTIMMUNE for the treatment of chronic granulomatous disease, and we currently market and sell ACTIMMUNE in the United States for this disease. Chronic granulomatous disease is a life-threatening congenital disorder of the immune system that causes patients to be vulnerable to severe recurrent infections. This disease affects children, and no other FDA-approved treatment currently exists. ACTIMMUNE was approved by the FDA based on its ability to reduce the frequency and severity of infections in these patients. Indications in Development Osteopetrosis. In August 1999, upon the completion of a Phase III clinical trial, we submitted a supplement to our biologics license application, or BLA, to the FDA for this indication. The FDA has designated osteopetrosis as eligible for both an accelerated review, known as fast track review, and orphan drug status. Osteopetrosis is a life-threatening, congenital disorder in which an overgrowth of bony structures leads to blindness, deafness and increased susceptibility to infection. This disorder primarily affects children, and no effective treatment is currently available. Idiopathic Pulmonary Fibrosis. We believe the most significant near-term use of ACTIMMUNE is for the treatment of idiopathic pulmonary fibrosis, a life-threatening lung condition that afflicts approximately 50,000 persons in the United States. Idiopathic pulmonary fibrosis is characterized by progressive scarring of the lungs, which leads to their deterioration and destruction. The prognosis of patients with idiopathic pulmonary fibrosis is poor and most patients die from progressive loss of lung function, which leads to suffocation. Therapeutic options for idiopathic pulmonary fibrosis are limited and only minimally effective. The results of a Phase II clinical trial published in October 1999 in The New England Journal of Medicine showed statistically significant evidence that interferon gamma-1b halts and reverses the progression of idiopathic pulmonary fibrosis. We are continuing the clinical development of ACTIMMUNE for idiopathic pulmonary fibrosis by initiating a Phase II/III pivotal clinical trial during the first half of 2000. Other indications. We are also developing ACTIMMUNE to treat a variety of other diseases, including infectious diseases and cystic fibrosis. Preclinical studies and clinical trials have demonstrated the therapeutic potential of ACTIMMUNE against a broad range of infectious diseases, notably mycobacterial and systemic fungal infections. A study published in May 1997 in The Lancet showed that ACTIMMUNE was effective in the treatment of multidrug-resistant tuberculosis, a type of mycobacterial infection. As a result of these studies, we are initiating a Phase III pivotal clinical trial for ACTIMMUNE in the treatment of multidrug-resistant tuberculosis and have commenced a Phase II clinical trial in cryptococcal meningitis, a type of systemic fungal infection. We intend to initiate Phase II clinical trials in cystic fibrosis and in atypical mycobacterial infections in the second half of 2000. We believe that the risks and time required to obtain FDA approval for new indications of ACTIMMUNE may be reduced because ACTIMMUNE has proven to be safe for patients since its approval in 1990 for the treatment of chronic granulomatous disease. Other Products In Development We also have two preclinical development programs that address infections caused by two types of bacteria, pseudomonas aeruginosa and staphylococcus aureus. We believe that these indications present combined market opportunities of approximately $2 billion annually in the United States. Strategy We plan to pursue a growth strategy through: growing product revenue; expanding the number of FDA-approved indications for ACTIMMUNE; enhancing physician awareness and education; developing a sales and marketing organization to serve pulmonologists and infectious disease specialists; and continuing to in-license preclinical and development-stage programs. Background InterMune was formed in 1998 and began operations as a wholly-owned subsidiary of Connetics Corporation. In 1998, Connetics acquired from Genentech Inc., and subsequently sublicensed to us, rights to develop and commercialize ACTIMMUNE for a broad range of indications. We initially focused on marketing ACTIMMUNE for chronic granulomatous disease and developing it for serious infectious diseases and congenital disorders. In October 1999, a study published in the The New England Journal of Medicine showed significant evidence that interferon gamma-1b halts and reverses the progression of idiopathic pulmonary fibrosis. As a result, we expanded our development and commercialization plans to include idiopathic pulmonary fibrosis as well as other life-threatening pulmonary diseases. intermune.com did not see a thread so, i started one... | ||||||||||||||
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