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MILES INC. FILES PRODUCT LICENSE APPLICATION FOR PEDIATRIC HIV THERAPY

MILES INC. FILES PRODUCT LICENSE APPLICATION FOR PEDIATRIC HIV THERAPY
 WEST HAVEN, Conn., Nov. 5 /PRNewswire/ -- The Biological Products Unit of Miles Inc. today announced that it has filed a Product License Application (PLA) with the Food and Drug Administration for Gamimune-N, an intravenous immunoglobulin (IVIG) to treat certain children with Human Immunodeficiency Virus (HIV).
 The PLA is based on results from a multi-center clinical study conducted by the National Institute of Child Health and Human Development (NICHD).
 HIV in children is commonly characterized by recurring infections. These include: viral infections, such as herpes simplex or measles; serious bacterial infections, including pneumonia; and minor bacterial infections, such as middle-ear infections.
 The double-blind, placebo-controlled study, published in the July 22 issue of the Journal of the American Medical Association (JAMA), found that Gamimune-N reduced the incidence of viral, serious bacterial and minor bacterial infections in HIV-infected children with CD4+, or lymphocyte (infection-fighting cells) counts of at least 200.
 The study also found that patients with CD4+ counts less than 200 failed to respond to Gamimune-N treatment.
 The NICHD study was halted Jan. 10, 1991, so that therapy could be provided to all eligible study participants.
 Miles Inc.
 In 1986, the Biological Products Unit of Miles Inc., formerly known as Cutter Biologicals, received FDA approval to market Gamimune-N for treatment in patients suffering from immune system disorders as a result of cancer chemotherapy, severe burns, primary immunodeficiency and idiopathic thromocytopenic purpura (ITP).
 Miles Inc. is a Fortune 100, research-based company with major business in health care, chemicals, and imaging technologies. Headquartered in Pittsburgh, Miles employs 26,000 people at its operations throughout North America. In 1991, the company's sales were $6.2 billion.
 -0- 11/5/92
 /CONTACT: Andrea Heller of Burson-Marsteller, 212-614-5158, for Miles/ CO: Miles Inc. ST: Connecticut IN: MTC SU:


GK-LD -- NY130 -- 7947 11/05/92 17:04 EST
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Date:Nov 5, 1992
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