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FDA COMMITTEE UNANIMOUSLY SUPPORTS MILES' RECOMBINANT FACTOR VIII FOR HEMOPHILIA

 FDA COMMITTEE UNANIMOUSLY SUPPORTS MILES'
 RECOMBINANT FACTOR VIII FOR HEMOPHILIA
 WASHINGTON, Dec. 12 /PRNewswire/ -- The Blood Products Advisory Committee (BPAC) of the Food and Drug Administration (FDA) today unanimously agreed that Miles Inc.'s Kogenate(R), a genetically engineered Factor VIII product, was shown to be safe and effective in treating people with hemophilia. If approved by the FDA, Kogenate will be the first product manufactured by recombinant DNA technology to treat hemophilia.
 "We're gratified with today's outcome," said Klaus H. Risse, Ph.D., chief executive officer, Miles Inc. "Kogenate is representative of Miles' commitment to the hemophilia community and to developing innovative healthcare products."
 Actions like today's committee vote frequently lead to FDA clearance for marketing of pharmaceutical products.
 Factor VIII, the protein necessary for blood to clot normally, is either present in insufficient quantities or absent in people with hemophilia. Until Kogenate, other Factor VIII products were developed from human plasma.
 "With Kogenate, Miles has developed a synthetic product that displays all of the characteristics of plasma-derived Factor VIII," said Ralph Galustian, president, Miles Inc., Pharmaceutical Division Biological Products. "Kogenate's other advantages are that it is not limited to the supply of human plasma, and it virtually eliminates the risk of viral transmission."
 There are approximately 20,000 people in the United States with hemophilia, and 50,000 worldwide. A genetic disorder, hemophilia is passed almost exclusively from mothers to sons. People with hemophilia do not produce enough Factor VIII of their own to control bleeding episodes by enabling blood to clot normally.
 Kogenate is the product of more than 10 years of research by Miles researchers and scientists, and marks the company's entry into the vital biotechnology arena. Kogenate is also the largest and most complex protein for therapeutic use synthesized from recombinant technology, according to Dietrich Horlein, project director for Miles.
 During the BPAC's public discussions, spokespeople from the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation (NHF) recommended approval of recombinant Factor VIII products.
 MASAC also recommended that post-licensure studies be implemented to continue studying incidences of low-level inhibitor development which were reported in some clinical trials.
 Miles Inc. is a healthcare company with businesses in pharmaceuticals, diagnostics and over-the-counter (OTC) products. The pharmaceutical division is based in West Haven, Conn.
 -0- 12/12/91
 /CONTACT: Don Hyman of Miles, 203-498-6545/ CO: Miles Inc. ST: Connecticut IN: MTC SU:


CK -- NY100 -- 2195 12/12/91 18:47 EST
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Date:Dec 12, 1991
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