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FUJISAWA SUBMITS NEW DRUG APPLICATIONS TO FDA FOR FK-506

 DEERFIELD, Ill., Sept. 7 /PRNewswire/ -- Fujisawa USA, Inc. (FUSA) today announced it has submitted New Drug Applications (NDAs) to the Food and Drug Administration for its immunosuppressive agent PROFGRAF(TM) (tacrolimus), known in the medical community as FK-506.
 Produced by Fujisawa Pharmaceutical Co., Ltd., of Japan, FK-506 is a drug whose primary goal is to suppress the immune system to prevent the rejection of organ transplants. The results of two extensive multi- center studies of FK-506 in the United States and Europe were presented at the American Society of Transplant Surgeons scientific meeting in Houston in May 1993.
 Hatsuo Aoki, Ph.D., managing director of Fujisawa Pharmaceutical Co., Ltd., and CEO of its subsidiary, Fujisawa USA, Inc., said, "FK-506 is a key component of our strategy to expand our business in the U.S. market. We are encouraged by the multi-center studies' results."
 FK-506 was discovered by Fujisawa Exploratory Research Laboratories in 1984 and was developed as an alternative to current immunosuppressive therapy.
 Bulk form of FK-506 will be produced at Fujisawa's plant in Toyama, Japan, and formulated and packaged at a dedicated new manufacturing plant in Killorglin, County Kerry, Ireland, which will supply finished products to the U.S. and European markets.
 Fujisawa Pharmaceutical Co., Ltd., is one of the world's leading- edge pharmaceutical companies with annual sales of approximately $2.5 billion. Fujisawa is a research-oriented group whose investment in research and development represents more than 14 percent of its net sales.
 Fujisawa USA, Inc., headquartered in Deerfield, is a manufacturer of proprietary and multisource pharmaceutical products and a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan.
 -0- 9/7/93
 /CONTACT: Paula Waters of Fujisawa USA, Inc., 312-329-7532/


CO: Fujisawa USA, Inc.; Fujisawa Pharmaceutical Co., Ltd. ST: Illinois IN: MTC SU: PDT

SM -- NY049 -- 9363 09/07/93 13:28 EDT
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Publication:PR Newswire
Date:Sep 7, 1993
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