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| |  Quadramet Receives FDA Clearance For Severe Bone Cancer Pain PRINCETON, N.J., March 31, 1997 -- The Food and Drug Administration (FDA) has granted its marketing approval to Quadramet(TM) (Samarium Sm 153 Lexidronam Injection) to treat the severe pain associated with cancers that have spread to bone. Quadramet is a therapeutic agent that concentrates in areas of bone that have been invaded with tumor.
Estimates, including those from the American Cancer Society and National Cancer Institute, show that over 200,000 patients annually in the United States will experience severe, chronic pain associated with bone metastases. This condition is most often experienced by patients with prostate, breast or lung cancers that have spread to the bone. Quadramet is a radiopharmaceutical that may be administered as a single intravenous injection on an outpatient basis. "Quadramet has been shown in a series of adequate and well-controlled clinical trials, to provide safe and effective relief of the severe pain caused by bone metastases," said William F. Goeckeler, Ph.D., Associate Director, Pharmaceutical Development at Cytogen. While at the University of Missouri-Columbia, Dr. Goeckeler was one of the inventors of Quadramet and has led the research and clinical development programs for this compound since 1984. Cytogen acquired an exclusive license for Quadramet in the United States, Latin America and Canada from The Dow Chemical Company. Cytogen previously announced that it has licensed the exclusive rights to manufacture and market Quadramet for oncology applications in these territories to the Radiopharmaceuticals Division of The DuPont Merck Pharmaceutical Company, while retaining the right to co-promote the product. Cytogen, with partial funding from DuPont Merck, continues to further develop Quadramet for other oncology applications. To obtain technical information about Quadramet, please contact DuPont Merck Radiopharmaceuticals at 1-800-635-2683. The Dow Chemical Company is a global operation with significant business activity in chemicals, plastics, agricultural products The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical and radiopharmaceutical company, formed in 1991 as a partnership between DuPont and Merck & Co., Inc.</a> Cytogen is a biopharmaceutical company engaged in the development, manufacture and commercialization of products for the targeted delivery of diagnostic and therapeutic substances directly to disease sites.
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