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MALLINCKRODT MEDICAL FILES OCTREOSCAN 111 NDA FOR ABDOMINAL TUMOR IMAGING

Executive Summary

MALLINCKRODT MEDICAL FILES OCTREOSCAN 111 NDA FOR ABDOMINAL TUMOR IMAGING on Oct. 22. A combination of Sandoz' somatostatin analog octreotide (Sandostatin) radiolabeled with Indium 111, Octreoscan is designed for early detection and evaluation of very small tumors and metastatic sites in the lung, breast and lymph nodes. The NDA is specifically for use of OctreoScan in the detection of tumors originating in neuro-endocrine cells, particularly in the abdomen, Mallinckrodt parent IMCERA said Oct. 23. More than 80% of neuro-endocrine tumors have receptors for somatostatin, studies show. These types of tumors may be good candidates for octreo tide therapy, Mallinckrodt said. In an Oct. 22 presentation at the Oppenheimer & Co. health care conference in New York City, Mallinckrodt President and CEO Ray Holman called the agent "one of the most exciting products to be developed in nuclear medicine" and predicted OctreoScan 111 "will actually begin a new generation of nuclear medicine products." Mallinckrodt described OctreoScan 111 as the first radiolabeled small peptide submitted for FDA approval specifically for tumor imaging. The company is pursuing a number of other applications for the agent. Mallinckrodt developed the radiolabeled small peptide agent in conjunction with Sandoz Pharma (Basel) and scientists from the University Hospital Dijkzigt in Rotterdam, the Netherlands. The product was introduced in Holland for gastrointestinal indications earlier in 1992. Mallinckrodt Medical also plans to register the tumor imaging agent for approval in Canada and Japan.

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