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Executive Summary

BENEDICT NUCLEAR DEVELOPING BRAIN IMAGING AGENT I-123 HIPDM under a licensing agreement with The State University of New York Research foundation, the Golden, Colorado-based radiopharmaceuticals firm pointed out in a recent S-1 registration outlining $ 2 mil. secondary offering. The product is currently in clinical trials. "Scientists have discovered that the chemical HIPDM, when tagged to the company's pure I-123 iodide tracer, allows a picture showing diagnostic function of the brain to be observed by the camera," the filing states. "There is no approved procedure available today in the medical community able to gain such a level of understanding of the blood flow in the brain." When approved, I-123 HIPDM will compete with a Roche product, I-123 IMP. Benedict Nuclear believes its product will prove superior to Roche's on the basis of an "advanced technology" for producing the diagnostic drug I-123. "Similar technology being implemented has resulted in the company capturing 50-75% of the I-123 sodium iodide market," the company said. Benedict's only marketed product to date, I-123 was approved in 1982 for use in detecting thyroid abnormalities. I-123 capsules are distributed by Mallinckrodt and more recently, by Syncor, which operates a chain of nuclear pharmacies. "For the fiscal years ended Aug. 31, 1985, 1986 and 1987, Mallinckrodt accounted for 100%, 97.1% and 90.6%, respectively of the company's sales of I-123," the filing states. "However, during the nine months ended May 31, 1988, Mallinckrodt accounted for only $ 1.4 mil., or 44.7% of the company's net sales while Syncor accounted for $ 981,150 or 53.3% of I-123 sales during the same nine-month period." During fiscal 1988, Benedict Nuclear Pharmaceuticals has begun to turn a profit. Through the first nine months ended May 31, the company reported net income of $ 69,596, compared to a net loss of $ 587,369 a year earlier. Total revenues were almost $ 3 mil., up from $ 1.3 mil. in the first nine months of fiscal 1987. In addition to I-123, Benedict has an approved NDA for stannous macroaggregated albumin (Sn MAA) for use in detecting lung disorders, and an NDA pending for thallium 201, for evaluating heart disorders. However, the company said that because of financial constraints and uncertain market conditions it has "no present plans to manufacture or distribute either drug at this time."

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