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Amgen/Ortho EPO arbitration

Executive Summary

Closed hearings will take place Sept. 6, 7 and 8 in Chicago. The companies entered into arbitration in January to resolve a dispute over their 1985 marketing agreement for erythropoietin. Amgen's Epogen was approved in June for the treatment of anemia associated with chronic renal failure using some of Ortho's data on predialysis patients. A PLA for Ortho's EPO product Eprex is currently pending at FDA. The agency is not expected to act on Ortho's application until the marketing dispute is resolved.
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PS016127

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