Executive Summary

Sales of nucleoside analogue Videx fell 27% to $19 mil. in the U.S. during the quarter as a "result of our repositioning Videx to be used in different therapy," Bristol Oncology & Immunology President Richard Winningham said. "Historically, Videx usage occurred quite a bit in combination with hydroxyurea. Beginning mid-to-late last year, we began to encourage physicians not to use Videx in combination with hydroxyurea and are positioning it with other regimens." Videx labeling was changed in October to warn of two fatalities in patients receiving Videx and hydroxyurea in ACTG 5025. Bristol received a warning letter from FDA for allegedly promoting the Videx/hydroxyurea combination despite the ACTG data (1"The Pink Sheet" Nov. 8, 1999, p. 29)