Executive Summary

LYPHOMED, NOT FISONS, PURSUING PCP TREATMENT INDICATION for its aersolized pentamidine product, Lyphomed asserted in a May 23 letter to five members of the Senate Appropriations Committee. "Lyphomed brought aerosolized pentamidine to the point of FDA approval for prevention of PCP [Pneumocystis carinii pneumonia] long before Fisons," Lyphomed President Brian Tambi contended. "In addition, Lyphomed, but not Fisons, has expended considerable sums in developing aerosolized pentamidine for treatment of PCP." Tambi linked the firm's grant of exclusivity to its ability to pursue development of pentamidine for treatment of PCP. "We have now made commitments to pay for additional very expensive research to continue the battle against PCP, commitments that rely on the marketing exclusivity, through October of 1991, granted to us by the Orphan Drug Act..." Tambi's letters were addressed to Sens. Bumpers (D-Ark.), Inouye (D-Hawaii), Burdick (N.D.), Adams (D-Wash.) and Hatfield (R-Ore.) in response to a letter they had cosigned and sent to HHS Secretary Sullivan. The Appropriations Committee members expressed support for Orphan Drug Act amendments that would allow marketing of the aerosolized pentamidine product developed by Fisons/Sloan-Kettering, and they asked Sullivan to explain HHS' opposition to such amendments ("The Pink Sheet" May 14, p. 8). Responding to the senators' arguments that PCP patients' treatment costs would be lowered by introduction of a competing product during the market exclusivity period granted under the Orphan Drug Act to the Fujisawa subsidiary, Tambi contended: " The Fisons regimen is not less costly than the Lyphomed regimen." Fisons' experimental nebulizer and regimen "would actually cost more than the FDA-approved Lyphomed regimen" because the Fisons regimen entails more frequent dosing. Whereas the Lyphomed regimen costs $2,085-$2,930.85 annually -- depending on whether it is administered in a hospital, in a physician's office or at home -- the Fisons regimen would cost $2,627-$4,718 annually, Tambi maintained. Tambi further argued that the Fisons drug and regimen have not been determined by FDA to be equivalent or superior to the Lyphomed product and that development of Lyphomed's product by researchers from Lyphomed and the University of California at San Francisco predated development of the Fisons product by Memorial Sloan-Kettering researchers. The letter cosigned by the five senators "reflects incomplete information on the issues involved," Tambi said. "Many of the assertions that Fisons has made in its attempts to secure amendment of the Orphan Drug Act are in fact simply wrong," he contended.