SmithKline Beecham stops proton pump development

Executive Summary

Phase III clinical trials of the irreversible proton pump inhibitor pantoprazole (formerly designated SK&F-96022) have been halted in the U.K. and Europe, the company confirms Nov. 27. The drug was in Phase II in the U.S. SB says it "will not continue with [pantoprazole's] development" but notes that it has several follow-on compounds in preclinicals and early clinicals, including SK&F 96067 and SK&F 97574. SB stopped the studies after results of a preliminary analysis of a two-year rate carcinogenicity study showed "an increased incidence of hepatocellular neoplasia at doses of 50 mg/kg/day and 200 mg/kg/day," doses greater than those used in human clinicals. Pantoprazole was being co-developed by SB and Byk Gulden, which is continuing development of the drug, SB says. . . .