Lilly pulls Xigris worldwide
Eli Lilly and Co. (NYSE:LLY) withdrew Xigris drotrecogin alfa from the global market after the sepsis drug missed the primary endpoint of significantly reducing the 28-day all-cause mortality rate vs. placebo in the postmarketing Phase III PROWESS-SHOCK trial in 1,696 patients. The trial was initiated in March 2008 as a condition for continued marketing authorization in Europe.
BioCritica Inc. (Indianapolis, Ind.), which was formed in May by Lilly and investors Care Capital and NovaQuest, has exclusive U.S. rights to develop and commercialize Xigris, while Lilly has rights elsewhere. BioCritica characterized the results as a "huge disappointment" and said it has not yet determined plans for the future of the company. Lilly does not break out sales of the recombinant human activated protein C (see BioCentury, June 13). ...