(Reuters) - Eli Lilly and Co said it is withdrawing its sepsis drug Xigris from all markets after it failed to help patients live longer in a clinical trial.
“While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use,” Timothy Garnett, Lilly’s chief medical officer, said in a statement on Tuesday.
Approved in the United States in 2001 and in Europe in 2002, Xigris never reached its initial lofty sales expectations. The intravenously infused drug, also known as drotrecogin alfa, had global sales of about $100 million last year.
Sepsis is a severe, often life-threatening illness caused by the body’s response to infections. Sepsis, which causes shock that can shut down multiple organs, occurs in 1 to 2 percent of all hospitalizations in the United States, according to The Journal of the American Medical Association.
Lilly estimated it would take a charge tied to the withdrawal in the range of $75 million to $95 million in the fourth quarter, or about 5 cents per share after taxes. It maintained its full-year profit forecast that excludes special items.
The setback comes only two days after Lilly’s top-selling product, the schizophrenia treatment Zyprexa, lost U.S. patent protection in the United States — making it prey to cheaper generics.
The clinical study of Xigris, known as PROWESS-SHOCK, began in March 2008 as a condition for continued market authorization in Europe.
Results of the 1,696-patient study showed Xigris did not meet the main goal of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.
According to European Medicines Agency, 26.4 percent of patients taking Xigris died compared with 24.2 percent taking a placebo, a difference that was not deemed statistically significant.
The risk of severe bleeding events in the study, the main risk with Xigris, was similar, “suggesting there was no increased harm” from the Lilly drug, according to the European regulators.
Patients currently receiving Xigris treatment should stop, while doctors should not start any new patients on the drug, Lilly said.
Lilly shares were down 0.7 percent at $37.94 on Tuesday morning on the New York Stock Exchange.
Reporting by Lewis Krauskopf and Ransdell Pierson in New York, editing by Gerald E. McCormick and Matthew Lewis