* Clinical study showed no survival benefit
* Xigris was approved in U.S. in 2001
* Lilly to take Q4 charge of $75 mln-$95 mln
* Shares down 1.6 percent
By Lewis Krauskopf and Ransdell Pierson
Oct 25 Eli Lilly and Co withdrew its
sepsis drug Xigris from all markets after the product, deemed a
potential big seller when it was approved a decade ago, failed
to improve survival in a clinical trial.
Sepsis is a severe, often life-threatening illness caused
by the immune system's over-aggressive response to infections
-- releasing inflammatory proteins that cause shock and shut
down multiple organs. The condition occurs in 1 to 2 percent of
all hospitalizations in the United States.
Xigris, which has never reached its lofty initial sales
projections, had global sales of about $100 million in 2010. It
has garnered total sales of $1.5 billion since being approved
in the United States in 2001 and in Europe the following year.
The intravenous drug increased the risk of serious bleeding
in earlier studies, although no significant higher risk was
found in the latest study.
"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.
Patients currently receiving Xigris treatment should stop,
while doctors should not start any new patients on the drug,
The failed study, called PROWESS-SHOCK, comes only two days
after Lilly's top-selling Zyprexa schizophrenia treatment lost
U.S. patent protection in the United States -- making it prey
to cheaper generics.
The PROWESS-SHOCK study began in March 2008 as a condition
for continued market authorization in Europe of Xigris, whose
chemical name is drotrecogin alfa.
Results of the 1,696-patient study showed Xigris did not
meet the main goal of a statistically significant reduction in
deaths from any cause over a 28-day period in patients with
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
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
Xigris has been used on top of standard treatments, most
notably intravenous fluids and antibiotics.
In large studies conducted more than a decade ago, Xigris
did significantly cut mortality, Lilly's Garnett said.
But in recent years, medical practice has greatly improved
in intensive care units, Garnett said. Faster and more
aggressive treatment with IV fluids and antibiotics has sharply
improved survival rates of sepsis patients.
"So the incremental benefit of Xigris is no longer
apparent, and no longer clinically relevant," Garnett said.
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
Barclays Capital analyst Tony Butler said the Xigris
withdrawal was not a major setback for Lilly because Wall
Street already had low expectations for the drug.
Lilly shares were down 1.6 percent at $37.57 on Tuesday
afternoon on the New York Stock Exchange.