Eli Lilly and Company

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Eli Lilly and Company: Improvement During First Twenty-Four Hours Is
Critical to Survival of Severe Sepsis

Experts Say Early Identification of Treatment Failure Should Guide
Therapeutic Decisions

Patients with severe sepsis who do not show an improvement in
organ function during the first 24 hours of therapy have a
significantly increased risk of mortality, according to scientific
research presented today at CHEST 2003, this year's annual meeting of
the American College of Chest Physicians (ACCP). Sepsis is a leading
cause of morbidity and mortality in the United States, claiming more
than 215,000 lives annually.

"If a patient with severe sepsis does not show improvement within
those first 24 hours, the risk of death dramatically increases," said
Dr. Mitchell Levy, M.D., F.C.C.P., of Brown Medical School/Rhode
Island Hospital, who served as the study's principal investigator. "At
that point, if treatment is failing to improve the patient's
condition, it is important to think about more aggressive therapy.
This study is clearly telling us that early identification of
treatment failure is vital in patients with severe sepsis."

First Day SOFA Scores Predictive of 28-Day Mortality

For this study, a total of 1,036 patients from two separate
clinical trial databases were evaluated. These patients met the
established criteria for severe sepsis and were being treated with
conventional supportive care, such as antibiotics and mechanical
ventilation, but not with any investigational drugs for sepsis.

Changes from baseline to day one in sequential organ failure
assessment (SOFA) scores were calculated for each patient's
cardiovascular, renal, hematologic, respiratory, and hepatic organ
systems. The 28-day mortality rates were also analyzed. Based upon an
analysis of changes in SOFA scores by day one, data indicate patients
who did not demonstrate organ function improvement during the first 24
hours of therapy were significantly less likely to survive.
Furthermore, during the first day of therapy for severe sepsis, the
change from baseline in organ dysfunction may be a better predictor of
28-day mortality than a static baseline assessment.

High Risk Severe Sepsis Patients Benefit From Xigris Treatment

Xigris(R) (drotrecogin alfa (activated)) is the first and only
therapy proven to improve survival in high-risk severe sepsis
patients. Based on the landmark PROWESS(1) trial, nearly one in three
patients who would have died, survived with the addition of Xigris.(2)
Early diagnosis and aggressive management, coupled with the use of
proven, efficacious medicines like Xigris, will enable physicians to
do more to improve survival in severe sepsis.

About Severe Sepsis

Sepsis can strike anyone. It is triggered by infection, often the
result of events such as trauma, surgery, and burns, or illnesses such
as cancer and pneumonia. Every year severe sepsis (sepsis associated
with acute organ dysfunction) strikes 750,000 Americans, at least
215,000 of whom die, about as many die as a result of an acute heart
attack.(3) The incidence of severe sepsis is expected to rise to one
million by the end of the decade.(3) It is the leading cause of death
in non-coronary intensive care units.(4) The estimated costs
associated with the treatment of patients with severe sepsis are $17
billion annually in the United States.(3)

About Xigris

Xigris (drotrecogin alfa (activated)) from Eli Lilly and Company
(NYSE:LLY) is a recombinant form of human Activated Protein C. It is
administered by intravenous infusion and is available in 5 and 20 mg
vials.

The U.S. Food and Drug Administration approved Xigris in November
2001 for the reduction of mortality in adult patients with severe
sepsis (sepsis associated with acute organ dysfunction) who have a
high risk of death. Phase III clinical trial results showed that the
relative risk of death for patients receiving Xigris and who were at
high risk of death (as defined by an APACHE II score of greater than
or equal to 25) was reduced by 29 percent in a trial involving 1,690
patients (p=0.0002).

Safety and efficacy of Xigris have not been established in adult
patients with severe sepsis and lower risk of death. Safety and
efficacy have not been established in pediatric patients with severe
sepsis. Lilly is undertaking large-scale trials to investigate the use
of Xigris in lower risk patients and in children with severe sepsis,
as well as the optimal use of low-dose heparin with Xigris.

Bleeding events are common in patients with severe sepsis. In the
PROWESS trial, bleeding was the most common adverse reaction
associated with Xigris therapy. Serious bleeding events, including
intracranial hemorrhage, were observed during the 28-day study period
in 3.5 percent of Xigris-treated patients and 2.0 percent of
placebo-treated patients. The difference in serious bleeding occurred
primarily during infusion.

For complete Xigris (drotrecogin alfa (activated)) prescribing
information and labeling, call 800-423-2313 or visit www.Xigris.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by applying
the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.
Additional information about Lilly is available at www.lilly.com.

Xigris(R) (drotrecogin alfa (activated)), Lilly

(1) Recombinant Human Activated Protein C Worldwide Evaluation in
Severe Sepsis (Xigris n = 850; placebo n = 840).

(2) Data on file. Eli Lilly and Company.

(3) Angus D, et al. Epidemiology of severe sepsis in the United
States: analysis of incidence, outcome, and associated costs of care.
Crit Care Med 2001; 29(7): 1303-1310.

(4) Sands KE, Bates DW, Lanken PN, et al. Epidemiology of sepsis
syndrome in 8 academic medical centers. JAMA. 1997; 278(3): 234-240.2