Eli Lilly and Company

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Eli Lilly and Company: Second Clinical Trial Substantiates Survival
Benefit Associated with Xigris in Lilly's Pivotal Phase III Trial

ENHANCE Study Corroborates Robust Treatment Effect Associated with
Xigris in Adult Severe Sepsis Patients

New research findings substantiate those observed in the landmark
PROWESS(1) trial, in which nearly one of every five adult severe
sepsis patients with multiple organ failure, who otherwise would have
died, survived with the addition of Xigris(R) (drotrecogin alfa
(activated))(2). Xigris is the first and only therapy proven to
increase survival in adult severe sepsis patients with multiple organ
failure when added to best standard care. Sepsis claims approximately
1,400 lives worldwide each day.(3)

ENHANCE, the largest trial ever conducted in severe sepsis, was a
global, single-arm, open-label trial of Xigris in patients with severe
sepsis. Results from this trial, which enrolled 2,378 adult patients,
were presented for the first time today at the 69th Annual
International Scientific Assembly of the American College of Chest
Physicians (ACCP).

Data from ENHANCE substantiate the survival benefit associated
with Xigris observed in PROWESS. In addition, compared to the PROWESS
placebo population, these data demonstrate that administration of
Xigris was associated with significant improvement in organ function.


                   Global
                   ENHANCE             PROWESS              PROWESS
                   (DrotAA)            (DrotAA)             (Placebo)
                   (N = 2378)          (n = 850)            (n = 840)
----------------------------------------------------------------------
28-Day mortality     25.3%               24.7%               30.8%
----------------------------------------------------------------------


The eligibility criteria and dosing regimen for both PROWESS and
ENHANCE were similar.

"If we are to adopt what we have learned from PROWESS and ENHANCE,
as we should, we must translate the clinical implications of the
findings into practical application at the bedside," said Jean-Louis
Vincent, M.D., P.H.D., head, department of Intensive Care, Erasme
University Hospital, Brussels, Belgium, and the principal European
investigator in both trials.

"To reduce mortality from severe sepsis, our challenge, then, is
twofold. First, we must identify severe sepsis patients earlier in the
disease progression. Second, we must employ aggressive interventions
earlier in the progression of severe sepsis. Clearly, this includes
use of Xigris for patients who meet the criteria."

ENHANCE was initiated shortly after completion of the PROWESS
trial. The purpose was to collect additional efficacy and safety data
for Xigris when treating adult severe sepsis patients.

"The successful completion of ENHANCE now provides a second trial
supporting the use of Xigris," said William Macias, M.D., medical
director, Xigris product team, Eli Lilly and Company. "The data from
ENHANCE were remarkably consistent with those of PROWESS, and,
furthermore, demonstrate that for the same level of disease severity,
patients treated within the first day of organ failure had
significantly lower mortality compared to those patients treated after
the first day."

Safety Assessment

Analysis of safety data from ENHANCE did not identify any new
risks associated with Xigris. Serious bleeding complications
associated with Xigris were observed in 2.4 percent of patients in
PROWESS and 3.6 percent in ENHANCE, as compared to 1.0 percent in the
placebo arm of the PROWESS study. In ENHANCE approximately 50 percent
of these complications were associated with procedures.

About Xigris

Xigris is a genetically engineered version of the human activated
protein C molecule, a naturally occurring protein in the body that
helps balance many of the major forces behind sepsis, including
coagulation (blood clotting) and suppression of fibrinolysis (the
body's clot-busting system).

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.

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) Bone RC, Balk RA, Cerra FB et al. Definitions for sepsis and
organ failure and guidelines for the use of innovative therapies for
sepsis. Chest, 1992; 101:1644-1655.