Eli Lilly and Company

     
BW20021105002447  20021105T160224Z UTC


( BW)(ELI-LILLY-&-CO)(BC43) Eli Lilly and Company: Xigris Sustains
Survival Long Term in Severe Sepsis Patients; Studies Show Drug Saves
Lives Without Lengthening Hospital Stays

    Business Editors
    UK REGULATORY NEWS

    INDIANAPOLIS--(BUSINESS WIRE)--Nov. 5, 2002-- Xigris(R)
(drotrecogin alfa (activated)) sustains survival of severe sepsis
patients long term, according to study results presented at the 68th
annual International Scientific Assembly of the American College of
Chest Physicians (ACCP) in San Diego. In one of four abstracts on
Xigris presented today, the analysis indicates that the drug also
saves lives without lengthening hospital stays compared with the use
of standard care alone.

Xigris already had proved effective in decreasing the short-term risk
of death (28 days) in adults with life-threatening severe sepsis in
the landmark PROWESS Phase III clinical trial. Eli Lilly and Company
(NYSE: LLY) received FDA approval for Xigris in November 2001 to
reduce mortality in adult severe sepsis patients at high risk of death
(e.g., as determined by APACHE II(1)) and was recently approved by the
European Commission for use in the 15 countries it represents.

Xigris Sustains Survival

Results of a long-term follow-up analysis of PROWESS (n=1,690),
conducted from September 2001 until April 2002, showed that reduction
in mortality in Xigris-treated patients was sustained over the
duration of the study, which followed patients up through two and a
half years.(2) "Xigris has already proven that it dramatically
improves patients' chances of making it through the most dangerous
stage of life-threatening severe sepsis - those first 28 days," said
study researcher Derek C. Angus, M.D., M.P.H., associate professor of
anesthesiology and critical care medicine, University of Pittsburgh.
"Our new data show that the survival benefit of Xigris is sustained
over the long term. These findings are wonderful news - and offer
much-needed hope - for thousands of patients with severe sepsis and
their families."

No Increase in Hospital Time

In the PROWESS trial, treatment with Xigris plus standard therapy in
adults with severe sepsis significantly reduced 28-day all-cause
mortality compared with placebo plus standard therapy. The long-term
follow-up analysis showed Xigris significantly decreased in-hospital
mortality (absolute reduction of 5.2 percent) without incurring extra
time in the hospital. Among hospital survivors with known discharge
status, patient discharge locations - nursing home, ICU, other
hospital location - were similar between arms, with about 75 percent
of the excess survivors being discharged directly to home.(3)

"These data indicate that treatment with Xigris is an investment that
pays off," said William Macias, M.D., Ph.D., medical director, Xigris
product team, Eli Lilly and Company. "Xigris saves lives and does so
without requiring any excess hospital stay, allowing the majority of
survivors to go home rather than requiring care at another
institution."

New Data Reaffirms Efficacy and Safety Profile of Xigris

Additional data presented today demonstrate that the survival rate in
Xigris-treated patients from all clinical trials to date has remained
consistent with the PROWESS clinical trial results.

In five clinical trials and two compassionate use studies of Xigris,
the 28-day mortality rate for all patients receiving active treatment
was 25.3 percent, comparable to the 24.7 percent Xigris mortality and
less than the 30.8 percent placebo mortality demonstrated in the
PROWESS trial. A comprehensive review of cumulative safety data from
both clinical trials and postapproval experience in the United States
shows that the only significant adverse event associated with Xigris
is bleeding, and the data suggest risk of bleeding is generally
manageable. Importantly, this analysis indicates that such events were
frequently associated with other hemorrhage-causing factors, such as
invasive procedures and thrombocytopenia (platelets less than 30,000
per milliliter).(4)

About Xigris

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

In November 2001, the U.S. Food and Drug Administration approved
Xigris for the reduction of mortality in adult patients with severe
sepsis (sepsis associated with acute organ dysfunction) who have a
high risk of death (e.g., as determined by APACHE II). 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 the PROWESS trial involving 1,690
patients (p=0.0002).

Efficacy of Xigris has not been established in adult patients with
severe sepsis and a 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.

(1) Acute Physiology and Chronic Health Evaluation Score

(2) Angus D, et al. The Effects of Drotrecogin Alfa (Activated) on
    Long-Term Survival After Sepsis. CHEST, Oct. 2002, Vol. 122, No. 4
    (suppl), p.51S.

(3) Laterre PF, et al. The Effects of Drotrecogin Alfa (Activated) on
    Hospital Mortality, Length of Stay, and Discharge Location. CHEST,
    Oct. 2002, Vol. 122, No. 4 (suppl), p.51S.

(4) Bernard G., et al. Drotrecogin Alfa (Activated) Safety Update.
    CHEST, Oct. 2002, Vol. 122, No. 4 (suppl), p.50S.

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00001143
   Time of Receipt (offset from UTC): 20021105T120008+0000

    --30--djl/cl*

    CONTACT: Eli Lilly and Company, Indianapolis
             Dan Collins, 317/277-2688
             Debbie Davis, 317/277-1172

    KEYWORD: INDIANA 
    INDUSTRY KEYWORD: MEDICAL BIOTECHNOLOGY PHARMACEUTICAL PRODUCT
    SOURCE: Eli Lilly and Company

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