BW20020826002385  20020826T181101Z UTC



( BW)(ELI-LILLY-&-CO)(BC43) Regulatory Approval

    Business Editors
    UK REGULATORY NEWS

   INDIANAPOLIS--(BUSINESS WIRE)--Aug. 26, 2002--

         European Commission Approves Eli Lilly and Company's
              Xigris for the Treatment of Severe Sepsis

Novel biotech treatment becomes the first proven therapy to reduce
mortality in patients with severe sepsis in Europe

Eli Lilly and Company (NYSE:LLY) today announced that the European
Commission has granted Marketing Authorisation for Xigris(TM)
(drotrecogin alfa (activated)) in all 15-member states of the European
Union. This novel, biotech therapy is approved for the treatment of
adult patients with severe sepsis with multiple organ failure when
added to best standard care. The approval decision follows a positive
opinion adopted by the European Committee for Proprietary Medicinal
Products (CPMP) on Thursday, 30 May 2002. Having received this
excellent news, Lilly will make Xigris available in the European Union
as soon as possible.

The European Commission based its decision on the results of an
international Phase III clinical trial known as PROWESS (Recombinant
Human Activated Protein C Worldwide Evaluation in Severe Sepsis),
which were published 8 March 2001, in The New England Journal of
Medicine. Xigris reduced the relative risk of death from severe sepsis
by nearly 20 percent in the trial involving 1,690 patients who had
sepsis with at least one associated organ dysfunction.

"The approval of Xigris within the European Union means adult patients
with severe sepsis will soon have a proven therapy to help reduce
mortality from this devastating condition," said Professor Jean-Louis
Vincent, Department of Intensive Care, Erasme Hospital, Brussels,
Belgium. "Severe sepsis is an extremely complex and difficult-to-treat
condition that can alter the function of the organs and even lead to
death."

"Today's approval is a major breakthrough in the treatment of severe
sepsis in Europe and brings new hope to patients with the condition
and their families," said Richard Pilnik, president of European
operations for Lilly. "Lilly has a long-standing commitment to
producing innovative treatments to improve patient care so we are
delighted to make Xigris available in Europe."

Every day 1,400 people worldwide die from severe sepsis(1), a
devastating syndrome characterized by an overwhelming systemic
response to infection, which can rapidly lead to organ dysfunction and
ultimately death. In European Union (EU) intensive care units (ICU),
severe sepsis and septic shock (severe sepsis combined with low blood
pressure) could be associated with the loss of 135,000(2) lives every
year and as much as EUR 7.6 billion (US$7.6 billion) in patient health
costs(3). In Europe, severe sepsis is associated with deaths on a
scale similar to that for lung cancer, breast cancer or colon cancer
every year.(4)

Xigris received approval from the US Food and Drug Administration on
21 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 (e.g., as determined by APACHE II). Since
the US approval, Xigris has also been approved in Puerto Rico, Israel,
Australia, Argentina, Peru, Romania, Columbia, Mexico, Switzerland,
India, Singapore, South Africa and now the European Union.

Xigris is a genetically engineered version of the human Activated
Protein C molecule, a naturally occurring protein in the body that
helps to balance many of the major forces behind sepsis, including
coagulation (blood-clotting) and suppression of fibrinolysis (the
body's clot-busting system). Additionally, patients with severe sepsis
treated with Xigris had a more rapid decline in interleukin-6 levels,
a global marker of inflammation, consistent with a reduction in the
inflammatory response. The drug is administered to patients as a
one-time, 96-hour infusion within an ICU setting. The precise dosage
depends on the weight of the patient.

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 (0.2 percent in Xigris-treated patients and
0.1 percent in placebo-treated patients), 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.

About Eli Lilly and Company

Lilly is a leading innovation-driven corporation and 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
the US in Indianapolis, Ind., Lilly provides answers -- through
medicines and information -- for some of the world's most urgent
medical needs.

This news release contains forward-looking statements that reflect
management's current beliefs about the potential for Xigris
(drotrecogin alfa (activated)) for the approved indication. However,
as with any pharmaceutical under development, there are significant
risks and uncertainties in the process of development and regulatory
review. There are no guarantees that the product will prove to be
commercially successful. For additional information about the factors
that affect the company's business, please see Exhibit 99 to the
company's latest Form 10-Q, filed August 2002. The company undertakes
no duty to update forward-looking statements.

Xigris(TM) (Drotrecogin alfa (activated)), Eli Lilly and Company,
Indianapolis, Indiana

(1) 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

(2) OECD Health Report (2000)

(3) Davies; Green; Hutton et al. Severe sepsis and septic shock: a
European estimate of the cost of illness in ICUs; June 2001; Abstract
presented at European Society of Intensive Care Medicine, October
2001.

(4) Davies A et al, June 2000, Severe sepsis and septic shock: a
European estimate of the cost of illness in ICUs: Official manuscript.

   Short Name: Lilly (Eli) & Co
   Category Code: REA
   Sequence Number: 00000676
   Time of Receipt (offset from UTC): 20020826T183442+0100

    --30--jgm/in*

    CONTACT: Lilly Global
             Carla L. Cox, 317/651-1473
             or
             Edelman
             Wendy Woods, +44 20 7344 1312 
             Steven Spurr, +44 20 7344 1340 

    KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE 
    INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL
    SOURCE: Eli Lilly and Company

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