Lilly Expresses Concerns With Opinion of ADA

    Date:                                                                          

For Release: Immediately

Refer to: [phone] Marni Lemons

[phone] Jeff Newton

       Lilly Expresses Concerns With Opinion of ADA Panelon Antipsychotic        

                        Drugs and Obesity and Diabetes                         

                    Company Reaffirms 2004 Earnings Guidance                    

INDIANAPOLIS, January 27, 2004 - Eli Lilly and Company does not agree with a
controversial conclusion of an opinion paper issued by an American Diabetes
Association-sponsored panel, which states that second generation antipsychotics
(SGAs) differ in their diabetes risk profiles. Not only are these findings not
supported by the total body of evidence available on the subject, they are in
direct conflict with the U.S. Food and Drug Administration's (FDA) recent class
labeling language which states, "Precise risk estimates for
hyperglycemia-related adverse events in patients treated with atypical
antipsychotics are not available." The FDA's class labeling decision called on
the makers of all SGAs to include a warning on hyperglycemia and diabetes in
their prescribing information.

Lilly does agree with the majority of the conclusions from this one-day
consensus conference, including the need for baseline screening and follow-up
monitoring for worsening of glucose control for patients taking all SGAs.
However, Lilly is concerned that the inconsistency between FDA labeling and
this consensus opinion conclusion may confuse patients and prescribers. This
could potentially lead to inappropriate discontinuation of certain medications
and a lack of appropriate monitoring for all patients, which could have
life-threatening consequences.

Lilly is also concerned that the paper seems to minimize the considerable
benefits that these medications provide to patients with debilitating and
life-threatening mental illnesses like schizophrenia and bipolar disorder,
which could outweigh metabolic risks, providing the paper with limited
real-world applicability.

The FDA based its September, 2003, labeling decision on an exhaustive, multi
year review of all available data, including case reports, epidemiologic
studies and clinical trial data. This class labeling includes the following
language:

"Assessment of the relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an increased background risk
of diabetes mellitus in patients with schizophrenia and the increasing
incidence of diabetes mellitus in the general population. Given these
confounders, the relationship between atypical antipsychotic use and
hyperglycemia-related adverse events is not completely understood. However,
epidemiological studies suggest an increased risk of treatment-emergent
hyperglycemia-related adverse events in patients treated with the atypical
antipsychotics. Precise risk estimates for hyperglycemia-related adverse events
in patients treated with atypical antipsychotics are not available."

The ADA-sponsored panel's paper was written following a one-day conference held
in November of 2003. The paper is to be published in the February issue of
Diabetes Care.

Lilly manufactures Zyprexa ®, which was recently approved by the FDA for
maintenance treatment of bipolar disorder. In addition to the newly approved
indication, Zyprexa is indicated in the United States for the short-term and
long-term treatment of schizophrenia, and either alone or in combination with
lithium or valproate for the short-term treatment of acute mixed or manic
episodes associated with bipolar disorder. Since Zyprexa was introduced in
1996, it has been prescribed to more than 1

The company reaffirmed today its earnings per share guidance for the first
quarter and full-year 2004. Specifically, the company expects earnings per
share to be in the range of $.65 to $.67 for the first quarter of 2004 and
$2.80 to $2.85 for the full-year 2004. The company 's earnings guidance for the
first quarter and full year excludes significant unusual items. As previously
disclosed, the company will report a substantial one-time charge for acquired
in-process research and development related to the Applied Molecular Evolution
merger, which is anticipated to close in the first quarter of 2004. At this
time, the amount of the charge has not been determined. The company is not
aware at this time of any other material unusual items that will occur in 2004.
Further, this guidance reflects Zyprexa's ongoing domestic competitive
pressures, which the company will continue to monitor. It also includes the
projected benefits for Zyprexa associated with the recently approved bipolar
maintenance indication, as well as Symbyax(tm) for the recently approved bipolar
depression indication, and the anticipated, near-term approval of Zyprexa
IntraMuscular, a rapid-acting, injectible formulation of the product.

Important Information on Zyprexa

The most common treatment-emergent adverse event associated with Zyprexa in
placebo-controlled, short-term schizophrenia and bipolar mania trials was
drowsiness. Other common events were dizziness, weight gain, personality
disorder (COSTART term for nonaggressive objectionable behavior), constipation,
restlessness, episodes of low blood pressure, dry mouth, weakness, upset
stomach, increased appetite, and tremor. A small number of patients experienced
asymptomatic elevations of certain liver enzymes; none of these patients
experienced jaundice.

Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has
been reported in patients treated with atypical antipsychotics including
Zyprexa. Assessment of the relationship between atypical antipsychotic use and
glucose abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia and the
increasing incidence of diabetes mellitus in the general population. The
available data are insufficient to provide reliable estimates of differences in
hyperglycemia-related adverse event risk among the marketed atypical
antipsychotics.All patients taking atypicals should be monitored for symptoms
of hyperglycemia. Persons with diabetes who are started on atypicals should be
monitored regularly for worsening of glucose control; those with risk factors
for diabetes should undergo baseline and periodic fasting blood glucose
testing. Patients who develop symptoms of hyperglycemia during treatment should
undergo fasting blood glucose testing.

Prescribing should be consistent with the need to minimize the risk of
neuroleptic malignant syndrome, tardive dyskinesia, seizures and low blood
pressure.

In short-term (six-week) acute bipolar mania trials in combination with lithium
or valproate, the most common treatment emergent adverse event associated with
Zyprexa and lithium or valproate was dry mouth. Other common events were weight
gain, increased appetite, dizziness, back pain, constipation, speech disorder,
increased salivation, amnesia and abnormal burning or tingling of the skin.

Although the efficacy of Zyprexa in elderly patients with dementia has not been
established in clinical trials and Zyprexa is not approved for use in this
patient population, it is important to note the label for Zyprexa includes a
warning for elderly patients with dementia. The warning states that strokes or
mini-strokes (also called transient ischemic attacks or TIAs), including
fatalities were reported in elderly patients with dementia-related psychosis
participating in Zyprexa clinical trials.

Full prescribing information is available at www.zyprexa.com.

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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.

This press release contains forward-looking statements that are based on
management

                                     # # #                                     

Alimta

Cialis

Cymbalta

Evista

Gemzar

Humalog

Humatrope

Humulin

Prozac

Prozac

ReoPro

Strattera

Xigris



Eli Lilly and Company

Lilly Corporate Center

Indianapolis, Indiana 46285

U.S.A.

www.lilly.com







                                     - 4 -                                     




END