Eli Lilly and Company

Eli Lilly and Company (NYSE:LLY) announced today that the U.S. Food and Drug
Administration (FDA) has approved Symbyax(TM) (olanzapine and fluoxetine HCl)
for the treatment of depressive episodes associated with bipolar disorder.
Symbyax (pronounced SIMM-bee-ax), which is a combination of olanzapine, the
active ingredient in Zyprexa(R), and fluoxetine, the active ingredient in
Prozac(R), is the first FDA-approved medication for bipolar depression, a
notoriously difficult-to-treat condition that afflicts millions of Americans.

"There is a desperate need for an effective treatment for bipolar depression, a
devastating condition which often leads patients to take their own lives," said
Terence A. Ketter, M.D., associate professor of psychiatry & behavioral
sciences, and chief, Bipolar Disorders Clinic, Stanford University School of
Medicine.

"We are pleased to be able to provide clinicians with Symbyax, the first
FDA-approved option to help physicians help their patients with bipolar
depression," said Mauricio Tohen, M.D., Dr.P.H., Lilly clinical research fellow,
Lilly Research Laboratories and Zyprexa Product Team Leader. "Patients suffering
from this debilitating condition can now benefit from the combination of the
active ingredients in Zyprexa and Prozac, two of the most successful and proven
medications in neuroscience history."

Bipolar disorder is a complex mental illness characterized by debilitating mood
swings ranging from episodes of deep depression marked by feelings of extreme
guilt, sadness, anxiety and, at times, suicidal thoughts to episodes of mania
(abnormal euphoria, elation and irritability), interspersed with periods of
normal mood.

Patients with bipolar disorder spend more than three times longer in the
depressive phase than in the manic phase of the disorder and take longer to
recover from it. Additionally, the depressive phase of bipolar disorder is
associated with higher rates of morbidity and mortality. It is estimated that
one in four people with bipolar disorder will attempt suicide at least once, and
the relative risk of suicide among patients with bipolar depression has been
shown to be nearly 35 times greater than for patients in the manic phase of
bipolar disorder.

Symbyax Patients Experienced Robust Symptom Relief In Clinical Trials

According to a study (Tohen, et al.) published in the November 2003 issue of
Archives of General Psychiatry, Symbyax helped to treat the symptoms of bipolar
depression more effectively and at a significantly faster rate than placebo. In
the pooled eight-week studies, patients in the Symbyax group experienced
significantly greater improvement in depressive symptoms at weeks one, three,
four, six and eight, compared with patients taking placebo. That robust symptom
improvement was sustained throughout the entire eight weeks of the study. In
addition, Symbyax patients had no statistically greater risk of
treatment-emergent mania than patients taking placebo. In patients with bipolar
depression, a manic episode is a potential consequence of treatment with a
conventional antidepressant alone.

"Medications that clinicians have traditionally used to treat bipolar patients
in a depressive phase can often take several weeks to work and have the
additional risk of sending the patient into a manic episode," said Dr. Ketter.
"Having a medication that can provide symptom relief quickly, while avoiding
mania, will be so important to physicians in effectively treating patients with
bipolar depression, particularly because these individuals are at a high risk of
suicide."

Important Information on Symbyax

Symbyax is indicated in the United States for the treatment of depressive
episodes associated with bipolar disorder.

The most common adverse events reported in patients taking Symbyax in clinical
trials was drowsiness. Other common events noticed in clinical trials were
weight gain, increased appetite, feeling weak, swelling, tremor, sore throat,
and difficulty concentrating.

Hyperglycemia, in some cases associated with ketoacidosis, coma or death, has
been reported in patients treated with atypical antipsychotics, including
olanzapine, and concomitant olanzapine and fluoxetine. 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.

Although Symbyax is not approved for elderly patients with dementia it is
important to note the label for Symbyax includes a warning for patients in this
population. 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 clinical
trials for olanzapine, an active ingredient in Symbyax. In fact, Symbyax has not
been studied in elderly patients with dementia, nor do we expect Symbyax to be
used to treat these patients.

Symbyax may induce orthostatic hypotension (a drop in blood pressure when
standing up), associated with dizziness, speeding or slowing of heart rate, and
in some patients, fainting, especially during initial therapy.

Symbyax prescribing should be consistent with the need to minimize the risk of
neuroleptic malignant syndrome, tardive dyskinesia, and orthostatic hypotension.

Symbyax should not be administered until at least two weeks have passed since
discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at
least five weeks after discontinuation with Symbyax. Thioridazine should not be
administered with Symbyax or within a minimum of 5 weeks after discontinuing
Symbyax. Symbyax should be discontinued immediately if rash or other possibly
allergic phenomena appear for which an alternative explanation cannot be
identified.

Due to the cyclical nature of bipolar disorder, patients should be monitored for
the signs of mania and hypomania during treatment with Symbyax.

Patients should inform their physicians if they are taking Zyprexa, Prozac,
Sarafem or fluoxetine.

Prescribing Information and Availability

Full prescribing information is accessible at www.symbyax.com. Symbyax will be
available in pharmacies by mid-January of 2004.

Bipolar Disorder Background

Bipolar disorder, also known as manic-depressive illness, affects an
individual's mood, behavior and thinking. Unlike many illnesses, symptoms may be
quite different in different phases of the illness. Treatment is more
challenging because some therapies that are effective in one phase of the
illness may be counterproductive in another, such as the observation that
treatment with an antidepressant alone can precipitate manic episodes.

More than 2.5 million Americans live with a diagnosis of bipolar disorder, but
recent research indicates the real number may be as high as 10 million. The
results of untreated bipolar disorder can be catastrophic. An estimated 25
percent of patients with bipolar disorder attempt suicide at least once and
approximately 20 percent actually succeed. This is one of the highest rates for
any psychiatric disorder and three times higher than that of the general
population. The World Health Organization estimates that bipolar disorder is the
sixth leading cause of disability in the world.

Zyprexa Background

Zyprexa is indicated in the United States for the treatment of schizophrenia and
the short-term treatment of acute manic episodes associated with bipolar
disorder and for the long-term therapy and maintenance of treatment response of
schizophrenia. Additionally, Zyprexa is under review by the FDA for long-term
maintenance of bipolar disorder. (Zyprexa is not indicated for the treatment of
bipolar depression.) Since Zyprexa was introduced in 1996, it has been
prescribed to more than 12.5 million people worldwide.

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,
akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased
appetite and tremor.

A small number of patients in premarketing trials experienced asymptomatic
elevations of hepatic transaminase; none of these patients developed jaundice.
Periodic assessment of transaminases is recommended in patients with significant
hepatic disease. Prescribing should be consistent with the need to minimize the
risk of neuroleptic malignant syndrome, tardive dyskinesia, seizures, and
orthostatic hypotension.

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.

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

Prozac Background

Prozac was the first of a new class of drugs, called selective serotonin
reuptake inhibitors

(SSRIs), to be approved for use in the United States. This type of medication
helps patients with depression by increasing the availability of serotonin in
the brain. Scientists believe serotonin affects many types of activity in the
brain, including the regulation of mood.

Prozac was initially approved for treatment of depression in Belgium in 1986 and
in the United States in 1987. (Prozac is not indicated for the treatment of
bipolar depression.) Since then, it has been approved and marketed in more than
90 countries and used by more than 40 million people worldwide. The safety and
effectiveness of Prozac have been thoroughly studied in clinical trials with
more than 11,000 patients. There have been more than 3,500 publications on
Prozac in medical and scientific journals.

The most commonly observed adverse events associated with the use of Prozac vs.
placebo in U.S.-controlled clinical trials for depression, obsessive compulsive
disorder (OCD) and bulimia combined were nausea (23 vs. 10 percent), headache
(21 vs. 20 percent), insomnia (20 vs. 11 percent), anxiety (13 vs. 8 percent),
nervousness (13 vs. 9 percent) and somnolence (13 vs. 6 percent).

Prozac is contraindicated until at least two weeks have passed since
discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at
least five weeks after discontinuation with Prozac. Thioridazine should not be
administered with Prozac or within a minimum of 5 weeks after discontinuing
Prozac. Prozac should be discontinued immediately if rash or other possibly
allergic phenomena appear for which an alternative explanation cannot be
identified.

Full prescribing information is available at www.prozac.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 about the potential of
Symbyax for the treatment of the depressive phase of bipolar disorder and
reflects Lilly's current beliefs. However, as with any pharmaceutical product,
there are substantial risks and uncertainties in the process of development and
commercialization. There is no guarantee that the product will prove to be
commercially successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update forward-looking
statements.


Eli Lilly and Company
Marni Lemons, 317-433-8990