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( BW)(ELI-LILLY-&-CO)(BC43) Miscellaneous

    Business Editors
    UK REGULATORY NEWS

    LONDON--(BUSINESS WIRE)--Sept. 16, 2002--

             Eli Lilly: New Data Suggest Zyprexa Superior
to Standard of Care (Lithium) for Preventing Mania Relapse in Bipolar
                               Disorder

Zyprexa was found to be more effective than lithium in helping
patients with bipolar disorder remain in remission and prevent relapse
into mania, according to new data presented at the Third European
Stanley Foundation Conference on Bipolar Disorder.

The year-long study showed that in the maintenance treatment of
bipolar disorder, patients taking Zyprexa relapsed into mania only
half as often as patients taking lithium, which has long been
considered a standard of care for stabilizing mood in bipolar
disorder. The two treatments were comparable with regard to preventing
relapse into depression. In addition, significantly more
Zyprexa-treated patients completed the study and significantly fewer
were hospitalized.

"While both drugs performed well, Zyprexa was found to be superior
to lithium. This is especially impressive from a clinical standpoint
given that lithium has been the gold standard for decades for the
prevention of mania," said Frederick Goodwin, M.D., Director, Center
on Neuroscience, Medical Progress, and Society, George Washington
University Medical Center, Washington, DC. "This advance is very
encouraging for the long-term treatment of the disease, meanwhile, we
must continue our efforts to improve outcomes for bipolar depression."

Devastation of Bipolar Disorder

An estimated three million Americans have bipolar disorder, a
chronic condition consisting of cycles of mania and depression
interspersed with periods of normal mood. People with the disorder
also may experience mixed episodes, marked by symptoms of mania and
clinical depression occurring simultaneously.

Without proper treatment, patients with bipolar disorder often
participate in harmful activities such as abusing drugs and spending
excessively. They are also more likely to attempt and commit suicide
than individuals with other psychiatric conditions or in the general
population. In fact, an estimated 25 percent of people with bipolar
disorder will attempt suicide at least once and between 10 to 
20 percent will succeed.

Effective treatment is available for many but not all patients.
However, patients with bipolar disorder often take multiple
medications or suffer unmanageable side effects that can interfere
with compliance. Lithium, for example, requires blood monitoring for
potential adverse reactions.

Study Design

Remission was defined as a score of less than or equal to 12 on
the Young Mania Rating Scale (YMRS), an 11-item scale used to assess
severity of mania, and less than or equal to 8 on the Hamilton
Depression Rating Scale (HAMD-21), a 21-item scale used to assess
severity of depression. 543 patients with bipolar I disorder (manic or
mixed episode), a history of at least two manic or mixed episodes
within six years, and YMRS =20 received open label Zyprexa and lithium
combination therapy for six to 12 weeks. 431 patients met remission
criteria and were randomized to 52 weeks of double-blind monotherapy
treatment with Zyprexa (n=217; 5-20 mg/d) or lithium (n=214; 0.6-1.2
mEq/L blood level in a dose range of 300-1800 mg/d).

Key Results

The study found that Zyprexa was superior to lithium for the
maintenance treatment of bipolar disorder:

--  Zyprexa-treated patients had lower rates of relapse into mania
    or depression compared to lithium-treated patients (30.0% vs.
    38.8%, p=.055).

--  Rates of relapse into mania were significantly less with
    Zyprexa than with lithium (14.3% vs. 28.0%, p less than .001).
    Rates of relapse into a depressive episode were similar
    between treatment groups (16.1% vs. 15.4% respectively,
    p=.895).

--  Patients taking lithium experienced a mania relapse
    significantly sooner than those taking Zyprexa (estimated time
    for 25% of patients on each treatment to relapse was 212 days
    for lithium vs. 380 days for Zyprexa; p less than .001).

--  Zyprexa-treated patients had a lower rate of hospital
    admissions than lithium-treated patients (14.3% vs. 22.9%,
    p=.026).

--  Significantly more Zyprexa-treated patients completed the
    trial than those taking lithium (46.5% vs. 32.7%, p=.004). The
    Zyprexa group experienced lower discontinuation rates due to
    adverse events compared to the lithium group (18.9% vs. 25.7%,
    p=.105).

--  Lithium patients had a significantly faster time to
    discontinuation (p=0.017). Median time to discontinuation was
    303 days for Zyprexa and 207 days for lithium.

"What we have are two solid treatment options," said Mauricio
Tohen, MD, Dr.PH., Lilly Clinical Research Fellow, Lilly Research
Laboratories. "This study provides further evidence that Zyprexa as a
foundational treatment can help patients maintain dependable control
in all phases of bipolar disorder, ultimately helping them to move
their lives forward."

The most common self-reported treatment-emergent adverse event for
patients treated with Zyprexa was depression. The most common adverse
events with lithium were insomnia and mania. Other common events were
insomnia, mania, drowsiness and nausea for the Zyprexa-group and
depression and nausea for the lithium group. Mean weight gain during
the stabilization of the index manic episode (lithium + olanzapine)
was 2.74 kg. During the double blind phase weight gain was
significantly greater in the Zyprexa group than in the lithium group
(1.79 kg vs. -1.38 kg, P less than .001).

The Stanley Medical Research Institute is the largest private
provider of research on schizophrenia and bipolar disorder in the
United States and is a major provider of research on these diseases in
England, Ireland, Germany, Sweden, Denmark, Israel, and Australia. The
Third European Stanley Foundation Conference on Bipolar Disorder was
held in Freiburg, Germany, on September 12th and 13th.

Zyprexa Background

Zyprexa is currently indicated for the treatment of schizophrenia,
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. Zyprexa is the first atypical
antipsychotic to prove its long-term effectiveness in patients with
schizophrenia. Since Zyprexa was introduced in 1996, it has been
prescribed to 10 million people worldwide.

In the original schizophrenia registration trials, Zyprexa was
generally well tolerated. However, as with all medications, Zyprexa
was associated with some side effects. In the original six-week,
acute-phase schizophrenia trials, the most common treatment-emergent
adverse event associated with Zyprexa was somnolence. Other common
events were dizziness, weight gain, constipation, akathisia
(restlessness) and postural hypotension. Modest elevations of
prolactin were also seen, although mean changes from baseline to
endpoint were not statistically significantly different between
Zyprexa and placebo. A small number of patients experienced
asymptomatic elevations of hepatic transaminase; none of these
patients developed jaundice or drug-induced hepatitis.

In short-term (3- and 4-week) acute bipolar mania trials, the most
common treatment-emergent adverse event associated with Zyprexa was
somnolence. Other common events were dry mouth, dizziness, asthenia,
constipation, dyspepsia, increased appetite and tremor.

For safety information regarding lithium, see the product's full
prescribing information.

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.

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000786
   Time of Receipt (offset from UTC): 20020916T132800+0100

    --30--kam/in* 

    CONTACT: Eli Lilly and Company
             Marni Lemons - U.S., 317/433-8990
             Megan Pace - Global, 317/433-6946

    KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE 
    INDUSTRY KEYWORD: BANKING MEDICAL PHARMACEUTICAL PRODUCT 
    SOURCE: Lilly (Eli) & Co

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