News Release

ATLANTA, May 23, 2005 /PRNewswire-FirstCall via COMTEX/ -- People taking atypical antipsychotics for schizophrenia were most likely to discontinue therapy due to continued presence of psychiatric symptoms, according to data presented today at the 158th annual meeting of the American Psychiatric Association (APA). Findings also revealed that patients taking olanzapine were significantly more likely to remain on medication longer than patients taking other atypical and conventional antipsychotics.

"Schizophrenia is a chronic disease that requires lifelong therapy. Finding a medication to which patients will adhere is essential," said Michael Stevens, M.D., director of Psychopharmacology Research at Valley Mental Health in Salt Lake City, Utah. "These data demonstrated that patients with schizophrenia were more likely to stay on medication longer with olanzapine compared to other antipsychotics."

Almost 60 percent of people with schizophrenia do not take their medications as prescribed by their physicians.(1) According to the APA's guidelines for the treatment of schizophrenia, 60 to 70 percent of patients relapse within one year without maintenance treatment and almost 90 percent relapse within two years.(2)

Key Findings

In the study, "Differential Rates of Treatment Discontinuation in Clinical Trials as a Measure of Treatment Effectiveness of Atypical Antipsychotics," researchers reviewed treatment discontinuation rates and reasons for discontinuation from four 24 to 28 week randomized, double-blind clinical trials involving 1627 patients with schizophrenia taking widely prescribed atypical antipsychotics (olanzapine, risperidone, quetiapine and ziprasidone). The study compared discontinuation rates and the probability of staying on medication for patients taking olanzapine against patients taking the other atypicals. According to the study:

* Olanzapine-treated patients (n=822) were significantly more likely to stay on medication longer (19.1 vs. 16.1 weeks, p. 0.0001) and to complete the full duration of the trial (53.9 vs. 39.3 percent, p. 0.001) than patients treated with the other atypicals (n=805);

* Patients taking the other atypicals were significantly more likely to discontinue their medication due to poor response (lack of efficacy) or a worsening of psychiatric symptoms (such as hallucinations, delusions, depression and agitation) than patients taking olanzapine (other atypicals 24.6 percent vs. olanzapine 14.2 percent, p. 0.0001);

* Poor response and symptom worsening were the primary reasons for discontinuation (36 percent), regardless of medication, based on physician and patient perceptions; and

* There was no significant difference in the rate of discontinuation due to patients' inability to tolerate medication related to adverse events or side effects (olanzapine 5.6 percent vs. other atypicals 7.5 percent, p=0.13).

The data were collected in clinical, controlled settings and as a result might not reflect naturalistic treatment.

In a second, open-label, one-year trial, "Time to All-Cause Discontinuation Following Randomization to Open-label Olanzapine, Risperidone, or Conventional Antipsychotic Treatment for Schizophrenia," patients randomized to olanzapine (n=222), risperidone (n=217), or conventional antipsychotics (n=209) of low (n=14), medium (n=135; perphenazine n=49) or high potency (n=49) were compared on time to all-cause medication discontinuation. In the treatment of schizophrenia, time to all-cause medication discontinuation is a recognized index used to measure an interruption or cessation of antipsychotic treatment for any reason.

Survival rate analyses were used to compare the rates of patients remaining on the medication they were randomized to during the one-year study period. Mean number of days to all-cause discontinuation of the randomized medication were also calculated and compared between the treatment groups.

According to the study:

* Average time to all-cause discontinuation for olanzapine was significantly longer (274 days) than for risperidone (228 days, p0.01), perphenazine (202 days, p0.01) and other conventionals, regardless of potency levels (p0.05);

* One-year survival rate was significantly higher for olanzapine (55 percent) than risperidone-treated patients (47 percent, p=0.006);

* Survival rate for olanzapine-treated patients was significantly higher (32 percent, p0.001) than conventional antipsychotics of high, medium (including perphenazine) or low potency levels; and

* Survival rate for risperidone-treated patients was significantly higher (p.01) than conventional antipsychotics of high or medium potency, but did not differ significantly (p.05) from conventionals of low potency or perphenazine.

"An effective medication needs to be one that patients will feel motivated to continue," said Dr. Stevens. "These studies showed that patients taking olanzapine stayed on treatment longer than other antipsychotics, and shows that antipsychotics differ when comparing time to all-cause medication discontinuation."

About Schizophrenia

Schizophrenia is a severe and debilitating psychiatric illness often characterized by acute psychotic episodes including delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices) and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms. In addition to psychiatric symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

About Olanzapine

Olanzapine (Eli Lilly and Company) is indicated for the treatment of schizophrenia, for acute bipolar mania, and for maintenance treatment in bipolar disorder.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.

The most common treatment-emergent adverse event associated with olanzapine in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. 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.

The most common treatment-emergent adverse event associated with olanzapine in combination with lithium or divalproex in 6-week combination bipolar mania trials was dry mouth. Other common events were weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, and paresthesia.

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

Safety experience in elderly patients with dementia-related psychosis -- In placebo-controlled clinical trials of elderly patients with dementia- related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs. 1.5%, respectively). Risk factors that may predispose this patient population to increased mortality when treated with olanzapine include age >80 years, sedation, concomitant use of benzodiazepines, or presence of pulmonary conditions (e.g., pneumonia, with or without aspiration). Olanzapine is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular adverse events (CVAE), including stroke, in elderly patients with dementia -- Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of CVAE in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.

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

For full prescribing information visit www.lilly.com .

About Eli Lilly and Company

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 .

LillyAnswers ensures that low-income Medicare enrollees with the greatest need have complete access to the Lilly products they require. The centerpiece of the patient assistance program, the LillyAnswers card, allows seniors and people with disabilities under Medicare to pay a flat $12 fee for a 30-day supply of certain retail distributed Lilly drugs, including olanzapine. Since Lilly implemented LillyAnswers in 2002, hundreds of thousands of people without prescription drug insurance have received more than a half million Lilly products. LillyAnswers enrollment applications are available by calling the toll-free number: 1-877-RX-LILLY (1-877-795-4559) or online at www.lillyanswers.com . P-LLY

This press release contains forward-looking statements about the potential of olanzapine for the treatment of schizophrenia 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 continue 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.

(1) Gilmer TP, Dolder CR, Lacro JP, Folsom DP, Lindamer L, et al. "Adherence to Treatment With Antipsychotic Medication and Health Care Costs Among Medicaid Beneficiaries With Schizophrenia." Am J Psychiatry 2004 161: 692-699.

(2) Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry 2004 Feb;161(2 Suppl):1-56.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

Kerry Dixon of GCI Group, +1-212-537-8261; or Heather Lusk of Eli Lilly and Company,
+1-317-433-5600

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