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Statement from Eli Lilly and Company: Response to Today's New York Times Article, 'Lilly E-Mail Discussed Off-Label Drug Use'
Date:3/14/2008

INDIANAPOLIS, March 14 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today called the assertions in a New York Times online article 'flat out wrong.' The Times report in question focused on the State of Alaska v. Eli Lilly and Company trial that is underway and attempted to interpret a 2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer. About this email and the Times report, the company makes the following statement:

-- The Times article not only mischaracterized Dr. Lechleiter's email,

which the court deemed inadmissible, but significantly minimized

Lilly's perspective on this topic, resulting in a very skewed and

inaccurate article.

-- At the time of the email referenced (2003), Dr. Lechleiter was the

company's vice president of pharmaceutical products and corporate

development, overseeing the area of the company that is responsible for

developing new products and conducting late-stage clinical programs to

address the most pressing medical questions and also to ensure Lilly

made successful regulatory submissions. Importantly, he did not

oversee or direct promotional or marketing activities.

-- Additionally, in 2003, no atypical antipsychotic treatments were

approved by the FDA for children or adolescents suffering from

schizophrenia and bipolar disorder; yet physicians, desperate to

improve their young patients' lives, were already prescribing these

medicines, albeit, with limited information on their safety, efficacy

or dosing considerations in these special patient populations. Dr.

Lechleiter had just returned from a trip where he had direct

interaction with healthcare professionals who made clear their need for

this important information.

-- Dr. Lechleiter's email was nothing more than a call to action to ensure

Lilly's development organization placed a high priority on conducting

clinical trials to address these important medical questions. His

specific reference to "the opportunity to expand our work with

Zyprexa(R) (olanzapine)" referred directly to clinical development

already underway, not promotional activity. This email indicates his

support for continued company investment and focus in gathering this

critical information (such as data on safety, efficacy and dosing in

these special populations) to ensure it was not only submitted to

regulatory bodies, but also accessible so that doctors and caregivers

could make informed treatment decisions.

-- Of note, since this 2003 email, Lilly has since completed studies and

presented their findings at major peer-review venues such as medical

meetings, included these data in our medicines' product label (in the

safety information section) as well as submitted these data to the US

Food and Drug Administration for approval consideration.

-- As stated on many occasions, Lilly is committed to the highest ethical

standards and to promoting our medications only for approved uses. This

steadfast commitment begins at the top of our organization -- and

remains an utmost priority of both our current and incoming chief

executive officer -- and is carried throughout the company. Although

we realize the above point does not make for exciting news

copy, it is information that anyone who read the Times coverage should

know.

Zyprexa Background

Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed to approximately 23 million people worldwide. Zyprexa is not approved for patients under 18 years of age.

Zyprexa is not approved for the treatment of patients with dementia-

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related psychosis. Elderly patients with dementia-related psychosis

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treated with atypical antipsychotic drugs are at an increased risk of

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death compared with those patients taking a placebo.

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In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa.

While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or who have borderline increased blood glucose level. Patients taking olanzapine should be monitored regularly for worsening of glucose control. Persons with risk factors for diabetes who are starting on atypical antipsychotics should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.

Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using olanzapine, is advised. Significant, and sometimes very high, elevations in triglyceride levels have been observed with olanzapine use. Modest mean increases in total cholesterol have also been seen with olanzapine use.

Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight.

As with all antipsychotic medications, a rare and potentially fatal condition known as NMS has been reported with Zyprexa. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation, and trouble swallowing.

The most common treatment-emergent adverse event associated with Zyprexa 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.

Full prescribing information, including a boxed warning, is available at http://www.zyprexa.com.

About Lilly

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 http://www.lilly.com.
C-LLY

Zyprexa(R) (olanzapine, Lilly)

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


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SOURCE Eli Lilly and Company
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