INDIANAPOLIS, Jan. 15 /PRNewswire-FirstCall/ -- Eli Lilly and Company
(NYSE: LLY) today announced that it has reached resolution with the United
States Attorney for the Eastern District of Pennsylvania (EDPA) and the Office
of Consumer Litigation of the Department of Justice regarding the
previously-reported government investigation into the company's past U.S.
marketing and promotional practices for the antipsychotic medication
Zyprexa(R) (olanzapine).
Lilly has been cooperating with the government in its investigation since
it began in 2004. As part of the resolution, Lilly has agreed to plead guilty
to one misdemeanor violation of the Food, Drug, and Cosmetic Act. The company
will also enter into a settlement agreement resolving the federal government's
civil investigation. Even though the company disagrees with and does not
admit to the civil allegations, the company has agreed to settle the dispute
over these allegations. In addition, the company has agreed to settle civil
investigations brought by the State Medicaid Fraud Control Units of the states
that have coordinated with the EDPA in its investigation.
"We deeply regret the past actions covered by the misdemeanor plea," said
John C. Lechleiter, Ph.D., chairman, president and chief executive officer of
Lilly. "At Lilly we take seriously our responsibilities to abide by all the
laws governing our business practices, and we realize that we have a
tremendous responsibility to the patients and healthcare professionals we
serve. Every day and with every interaction we strive to operate in a
responsible and compliant manner. Doing the right thing is non-negotiable at
Lilly, and I remain personally committed to all of us at Lilly maintaining the
highest standards of conduct."
Continued Lechleiter, "The company's comprehensive compliance program is
an embedded part of our company's culture. These are not just words to us -
we continue to implement a range of programs and policies to help ensure that
we operate in a manner consistent with all applicable laws and regulations.
These programs apply to all parts of our business, and all of our employees
are aware of the imperative for them to be models of compliance and of ethical
behavior."
The misdemeanor plea is for the off-label promotion of Zyprexa between
September of 1999 and March of 2001. Specifically, the plea states that Lilly
promoted Zyprexa in elderly populations as treatment for dementia, including
Alzheimer's dementia, although Zyprexa is not approved for such uses. As part
of this agreement regarding the criminal investigation, Lilly has agreed to
pay $615 million.
Under terms for the resolution of the civil investigations, Lilly has
agreed to make payments totaling nearly $800 million. Approximately $438
million will be paid to the federal government and approximately $362 million
will be made available for payment to settling states. As previously
reported, Lilly took a charge of $1.415 billion, or $1.29 per share, in the
third quarter of 2008 in connection with this investigation. The 2008 charge
will be sufficient to cover the payments announced today. The company is now
finalizing the tax treatment of these payments, and will communicate this
impact when the company announces fourth quarter 2008 financial results on
January 29, 2009.
Lilly has a comprehensive compliance program that is designed to ensure
that the company's global business practices fully comply with all laws and
regulations. Lilly's compliance program, which the company is committed to
continually improving and enhancing, includes each of the elements of
compliance guidelines issued by the Department of Health and Human Services,
Office of Inspector General, for the pharmaceutical industry. The company has
a vice president and chief compliance officer, who reports directly to Lilly's
chief executive officer; a corporate compliance committee; a code of conduct;
policies and procedures specific to promotion and marketing; extensive
training; auditing, monitoring and reporting programs, including a compliance
hotline; and processes for disciplinary and corrective action.
Also, as part of the settlement, Lilly has entered into a corporate
integrity agreement with the Office of Inspector General (OIG) of the U.S.
Department of Health and Human Services (HHS). This agreement will require
Lilly to maintain its compliance program and to undertake a set of defined
corporate integrity obligations for five years. The terms of the corporate
integrity agreement are largely consistent with the company's existing
compliance program. They also provide for an independent third-party review
organization to assess and report on the company's systems, processes,
policies, procedures and practices. This agreement reflects Lilly's
commitment to continually build on a foundation of compliance, accuracy and
transparency.
The settlement is subject to approval by the federal court in
Philadelphia; the company anticipates a hearing on the settlement will occur
within the next few weeks.
Zyprexa Background
Zyprexa is indicated in the United States for the short- and long-term
treatment of schizophrenia, acute mixed or manic episodes of bipolar I
disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was
introduced in 1996, it has been prescribed for an estimated 26 million
patients around the world. 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 levels.
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.
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 knows as Neuroleptic Malignant Syndrome 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 treatments, 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 nonagressive objectionable behavior), constipation,
akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased
appetite and tremor.
Full prescribing information, including a boxed warning, is available at
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 www.lilly.com. C-LLY
This press release contains forward-looking statements that are based on
management's current expectations, but actual results may differ materially
due to various factors. The company cannot guarantee court approval of the
settlement. There are significant risks and uncertainties in pharmaceutical
research and development. There can be no guarantees with respect to pipeline
products that the products will receive the necessary clinical and
manufacturing regulatory approvals or that they will prove to be commercially
successful. The company's results may also be affected by such factors as
competitive developments affecting current products; rate of sales growth of
recently launched products; the timing of anticipated regulatory approvals and
launches of new products; regulatory actions regarding currently marketed
products; other regulatory developments and government investigations
(including state claims relating to Zyprexa that are not resolved in this
settlement); patent disputes and other litigation involving current and future
products; the impact of governmental actions regarding pricing, importation,
and reimbursement for pharmaceuticals; changes in tax law; asset impairments
and restructuring charges; acquisitions and business development transactions;
and the impact of exchange rates. For additional information about the factors
that affect the company's business, please see the company's latest Form 10-Q
filed November 2008. The company undertakes no duty to update forward-looking
statements.
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Zyprexa(R) (olanzapine, Lilly)
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