Eli Lilly and Company Resolves Investigation Involving Numerous States
Resolution Seen as Best Option for Company and Patients Who Rely on Zyprexa
INDIANAPOLIS, Ind., Oct. 7 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE:LLY) today announced that it has resolved a multi-state investigation involving 32 states and the District of Columbia (DC) related to the sales, marketing and promotion of its antipsychotic medication Zyprexa(R) (olanzapine).
"We believe all of the parties involved share an interest in putting this dispute behind us," said Robert A. Armitage, Lilly's senior vice president and general counsel. "From our standpoint, it's certainly in the best interests of the company and the patients, care-givers and healthcare professionals who continue to rely on this life-saving medication," he said, adding that Zyprexa remains available to patients and on formularies for Medicaid programs in all 50 states and DC.
While there is no finding that Lilly has violated any provision of the state laws under which the investigations were conducted, the company will pay $62 million to be divided among the settling states. This payment will result in a charge in the third quarter of $.04 per share. In addition, Lilly will undertake certain commitments regarding Zyprexa for a period of six years following the agreement via consent decrees filed in the various states. These commitments relate to the company's promotional practices, dissemination of medical information, funding of continuing medical education (CME) and grants related to Zyprexa, and continued disclosure of Zyprexa clinical trials and their results. Lilly would also agree to provide signatory attorneys general with information related to compensation made to healthcare professionals who have received more than $100 annually from the company for promotional speaking or consulting regarding Zyprexa in the U.S.
"Lilly's policies and practices already mirror most of the provisions included in the proposed consent decrees. This resolution reflects our commitment to continually build on a foundation of compliance, accuracy and transparency," said Armitage.
Lilly's Commitment to Compliance
Lilly has implemented and continues to review and enhance a broadly based compliance program that includes comprehensive compliance-related activities designed to ensure that its marketing and promotional practices comply with promotional laws and regulations. Lilly's compliance program includes 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 Chairman and its Board of Directors; 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 disciplinary and corrective action processes.
The 32 states participating in the agreement are Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin, as well as the District of Columbia. The company previously disclosed these state investigations, which were brought under those states' various consumer protection laws, in May 2007, in a quarterly filing with the U.S. Securities and Exchange Commission.
Eleven other states (Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia, Connecticut, Arkansas and Idaho) have filed lawsuits over Zyprexa and are not covered by this agreement. In March, Lilly entered into a $15 million settlement with the State of Alaska, which concluded an ongoing trial involving various issues surrounding Zyprexa. In addition, since 2005, Lilly has settled approximately 31,000 individual product liability lawsuits alleging that certain adverse events are associated with Zyprexa.
Since its initial approval by the FDA in 1996, Zyprexa has been prescribed for more than an estimated 26 million patients around the world, and is regularly used in the U.S. and in more than 80 other countries.
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 more than 26 million times by physicians 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- related psychosis. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with those patients taking a placebo. 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.
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 .
Source: Eli Lilly and Company
Web site: http://www.lilly.com/
Posted: October 2008
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