Eli Lilly to pay over Zyprexa probes

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OK....: Eli Lilly to pay $1.42 billion to resolve Zyprexa probes - Yahoo! News

Eli Lilly and Co said on Thursday it will pay about $1.42 billion to settle criminal and civil investigations into the marketing of its antipsychotic drug Zyprexa and has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act.

The drug maker has agreed to pay $615 million to settle the criminal investigation and about $800 million to settle the civil investigations brought by the State Medicaid Fraud Control Units of the states that have coordinated with the Eastern District of Pennsylvania in its investigation.

Lilly said the misdemeanor plea is for the off-label promotion of Zyprexa between September 1999 and March 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," the company said in a statement.

Such a settlement was anticipated. Lilly booked $1.48 billion in charges related to the probes in the third quarter last year.

Zyprexa is one of Lilly's biggest drugs, with 2007 sales of $4.8 billion. The drug is considered by many physicians to be the most effective in a class of drugs known as atypical antipsychotics used to treat schizophrenia, but it is also seen as one of the worst offenders in causing weight gain, which can be a precursor to diabetes.

Zyprexa is set to lose patent protection in 2011. Earlier this month, U.S. regulators delayed a final decision on whether to approve a long-acting form of the drug.

As part of the settlement, Lilly has entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.