(By Balachander) Amgen Inc. (NASDAQ: AMGN) has agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs.
The Thousand Oaks, California-based biotechnology company pleaded guilty for illegally introducing a misbranded drug, Aranesp, into interstate commerce.
Aranesp is an erythropoiesis-stimulating agent (ESA) that was approved by the FDA at calibrated doses for particular patient populations suffering from anemia.
Beginning at the launch of Aranesp in 2002 and extending until 2007, the Justice Department said, Amgen illegally introduced Aranesp for uses and at dosage levels that the FDA had specifically declined to approve due to insufficient clinical evidence to establish their safety and efficacy.
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According to the Justice Department, Amgen also illegally introduced Aranesp into the oncology ESA market intending that it be used to treat anemia caused by cancer, irrespective of whether the patient had been prescribed chemotherapy - a use which the FDA had never approved and which the FDA subsequently determined caused an increased risk of death.
As part of the civil settlement, Amgen has agreed to pay $612 million to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs.
Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.
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The stock, which has been trading in the 52-week range of $60.67 to $90.81, traded 0.55 percent lower at $88.80 on Wednesday.