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Quotes & Info
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| AMGN > SEC Filings for AMGN > Form 8-K on 19-Dec-2012 | All Recent SEC Filings |
19-Dec-2012
Other Events, Financial Statements and Exhibits
On December 19, 2012, Amgen Inc. (the "Company") issued a press release announcing that it has finalized a settlement agreement (the "Settlement Agreement") with the U.S. government, 49 states and the District of Columbia related to previously disclosed investigations. Under the Settlement Agreement, the Company will pay approximately $612 million to resolve its civil liability related to certain promotional practices related to the drugs Aranesp® (darbepoetin alfa), EPOGEN® (epoetin alfa), NEUPOGEN®(Filgrastim), Neulasta® (pegfilgrastim), Enbrel® (etanercept) and Sensipar®(cinacalcet) as alleged in the unsealed qui tam complaints and $150 million to resolve its criminal liability relating to the marketing of Aranesp. The Company previously disclosed that, as of September 30, 2012, it had accrued $806 million associated with the proposed settlement of the allegations now being resolved by the Settlement Agreement.
As part of the Settlement Agreement, the Company has pleaded guilty to a single misdemeanor count of misbranding Aranesp by promoting it in a way that was different from the dosages in the label. The plea was entered on December 18, 2012 in the U.S. District Court for the Eastern District of New York and was accepted on December 19, 2012 by the same court. The Company also entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services that requires the Company to maintain its corporate compliance program and to undertake a set of defined corporate integrity obligations for a period of five years.
A copy of the press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
(d) Press Release.
99.1 Press Release dated December 19, 2012.
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