(Reuters) – A federal judge on Wednesday approved a $762 million payment from Amgen Inc, the final step to resolve nearly a dozen criminal and civil cases stemming from the sale of its once-blockbuster anemia drug Aranesp and several others.
Prosecutors previously said in Brooklyn federal court on Tuesday the company had agreed to pay $612 million in a civil settlement, a $14 million criminal forfeiture payment, and a $136 million criminal fine. It is the single largest criminal and civil fraud settlement involving a biotechnology company in U.S. history, according to the U.S. attorney’s office in Brooklyn.
Amgen pleaded guilty on Tuesday to one misdemeanor criminal count that it promoted Aranesp for higher, less frequent doses than approved in the drug’s label by federal regulators. The company was also accused of marketing the drug to treat anemia caused by cancer, for which it was not approved, rather than to combat anemia as a side effect of chemotherapy treatments.
Amgen recorded a $780 million charge in the third quarter of 2011 to resolve civil and criminal litigation. In a recent regulatory filing with the U.S. Securities and Exchange Commission, Amgen said it had set aside $806 million related to the proposed settlement of charges arising out of the federal civil and criminal investigations.