| NEW YORK
NEW YORK Dec 19 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
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.
U.S. District Judge Sterling Johnson accepted the company's
plea on Wednesday and approved its plea agreement with the
government. The agreement includes a call for Amgen to abide by
a five-year corporate integrity agreement, which imposes new
compliance, transparency and accountability measures on the
company's top executives and directors.
The agreement resolves a more than five-year investigation
by the U.S. attorney's office in Brooklyn, as well as a related
investigation by federal prosecutors in Washington state,
according to court papers.
"Instead of working to extend and enhance human lives, Amgen
illegally pursued corporate profits while jeopardizing the
safety of vulnerable consumers suffering from disease," acting
U.S. attorney Marshall Miller of the Eastern District of New
York said in a statement.
Details of the $612 million civil portion of the settlement
were also unsealed Wednesday, encompassing a wider scope of
allegations than the criminal case. The civil settlement
resolves 10 whistleblower lawsuits from Brooklyn, Massachusetts
and Washington federal courts, prosecutors said.
The civil settlement covers allegations that Amgen market
Aranesp and two other drugs, Enbrel and Neulasta, for uses and
doses that had not been approved. The company was also accused
of offering illegal kickbacks to try to persuade health-care
providers to prescribe their drugs, and engaged in false price
reporting practices, federal prosecutors said.
Other Amgen drugs named in the civil suits include Epogen,
Neupogen and Sensipar, according to court papers.
"The government raised important concerns in the criminal
prosecution," Amgen chief compliance officer Cynthia Patton said
in a statement. "Amgen acknowledges that mistakes were made, and
we did not live up to our standards."
Amgen shares were down 53 cents to $88.76 in midafternoon
(Reporting by Jessica Dye; Editing by Neil Stempleman)