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Amgen offers $762m to end Aranesp lawsuits

Pleads guilty to illegal marketing of anaemia drug


Amgen has pleaded guilty in a US court to illegally marketing its anaemia drug Aranesp, offering to pay $762m in fines and settlement payments.

The whistleblower suit accused Amgen of offering inducements to doctors to prescribe Aranesp (darbepoetin alfa) and also promoting the red blood cell stimulator for unapproved indications.

The biotech major entered a guilty plea to one misdemeanour charge in the New York court, with the judge in the case due to decide whether or not to accept the deal later today.

In the US, Aranesp is approved for treating anaemia caused by chronic kidney disease (CKD) or occurring as a result of cancer chemotherapy, but Amgen's sales representatives reportedly also promoted it for off-label dosing.

Specifically, the company said the drug could be delivered once-monthly in a bid to make it more competitive with rival drugs such as Johnson & Johnson's Procrit (epoetin alfa), which is given once every two weeks, according to the complaint.

Aranesp is FDA-approved only for weekly or biweekly dosing, depending on the indication. Attempts to win FDA approval for a biweekly dose in chemotherapy-related anaemia and a once-monthly dose in CKD resulted in failure.

According to the prosecutors in the case, Amgen will pay $612m to settle civil charges, $136m in criminal fines and forfeit a further $14m, according to the lawfirm representing one of the whistleblowers in the case.

Earlier this year, the company said it had set aside more than $800m in anticipation of charges associated with the suit, which has been ongoing for five years.

Aranesp generated turnover of $2.3bn in 2011, but has seen sales decline this year as a result of changing practice patterns, competition in the oncology setting and safety concerns - namely a link to increased risk of stroke - which resulted in changes to the drug's labelling in 2011.

19th December 2012

From: Sales, Regulatory



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