Mylan, U.S. finalize $465 million EpiPen settlement

Mylan NV has finalized a$465 million US settlement with the U.S. Justice Department,resolving claims it overcharged the government for its EpiPenemergency allergy treatment, which became the centre of afirestorm over price increases.

The U.S. Attorney's Office in Massachusetts revealed theaccord on Thursday, 10 months after Mylan said it reached a dealresolving claims it misclassified the EpiPen as a generic ratherthan a branded product to avoid paying rebates owed to Medicaid.

"Taxpayers rightly expect companies like Mylan that receivepayments from taxpayer-funded programs to scrupulously followthe rules," Acting U.S. Attorney William Weinreb said in astatement.

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Mylan did admit wrongdoing in entering into the settlement.

"Bringing closure to this matter is the right course ofaction for Mylan and our stakeholders to allow us to moveforward," Mylan Chief Executive Heather Bresch said in astatement.

The deal followed a False Claims Act whistleblower lawsuitfiled by French rival Sanofi SA in 2016, two yearsafter it first raised the matter with authorities, Weinreb'soffice said.

Sanofi, which in 2015 ceased marketing a rival productcalled Auvi-Q, will receive nearly $38.8 million as a rewardfrom the government.

Sanofi said in a statement it considered pursuing the matter"the right thing to do." It has a separate antitrust lawsuitpending, claiming that Mylan engaged in illegal conduct tosquelch competition to EpiPen.

The EpiPen, which Mylan acquired in 2007, is a handhelddevice that treats life-threatening allergic reactions byautomatically injecting a dose of epinephrine.

Mylan came under fire last year after raising the price of apair of EpiPens to $600, from $100 in 2008, enraging consumersand putting it in the center of the ongoing debate over the highcost of prescription medicines in the United States.

Mylan has since offered its own generic version for about$300.

The Justice Department settlement centred on claims thatMylan avoided higher rebates to state Medicaid programs bymisclassifying the EpiPen as a generic product, even through thecompany marketed and priced it as a brand-name product.

Some members of Congress in both parties have previouslycriticized the $465-million settlement as too small.

A U.S. Department of Health and Human Services' Office ofInspector General analysis released in May found the U.S.government may have overpaid for EpiPens by up to $1.27 billionbetween 2006 and 2016.