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Biogen finalizes $900M deal to settle whistleblower's long-running MS kickback suit
  • Publisher:Phexcom
  • Publication:2022/9/27

Years into a whistleblower suit thatalleged illegal kickbacks to physicians, Biogen is now finally able to end thelegal saga just as the troubled drugmaker attends to a corporate restructuring.

Biogen has finalized an agreement to pay $900 million to resolvea lawsuit in which a former employee alleged that the Massachusetts biotechpaid kickbacks to doctors over a five-year span starting in 2009 to boost salesof its multiple sclerosis drugs, the Department of Justice said Monday. Biogenin July said it had reached the $900 million deal in principle.

Like many companies have done inresponse to kickback suits filed under the False Claims Act, Biogen didn’tadmit to any wrongdoing. The company “believes its intent and conduct was atall times lawful and appropriate, and Biogen denies all allegations raised inthis case,” Biogen said in a Monday statement.

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Former Biogen sales manager MichaelBawduniak initiated the litigation. Bawduniak alleged that Biogen heldsham events between January 2009 and March 2014 to pay doctors kickbacks underthe pretense of remuneration, speaker training fees and consulting fees. Thecompany’s goal was to induce them to prescribe Biogen’s MS drugs Avonex,Tysabri and Tecfidera, the plaintiff said.

The settlement will see Biogen pay about$843.8 million to the U.S. federal government and $56.2 million to 15 states.Bawduniak himself will receive about 29.6% of the federal proceeds, or about$250 million, from the settlement, the DOJ said. 

Biogen’s flagship MS portfolio has been ona fast decline after Tecfidera lost U.S. patent protection in 2020, butit’s still a large business. For the three months ended in June, Tecfidera,Avonex and Tysabri together brought in $1.17 billion in sales for Biogen.

“Biogen determined that now was the righttime to resolve the litigation and allow the company to remain focused on ourpatients and strategic priorities,” the company said in a Monday statement.

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The company could certainly use fewerdistractions at this moment. Because of the MS revenue decline andits disastrous Alzheimer’s disease launch, Biogen has recently launched a company reshuffling, which aims to save $1billion in annual costs. CEO Michel Vounatsos is on his way out, and Biogen hasyet to name his successor after announcing his departure in May.

For the MS franchise, Biogen has beentrying to put patients on Tecfidera follow-on therapy Vumerity, but so far, thenewer drug’s growth hasn’t been able to compensate for the loss from itspredecessor amid generic competition to Tecfidera.

Elsewhere, while Biogen is still pluggingaway with a confirmatory trial for Alzheimer’s drug Aduhelm, it hasculled the commercial team supporting the drug after a negative Medicarecoverage ruling practically denied it any meaningful sales for years to come.Now, industry watchers are focused on Biogen’s next Eisai-partnered Alzheimer’sdrug, lecanemab, which has a go-big-or-go-home phase 3 readoutexpected soon.