Sanofi to Pay $11.85 Million, Enter Corporate-integrity Agreement to Resolve Kickbacks Complaint

   By Maria Armental

Sanofi agreed to pay $11.85 million to resolve allegations that sought to boost sales of multiple-sclerosis treatment Lemtrada by using a charity to cover Medicare patients' out-of-pocket costs, federal prosecutors said.

As part of the settlement, the French drug maker also entered into a corporate-integrity agreement with the federal government, a pact that typically requires companies to adhere to certain business practices for several years.

"This resolution reflects the company's desire to put this investigation behind it and to continue its focus on the needs of patients," Sanofi said in a statement. "It does not constitute any admission of guilt."

The case stems form a so-called whistleblower complaint filed in Boston federal court.

Federal prosecutors accused Sanofi of funneling kickback payments through The Assistance Fund, which had several funds, including one for MS patients that covered the co-pays of some Medicare patients who were prescribed Lemtrada.

TAF, federal prosecutors said, raised its maximum per-patient grant allocation to $20,000, specifically to accommodate Lemtrada patients.

Sanofi, the prosecutors said, worked with its third-party reimbursement hub to identify Medicare patients who had been prescribed Lemtrada but hadn't received infusions because they couldn't afford the co-pays.

Sanofi made nine payments to TAF during 2015 and 2016, according to prosecutors.

TAF, prosecutors said, didn't keep a wait list of patients. Instead, when it received money, it would cover the costs of those patients who had applied first.

Sanofi, prosecutors said, instructed its hub to quickly refer the Lemtrada patients they had identified as soon as TAF opened its fund to new patients.

"They rigged the system so those taking its drug Lemtrada gained an unfair advantage over patients using other medications," said in a statement Joseph R. Bonavolonta, special agent in charge of the Federal Bureau of Investigation Boston division.

The whistleblower that filed the original claim, a limited liability partnership formed by a former employee of Sanofi's predecessor, Genzyme Corp., will receive about $2.7 million.

Write to Maria Armental at maria.armental@wsj.com

(END) Dow Jones Newswires

February 28, 2020 17:10 ET (22:10 GMT)

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