Biotech and Pharma

Mallinckrodt to pay $100 million to settle FTC, state charges on antitrust violations linked to Martin Shkreli-backed lawsuit

Mallinckrodt to pay $100M to settle FTC charges
Mallinckrodt to pay $100M to settle FTC charges

The drugmaker Mallinckrodt has agreed to pay $100 million to settle Federal Trade Commission and state charges that the company and its Questcor division violated antitrust laws after Questcor purchased rights to a drug that "threatened its monopoly in the U.S. market" for its own drugs, the FTC said.

The FTC's complaint claims that while benefiting from its monopoly in ultra-pricey Achthar drugs, which are used to treat spasms in infants and as a drug of last resort in other serious conditions, Questcor illegally acquired the U.S. rights to develop a competing drug, Synacthen Depot, from Novartis, in 2014.

Martin Shkreli, former Chief Executive Officer of Turing Pharmaceuticals LLC, exits federal court on May 3, 2016 in the Brooklyn borough of New York City.
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"The acquisition stifled competition by preventing any other company from using the Synacthen assets to develop a synthetic ACTH drug, preserving Questcor's monopoly and allowing it to maintain extremely high prices for Acthar," the FTC said.

After that purchase, "Questcor took advantage of its monopoly to repeatedly raise the price of Acthar, from $40 per vial in 2001 to more than $34,000 per vial today — an 85,000 percent increase," said FTC Chairwoman Edith Ramirez. According to the FTC's complaint, an Acthar treatment for infantile spasms can cost more than $100,000.

"We charge that, to maintain its monopoly pricing, it acquired the rights to its greatest competitive threat, a synthetic version of Acthar, to forestall future competition. This is precisely the kind of conduct the antitrust laws prohibit," Ramirez said.

The FTC said that, "In addition to the $100 million monetary payment, the proposed stipulated court order requires that Questcor grant a license to develop Synacthen Depot to treat infantile spasms and nephrotic syndrome to a licensee approved by the commission."

Under terms of the deal, the states of Alaska, Maryland, New York, Texas and Washington will split $10 million from the settlement, and an additional $2 million in attorneys' fees and costs.

Mallinckrodt shares fell more than 8 percent before trading was halted in advance of the company's disclosure of the FTC settlement. It resumed trading less than an hour later, and recouped some of its losses. The stock ended the day down 5.9 percent at 46.53, and was active in after-hours trading.

After trading was halted, Mallinckrodt issued a statement that said, "We are pleased to confirm that we have entered into a settlement agreement with the FTC staff to fully resolve this matter, subject to approval by the Commission. We will comment further at the appropriate time."

The stock plunge came after The New York Post reported Wednesday that the FTC "is preparing to file charges" against the company."

The Post's story noted that the FTC has been investigating Mallinckrodt's Questcor Pharmaceuticals unit since a 2014 lawsuit filed by notorious pharmaceutical executive Martin Shkreli, then CEO of drugmaker Retrophin.

Retrophin's suit claimed Questcor violated federal antitrust laws by purchasing Synacthen from Novartis for $135 million after Retrophin bid $16 million for the drug. Retrophin claimed Questcor's purchase was illegal because it was allegedly done to shut down a drug that could compete with Achthar.

Retrophin settled its case against Questcor in 2015 after Questcor paid Retrophin $15.5 million.

Shkreli gained public notoriety in 2015 after he raised the price of the antiparasitic drug Daraprim to $750 per dose after the company he then was leading, Turing Pharmaceuticals, acquired the medication. Daraprim had been selling for just $13.50 per pill.

Shkreli, 33, later was charged with securities fraud by federal prosecutors, who claim he looted Retrophin's assets to pay off investors he had allegedly swindled while earlier running hedge funds. He has denied any wrongdoing.