EM Karuna / shutterstock.com
19 January 2017Americas

Mallinckrodt to pay $100m in antitrust case over infant drug

Mallinckrodt ARD, formerly known as Questcor Pharmaceuticals, and its parent company, Mallinckrodt, will pay $100 million in a settlement over antitrust charges made by the Federal Trade Commission (FTC).

The FTC accused Mallinckrodt of having violated antitrust laws when it acquired the rights to a drug that threatened its monopoly in the US market for the infant drug adrenocorticotropic hormone (ACTH).

The drug, which is marketed under the name Acthar, is used as a treatment for infantile spasms, a rare seizure disorder afflicting infants, and is a last resort to treat several other serious medical conditions.

Edith Ramirez, FTC chairwoman, said: “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% increase.”

She added: “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.”

The FTC alleged that Questcor illegally acquired the US rights to develop a competing drug known as Synacthen Depot.

Questcor acquired the rights to Synacthen from Novartis, preventing other companies from acquiring the rights to Synacthen.

According to a statement released by the FTC yesterday, January 18, alternative bidders were interested in developing the drug and had plans to sell it at a significant discount to Acthar’s price, which would have captured a substantial amount of Questcor’s business.

A Mallinckrodt  spokesperson said: "We are pleased with the agreement reached to resolve this legacy matter, although we continue to strongly disagree with allegations outlined in the FTC's complaint, believing that key claims are unsupported and even contradicted by scientific data and market facts, and appear to be inconsistent with the views of the FDA.”

The spokesperson said that “removing the distraction of litigation” enables the company to focus on advancing its portfolio and retain the rights to manufacture and market Synachten Depot in other countries around the world.

The court order also requires that Mallinckrodt grants a licence to develop Synacthen Depot to a licensee approved by the FTC.

Under the settlement, the states of Alaska, Maryland, New York, Texas and Washington, which joined the FTC in the complaint, will receive $10 million from the $100 million judgment.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk