Amgen settles with FTC, clearing way for $28bn Horizon deal

One of the final hurdles in front of Amgen's $28 billion acquisition of Horizon Pharma has fallen after an agreement was reached between the two companies and the Federal Trade Commission (FTC), averting a trial that was due to start later this month.

Under the terms of the settlement, Amgen is prohibited from bundling any of its medicines with either of Horizon's two marketed products – Tepezza (teprotumumab) for thyroid eye disease (TED) and chronic refractory gout treatment Krystexxa (pegloticase) – when reaching formulary access agreements with insurers and pharmacies.

In May, the FTC and half a dozen state attorneys general filed a lawsuit seeking to block the takeover, claiming that Amgen would be able to "stifle competition" for Horizon's drugs – both of which are the only FDA-approved products to treat their respective disease – and prevent access to any newer rivals that may emerge from competing companies.

There were signs of a thawing in the relationship last week when the FTC paused its legal challenge in order for its commissioners to decide whether other ways to resolve the case could be found. Along with the prohibition on bundling, Amgen will also have to seek prior approval before it can acquire other products treating the same indications.

The resolution of the dispute will be a relief to the pharma sector, which has been growing increasingly concerned about antitrust intervention in its M&A dealmaking, but perhaps a sign of things to come in future transactions.

"Consolidation in the pharmaceutical industry has given companies the power and incentive to engage in exclusionary rebating practices, which can lead to sky-rocketing prices on essential medications," said Henry Liu, director of the FTC's Bureau of Competition.

He said the agreement "sends a clear signal that the FTC and its state partners will scrutinise pharmaceutical mergers that enable such practices, and defend patients and competition in this vital marketplace."

For its part, Amgen said it "has consistently stated to the FTC, the courts, and the public that it has no reason, ability, or intention to bundle Horizon's [Tepezza or Krystexxa] with any of its products. This narrow assurance, formalised in the consent order with the FTC, will have no impact on Amgen's business."

It agreed to acquire Dublin-based Horizon in December 2022, after Sanofi and Johnson & Johnson pulled out of negotiations. The companies said they "anticipate being able to close the acquisition in early fourth-quarter 2023 and look forward to the opportunity to serve patients around the world suffering from rare diseases."