The Federal Trade Commission today finalized a consent order that resolves potential competitive harm stemming from Amgen Inc.’s acquisition of Horizon Therapeutics plc. As part of a nationwide settlement of their challenge to the acquisition, the FTC and attorneys general from six states – California, Illinois, Minnesota, New York, Washington, and Wisconsin – previously dismissed the related federal court preliminary injunction action.
In May 2023, the FTC sued to block the deal alleging that the acquisition would enable Amgen to leverage its large portfolio of blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring Horizon’s two monopoly products – Tepezza and Krystexxa – or disadvantaging rivals to these two products. The FTC also alleged that the deal would entrench Tepezza’s and Krystexxa’s monopoly positions in the thyroid eye disease and chronic refractory gout markets, respectively, by substituting Amgen, with its broad and powerful portfolio of blockbuster drugs, for Horizon with its smaller portfolio, thus raising entry barriers and dissuading smaller firms from competing aggressively.
This case was the FTC’s first litigated challenge to a pharmaceutical merger in more than a decade.
Under the final consent order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa, Horizon’s medications used to treat thyroid eye disease and chronic refractory gout, respectively. In addition, Amgen may not condition any product rebate or contract term related to an Amgen product on the sale or positioning of either one of these drugs. Amgen also is barred from using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.
Amgen, under the terms of the final consent order, must seek FTC approval if it seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either thyroid eye disease or chronic refractory gout. Amgen is also required to seek prior FTC approval through 2032 and notify the states if it is seeking Commission approval.
The final consent order, among other provisions, also prohibits Amgen from entering into any agreement or understanding to acquire any products or interest in any business engaged in the manufacturing or sale of any products, biosimilars, or therapeutic equivalents that treat either thyroid eye disease or chronic refractory gout, unless it receives prior approval from the Commission.
All other requirements in the consent order will be effective for 15 years, including a requirement that Amgen submit annual compliance reports to the FTC and states.
Additionally, the Commission approved the appointment of Ms. Jeri Hilleman as the monitor in this case.
Following a public comment period, the Commission voted 3-0 to approve the final order and to appoint Ms. Hilleman as monitor.