The Federal Trade Commission (FTC) has recently finalized a consent order that resolves potential competition issues arising from Amgen Inc.’s acquisition of Horizon Therapeutics plc. This follows the dismissal of a related federal court preliminary injunction action by the FTC and attorneys general from six states – California, Illinois, Minnesota, New York, Washington, and Wisconsin.
In May 2023, the FTC launched a lawsuit to block the deal. The FTC alleged that the acquisition would allow Amgen to use its extensive portfolio of blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring or disadvantaging rivals to Horizon’s monopoly products, Tepezza and Krystexxa. These drugs are used for treating thyroid eye disease and chronic refractory gout, respectively.
This case marked the FTC’s first litigated challenge to a pharmaceutical merger in over a decade.
Under the final consent order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa. Furthermore, Amgen cannot condition any product rebate or contract term related to an Amgen product on the sale or positioning of either one of these drugs. The order also prevents Amgen from using any product rebate or contract term to exclude or disadvantage any product that competes with Tepezza or Krystexxa.
Additionally, if Amgen seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either thyroid eye disease or chronic refractory gout, it must seek FTC approval. This requirement extends through 2032, and Amgen must notify the states if it is seeking Commission approval.
The order also prohibits Amgen from entering into any agreement to acquire any products or interest in any business engaged in the manufacturing or sale of products 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, including a requirement that Amgen submit annual compliance reports to the FTC and states, will be effective for 15 years.
The FTC also 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. This development signifies the FTC’s commitment to maintaining competition in the pharmaceutical industry and safeguarding consumer interests.
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