The Federal Trade Commission (FTC) reached a settlement with Amgen Inc. to resolve competitive concerns arising from Amgen's acquisition of Horizon Therapeutics (Horizon). The FTC stated that the settlement would resolve objections to the acquisition on a nationwide basis and dismiss the federal court injunction action.

In May, the FTC filed a complaint in court to block the proposed transaction. This was the FTC's first lawsuit against a pharmaceutical merger in more than a decade. Accordingly, the FTC stated that the transaction would give Amgen the power to exclude competitors by strengthening Horizon's monopoly positions in the market for Tepezza and Krystexxa, Horizon's drugs used to treat thyroid eye disease (TED) and chronic refractory gout (CRG), thereby increasing barriers to entry and preventing smaller firms from competing in the market. In order to prevent all these, the FTC proposed a settlement, which was accepted by Amgen. Accordingly, Amgen is;

  • Prohibited from co-packaging its product with Tepezza or Krystexxa.
  • Prohibited from tying any product rebate or contractual terms related to its product to the sale or positioning of either of these drugs.
  • Prohibited from using any product rebate or contractual term to exclude or disadvantage any product that may compete with Tepezza or Krystexxa.
  • Prohibited from entering into any agreement or understanding to acquire any product or interest in any business engaged in manufacturing or selling any product treating TED or CRG or its equivalents, unless it has obtained prior approval from the Commission.
  • Obligated to seek the Commission’s approval for any pre-commercial product that has completed clinical trials to treat TED or CRG.
  • Obligated to submit all agreements with payers regarding the formulary, placement, or positioning of Krystexxa or Tepezza to the auditor within 30 days of the agreement.
  • Obligated to ensure that all of its employees directly involved in contracts or negotiations with payors regarding the acquisition, scoping, placement, or positioning of Krystexxa or Tepezza, review the agreement and declare in writing that they understand and comply with the obligations of the agreement.
  • Obligated to inform the auditor if Krystexxa or Tepezza meets all of the following conditions; 
  • Krystexxa or Tepezza is approved by the FDA for patient self-administration,
  • A self-administered version of Krystexxa or Tepezza is commercially available, and
  • A self-administered version of Krystexxa or Tepezza is eligible for coverage as a pharmacy benefit.

Lastly, the FTC announced that it will publish the commitment package shortly.

(FTC - 01.09.2023)


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