Seven months after the Federal Trade Commission (FTC) filed an antitrust lawsuit to block Amgen Inc. from purchasing Horizon Therapeutics plc, the commission has approved a final consent order to resolve potential competitive harm from the acquisition.
Refresh me on this acquisition first.
California-based Amgen, one of the world’s largest independent biotechnology companies, originally announced in December 2022 that it would be acquiring Horizon for $27.8 billion.
The deal includes notable drugs like Horizon’s Tepezza (teprotumumab-trbw)—the first FDA-approved treatment for thyroid eye disease (TED)—as well as Uplizna (inebilizumab-cdon), the only FDA-approved, B cell-depleting antibody monotherapy treatment for neuromyelitis optica spectrum disorder (NMOSD) in adults.
And this lawsuit?
The FTC filed a lawsuit against the deal on May 16, 2023, stating its concern over the potential that Amgen would use it to “leverage its profile of blockbuster drugs to entrench monopoly positions of Horizon medications used to treat two serious conditions,” including TED.
With no other market competition for these products, such control could allow Amgen to pressure insurance companies and pharmacy benefit managers (PBMs) into favoring Tepezza and Krystexxa (for chronic refractory gout [CRG]), according to the FTC.
See here for Amgen’s response, which included them stating that they " would not bundle the Horizon products raised as issues.”
What was so significant about this ordeal?
The antitrust lawsuit marked the first time the FTC has resorted to such an approach.
Prior to this case, it had historically worked to prevent pharmaceutical companies from using market power to raise drug prices.
And what exactly is the resolution?
The FTC resolved this lawsuit via a final consent order (read it here) that prohibits Amgen, among other requirements from the following:
- Bundling any of its products with either Tepezza or Krystexx.
- Conditioning any product rebate or contract term related to an Amgen product on the sale or positioning of either one of these drugs.
- Using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.
- Entering into any agreement /understanding to acquire any products or interest in business relating to the manufacturing or sale of products, biosimilars, or therapeutic equivalents to treat TED or CRG—unless granted approval by the FTC.
Any other requirements for Amgen?
Oh yes … the company is required to seek prior FTC approval—through 2032—if it wants to “acquire any pre-commercial products that have completed FDA clinical trials” to treat either TED or CRG.
It must also notify the states involved (California, Illinois, Minnesota, New York, Washington, and Wisconsin) if it seeks’ the commission’s approval.
And how long are these contingencies in effect?
Per the FTC: 15 years—“including a requirement that Amgen submit annual compliance reports to the FTC and states.”
So about this Horizon deal …
The companies actually already closed the deal back in October 2023, with Amgen acquiring Horizon in a transaction equity value of an estimated $27.8 billion. See here for details.
Lastly, any word from Amgen on the FTC’s final consent order?
The company told Glance it has “no comment” since closing the Horizon deal.