Following an antitrust lawsuit filed by the U.S. Federal Trade Commission (FTC)—and a temporary restraining order issued by a U.S. district court judge—biopharmaceutical company Amgen Inc. announced it will not be closing its deal to purchase Horizon Therapeutics plc in the first half of 2023, as previously planned.
Give me a refresh on Amgen.
Amgen is one of the largest independent biotechnology companies in the world. Based in California, it focuses on the research and development of therapies in areas such as inflammation, nephrology, and hematology/oncology.
Now some background on this deal.
Amgen originally announced in December 2022 that it would be acquiring Horizon for $27.8 billion.
The deal include 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.
See here for a complete list of Horizon’s current and upcoming programs.
And this lawsuit?
The FTC filed a lawsuit against the deal on May 16, 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.
What effect would this have?
With no other market competition for these products, such control would allow Amgen to pressure insurance companies and pharmacy benefit managers (PBMs) into favoring Tepezza and Krystexxa (for chronic refractory gout), according to the FTC.
How did Amgen respond?
The company issued a statement, reporting it has been cooperative with the agency prior to the lawsuit, stating that “there are no overlaps of competitive concern” with the Amgen and Horizon medications.
Amgen further stated that ”we would not bundle the Horizon products raised as issues.”
What else has happened since the filing?
Amgen has agreed to not close its transaction with Horizon before Sept. 15, 2023, or on the second business day after a court gives a verdict on the FTC’s request for a preliminary injunction.
Give me a timeframe.
According to Amgen, the company is planning to work with the court in a bid to complete the acquisition by mid-December 2023.
Significance?
This antitrust lawsuit marks the first time the FTC has resorted to such an approach; it has historically worked to prevent pharmaceutical companies from using market power to raise drug prices.