Amgen’s $28 billion acquisition of Horizon Therapeutics has been given the green light by the Federal Trade Commission (FTC) after a settlement was reached. The agreement includes measures aimed at preserving competition in two rare diseases currently monopolized by Horizon’s drugs.
The settlement, announced on Friday, resolves the FTC’s lawsuit which sought to block the acquisition. In addition, six states that had also sued to halt the M&A deal—California, Illinois, Minnesota, New York, Washington, and Wisconsin—will now dismiss their suits.
When Amgen initially announced the acquisition agreement with Dublin-based Horizon, it positioned the rare disease drugmaker’s products as complementary to its own portfolio. Horizon brings two commercially available products to Amgen’s lineup: Tepezza, a highly successful drug for the treatment of a rare thyroid eye disease, and Krystexxa, a therapy for chronic refractory gout.
The FTC has consistently taken a firm stance against mergers and acquisitions in the life sciences sector. In May, it filed a complaint in the U.S. District Court for the Northern District of Illinois, aiming to block the Horizon deal. The regulator’s primary concern was a practice known as bundling, in which a company provides a health plan or pharmacy benefit manager with greater rebates for one or more blockbuster medicines to secure favorable coverage for another product on the plan’s list of covered medications. The FTC alleged that Amgen employs this strategy with its current products, and it feared the company could potentially do the same with Horizon’s drugs—a rare case where there is currently no competition.
Amgen vehemently denied the FTC’s claims and stated their commitment to not bundling any of Horizon’s products. The settlement now enforces this commitment. The proposed order prohibits Amgen from bundling any of its products with Tepezza or Krystexxa and from making the sale or formulary placement of these drugs contingent on a rebate for any Amgen product.
The consent order also addresses potential actions Amgen could take against emerging competitors to Horizon’s drugs. It prohibits Amgen from using product rebates or contract terms to exclude or disadvantage any competitor to Tepezza or Krystexxa. Additionally, Amgen is barred from acquiring any product or business in the areas of thyroid eye disease or chronic refractory gout—whether commercialized or in clinical stages—without prior approval from the FTC until 2032. Notification to states is also required if seeking such approval.
The consent order’s requirements will be effective for 15 years and include the submission of an annual compliance report by Amgen to the FTC and states. A monitor will be appointed to oversee compliance, and their reports will also be provided to the FTC and states.
In a brief statement, Amgen clarified its consistent position that it has no intention or reason to bundle the Horizon drugs with any of its own products. The company emphasized that this “narrow assurance” laid out in the consent order will have no impact on its business.
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