Amid the ongoing legal battle with the Federal Trade Commission (FTC) over its $28 billion acquisition of Horizon Therapeutics, Amgen has responded with strong assertions in court documents.
In response to the FTC’s request for a preliminary injunction, Amgen’s legal team has stated that the FTC’s case is detached from reality and lacks grounding in decades of legal precedent. The company submitted this response to a federal court in Illinois.
This exchange of arguments follows the FTC’s announcement that it had ceased settlement negotiations with Amgen. At that time, an FTC representative expressed the agency’s openness to considering proposals, according to Bloomberg.
The FTC, along with several states, is challenging the Amgen-Horizon deal due to concerns that Amgen might merge its products with Horizon’s drugs during reimbursement negotiations.
Amgen has countered that the FTC’s case is overly speculative and not sufficient to justify an injunction at this stage. The company has provided explicit assurances, even through sworn testimonies of its executives, that it will not bundle any of its products with Tepezza or Krystexxa—the rare disease drugs developed by Horizon for thyroid eye disease and gout, respectively.
Related: Humira Biosimilars: Benefits, Availability, Price, Comparison And More
Amgen’s stance is that its own products, such as the TNF inhibitor Enbrel and psoriasis medication Otezla, belong to distinct reimbursement categories compared to Horizon’s assets, which are administered by healthcare professionals. Amgen argues that the differences in reimbursement mechanisms, coupled with existing medical benefit regulations, would render any potential bundling both challenging and financially unviable.
Furthermore, Amgen contends that the FTC has not presented evidence that competitors to Tepezza and Krystexxa could imminently enter the market.
Related: AbbVie Raises Profit Expectations Despite Q2 Decrease In Humira And Imbruvica Sales
Legal experts and industry observers are closely monitoring this case, as it marks the FTC’s first major legal challenge against a pharmaceutical M&A deal since 2009. This lawsuit comes as the FTC adopts a more comprehensive approach to reviewing pharmaceutical mergers, extending beyond evaluating specific product overlaps. Amgen’s legal team asserts that the FTC is attempting to establish a legal precedent based on an untested theory.
Despite the legal confrontation, Amgen remains resolute. During its second-quarter earnings call, CEO Bob Bradway expressed confidence in closing the deal by mid-December.
