As the Federal Trade Commission tries to block Amgen’s $28 billion acquisition of Horizon Therapeutics with an injunction, Amgen has a lot to say in court filings.
The FTC’s case is “far too removed from reality and unmoored from decades of legal precedent,” Amgen’s lawyers wrote in a response to FTC’s request for a preliminary injunction. The company filed the note to a federal court in Illinois on Tuesday.
The trade of barbs comes a month after the FTC said it had ended settlement talks with Amgen. At the time, an FTC lawyer said the agency remained “open to hearing proposals,” according to Bloomberg.
The U.S. antitrust watchdog and several states are challenging the Amgen-Horizon transaction out of concerns that Amgen might one day bundle its products with Horizon’s drugs during reimbursement negotiations.
Amgen argues the FTC’s case is “far too speculative” to warrant an injunction at this stage.
For starters, Amgen has already promised—including in sworn testimony of its execs—that it’s “not going to bundle any of its products, for any reason or at any time, with Tepezza or Krystexxa,” the company’s response shows.
Tepezza and Krystexxa are Horizon’s rare disease drugs for thyroid eye disease and gout, respectively.
The FTC was uneased by the possibility that Amgen might use some of its blockbuster drugs such as TNF inhibitor Enbrel and psoriasis pill Otezla to reach favorable deals for Tepezza and Krystexxa against potential rivals. But as Amgen noted, the company’s top-selling drugs and the Horizon assets belong to different reimbursement categories, making bundling “extremely difficult (if not impossible)."
Amgen’s own products are self-administered by patients and are covered under pharmacy benefit plans. Tepezza and Krystexxa are infusions administered by healthcare professionals and primarily managed under medical benefit plans, the company pointed out.
“These are vastly different reimbursement mechanisms,” Amgen said, adding that it has never done cross-benefit bundling before.
Even if this type of bundling is doable, Amgen said, existing medical benefit regulations means the two Horizon drugs’ prices would have to come down sharply, “eventually rendering them unprofitable and destroying the rationale for the transaction.”
In addition, Amgen argues the FTC hasn’t provided any proof that rivals to Tepezza and Krystexxa could reach the market in the near term.
The company’s lawyers are asking the court to deny the FTC’s motion for a preliminary injunction.
Industry watchers are following the case closely because it’s the first major pharma M&A deal that the FTC has challenged in court since 2009. The lawsuit comes as the agency adopts a more holistic approach of reviewing pharma M&A deals beyond looking at specific product overlaps. As Amgen’s lawyers put it, the FTC is trying to create a legal precedent based on a theory never before adopted by a court.
Amgen seems unfazed by the FTC challenge. During the company’s second-quarter earnings call earlier this month, CEO Bob Bradway said Amgen still aimed to close the deal mid-December.