The proposed $28 billion purchase of Horizon Therapeutics by biopharmaceutical company, Amgen, has been given the all clear to proceed following a settlement with the Federal Trade Commission (FTC). The deal, brought into question by the FTC due to potential competition issues, has been resolved under certain conditions to maintain competition in regards to two rare diseases.
Six states initially joined in legal opposition to the proposed join-up and engagement in a lawsuit intended to prevent the acquisition. These states have agreed, as a component of the settlement, to dismiss their lawsuits, thus no longer posing a legal obstacle to the deal.
When the agreement of acquisition for Horizon, based in Dublin, was announced by Amgen, the purchase was portrayed as complementing Amgen’s existing portfolio. Horizon currently has two commercialized products: Tepezza, a drug for the treatment of a rare thyroid eye disease, and Krystexxa, which treats chronic refractory gout.
The FTC had expressed concern over an alleged bundling practice by Amgen, which was feared would result in an unfavourable position for other drugs on a health plan’s list of covered medications. Amgen had rebutted these allegations, and as part of the settlement, has now formally committed to avoid bundling any of Horizon’s products. The binding agreement also prevents the sale or formulary placement of either Tepezza or Krystexxa being contingent on a rebate for any Amgen product.
The consent order further takes into consideration any potential actions by Amgen against potential competitors to Horizon drugs. The order also places requirements on Amgen in regards to products or businesses surrounding thyroid eye disease or chronic refractory gout – prohibiting acquisition without FTC approval.
Constraints detailed in the consent order will remain effective for a 15-year period and require an annual compliance report to be submitted by Amgen to both the FTC and accompanying states. An appointed monitor will ensure compliance, submitting reports to the FTC and involved states.
In response to the settlement, Amgen released a statement asserting their consistent stance that there were no plans, intentions or reasons to bundle Horizon products with their own. The company further stated that the “narrow assurance”, as formalized in the consent order, will not impact Amgen’s business.