Chicago – Attorney General Kwame Raoul today reached a proposed consent order with Amgen Inc., one of the world’s largest biopharmaceutical drug companies, to address the potential competitive harm that would result from Amgen’s $27.8 billion purchase of Horizon Therapeutics plc. As part of the nationwide settlement with the Federal Trade Commission (FTC) and five other state attorneys general, the settlement will also dismiss the related federal court preliminary injunction action.
Horizon specializes in manufacturing medications for rare and often severe autoimmune diseases. Two of its main drugs are Tepezza, the only FDA-approved treatment for thyroid eye disease (TED), and Krystexxa, the only FDA-approved treatment for chronic refractory gout (CRG). Over the next few years, competing companies are expected to introduce new medications that could be strong market competitors for Krystexxa and Tepezza. For patients, the new medications could be safer, more affordable, more durable and better at preventing debilitating disability.
“This proposed resolution would preserve competition within the pharmaceutical industry to improve access and affordability for certain crucial medications for vulnerable patients in Illinois,” Raoul said. “I am pleased with this progress and will continue to partner with other attorneys general and the FTC to stop the concerning increase in consolidations that raise health care costs for patients.”
In June 2023, Raoul and the FTC filed an amended complaint in the U.S. District Court for the Northern District of Illinois to prevent the finalization of the acquisition because Amgen’s proposed acquisition of Horizon likely violated federal law. If the acquisition proceeded, the newly-consolidated company would be free to muscle out competitors from the market for the autoimmune disease medications.
Raoul and the FTC’s proposed consent order resolves challenges that Amgen’s acquisition of Horizon is anticompetitive. Under the proposed order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa, In addition, Amgen may not condition any product rebate or contract terms related to an Amgen product on the sale or positioning either one of these drugs. Amgen is also barred from using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.
The proposed order also will prohibit Amgen from entering into any agreement or understanding to acquire any products or interest in any business engaged in the manufacturing or sale of any products, biosimilars or therapeutic equivalents that treat either TED or CRG, unless it receives prior approval from the FTC.
Additionally, Amgen must seek FTC approval if it seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either TED or CRG. Under the terms of the consent order, Amgen is required to seek FTC prior approval through 2032 and notify the states if it is seeking FTC approval.
All other requirements in the consent order will be effective for 15 years after it is finalized, including a requirement that Amgen submit annual compliance reports to the FTC and states. A monitor will be appointed to oversee Amgen’s compliance, and the monitor’s reports will likewise be submitted to the FTC and the states.
Joining Attorney General Raoul in this settlement are attorneys general from California, New York, Minnesota, Washington and Wisconsin.