By Jake Piazza Friday, September 1st, 2023

The Federal Trade Commission entered into a consent agreement with Amgen and Horizon Therapeutics, clearing the way for Amgen’s $28 billion acquisition of Horizon to go through.

Announced on Sept. 1, Amgen agreed to not use its drug list to inhibit competition for Tepezza and Krystezza, which are Horizon’s biggest two drugs and the only available FDA-approved treatments for thyroid eye disease and chronic refractory gout, respectively, according to the filing. 

Amgen cannot engage in any product rebates for “the purchase, coverage, placement, or positioning” of Tepezza and Krystezza and it cannot create a disadvantage for competitive products to either drug, according to the consent agreement. 

Amgen has repeatedly said it has no plans to leverage its drug portfolio to bundle Tepezza or Krystezza to stifle competition.

The company said the agreement will have no effect on Amgen’s existing business. 

The consent agreement also said that until Dec. 31, 2032, Amgen must ask the FTC for approval before acquiring any other drugs that treat thyroid eye disease or chronic refractory gout. As a whole, the consent agreement expires in 15 years. 

Amgen’s approval of the agreement is a settlement and not an admission that the acquisition would violate the antitrust laws that the FTC alleged. The states that had joined in on the FTC’s lawsuit, one of which is California, will also dismiss the lawsuit 

The deal will close early in the fourth quarter of 2023, according to a joint press release from Amgen and Horizon. 

The acquisition is one of the largest deals to ever take place in the biotech and biopharmaceutical industry and is the largest in Amgen’s acquisition history. 

Some of Amgen’s highest-selling drugs have been the product of acquisitions. Otezla and Enbrel were both multi-billion dollar purchases and in the company’s most recent earnings report, they were two of the top three performing drugs from a sales standpoint. 

FTC Chair Lina M. Khan filed a five-page statement joined by the other two FTC commissioners outlining in greater detail why the FTC was so concerned with Amgen’s acquisition of Horizon. Khan mentioned several anecdotes as well as national data on difficulties Americans are having in affording prescription drugs as reasons why the FTC believed the lawsuit and subsequent agreement were necessary. 

Khan also highlighted the 2021 launch of the Pharmaceutical Merger Task Force, which the FTC is a part of, and wrote that the lawsuit “reflects an advance in our pharmaceutical merger program.”

The FTC has not just focused on mergers and acquisitions within the pharmaceutical industry. President Joe Biden made it clear in a 2021 executive order that he wanted to crack down on any practices that would stifle competition in any industry. 

The result has been several lawsuits filed by the FTC against some of the largest companies in the world, including Microsoft and Meta, as well as the Department of Justice filing a lawsuit against JetBlue Airways’ acquisition of Spirit Airlines. 

Amgen first announced its acquisition of Horizon in December 2022 and in May of this year, the FTC filed a lawsuit in federal court alleging that the purchase would lessen competition and create a monopoly in the thyroid eye disease and chronic refractory gout markets. The legal saga continued for months until last week the FTC approved an order withdrawing the matter from adjudication, meaning the lawsuit was put on pause. 

The move was made so that a settlement could be properly considered, according to FTC filings. 

Days later, the consent agreement was approved and now the deal just needs approval from Irish law — where Horizon is headquartered — before it can officially be completed. 

Horizon’s stock jumped up 2.3% after the news and Amgen’s stock remained relatively unchanged. 

email: jpiazza@pacbiztimes.com