FTC’s Lawsuit Against Amgen Horizon Deal to Reach Court in September

The legal challenge is a rare move that may spell trouble for future pharmaceutical M&A activity.

Federal Trade Commission (FTC) officials are taking Amgen and Horizon to court this September to block a prospective pharmaceutical acquisition of the two companies. The FTC announced that it planned to stop Amgen’s $27.8 billion acquisition of Horizon Therapeutics last week, citing the threat of monopolization in treatments for thyroid eye disease and chronic refractory gout.

“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” said FTC Bureau of Competition Director Holly Vedova.

The FTC’s decision to completely block the acquisition is a divergence from its usual practice of forcing companies to divest monopolized properties.

Ireland-based Horizon distributes 11 drug products in the United States and is responsible for $3.6 billion in sales annually. Its two primary moneymakers are Tepezza, a thyroid eye disease treatment, and Krystexxa, a treatment for chronic gout.

Both treatments cost more than $600,000 for an annual course.

Amgen and Horizon’s combination would likely impact access to generic and competing drugs that treat these rare diseases. This could lead to an increase in prices and a contraction in the market.

In its announcement, the FTC detailed Amgen’s history of leveraging blockbuster drug rebates to gain preferred placement on PBMs’ covered medications lists. Senator Elizabeth Warren shared the same concerns with the FTC in a letter sent in early 2023.

“Amgen’s $28.7 billion proposed acquisition of Horizon Therapeutics would be among the largest healthcare deals of recent years,” wrote Warren. “Both Amgen and Horizon have engaged in brazen price increases on drugs that face little or no competition, while Amgen has abused the patent process, creating patent thickets to ‘evergreen’ their products, prevent generic competition, and maintain market dominance.”

Chronic refractory gout is a rare disease that affects 2% of those who have gout. Thyroid eye disease is also rare, affecting 19 of 100,000 people annually. Courtney Silverthorn, PhD, Associate Vice President of Science Partnerships at the Foundation for the National Institutes of Health, recently explained why there are few options for rare disease patients in an interview with PharmaNewsIntelligence.

“Much pharmaceutical development is more on the large market. While some rare diseases, at the very high end of the prevalence scale, could fall into something that might be of commercial interest, for the diseases with a very low prevalence, there is no viable path forward.”

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