In the long-running feud between Regeneron and Amgen around the companies’ competing PCSK9 cholesterol meds, Regeneron has eked out another legal win over its rival.
A federal jury in Delaware has determined that Amgen violated U.S. antitrust laws by engaging in a bundling scheme with pharma middlemen that unfairly advantaged its cholesterol-lowering drug Repatha over Regeneron’s PCSK9 counterpart Praluent.
In turn, the jury has put Amgen on the hook to pay Regeneron $135.6 million in compensatory damages and another $271.2 million in punitive damages, according to a verdict form filed Thursday.
“Since the FDA approved Praluent in 2015, Amgen has tried to remove and exclude Praluent from the market,” Joseph LaRosa, general counsel and secretary of Regeneron, said in a statement about the verdict.
“After a failed patent litigation campaign, they pivoted toward an anticompetitive bundling scheme that created a dangerous precedent that virtually eliminated all competition,” he said, adding that the jury’s decision offers a “clear sign that anticompetitive efforts will not remain unchecked.”
Amgen sees the situation differently and is naturally disappointed with the jury’s decision.
“Amgen has always competed fairly and in compliance with the antitrust laws, and the trial made clear Regeneron had every opportunity to compete in the marketplace,” an Amgen spokesperson told Fierce Pharma over email, adding that the California drugmaker looks forward to post-trial proceedings.
In civil cases, a judge may raise or reduce a jury’s damage award.
The antitrust kerfuffle kicked off in May 2022 when Regeneron asserted in a lawsuit that Amgen had “sought by hook or crook” to exclude Praluent from the market and “entrench Repatha’s monopoly position.”
The New York drugmaker specifically accused Amgen of tying rebates for Repatha to its unrelated and in-demand therapies Otezla and Enbrel, which are used to treat inflammatory conditions like arthritis and psoriasis.
“When the value of these massive, unavoidable bundled rebates is compared to the cost of Repatha standing alone, it becomes clear that Amgen is pricing Repatha so that Regeneron cannot make a viable financial offer to compete,” Regeneron’s original lawsuit states.
Amgen allegedly threatened to withhold those rebates unless pharmacy benefit managers preferred Repatha and excluded Praluent on their formularies. The move unfairly denied patients access to Praluent, Regeneron argued in a Thursday press release celebrating the jury verdict.
Amgen attempted to get Regeneron’s lawsuit dismissed in August 2022, arguing in a motion at the time that Regeneron’s “allegations do not come close to meeting the standards required to state a claim” for antitrust violations.
Amgen argued that Regeneron’s lawsuit was an effort to interfere with PBM competition, which has helped lower the price of Repatha and Praluent over the years.
Meanwhile, this isn’t the only instance of Regeneron and Amgen duking it out over their PCSK9 drugs in court.
Back in 2014, Amgen sued Sanofi and Regeneron over allegations that the partners’ drug Praluent—then in development as alirocumab—violated Amgen intellectual property tied to Repatha. After various twists and turns in appeals and ultimately the U.S. Supreme Court, Regeneron prevailed, with nine justices voting unanimously in May 2023 to uphold a lower court ruling invalidating a pair of Repatha patents.
Praluent and Repatha won U.S. approvals just weeks apart in 2015. Both drugs work to help lower “bad” LDL cholesterol by blocking the protein PCSK9.