Since their PCSK9 drugs to lower bad cholesterol won FDA approvals a month apart in the summer of 2015, Amgen and Regeneron have waged a war for supremacy in the market—with the California-based drugmaker a decided winner.
But has Amgen crossed the line with its marketing strategy for Repatha? In an antitrust lawsuit filed in Delaware Friday, Regeneron says Amgen has “sought by hook or by crook” to exclude its cholesterol drug Praluent from the market to “entrench Repatha’s monopoly position.”
Regeneron says Amgen is employing an “illegal, anticompetitive bundling scheme,” to compel payers to use Repatha to receive rebates for must-have blockbuster drugs. In the case of Repatha, Amgen has tied its rebates for psoriasis drug Otezla and rheumatoid arthritis treatment Enbrel to its PCSK9 med, Regeneron says.
“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,” the lawsuit says.
Regeneron maintains that Amgen has made it “economically unfeasible” to continue selling Praluent. The company is seeking relief to the tune of “three times the actual damages” it has sustained because of Amgen’s alleged violations of the Sherman Act. Regeneron also seeks punitive damages, interest and more.
An Amgen spokesperson didn't immediately respond to a request for comment on the lawsuit.
The suit is the latest salvo in a long-running feud between the rivals. Six weeks ago, the U.S. Supreme Court said that it was enlisting the United States' top lawyer to review Amgen’s appeal of a ruling that invalidated two Repatha patents.
The patent infringement squabbles go back to 2014 when Amgen sued Regeneron and Sanofi after they filed for FDA approval of Praluent. In early 2017, Amgen scored a brief legal injunction against Praluent sales, but Sanofi and Regeneron were able to get that ruling overturned in appeals.
After launching with price tags of around $14,000, the drugs never met initial commercial expectations. In 2018, Amgen lowered the annual list price of its med from $14,520 to $5,850. Sanofi and Regeneron followed suit and lowered their drug's price to the same level in 2019.
Amgen reported sales of $1.117 billion for Repatha last year, which represented a 26% increase from 2020. Meanwhile, Regeneron registered sales of Praluent at $170 million, a 13% increase from 2020, while Sanofi said that it sold $218 million worth of the drug, which was a 16% decrease from 2020.
“Even if Regeneron offered a lower price for the PCSK9i market with competitive single-product rebate offers, as it has done, those savings do not and cannot offset the increased prices for Otezla and Enbrel that Amgen leverages to block such competitive single-product offers,” the Regeneron lawsuit says.