In the long-running fight between Amgen and Regeneron over their respective PCSK9 drugs to lower cholesterol, the California biopharma has often beaten the New York biotech to the punch—especially when it comes to sales.
In May, Regeneron took what appeared to be one last swing when it filed an antitrust suit that alleged Amgen conducted a bundling scheme that allowed the company to charge low prices with which Regeneron couldn’t compete.
Now, Amgen has responded (PDF) with a motion to dismiss the case in federal district court in Delaware, saying that Regeneron’s “allegations do not come close to meeting the standards required to state a claim” for antitrust.
“Regeneron complains in this action about that competition, insisting it cannot compete for contracts on these terms and at these low prices,” Amgen said in the first paragraph of its opening brief. “But antitrust law does not condemn—indeed, it embraces—competition and low prices. For that reason, Regeneron’s claims face a very high bar.”
The case involves Amgen’s blockbuster Repatha and Regeneron and Sanofi’s Praluent, which were approved a month apart in the summer of 2015.
In its antitrust suit, Regeneron contends that Amgen “sought by hook or crook” to exclude Praluent from the market to “entrench Repatha’s monopoly position.”
Regeneron says Amgen conducted a bundling scheme, tying rebates for Repatha to a pair of high-demand drugs— psoriasis treatment Otezla and rheumatoid arthritis therapy Enbrel.
“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.
In its new motion, Amgen says Regeneron is trying to interfere with the competition between pharmacy benefit managers, which has helped lower the price of Repatha and Praluent.
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 answered a year later, dropping the price of Praluent to the same level.
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.
Amgen’s motion is the latest salvo in a long-running feud. In March of this year, 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.