Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust lawsuit against Amgen Inc. in the U.S. District Court for the District of Delaware. Regeneron alleges that “Amgen is engaged in a persistent exclusionary campaign to deprive patients of the vital benefits of  Regeneron’s cholesterol-lowering drug, Praluent® (alirocumab). According to Regeneron, the reason for Amgen’s campaign “is simple: For years, Praluent® has been the only direct competitor to Amgen’s own drug Repatha® (evolocumab) and Amgen is doing everything it can to avoid compete with Regeneron on substance”. Praluent® and Repatha® are both PCSK9 (“PCSK9i”) inhibitors intended to help patients lower their low-density lipoprotein cholesterol levels.
Regeneron alleges that Amgen is engaged in an “unlawful and anti-competitive consolidation scheme”. According to Regeneron, this scheme forces third-party payers to “ditch Regeneron’s Praluent® in favor of Amgen’s Repatha®.” Regeneron alleges that Amgen ties deep discounts on its blockbuster drugs Otezla® and Enbrel® to “exclusivity or practical exclusivity” for Repatha® on third-party payer formularies. Regeneron claims that “Amgen’s bundled rebate program further excludes competition” by pricing Repatha® below its cost, so Regeneron “cannot make a financially viable case for Praluent®”. And, according to Regeneron, Amgen’s “scheme” is working: “Due to anti-competitive practices by Amgen, in 2022 Regeneron may lose money for the first time on the former Praluent®, which was once profitable .”
Regeneron filed a 103-page complaint setting out the details of its claims. Among the allegations in the Complaint, Regeneron alleges that Amgen has monopoly or market power in the affected markets for PCSK9 inhibitors (“PCSK9i”) and PCSK9i products distributed in pharmacies. Regeneron alleges that Amgen is “using unrelated mega-products,” including Otezla® and Enbrel®, “to coerce middlemen who cover and pay the majority of the costs of these drugs out of competition in the much smaller market of the PCSK9i”. According to Regeneron, Amgen “threatens to withhold deep discounts on these flagship products unless payers agree to either outright exclusivity for Repatha® or an ‘equal’ position in the formulary.”
Regeneron argues that a number of factors together create significant barriers to entry into the pharmaceutical industry, including:
- branded products are protected by patents;
- a company must invest a lot of time and money in the research and development of a new drug;
- even if a new drug shows promise in preclinical studies, it then goes through years of clinical trials, during which it is tested on large cohorts of patients to determine its safety and efficacy; and
- even if these trials are successful, the drug company must compile the data and submit a new drug application to the FDA, which can take a year or more to process, and often takes much longer if the FDA finds gaps in the data. data or request.
Regeneron further alleges that there are also unique barriers to the PCSK9i market and the PCSK9i submarket distributed in pharmacies. They argue that although PCSK9 inhibitors are an essential new drug for a high-risk population, that population is relatively small.
Regeneron also argues that biosimilar drugs also face “tremendous skepticism from patients and prescribers,” contributing to barriers to entry into the rheumatoid arthritis market, the market in which Enbrel d ‘Amgen is sold.
Finally, Regeneron describes the alleged antitrust harm it suffered as a result of Amgen’s “scheme.” Regeneron alleges that Amgen’s conduct has already harmed and, if unresolved, will continue to harm competition in the US PCSK9i market and the PCSK9i pharmacy submarket. As a result, Regeneron has suffered and will continue to suffer harm to its business or property, including lost sales, business opportunities, and its ability to recoup the significant investments made in the development and commercialization of PRALUENT in the United States. States, including the tens of millions of dollars normally required to fund clinical trials. In addition, Regeneron alleges that competition in the PCSK9i market has been impeded by Amgen’s below-cost pricing and bundled conditional rebate program.
Regeneron asserted ten counts in its complaint, listed below:
- Count 1: Monopolization of the PCSK9i market and the PCSK9i sub-market distributed in pharmacies through an aggregation in violation of Article 2 of the Sherman Act
- Count 2: Attempted Monopolization of the PCSK9i Market and the PCSK9i Submarket Distributed in Pharmacies through Consolidation in Violation of Section 2 of the Sherman Act
- Count 3: Monopolizing the PCSK9i market and the PCSK9i submarket distributed in pharmacies through below-cost pricing in violation of Section 2 of the Sherman Act
- Count Four: Attempt to monopolize the PCSK9i market and the PCSK9i submarket distributed in pharmacies through below-cost pricing in violation of Section 2 of the Sherman Act
- Count 5: Unreasonable Restraint of Trade Violating Section 1 of the Sherman Act
- Count Six: Disqualified Sale of Praluent® in Violation of Section 3 of the Clayton Act
- Count Seven: Violation of the California Unfair Competition Act (“UCL”), Cal. Bus. & Code Prof. § 17200 et seq.
- Count Eight: Violation of California’s Unfair Practices Act (“UPA”), Cal. Bus. & Code Prof. § 17043 et seq.
- Count Nine: Violation of the Cartwright Act of California, Cal. Bus. & Prof. Code §§ 16720, 16727
- Count 10: Violation of the Donnelly Act of New York, § 340 of the General Business Law (“GBL”) of New York
- Count Eleven: tortious interference with potential business relationships
Regeneron seeks injunctive relief, actual damages, treble damages, costs and attorneys’ fees, and demands a jury trial.
Stay tuned to Big Molecule Watch for developments on this new case.