Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced a significant legal victory after a jury in the U.S. District Court for the District of Delaware ruled that Amgen Inc. violated multiple antitrust and tort laws. The jury found that Amgen unlawfully leveraged the market power of its blockbuster anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast) to secure exclusive placement of its cholesterol-lowering drug Repatha® (evolocumab) with pharmacy benefit managers (PBMs), effectively excluding Regeneron’s competing therapy, Praluent® (alirocumab).
The jury concluded that Amgen’s bundling practices breached the federal Clayton Act, Sherman Act, as well as the New York State Donnelly Act, California Cartwright Act, and Delaware tort law.
Though Enbrel and Otezla treat conditions unrelated to cardiovascular disease, Amgen allegedly threatened to withhold significant rebates unless PBMs selected Repatha as the sole PCSK9 inhibitor, excluding Praluent. According to Regeneron, these coercive tactics blocked fair competition and prevented patients from accessing Praluent—not due to price or medical efficacy, but due to bundling unrelated drugs to dominate the market.
As a result, the jury awarded $135.6 million in compensatory damages and an additional $271.2 million in punitive damages, underscoring the egregious nature of Amgen’s conduct. Punitive damages are designed to penalize particularly harmful behavior and deter future violations.
Leonard S. Schleifer, M.D., Ph.D., Regeneron’s Board co-Chair, President, and CEO, emphasized the broader implications of the verdict:
“Patients depend on the biotech industry for life-changing therapies. Fair competition ensures that innovative treatments reach those in need. Larger companies should not be allowed to abuse their market power to edge out competitors.”
Joseph J. LaRosa, Executive Vice President, General Counsel, and Secretary of Regeneron, highlighted the company’s long-standing battle to maintain access to Praluent:
“Since Praluent received FDA approval in 2015, Amgen has consistently attempted to block its access—first through failed patent lawsuits, and then through this anticompetitive bundling scheme. This verdict reaffirms our commitment to defending fair market practices and patient access.”
About Praluent
Praluent inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company’s proprietary VelocImmune® technology that yields optimized fully-human monoclonal antibodies.
In addition to the U.S., Praluent is approved in 60 countries, including the European Union, Japan, Canada, Switzerland and Brazil.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopouloswas a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV®(casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
Indications and Important Safety Information
PRALUENT is an injectable prescription medicine used:
- in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.
- along with diet, alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol.
- along with other LDL-lowering treatments in adults with a type of high cholesterol called homozygous familial hypercholesterolemia, who need additional lowering of LDL-C.
- along with diet and other LDL-C lowering treatments in children aged 8 years and older with HeFH to reduce LDL-C.
It is not known if PRALUENT is safe and effective in children who are younger than 8 years of age or in children with other types of high cholesterol (hyperlipidemias).
