Federal court jury found Amgen liable for violating antitrust and tort laws by using cross-therapeutic bundled rebates to prevent Praluent® (alirocumab) from competing in the market
Jury awarded Regeneron $135.6 million dollars of compensatory damages and $271.2 million dollars in punitive damages
TARRYTOWN, N.Y., May 15, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) applauds the jury verdict in the U.S. District Court for the District of Delaware that found that Amgen Inc. violated antitrust and tort laws by creating a bundling scheme that illegally leveraged its blockbuster anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast) to convince pharmacy benefit managers (PBMs) to select Repatha® (evolocumab) as the exclusive PCSK9 category product over Praluent® (alirocumab). The jury found that Amgen violated the Clayton Act, the Sherman Act, the New York State Donnelly Act, the California Cartwright Act and Delaware tort law.
Enbrel and Otezla are therapeutically different medicines that do not treat the heart conditions that Praluent or Repatha address. Amgen threatened to withhold rebates unless PBMs preferred Repatha and excluded Praluent. Amgen prevented Regeneron from competing on a level playing field and unfairly denied patients access to Praluent. This anticompetitive practice shut out an innovative therapy from the PCSK9 marketplace, not based on clinical merit or price. Because of Amgen’s size and unrelated product portfolio, their anticompetitive actions ultimately hurt competition and patients.
The jury awarded Regeneron $135.6 million dollars of compensatory damages. The jury also awarded Regeneron $271.2 million dollars in punitive damages. Punitive damages may be awarded to punish a party for outrageous conduct and deter a party, and others like it, from engaging in similar conduct in the future.
"Patients rely on the biotech industry to find solutions for their most urgent medical conditions. At Regeneron, we take this responsibility very seriously and are committed to delivering breakthrough therapies that improve patient lives. To achieve this, companies must be able to compete fairly based on the clinical and economic value of their products. Larger companies should not be allowed to use anticompetitive tactics to push competitors out of the market," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. “Fair competition is critical as it expands patient access to life-changing therapies and drives innovation forward so we can continue to address the medical challenges of tomorrow.”
“Since the FDA approved Praluent in 2015, Amgen has tried to remove and exclude Praluent from the market. After a failed patent litigation campaign, they pivoted toward an anticompetitive bundling scheme that created a dangerous precedent that virtually eliminated all competition,” said Joseph J. LaRosa, Executive Vice President, General Counsel and Secretary of Regeneron. “Today’s verdict validates Regeneron’s efforts to help protect patient access to our innovations and provides a clear sign that anticompetitive efforts will not remain unchecked.”
Regeneron thanks the jury for their time and thoughtful consideration of the facts of this case.
Regeneron’s lead counsel was Jonathan D. Polkes of White & Case LLP.
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.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.