Regeneron Pharmaceuticals

American biotechnology company

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both cytokine and tyrosine kinase receptors, which gave rise to their first product, which is a VEGF trap.

On February 4, 2020, the U. S. Department of Health and Human Services, which already worked with Regeneron, announced that Regeneron would pursue monoclonal antibodies to fight COVID 19. In July 2020, under Operation Warp Speed, Regeneron was awarded a $450 million government contract to manufacture and supply its experimental treatment REGN COV2, an artificial "antibody cocktail" which was then undergoing clinical trials for its potential both to treat people with COVID 19 and to prevent SARS CoV 2 coronavirus infection. The $450 million came from the Biomedical Advanced Research and Development Authority (BARDA), the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, and Army Contracting Command. Regeneron expected to produce 70,000–300,000 treatment doses or 420,000–1,300,000 prevention doses. "By funding this manufacturing effort, the federal government will own the doses expected to result from the demonstration project," the government said in its July 7 news release. Regeneron similarly said in its own news release that same day that "the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution," noting that this depended on the government granting emergency use authorization or product approval. California based laboratory, FOMAT, is part of the clinical investigation through their doctors Augusto and Nicholas Focil. In October 2020 when U. S. President Donald Trump was infected with COVID 19 and taken to Walter Reed National Military Medical Center in Bethesda, Maryland, he was administered REGN COV2. His doctors obtained it from Regeneron via a compassionate use request (as clinical trials had not yet been completed and the drug had not yet been approved by the US Food and Drug Administration (FDA)). On October 7, Trump posted a five minute video to Twitter reasserting that this drug should be "free." That same day, Regeneron filed with the FDA for emergency use authorization. In the filing, it specified that it currently had 50,000 doses and that it expected to reach a total of 300,000 doses "within the next few months." The FDA granted approval for emergency use authorization in November 2020.

Arcalyst (rilonacept) is used for specific, rare autoinflammatory conditions. Approved by the FDA in February 2008. Eylea (aflibercept injection) was approved by the U. S. Food and Drug Administration (FDA) in November 2011 to treat a common cause of blindness in the elderly. Eylea is reported to cost $11,000 per year for each eye treated. Zaltrap (aflibercept injection) is used for metastatic colorectal cancer approved by the FDA in August 2012. Praluent (alirocumab) is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low density lipoprotein (LDL) cholesterol. Approved by the FDA in July 2015, It is reported to cost $4,500 to $8,000 per year. Dupixent (dupilumab injection) is for the treatment of adolescent and adult patients' atopic dermatitis. It was approved by the FDA in March 2017 and is reported to cost $37,000 per year. Trials commenced in March 2020 to evaluate the effectiveness of Kevzara in the treatment of COVID 19. Libtayo (cemiplimab injection) is a monoclonal antibody targeting the PD 1 pathway as a checkpoint inhibitor, for the treatment of people with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Libtayo was approved by the FDA in September 2018. Inmazeb (atoltivimab/maftivimab/odesivimab) is a drug made of three antibodies, developed to treat deadly Ebola virus. In October 2020, the U. S. Food and Drug Administration (FDA) approved it with an indication for the treatment of infection caused by Zaire ebolavirus. Veopoz (pozelimab bbfg) is a fully human monoclonal antibody targeting complement factor C5, a protein involved in complement system activation. In August 2023, it was approved by the FDA for children and adults with CHAPLE disease or CD55 deficient protein losing enteropathy.

Trap Fusion Proteins: Regeneron's novel and patented Trap technology creates high affinity product candidates for many types of signaling molecules, including growth factors and cytokines. The Trap technology involves fusing two distinct fully human receptor components and a fully human immunoglobulin G constant region. Fully Human Monoclonal Antibodies: Regeneron has developed a suite (VelociSuite) of patented technologies, including VelocImmune and VelociMab, that allow Regeneron scientists to determine the best targets for therapeutic intervention and rapidly generate high quality, fully human antibodies drug candidates addressing these targets.

Financial Year Revenue 2012 $1.4 billion 2013 $2.1 billion 2014 $2.8 billion 2015 $4.1 billion 2016 $4.8 billion 2017 $5.8 billion 2018 $6.7 billion 2019 $7.8 billion 2020 $8.5 billion 2021 $16.1 billion 2022 $12.2 billion 2023 $13.1 billion

The founders Leonard Schleifer and George Yancopoulos are reported to hold $1.3 billion and $900 million in company stock, respectively. Both are from Queens, New York. Schleifer was formerly a professor of medicine at Weill Cornell Medical School. Yancopoulos was a post doctoral fellow, and MD/PhD student at Columbia University. Yancopoulos was involved in each drug's development.