Regeneron Pharmaceuticals, Inc. is an American

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...

company A company, abbreviated as co., is a legal entity representing an association of people, whether natural, legal or a mixture of both, with a specific objective. Company members share a common purpose and unite to achieve specific, declared ...

headquartered in

Westchester County Westchester County is located in the U.S. state of New York. It is the seventh most populous county in the State of New York and the most populous north of New York City. According to the 2020 United States Census, the county had a population ...

New York New York most commonly refers to: * New York City, the most populous city in the United States, located in the state of New York * New York (state), a state in the northeastern United States New York may also refer to: Film and television * '' ...

. The company was founded in 1988. Originally focused on

neurotrophic factors Neurotrophic factors (NTFs) are a family of biomolecules – nearly all of which are peptides or small proteins – that support the growth, survival, and differentiation of both developing and mature neurons. Most NTFs exert their trop ...

and their regenerative capabilities, giving rise to its name, the company then branched out into the study of both

cytokine Cytokines are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are peptides and cannot cross the lipid bilayer of cells to enter the cytoplasm. Cytokines have been shown to be involved in au ...

and

tyrosine kinase A tyrosine kinase is an enzyme that can transfer a phosphate group from ATP to the tyrosine residues of specific proteins inside a cell. It functions as an "on" or "off" switch in many cellular functions. Tyrosine kinases belong to a larger cla ...

receptors.

Company history

The company was founded by CEO Leonard Schleifer and scientist George Yancopoulos in 1988. Regeneron has developed aflibercept, a

VEGF Vascular endothelial growth factor (VEGF, ), originally known as vascular permeability factor (VPF), is a signal protein produced by many cells that stimulates the formation of blood vessels. To be specific, VEGF is a sub-family of growth factors ...

inhibitor, and rilonacept, an interleukin-1 blocker. VEGF is a protein that normally stimulates the growth of blood vessels, and interleukin-1 is a protein that is normally involved in inflammation. On March 26, 2012, Bloomberg announced that

Sanofi Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Syn ...

and Regeneron were in development of a new drug that would help reduce cholesterol up to 72% more than its competitors. The new drug would target the PCSK9 gene. In July 2015, the company announced a new global collaboration with Sanofi to discover, develop, and commercialize new immuno-oncology drugs, which could generate more than $2 billion for Regeneron, with $640 million upfront, $750 million for proof-of-concept data, and $650 million from the development of REGN2810. REGN2810 was later named cemiplimab. In 2019, Regeneron Pharmaceuticals was announced the 7th best

stock In finance, stock (also capital stock) consists of all the shares by which ownership of a corporation or company is divided.Longman Business English Dictionary: "stock - ''especially AmE'' one of the shares into which ownership of a compan ...

of the 2010s, with a total return of 1,457%. Regeneron Pharmaceuticals was home to the two highest-paid pharmaceutical executives as of 2020. In October 2017, Regeneron made a deal with the US-government

Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, inc ...

that the government would fund 80% of the costs for Regeneron to develop and manufacture antibody treatments, including now their

Coronavirus disease 2019 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickl ...

treatments, and Regeneron would retain the right to set prices and control production. This deal was criticized in ''

The New York Times ''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...

''. Such deals are not unusual for routine drug development in the American pharmaceutical market. In May 2020, Regeneron announced it would repurchase around $5 billion of its shares, held directly by Sanofi. Prior to the transaction, Sanofi held 23.2 million Regeneron shares. In April 2022, the business announced it would acquire

Checkmate Pharmaceuticals Checkmate (often shortened to mate) is any game position in chess and other chess-like games in which a player's king is in check (threatened with ) and there is no possible escape. Checkmating the opponent wins the game. In chess, the king is ...

for around $250 million, enhancing its number of immuno-oncology drugs.

Experimental treatment for COVID-19

On February 4, 2020, the

U.S. Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...

, which already worked with Regeneron, announced that Regeneron would pursue

monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. 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 Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination medicine ...

, an artificial "antibody cocktail" which was then undergoing clinical trials for its potential both to treat people with

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quick ...

and to prevent

SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...

coronavirus infection. The $450 million came from the

(BARDA), the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, and

Army Contracting Command The Army Contracting Command (ACC) is a contracting services command of the United States Army. "On October 1, 2008, the Army recognized the formal establishment of the Army Contracting Command as a major subordinate command of the U.S. Army Mater ...

. 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 An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...

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 Donald John Trump (born June 14, 1946) is an American politician, media personality, and businessman who served as the 45th president of the United States from 2017 to 2021. Trump graduated from the Wharton School of the University of P ...

was infected with

and taken to

Walter Reed National Military Medical Center The Walter Reed National Military Medical Center (WRNMMC), formerly known as the National Naval Medical Center and colloquially referred to as the Bethesda Naval Hospital, Walter Reed, or Navy Med, is a United States' tri-service military medi ...

Bethesda, Maryland Bethesda () is an unincorporated, census-designated place in southern Montgomery County, Maryland. It is located just northwest of Washington, D.C. It takes its name from a local church, the Bethesda Meeting House (1820, rebuilt 1849), which ...

, he was administered

. 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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(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.

Marketed products

* Arcalyst ( rilonacept) is used for specific, rare

autoinflammatory Periodic fever syndromes are a set of disorders characterized by recurrent episodes of systemic and organ-specific inflammation. Unlike autoimmune disorders such as systemic lupus erythematosus, in which the disease is caused by abnormalities of t ...

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 Colorectal cancer (CRC), also known as bowel cancer, colon cancer, or rectal cancer, is the development of cancer from the colon or rectum (parts of the large intestine). Signs and symptoms may include blood in the stool, a change in bowel ...

approved by the FDA in August 2012. * Praluent (

alirocumab Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. It is a human monoclonal antibody that belongs to ...

) is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous

familial hypercholesterolemia Familial hypercholesterolemia (FH) is a genetic disorder characterized by high cholesterol levels, specifically very high levels of low-density lipoprotein (LDL cholesterol), in the blood and early cardiovascular disease. The most common mutati ...

or clinical

atherosclerotic cardiovascular disease Coronary artery disease (CAD), also called coronary heart disease (CHD), ischemic heart disease (IHD), myocardial ischemia, or simply heart disease, involves the reduction of blood flow to the heart muscle due to build-up of atherosclerotic pl ...

(ASCVD) who require additional lowering of

low-density lipoprotein Low-density lipoprotein (LDL) is one of the five major groups of lipoprotein that transport all fat molecules around the body in extracellular water. These groups, from least dense to most dense, are chylomicrons (aka ULDL by the overall densi ...

(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 Atopic dermatitis (AD), also known as atopic eczema, is a long-term type of inflammation of the skin ( dermatitis). It results in itchy, red, swollen, and cracked skin. Clear fluid may come from the affected areas, which often thickens over tim ...

. It was approved by the FDA in March 2017 and is reported to cost $37,000 per year. * Kevzara (

sarilumab Sarilumab, sold under the brand name Kevzara, is a human monoclonal antibody medication against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA), for which it re ...

injection) is an

interleukin-6 Interleukin 6 (IL-6) is an interleukin that acts as both a pro-inflammatory cytokine and an anti-inflammatory myokine. In humans, it is encoded by the ''IL6'' gene. In addition, osteoblasts secrete IL-6 to stimulate osteoclast formation. Smoo ...

(IL-6) receptor antagonist for treatment of adults with

rheumatoid arthritis Rheumatoid arthritis (RA) is a long-term autoimmune disorder that primarily affects joints. It typically results in warm, swollen, and painful joints. Pain and stiffness often worsen following rest. Most commonly, the wrist and hands are inv ...

approved by the FDA in May 2017. Trials commenced in March 2020 to evaluate the effectiveness of Kevzara in the treatment of COVID-19. * Libtayo (

cemiplimab Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD ...

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 Squamous-cell carcinomas (SCCs), also known as epidermoid carcinomas, comprise a number of different types of cancer that begin in squamous cells. These cells form on the surface of the skin, on the lining of hollow organs in the body, and on the ...

(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 An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of ...

, developed to treat deadly

Ebola Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Symptoms typically start anywhere between two days and three weeks after becom ...

virus. In October 2020, the U.S.

(FDA) approved it with an indication for the treatment of infection caused by ''Zaire ebolavirus''.

Technology platforms

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.Susana Magadán Mompó and África González-Fernández. "Human Monoclonal Antibodies from Transgenic Mice". Chapter 13 i
''Human Monoclonal Antibodies: Methods and Protocols''
Ed. Michael Steinitz. Springer Science+Business Media, 2014.

Financial performance

Key people

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 Queens is a borough of New York City, coextensive with Queens County, in the U.S. state of New York. Located on Long Island, it is the largest New York City borough by area. It is bordered by the borough of Brooklyn at the western tip of Long ...

. Schleifer was formerly a professor of medicine at Weill Cornell Medical School. Yancopoulos was an assistant professor at

Columbia University Columbia University (also known as Columbia, and officially as Columbia University in the City of New York) is a private research university in New York City. Established in 1754 as King's College on the grounds of Trinity Church in Manhatt ...

. Yancopoulos was involved in each drug's development.

References

External links

*
Success Long in Coming for Eylea, a Vision Treatment
{{Authority control 1988 establishments in New York (state) American companies established in 1988 Biotechnology companies established in 1988 Biotechnology companies of the United States Companies based in Westchester County, New York Health care companies based in New York (state) Life sciences industry Companies associated with the COVID-19 pandemic Pharmaceutical companies established in 1988 Pharmaceutical companies of the United States