Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals, Inc.
Public
Traded as
IndustryPharmaceuticals; Biotech
Founded1988; 32 years ago (1988)
HeadquartersEastview, New York, US (Headquarters)
Area served
Global
Key people
RevenueIncrease $7.86 billion (2019)[1]
Increase $1.4 billion[2]
Total assetsIncrease $5.6 billion[2]
Number of employees
8,100 [1] (2019)
Websitewww.regeneron.com Edit this at Wikidata

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Tarrytown, New York. The company was founded in 1988.[3] Originally focused on neurotrophic factors and their regenerative capabilities (thus the name), it branched out into the study of both cytokine and tyrosine kinase receptors.

Company history[edit]

Regeneron has developed aflibercept, a VEGF 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 and Regeneron are in development of a new cholesterol drug which will help reduce cholesterol up to 72% more than the leading brands. The new drug targets the PCSK9 gene.[4][citation needed]

In July 2015, the company announced a new global collaboration with Sanofi to discover, develop, and commercialise new immuno-oncology drugs, which could generate more than $2 billion for Regeneron,[5] with $640 million upfront, $750 million for proof of concept data and $650 million from the development of REGN2810.[6] REGN2810 was later named cemiplimab. In 2019, Regeneron Pharmaceuticals was announced the 7th best stock of the 2010s, with a total return of 1,457%.[7]

Regeneron Pharmaceuticals was home to the two highest-paid pharmaceutical executives as of 2020.[8]

In October 2017, Regeneron made a deal with the US-government Biomedical Advanced Research and Development Authority that the government would fund 80% of the costs for Regeneron to develop and manufacture antibody treatments, including now their Coronavirus disease 2019 treatments, and Regeneron would retain the right to set prices and control production. This deal was criticized in the New York Times. Such deals are not unusual for routine drug development in the American pharmaceutical market.[8]

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.[9]

Experimental treatment for COVID-19[edit]

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.[10]

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.[11][12][13] 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.[14] 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.[15] California based laboratory, FOMAT, is part of the clinical investigation through their doctors Augusto and Nicholas Focil.[16]

In October 2020 when U.S. President Donald Trump was infected with COVID-19 and taken to Walter Reed Medical Center in Bethesda, Maryland, he was administered REGN-COV2.[17] 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)).[18] On October 7, Trump posted a five-minute video to Twitter reasserting that this drug should be "free."[19] 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."[20]

Marketed products[edit]

Arcalyst (rilonacept) for specific, rare autoinflammatory conditions. Approved by the FDA in February 2008.

Eylea (aflibercept injection) approved by the U.S. Food and Drug Administration (FDA) in November 2011,[3][21] to treat a common cause of blindness in the elderly. Eylea is reported to cost $11,000 per year for each eye treated.[22]

Zaltrap (aflibercept injection) for metastatic colorectal cancer approved by the FDA in August 2012.[23]

Praluent (alirocumab) 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,[24] It is reported to cost $4,500 to $8,000 per year.[25]

Dupixent (dupilumab injection) is for the treatment of adolescent and adult patients' atopic dermatitis. Approved by the FDA in March 2017.[26] It is reported to cost $37,000 per year.[22]

Kevzara (sarilumab injection) is an interleukin-6 (IL-6) receptor antagonist for treatment of adults with rheumatoid arthritis. Approved by the FDA in May 2017.[27] Trials commenced in March 2020, to evaluate the effectiveness of Kevzara in the treatment of COVID-19.[28][29]

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. Approved by the FDA in September 2018.[30]

REGN-EB3 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 atoltivimab/maftivimab/odesivimab (Inmazeb, formerly REGN-EB3) with an indication for the treatment of infection caused by Zaire ebolavirus.[31]

Technology platforms[edit]

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.[32]:255–258

Financial performance[edit]

Financial Year Revenue Ref
2012 $1.4 billion [33]
2013 $2.1 billion [34]
2014 $2.8 billion [34]
2015 $4.1 billion [34]
2016 $4.8 billion [34]
2017 $5.8 billion [34]
2018 $6.7 billion [34]
2019 $7.8 billion [34]

Key people[edit]

The company was founded by CEO Leonard Schleifer and scientist George Yancopoulos. They are reported to hold $1.3 billion and $900 million in company stock, respectively. Both are from Queens, New York.[22]

Schleifer was formerly a professor of medicine at Weill Cornell Medical School. Yancopoulos was an assistant professor at Columbia University. Yancopoulos was involved in each drug's development.[22]

See also[edit]

References[edit]

  1. ^ a b "SEC Filing | Regeneron Pharmaceuticals Inc". investor.regeneron.com.
  2. ^ a b (PDF). September 15, 2016 https://web.archive.org/web/20160915180520/http://files.shareholder.com/downloads/REGN/2773703469x0x873937/63301CCD-A156-46CE-8521-64D7984E3107/REGN_News_2016_2_9_General_Releases.pdf. Archived from the original (PDF) on 2016-09-15. Missing or empty |title= (help)
  3. ^ a b Herper, Matthew (August 14, 2013). "How Two Guys From Queens Are Changing Drug Discovery". Forbes. Archived from the original on March 16, 2014. Retrieved March 22, 2014.open access
  4. ^ Husten, Larry. "Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race". Forbes. Retrieved 2018-02-22.
  5. ^ "Regeneron, Sanofi Launch $2B+ Immuno-Oncology Collaboration - GEN News Highlights - GEN". 2015-07-28.
  6. ^ "UPDATED: Struggling Sanofi paying $1.8B to partner with Regeneron on immuno-oncology - FierceBiotech".
  7. ^ Hough, Jack. "10 Stocks That Had Better Decades Than Amazon and Google". www.barrons.com. Retrieved 2019-12-19.
  8. ^ a b Mazzucato, Mariana; Momenghalibaf, Azzi (18 March 2020). "Drug Companies Will Make a Killing From Coronavirus". The New York Times.
  9. ^ Staff, Reuters (May 25, 2020). "U.S.' Regeneron to buy back $5 billion stake held by Sanofi" – via www.reuters.com.
  10. ^ News Division (4 February 2020). "HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment". HHS.gov. Retrieved 8 October 2020.
  11. ^ Kelland, Kate (2020-09-14). "Regeneron's antibody drug added to UK Recovery trial of COVID treatments". Reuters. Retrieved 2020-10-08.
  12. ^ Morelle, Rebecca (2020-09-14). "Antibody treatment to be given to Covid patients". BBC News. Retrieved 2020-10-08.
  13. ^ "Regeneron's COVID-19 Response Efforts". Regeneron Pharmaceuticals Inc. Retrieved 2020-10-08.
  14. ^ News Division (6 July 2020). "HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment". HHS.gov. Retrieved 8 October 2020.
  15. ^ Regeneron (7 July 2020). "Regeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail". Regeneron Pharmaceuticals Inc. Retrieved 2020-10-08.
  16. ^ Largacha, María Cecilia (6 August 2020). "2 ecuatorianos, cerca del medicamento contra el Covid-19". Retrieved 13 October 2020.
  17. ^ Press, Associated (2020-10-03). "Trump taking Regeneron drug, Remdesivir therapy for coronavirus diagnosis: ex-WH doctor explains". Associated Press. Retrieved 2020-10-13.
  18. ^ Cunningham, Paige Winfield. "Analysis | The Health 202: Trump is taking Regeneron's new coronavirus treatment. It's used for mild symptoms" – via www.washingtonpost.com.
  19. ^ Trump, Donald (7 October 2020). "A Message From The President!". Twitter. Retrieved 7 October 2020.
  20. ^ Regeneron (7 October 2020). "Statement on REGN-COV2 Emergency Use Authorization Request (PDF)". Regeneron Pharmaceuticals Inc. Retrieved 8 October 2020.
  21. ^ "Regulators Approve a Drug for an Eye Condition". The New York Times. Associated Press. November 18, 2011.
  22. ^ a b c d "Regeneron's Billionaire Founder Battles The Drug Pricing System". Forbes. 26 July 2018. Retrieved 26 July 2018.
  23. ^ "FDA approves Zaltrap for metastatic colorectal cancer" (Press release). U.S. Food and Drug Administration (FDA). August 3, 2012. Archived from the original on June 25, 2013.
  24. ^ "FDA approves Praluent to treat certain patients with high cholesterol" (Press release). U.S. Food and Drug Administration (FDA). Archived from the original on 2015-07-27. Retrieved 2015-07-29.
  25. ^ Tirrell, Meg (2018-05-01). "A $14,000 cholesterol drug gets a price cut as Regeneron, Sanofi strike deal with Express Scripts". CNBC. Retrieved 2018-08-22.
  26. ^ "Regeneron and Sanofi Announce FDA Approval of Dupixent (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis" (Press release). Regeneron Pharmaceuticals Inc. – via PRNewswire.
  27. ^ "Regeneron and Sanofi Announce FDA Approval of Kevzara (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients (NASDAQ:REGN)". Regeneron Pharmaceuticals Inc. (Press release).
  28. ^ "Regeneron's COVID-19 Response Efforts". Regeneron Pharmaceuticals Inc.
  29. ^ "Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19". clinicaltrials.gov.
  30. ^ "FDA approves first treatment for advanced form of the second most common skin cancer". U.S. Food and Drug Administration (FDA) (Press release). 2019-09-11.
  31. ^ "FDA Approves First Treatment for Ebola Virus". U.S. Food and Drug Administration (FDA) (Press release). 14 October 2020. Retrieved 14 October 2020. This article incorporates text from this source, which is in the public domain.
  32. ^ Susana Magadán Mompó and África González-Fernández. Human Monoclonal Antibodies from Transgenic Mice. Chapter 13 in Human Monoclonal Antibodies: Methods and Protocols Ed. Michael Steinitz. Springer Science+Business Media, 2014. ISBN 978-1-62703-585-9
  33. ^ "REGENERON PHARMACEUTICALS INC 2013 Annual Report Form (10-K)" (XBRL). United States Securities and Exchange Commission. February 13, 2014.
  34. ^ a b c d e f g "Regeneron Pharmaceuticals Revenue 2006-2020 | REGN". www.macrotrends.net. Retrieved 2020-06-12.

External links[edit]