Regeneron Pharmaceuticals

Last updated
Regeneron Pharmaceuticals, Inc.
Type Public
Industry
Founded1988;35 years ago (1988)
Founders
Headquarters Tarrytown, New York, U.S.
Area served
Global
Key people
  • Leonard Schleifer (CEO)
  • George Yancopoulos (CSO)
RevenueDecrease2.svg US$12.17 billion (2022)
Decrease2.svg US$4.74 billion (2022)
Decrease2.svg US$4.34 billion (2022)
Total assets Increase2.svg US$29.21 billion (2022)
Total equity Increase2.svg US$22.66 billion (2022)
Number of employees
11,851 (December 2022)
Website www.regeneron.com OOjs UI icon edit-ltr-progressive.svg
Footnotes /references
[1]

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. [2] 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.

Contents

Company history

The company was founded by CEO Leonard Schleifer and scientist George Yancopoulos in 1988. [3]

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.[ citation needed ]

On March 26, 2012, Bloomberg announced that Sanofi 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. [4]

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, [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 Biomedical Advanced Research and Development Authority (BARDA) that the U.S. government would fund 80% of the costs for Regeneron to develop and manufacture antibody-based medications, which subsequently, in 2020, included their COVID-19 treatments, and Regeneron would retain the right to set prices and control production. [9] This deal was criticized in The New York Times . [8] Such deals are not unusual for routine drug development in the American pharmaceutical market.

In May 2020, Regeneron announced it would repurchase approx. 19.2 million of its shares for around $5 billion, held directly by Sanofi. Prior to the transaction, Sanofi held 23.2 million Regeneron shares. [10] [11]

In April 2022, the business announced it would acquire Checkmate Pharmaceuticals for around $250 million, enhancing its number of immuno-oncology drugs. [12]

In August 2023, Regeneron announced it would acquire Decibel Therapeutics. [13]

Experimental treatment for COVID-19

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. [14]

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. [15] [16] [17] 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. [18] 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. [19] California based laboratory, FOMAT, is part of the clinical investigation through their doctors Augusto and Nicholas Focil. [20]

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. [21] 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)). [22] On October 7, Trump posted a five-minute video to Twitter reasserting that this drug should be "free." [23] 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." [24] The FDA granted approval for emergency use authorization in November 2020. [25]

Marketed products

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.[ citation needed ]

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. [37] : 255–258 

Financial performance

Financial YearRevenue [38]
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

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. [3] 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. [3]

See also

Related Research Articles

Leronlimab is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes of the human immune system. It is being investigated as a potential therapy in the treatment of COVID-19, triple negative breast cancer, and HIV infection. The United States Food and Drug Administration has designated PRO 140 for fast-track approval. In February 2008, the drug entered Phase 2 clinical trials and a phase 3 trial was begun in 2015. In February 2018, Cytodyn Inc reported that the primary endpoint had been achieved in the PRO 140 pivotal combination therapy trial in HIV infection. In 2020 CytoDyn submitted a fast-track biologics license application for treatment of CCR5-tropic HIV-1 Infection.

Aflibercept, sold under the brand names Eylea among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals and is approved in the United States and the European Union.

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 received US FDA approval on 22 May 2017 and European Medicines Agency approval on 23 June 2017.

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 a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors, and it was the first such agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety.

Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as eczema, asthma and nasal polyps which result in chronic sinusitis. It is also used for the treatment of eosinophilic esophagitis and prurigo nodularis.

Evolocumab is a monoclonal antibody that is a immunotherapy medication for the treatment of hyperlipidemia.

ImmunoGen, Inc. is a biotechnology company focused on the development of antibody-drug conjugate (ADC) therapeutics for the treatment of cancer. ImmunoGen was founded in 1981 and is headquartered in Waltham, Massachusetts.

Leonard S. Schleifer is an American businessman and is the co-founder and chief executive of the biotechnology company Regeneron Pharmaceuticals.

Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH).

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-L1 pathway.

Ansuvimab, sold under the brand name Ebanga, is a monoclonal antibody medication for the treatment of Zaire ebolavirus (Ebolavirus) infection.

<span class="mw-page-title-main">COVID-19 drug development</span> Preventative and therapeutic medications for COVID-19 infection

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

<span class="mw-page-title-main">Casirivimab/imdevimab</span> Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.

Atoltivimab/maftivimab/odesivimab, sold under the brand name Inmazeb, is a fixed-dose combination of three monoclonal antibodies for the treatment of Zaire ebolavirus. It contains atoltivimab, maftivimab, and odesivimab-ebgn and was developed by Regeneron Pharmaceuticals.

Atoltivimab is a Zaire ebolavirus glycoprotein-directed human monoclonal antibody that is part of the fixed-dose combination atoltivimab/maftivimab/odesivimab that is used for the treatment of Zaire ebolavirus.

Maftivimab is a Zaire ebolavirus glycoprotein-directed human monoclonal antibody that is part of the fixed-dose combination atoltivimab/maftivimab/odesivimab that is used for the treatment of Zaire ebolavirus.

Odesivimab is a Zaire ebolavirus glycoprotein-directed human monoclonal antibody that is part of the fixed-dose combination atoltivimab/maftivimab/odesivimab that is used for the treatment of Zaire ebolavirus.

<span class="mw-page-title-main">Janssen COVID-19 vaccine</span> Vaccine against COVID-19

The Janssen COVID‑19 vaccine, sold under the brand name Jcovden, is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson.

<span class="mw-page-title-main">Tixagevimab/cilgavimab</span> Monoclonal antibody treatment for COVID-19

Tixagevimab/cilgavimab, sold under the brand name Evusheld, is a combination of two human monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2 used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca. It is co-packaged and given as two separate consecutive intramuscular injections.

References

  1. ↑ "Regeneron Pharmaceuticals, Inc. 2022 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. February 6, 2023.
  2. 1 2 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 logo PLoS transparent.svg
  3. 1 2 3 4 5 "Regeneron's Billionaire Founder Battles The Drug Pricing System". Forbes. 26 July 2018. Retrieved 26 July 2018.
  4. ↑ "Sanofi-Regeneron Drug Lowers Cholesterol Up to 72% in Study". Bloomberg. 26 March 2012. Retrieved 25 July 2021.
  5. ↑ Staff (July 28, 2015). "Regeneron, Sanofi Launch $2B+ Immuno-Oncology Collaboration". Genetic Engineering & Biotechnology News. Archived from the original on September 21, 2020. Retrieved October 9, 2022. Open Access logo PLoS transparent.svg
  6. ↑ Carroll, John (July 28, 2015). "UPDATED: Struggling Sanofi paying $1.8B to partner with Regeneron on immuno-oncology". FierceBiotech. Archived from the original on May 4, 2016. Retrieved October 9, 2022. Open Access logo PLoS transparent.svg
  7. ↑ Hough, Jack (December 18, 2019). "10 Stocks That Had Better Decades Than Amazon and Google" . Barron's . Archived from the original on December 18, 2019. Retrieved December 19, 2019.
  8. 1 2 Mazzucato, Mariana; Momenghalibaf, Azzi (March 18, 2020). "Drug Companies Will Make a Killing From Coronavirus" . The New York Times . Archived from the original on March 18, 2020. Retrieved October 9, 2022.
  9. ↑ Pagliarulo, Ned (February 4, 2020). "Regeneron partners with US government to develop coronavirus treatment". BioPharma Dive. Washington, D.C.: Industry Dive. Archived from the original on February 27, 2020. Retrieved July 25, 2021.
  10. ↑ Protard, Matthieu (May 25, 2020). "U.S.' Regeneron to buy back $5 billion stake held by Sanofi". Reuters. Ed. John Stonestreet. Archived from the original on October 18, 2020. Retrieved October 9, 2022. Open Access logo PLoS transparent.svg
  11. ↑ "Sanofi intends to sell its equity investment in Regeneron; confirms no change to ongoing collaboration". Sanofi. May 25, 2020. Retrieved February 17, 2023. Open Access logo PLoS transparent.svg
  12. ↑ "Regeneron to Acquire Checkmate Pharmaceuticals and Its Investigational Immune Activator for Potential Use in Multiple Tumor Types" (Press release). Regeneron. April 19, 2022. Retrieved October 9, 2022– via BioSpace.
  13. ↑ "Regeneron to Acquire Decibel Therapeutics, Strengthening Gene Therapy and Hearing Loss Programs".
  14. ↑ News Division (4 February 2020). "HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment". HHS.gov. Archived from the original on 22 January 2021. Retrieved 8 October 2020.
  15. ↑ Kelland, Kate (2020-09-14). "Regeneron's antibody drug added to UK Recovery trial of COVID treatments". Reuters. Retrieved 2020-10-08.
  16. ↑ Morelle, Rebecca (2020-09-14). "Antibody treatment to be given to Covid patients". BBC News. Retrieved 2020-10-08.
  17. ↑ "Regeneron's COVID-19 Response Efforts". Regeneron Pharmaceuticals Inc. Retrieved 2020-10-08.
  18. ↑ News Division (6 July 2020). "HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment". HHS.gov. Archived from the original on 18 December 2020. Retrieved 8 October 2020.
  19. ↑ 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.
  20. ↑ Largacha, María Cecilia (6 August 2020). "2 ecuatorianos, cerca del medicamento contra el Covid-19". YouTube . Archived from the original on 2021-12-21. Retrieved 13 October 2020.
  21. ↑ "Trump taking Regeneron drug, Remdesivir therapy for coronavirus diagnosis: ex-WH doctor explains". Associated Press. Associated Press. 2020-10-03. Retrieved 2020-10-13.
  22. ↑ 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.
  23. ↑ Trump, Donald (7 October 2020). "A Message From The President!". Twitter. Retrieved 7 October 2020.
  24. ↑ Regeneron (7 October 2020). "Statement on REGN-COV2 Emergency Use Authorization Request (PDF)". Regeneron Pharmaceuticals Inc. Retrieved 8 October 2020.
  25. ↑ Conover, Damien (January 19, 2021). "Biopharma Companies With COVID-19 Treatments See $10 Billion Market in 2021". Morningstar.com. Retrieved 2021-01-19.
  26. ↑ "Regulators Approve a Drug for an Eye Condition". The New York Times . Associated Press. November 18, 2011.
  27. ↑ "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.
  28. ↑ "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.
  29. ↑ 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.
  30. ↑ "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.
  31. ↑ "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).
  32. ↑ "Regeneron's COVID-19 Response Efforts". Regeneron Pharmaceuticals Inc.
  33. ↑ "Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19". clinicaltrials.gov. 30 September 2020.
  34. ↑ "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.
  35. ↑ "FDA Approves First Treatment for Ebola Virus". U.S. Food and Drug Administration (FDA) (Press release). 14 October 2020. Retrieved 14 October 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  36. ↑ "Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease | Regeneron Pharmaceuticals Inc". August 18, 2023.
  37. ↑ 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   978-1627035859
  38. ↑ "Regeneron Pharmaceuticals Revenue 2006–2021 | REGN". Stock Research. MacroTrends. Table (Regeneron Pharmaceuticals Annual Revenue). Retrieved July 26, 2021.
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