Regeneron

Last updated
Regeneron Pharmaceuticals, Inc.
Public
Traded as
Industry Pharmaceuticals; Biotech
Founded1988
Headquarters Eastview, New York, US (Headquarters)
Area served
Worldwide
Key people
RevenueIncrease2.svg $5.87 billion (2017) [1]
Increase2.svg $1.4 billion [1]
Total assets Increase2.svg $5.6 billion [1]
Number of employees
6,200 [2]  (2017)
Website www.regeneron.com

Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Eastview, near 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.

Biotechnology Use of living systems and organisms to develop or make useful products

Biotechnology is the broad area of biology involving living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use". Depending on the tools and applications, it often overlaps with the (related) fields of molecular biology, bio-engineering, biomedical engineering, biomanufacturing, molecular engineering, etc.

Eastview, New York Business district in New York, United States

Eastview is a business district and former hamlet in Mount Pleasant, New York. It was primarily residential, and had a post office, railroad station, and school. In the late 1920s, John D. Rockefeller, Jr. purchased most of the hamlet's property and razed the buildings. Currently a variety of commercial buildings are present in the area. The Hammond House, a National Register of Historic Places-listed farmhouse dating to the 1720s, is located in the district, on New York State Route 100C.

Tarrytown, New York Town in New York, United States

Tarrytown is a village in the town of Greenburgh in Westchester County, New York, United States. It is located on the eastern bank of the Hudson River, about 25 miles (40 km) north of midtown Manhattan in New York City, and is served by a stop on the Metro-North Hudson Line. To the north of Tarrytown is the village of Sleepy Hollow, to the south the village of Irvington and to the east unincorporated parts of Greenburgh. The Tappan Zee Bridge crosses the Hudson at Tarrytown, carrying the New York State Thruway to South Nyack, Rockland County and points in Upstate New York. The population was 11,277 at the 2010 census.

Contents

Company history

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.

Aflibercept is a biopharmaceutical drug invented by Regeneron Pharmaceuticals, approved in the United States and Europe for the treatment of wet macular degeneration under the trade name Eylea, and for metastatic colorectal cancer as Zaltrap. As the active ingredient of Zaltrap, the substance is called ziv-aflibercept in the US.

Rilonacept, also known as IL-1 Trap, is an interleukin 1 inhibitor.

On March 26, 2012, Bloomberg announced that Sanofi and Regeneron are in development with 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 ]

Sanofi French pharmaceutical company

Sanofi S.A. is a French multinational pharmaceutical company headquartered in Paris, France, as of 2013 the world's fifth-largest by prescription sales. The company was formed as Sanofi-Aventis in 2004 by the merger of Aventis and Sanofi-Synthélabo, which were each the product of several previous mergers. It changed its name to Sanofi in May 2011. The company is a component of the Euro Stoxx 50 stock market index.

PCSK9 protein-coding gene in the species Homo sapiens

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme encoded by the PCSK9 gene in humans on chromosome 1. It is the 9th member of the proprotein convertase family of proteins that activate other proteins. Similar genes (orthologs) are found across many species. As with many proteins, PCSK9 is inactive when first synthesized, because a section of peptide chains blocks their activity; proprotein convertases remove that section to activate the enzyme. The PCSK9 gene also contains one of 27 loci associated with increased risk of coronary artery disease.

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.

Marketed products

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] [7] EYLEA developed to treat a common cause of blindness in the elderly. EYLEA is reported to cost $11,000 per year for each eye treated. [8]

ZALTRAP (aflibercept injection) for metastatic colorectal cancer: Approved by the FDA in August 2012. [9]

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 FDA on 24 July 2015 [10] It is reported to cost $4,500 to $8,000 per year. [11]

DUPIXENT (dupilumab injection) is for the treatment of adolescent and adult patients' atopic dermatitis. Approved by FDA on 28 March 2017. [12] It is reported to cost $37,000 per year. [8]

KEVZARA (sarilumab injection) is an interleukin-6 (IL-6) receptor antagonist for treatment of adult patients with rheumatoid arthritis. Approved by FDA on 22 May 2017. [13]

LIBTAYO (cemiplimab injection) is a monoclonal antibody targeting the PD-1 pathway as a checkpoint inhibitor, for the treatment of patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Approved by FDA on 28 September 2018. [14]

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. [15] :255–258

Financial performance

Financial YearRevenueRef
2012$1.4 billion [16]
2013$2.1 billion [16]
2014$2.8 billion [1]
2015$4.1 billion [1]
2016$4.8 billion [1]
2017$5.8 billion [1]
2018$6.7 billion [1]

Key people

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. [8]

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. [8]

See also

Related Research Articles

Cancer immunotherapy The artificial stimulation of the immune system to treat cancer, improving on the systems natural ability to fight cancer

Cancer immunotherapy is the artificial stimulation of the immune system to treat cancer, improving on the immune system's natural ability to fight cancer. It is an application of the fundamental research of cancer immunology and a growing subspeciality of oncology. It exploits the fact that cancer cells often have tumor antigens, molecules on their surface that can be detected by the antibody proteins of the immune system, binding to them. The tumor antigens are often proteins or other macromolecules. Normal antibodies bind to external pathogens, but the modified immunotherapy antibodies bind to the tumor antigens marking and identifying the cancer cells for the immune system to inhibit or kill. In 2018 James Allison and Tasuku Honjo received the Nobel Prize in Physiology or Medicine for their discovery of cancer therapy by inhibition of negative immune regulation.

Panitumumab (INN), formerly ABX-EGF, is a fully human monoclonal antibody specific to the epidermal growth factor receptor.

Mepolizumab is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma. It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.

Siltuximab is a chimeric monoclonal antibody. It binds to interleukin-6. Siltuximab has been investigated for the treatment of neoplastic diseases: metastatic renal cell cancer, prostate cancer, and Castleman's disease, among other types of cancer.

Spectrum Pharmaceuticals is an American biopharmaceutical company. The company is located in Irvine, California.

Secukinumab, trade name Cosentyx, is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A, and is marketed by Novartis for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis.

Sarilumab is a human monoclonal antibody against the interleukin-6 receptor. Regeneron 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.

Nivolumab pharmaceutical drug

Nivolumab, marketed as Opdivo, is a medication used to treat cancer. It is used as a first line treatment for inoperable or metastatic melanoma in combination with ipilimumab if the cancer does not have a mutation in BRAF, as a second-line treatment following treatment with ipilimumab and if the cancer has a mutation in BRAF, with a BRAF inhibitor, as a second-line treatment for squamous non-small cell lung cancer, and as a second-line treatment for renal cell carcinoma. Nivolumab has recently been approved for small cell lung cancer.

Alirocumab is a biopharmaceutical drug approved by the FDA on July 24, 2015 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.

Fasinumab is a human monoclonal antibody designed for the treatment of acute sciatic pain.

Dupilumab, sold under the trade name Dupixent, is a monoclonal antibody designed for the treatment of allergic diseases such as eczema. Side effects include allergic reactions, cold sores, and inflammation of the cornea. It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme. It received approval from the United States Food and Drug Administration for moderate-to-severe atopic dermatitis in 2017. As of 2017 it costs about 37,000 USD per year.

Tildrakizumab is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis.

Evolocumab is a monoclonal antibody designed for the treatment of hyperlipidemia.

Anti–vascular endothelial growth factor therapy, also known as anti-VEGF therapy or anti-VEGF medication, is the use of medications that block vascular endothelial growth factor. This is done in the treatment of certain cancers and in age-related macular degeneration. They can involve monoclonal antibodies such as bevacizumab, antibody derivatives such as ranibizumab (Lucentis), or orally-available small molecules that inhibit the tyrosine kinases stimulated by VEGF: lapatinib, sunitinib, sorafenib, axitinib, and pazopanib.

MM-151 is an oligoclonal mixture of fully human monoclonal antibodies, which binds multiple parts of the EGFR molecule It has started clinical trials in patients with RAS wild-type colorectal cancers (CRCs) that were resistant to other anti-EGFR therapies. It is intended to overcome the problem of cancers becoming resistant to monoclonal antibody therapies.

Cemiplimab (REGN-2810) is a monoclonal antibody under development as a drug for the treatment of squamous cell skin cancer, myeloma, and lung cancer.

SillaJen company in Busan, South Korea

SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan, Yangsan and Seoul, South Korea, and San Francisco, California.

References

  1. 1 2 3 4 5 6 7 8 [ dead link ]
  2. ↑ "Regeneron Pharmaceuticals". Fortune. Retrieved 2018-12-31.
  3. 1 2 Herper, Matthew (August 14, 2013). "How Two Guys From Queens Are Changing Drug Discovery". Forbes . United States. Archived from the original on March 16, 2014. Retrieved March 22, 2014. Open Access logo PLoS transparent.svg
  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".
  6. ↑ "UPDATED: Struggling Sanofi paying $1.8B to partner with Regeneron on immuno-oncology - FierceBiotech".
  7. ↑ "Regulators Approve a Drug for an Eye Condition". The New York Times . Associated Press. November 18, 2011.(registration required)
  8. 1 2 3 4 "Regeneron's Billionaire Founder Battles The Drug Pricing System". Forbes. 26 July 2018. Retrieved 26 July 2018.
  9. ↑ "FDA approves Zaltrap for metastatic colorectal cancer" (Press release). U.S. Food and Drug Administration. August 3, 2012. Archived from the original on June 25, 2013.
  10. ↑ "Archived copy". Archived from the original on 2015-07-27. Retrieved 2015-07-29.CS1 maint: Archived copy as title (link)
  11. ↑ 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.
  12. ↑ Inc., Regeneron Pharmaceuticals,. "Regeneron and Sanofi Announce FDA Approval of DUPIXENT® (dupilumab), the First Targeted Biologic Therapy for Adults with Moderate-to-Severe Atopic Dermatitis". www.prnewswire.com.
  13. ↑ "Regeneron and Sanofi Announce FDA Approval of Kevzara® (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients (NASDAQ:REGN)". newsroom.regeneron.com.
  14. ↑ "FDA approves first treatment for advanced form of the second most common skin cancer (NASDAQ:REGN)". fda.gov/NewsEvents.
  15. ↑ 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
  16. 1 2 "REGENERON PHARMACEUTICALS INC 2013 Annual Report Form (10-K)" (XBRL). United States Securities and Exchange Commission. February 13, 2014.
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