Amgen

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Amgen Inc.
FormerlyApplied Molecular Genetics (1980–1983)
TypePublic
ISINUS0311621009
IndustryBiotechnology
FoundedApril 8, 1980; 42 years ago (1980-04-08)
HeadquartersThousand Oaks, California, U.S.
Key people
Robert A. Bradway (Chairman, President, & CEO)
ProductsAimovig, Aranesp, Blincyto, Epogen, Kineret, Enbrel, Kyprolis, Neulasta, Neupogen, Nplate, Parsabiv, Prolia, Repatha, Sensipar/Mimpara, Vectibix, Xgeva
RevenueIncrease US$25.424 billion (2020)
Decrease US$9.672 billion (2019)
Decrease US$7.842 billion (2019)
Total assetsDecrease US$59.707 billion (2019)
Total equityIncrease US$9.675 billion (2019)
Number of employees
22,000 (February 2020)
Websiteamgen.com
Footnotes / references
[1][2][3]

Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.[4][5] One of the world's largest independent biotechnology companies, Amgen was established in Thousand Oaks, California, in 1980.[6][7] Amgen's Thousand Oaks staff in 2017 numbered 5,125 (7.5% of total city employment) and included hundreds of scientists, making Amgen the largest employer in Ventura County.[8][7][9] Focused on molecular biology and biochemistry, its goal is to provide a healthcare business based on recombinant DNA technology.[10]

In 2018, the company's largest selling product lines were Neulasta, an immunostimulator used to prevent infections in patients undergoing cancer chemotherapy and Enbrel, a tumor necrosis factor blocker used in the treatment of rheumatoid arthritis and other autoimmune diseases. Other products include Epogen, Aranesp, Sensipar/Mimpara, Nplate, Vectibix, Prolia and XGEVA. Amgen sponsors the Tour of California.[11]

History

AMGen corporate logo, 1983
Argentine president Mauricio Macri meets with heads of Amgen, in 2018

The word AMGen is a portmanteau of the company's original name, Applied Molecular Genetics, which became the official name of the company in 1983 (three years after incorporation and coincident with its initial public offering). The company's first chief executive officer, from 1980, was co-founder George B. Rathmann, followed by Gordon M. Binder in 1988,[12] followed by Kevin W. Sharer in 2000.[13] Robert A. Bradway became Amgen’s president and chief executive officer in May 2012 following Sharer's retirement.[14]

The company has made at least five major corporate acquisitions.

Timeline

  • 1980. William Bowes from Cetus Corporation recruits Winston Salser from UCLA to start Amgen with a scientific advisory board consisting of Norman Davidson, Leroy Hood, Arnold Berk, John Carbon, Robert Schimke, Arno Motulsky, Marvin H. Caruthers, and Dave Gibson.[15]
  • 1989. Amgen received approval for the first recombinant human erythropoetin product, Epogen, for the treatment of anemia associated with chronic kidney failure. Epogen (also marketed by Johnson and Johnson under the tradename Procrit) would later be approved for anemia due to cancer chemotherapy, anemia due to treatment with certain HIV drugs, and for the reduction of the need for transfusions associated with surgery.[16]
  • 1991. In February 1991, Amgen received FDA approval for Neupogen for the prevention of infections in patients whose immune systems are suppressed due to cancer chemotherapy.[17] A 2002 meta-analysis found that Neupogen treatment reduced the risk of febrile neutropenia by 38%, reduced the risk of documented infection by 49%, and reduced the risk of infection-related mortality by 40%.[18]
  • 1998. In November 1998, Immunex, a future acquisition of Amgen, received approval for Enbrel (etanercept), the first rheumatoid arthritis drug targeting tumor necrosis factor alpha (TNF-alpha).[16] A 2006 assessment by the National Institute of Clinical Excellence of the United Kingdom concluded that etanercept and related rheumatoid arthritis drugs later introduced by competitors "are effective treatments compared with placebo for RA patients who are not well controlled by conventional DMARDs, improving control of symptoms, improving physical function, and slowing radiographic changes in joints."[19] A more recent study demonstrated that compared to traditional disease-modifying anti-rheumatic drugs, treatment with etanercept improved survival, reduced cardiovascular events and reduced the incidence of hematological cancers.[20]
  • 2010. On June 6, 2010 Amgen received FDA approval for Prolia, a protein drug for the treatment of post-menopausal osteoporosis.[21] In clinical trials, Prolia reduced the rate of vertebral fractures by 61% and the risk of hip fractures by 40%.[22]
  • 2010 In November 2010 the FDA approved Xgeva for the prevention of complications of bone metastases in patients with solid tumors.[23] The clinical trials primarily enrolled patients with breast or prostate cancer.
  • 2012. Illegal marketing practices. The Los Angeles Times reported on December 18, 2012 that Amgen pleaded guilty and agreed to pay $150 million in criminal penalty and $612 million to resolve 11 related whistleblower complaints. Federal prosecutors accused the company of pursuing profits while putting patients at risk.[24] Larry Husten, a contributor at Forbes.com elaborates on AMGEN's illegal marketing practices in this case, namely that the "government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices".[25] One of the drugs mentioned in the lawsuit had sales of $492 million in the third quarter of 2012, down 17% from the same quarter the previous year due to "reimbursement problems and label changes".[26]
  • 2013. Lawmakers inserted text into the fiscal cliff bill that will allow the drugmaker to sell a class of drugs that includes Sensipar without government controls for an additional two years. The New York Times estimated that the paragraph in the fiscal cliff bill will cost taxpayers an estimated $500 million[27] but other assessments concluded that the change would protect seniors in rural areas and reduce overall Medicare spending.[28][29]
  • 2015. In September the company announced it would acquire Dezima Pharma for more than $1.55 billion.[30] The same day the company announced a collaboration with Xencor on 6 early stage immuno-oncology and inflammation programmes. As part of the deal Amgen will pay $45 million upfront, with the deal being worth up to another $1.7 billion.[31][32]
  • 2016. In September, the company announced it would purchase the rights to Boehringer Ingelheims Phase I bispecific T-cell engager compound (BI 836909, now AMG 420) for use in the treatment of multiple myeloma.[33]
  • 2017. Cash returned to shareholders totalled a record $6.5 billion through dividends and share repurchases.[34]
  • 2018. Amgen was ranked 123 on the Fortune 500 list of the largest United States corporations by revenue.[35]
  • 2019. Amgen announced it would acquire Nuevolution AB for 1.61 billion Swedish crowns ($166.8 million) to enhance its drug discovery capabilities.[36] In August the company announced it would acquire the Otezla drug programme from Celgene for $13.4 billion, as part of Celgene and Bristol-Myers Squibbs merger deal.[37][38] In October, Amgen announced it would be acquiring a 20.5% stake in the Beijing-based BeiGene for $2.7 billion.[39]
  • 2021. In March, the company announced it would acquire Five Prime Therapeutics and its lead candidate, bemarituzumab, for $1.9 billion[40][41] and Rodeo Therapeutics for up to $720 million.[42] In July, Amgen acquired Teneobio for $900 million

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
  • Amgen (Founded 1983 as Applied Molecular Genetics)
    • Synergen Inc (Acq 1994)
    • Kinetix Pharmaceuticals Inc (Acq 2000)
    • Immunex Corporation (Acq 2002)
    • Tularik Inc (Acq 2004)
    • Abgenix Inc (Acq 2006)
    • Avidia Inc (Acq 2006)
    • Alantos Pharmaceuticals (Acq 2007)
    • Ilypsa Inc (Acq 2007)
    • BioVex Group Inc (Acq 2011)
    • Micromet Inc (Acq 2012)
    • Mustafa Nevzat İlaç (Acq 2012)
    • KAI Pharmaceuticals (Acq 2012)
    • deCODE genetics (Acq 2012)
    • Onyx Pharmaceuticals (Acq 2013)
    • NextCODE genetics (Spun off 2013)
    • Dezima Pharma (Acq 2015)
    • Catherex (Acq 2015)
    • Nuevolution AB (Acq 2019)
    • Otezla (Acq 2019)
    • Five Prime Therapeutics (Acq 2021)
    • Rodeo Therapeutics (Acq 2021)
    • Teneobio (Acq 2021)

Products

Amgen's approved drugs or therapeutic biologicals include:

Products developed and then sold off

Pipeline and clinical trials

In December 2013, Amgen had 11 drugs in Phase III clinical trials.[46] In November 2014 the company announced it was halting all trials of rilotumumab in advanced gastric cancer patients after one of the trials found more deaths in those who took the compound with chemotherapy, than those without.[47] Later in the same week, the company in conjunction with AstraZeneca reported positive results for brodalumab in a Phase III trial comparing the compound with ustekinumab and a placebo in treating psoriasis.[48]

In March 2015, the company announced it would license its Phase II candidate drug AMG 714 to developer Celimmune who plan to develop the anti-IL-15 monoclonal antibody for treatment against diet nonresponsive celiac disease and refractory celiac disease.[49]

In June 2015, Amgen presented Phase II clinical trial data for their anti-CGRP antibody AMG 334 for migraine, approved for sale as Aimovig in 2019.[50]

In 2019, FDA granted fast track designation to sotorasib for the treatment of metastatic non-small-cell lung carcinoma (NSCLC) with the KRAS G12C mutation.[51] In May 2021, sotorasib received accelerated approval from FDA for treatment of adult patients with NSCLC whose tumors have a KRAS G12C mutation and who have received at least one prior systemic therapy; this was the first approved targeted therapy for tumors with any KRAS mutation.[52] Similar approvals for sotorasib in NSCLC followed in January 2022 in Europe[53] and Japan.[54]

Carbon footprint

Amgen reported Total CO2e emissions (Direct + Indirect) for the twelve months ending 31 December 2020 at 243 Kt (-6 /-2.4% y-o-y)[55] and aims to reach net zero emissions by 2027.[56]

Amgen's annual Total CO2e Emissions - Location-Based Scope 1 + Scope 2 (in kilotonnes)[55]
Dec 2014 Dec 2015 Dec 2016 Dec 2017 Dec 2018 Dec 2019 Dec 2020
354 369 292 279 264 249 243

Controversy

During the 2022 Russian invasion of Ukraine, Amgen refused to join the international community and withdraw from the Russian market. Research from Yale University updated on April 28, 2022 identifying how companies were reacting to Russia's invasion identified Amgen in the worst category of "Digging In", meaning Defying Demands for Exit: companies defying demands for exit/reduction of activities. [57]

See also

References

  1. ^ Vilaca, Tatiane; Schini, Marian; Harnan, Susan; Sutton, Anthea; Poku, Edith; Allen, Isabel E.; Cummings, Steven R.; Eastell, Richard (2021-02-02). "Amgen Reports Fourth Quarter And Full Year 2020 Financial Results". Bone. 137: 115457. doi:10.1016/j.bone.2020.115457. PMID 32480023. S2CID 219169884. Archived from the original on 2021-03-30. Retrieved 2021-03-30.
  2. ^ "About Amgen Fact Sheet". amgen.com. Retrieved 9 March 2020.
  3. ^ "US SEC: 2019 Form 10-K Amgen Inc". U.S. Securities and Exchange Commission. February 12, 2020. Retrieved August 28, 2020.
  4. ^ Amgen History official site page accessed January 2, 2016
  5. ^ Ronald Vogel. Pharmaceutical Economics and Public Policy. CRC Press, 2007. ISBN 9781439801345. P. 208
  6. ^ Bidwell, Carol A. (1989). The Conejo Valley: Old and New Frontiers. Windsor Publications. Page 128. ISBN 9780897812993.
  7. ^ a b Baker, Pam (2002). Thousand Oaks Westlake Village: A Contemporary Portrait. Community Communications, Inc. Page 37. ISBN 978-1581920611.
  8. ^ http://www.toaks.org/home/showdocument?id=17130 (Page 162).
  9. ^ "Biotech giant Amgen has big plans for new plant". Moorpark Acorn. 16 February 2018.
  10. ^ Bidwell, Carol A. (1989). The Conejo Valley: Old and New Frontiers. Windsor Publications. Pages 128–129. ISBN 9780897812993.
  11. ^ "AMGEN TOUR OF CALIFORNIA". Amgen Tour of California. Archived from the original on 2020-02-04. Retrieved 2020-02-07.
  12. ^ "Amgen, Form 10-K, Annual Report, Filing Date Mar 24, 1998". secdatabase.com. Retrieved Jan 8, 2013.
  13. ^ "Amgen, Form 10-K405, Filing Date Mar 7, 2000". secdatabase.com. Retrieved Jan 8, 2013.
  14. ^ "Amgen, Form 8-K, Current Report, Filing Date May 24, 2012". secdatabase.com. Retrieved Jan 8, 2013.
  15. ^ "Amgen—A biotechnology success story | From drug development to the mass market". Archived from the original on 2014-10-24. Retrieved 2016-09-12.
  16. ^ a b "Drugs@FDA: FDA Approved Drug Products".
  17. ^ "Drugs@FDA: FDA Approved Drug Products".
  18. ^ Lyman GH, Kuderer NM, Djulbegovic B (April 2002). "Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis". Am. J. Med. 112 (5): 406–11. doi:10.1016/s0002-9343(02)01036-7. PMID 11904116.
  19. ^ Chen YF, Jobanputra P, Barton P, et al. (November 2006). "A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness". Health Technol Assess. 10 (42): iii–iv, xi–xiii, 1–229. doi:10.3310/hta10420. PMID 17049139.
  20. ^ Morgan CL, Emery P, Porter D, et al. (January 2014). "Treatment of rheumatoid arthritis with etanercept with reference to disease-modifying anti-rheumatic drugs: long-term safety and survival using prospective, observational data". Rheumatology (Oxford). 53 (1): 186–94. doi:10.1093/rheumatology/ket333. PMID 24140761.
  21. ^ "Drugs@FDA: FDA Approved Drug Products".
  22. ^ "www.accessdata.fda.gov" (PDF).
  23. ^ "FDA approves Xgeva to help prevent cancer-related bone injury". Food and Drug Administration.
  24. ^ Terhune, Chad (18 December 2012). "Amgen pleads guilty to improper marketing of anemia drug Aranesp". Los Angeles Times. Retrieved 2 February 2013.
  25. ^ Husten, Larry. "Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp". Forbes. Retrieved 2 February 2013.
  26. ^ "Article > Amgen's Aranesp fails in heart trial, Singapore plant planned". 17 January 2013.
  27. ^ Lipton, Eric (19 January 2013). "Fiscal Footnote: Big Senate Gift to Drug Maker". New York Times. Retrieved 2 February 2013.
  28. ^ "Jon Entine: New York Times Mum After Congressional Budget Office Rebukes Bungled Amgen/Medicare Investigation". Huffington Post. 26 February 2013.
  29. ^ "CBO analysis shows keeping oral drugs out of ESRD bundle could save money | Nephrology News & Issues". Archived from the original on 2013-06-05.
  30. ^ "For Up to $1.55B, Amgen Acquires Dezima Pharma". GEN. 16 September 2015.
  31. ^ "Amgen bets up to $1.7B on Xencor's antibody technology". FierceBiotech.
  32. ^ "Amgen, Xencor to Partner on Cancer Immunotherapy, Inflammation Drugs". GEN. 16 September 2015.
  33. ^ "Amgen Buys Rights to Myeloma BiTE Immunotherapy from Boehringer Ingelheim - GEN News Highlights - GEN". September 2016.
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  35. ^ "Fortune 500 company by revenue 2018 cial". www.fortune.com. Retrieved 2019-03-18.
  36. ^ "Amgen to buy Copenhagen-based Nuevolution for $167 million". Reuters. 22 May 2019 – via uk.reuters.com.
  37. ^ "Amgen to Acquire Otezla® for $13.4 Billion in Cash, or Approximately $11.2 Billion Net of Anticipated Future Cash Tax Benefits".
  38. ^ "Amgen to buy Celgene psoriasis drug Otezla for $13.4 billion". Reuters. 26 August 2019.
  39. ^ "Amgen acquires stake in BeiGene to grow cancer drug business to China". 31 October 2019.
  40. ^ "Amgen to Acquire Five Prime Therapeutics for $1.9 Billion in Cash".
  41. ^ "Amgen bets on $1.9-billion Five Prime deal to grow in Asia-Pacific oncology market". Reuters. 4 March 2021.
  42. ^ "In Second Acquisition this Month, Amgen Buys Rodeo for $721 Million".
  43. ^ Food and Drug Administration December 3, 2014 FDA Press release: Blinatumomab
  44. ^ a b c Amgen press office. Biovitrum Closes Product Acquisition Deal with Amgen Archived July 3, 2012, at the Wayback Machine
  45. ^ "Stemgen® (ancestim)". sobi.com. Archived from the original on 2013-12-30. Retrieved 2013-12-30.
  46. ^ Amgen Phase III Pipeline Archived 2015-07-29 at the Wayback Machine, accessed December 29, 2013
  47. ^ "GEN - News Highlights:Amgen Halts Rilotumumab Trials in Advanced Gastric Cancer". GEN. 24 November 2014.
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  49. ^ "GEN - News Highlights:Celimmune Licenses Amgen's AMG 714 for Celiac Disease". GEN.
  50. ^ "New Data on CGRP Monoclonal Antibodies for Migraine Prevention". Medscape.
  51. ^ Lisa Astor (September 9, 2019). "FDA Grants AMG 510 Fast Track Designation for KRAS G12C+ NSCLC". targetedonc.com. Retrieved November 16, 2019.
  52. ^ ASCO Post Staff (June 25, 2021). "FDA Approves Sotorasib for KRAS G12C–Mutated NSCLC". ascopost.com. Retrieved March 4, 2022.
  53. ^ Kristi Rosa (January 10, 2022). "Sotorasib Approved in Europe for KRAS G12C–Mutated Advanced NSCLC". www.onclive.com. Retrieved March 4, 2022.
  54. ^ Audrey Sternberg (January 20, 2022). "Sotorasib Earns Approval in Japan for KRAS G12C+ NSCLC". cancernetwork.com. Retrieved March 4, 2022.
  55. ^ a b "Amgen's ESG Datasheet for 2020Q4" (PDF). Alt URL
  56. ^ "Amgen's Sustainability Report for 2020Q4" (PDF). Archived from the original (PDF) on July 17, 2021. [Total%20CO2e%20emissions%20(Scope%201%20%2b%20Scope%202)/2020Q4/0/2020Q4 Alt URL]
  57. ^ "Over 750 Companies Have Curtailed Operations in Russia—But Some Remain". Yale School of Management. Retrieved 28 April 2022.

External links