Amgen

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Amgen Inc.

logo
legal form Incorporated
ISIN US0311621009
founding 1980
Seat Thousand Oaks , United StatesUnited StatesUnited States 
management Robert Bradway ( Chairman , President and CEO )
Number of employees approx. 21,000 (2019)
sales $ 23.4 billion (2019)
Branch biotechnology
Website www.amgen.com
www.amgen.de

The biotechnology company Amgen was founded in 1980 as AMGen ( Applied Molecular Genetics ). With approximately 20,000 employees, Amgen is one of the world's largest biotechnology companies with annual sales of approximately 24 billion US dollars in 2018. Amgen has been listed on the US technology exchange NASDAQ under the symbol AMGN since 1983 . In addition to the headquarters in Thousand Oaks ( California ) and various branches in the USA (including Seattle ( Washington ), San Francisco (California) and Cambridge (Massachusetts) ), the company has branches in Canada, Europe (including Austria, France, Germany, Italy and England) as well as in Australia, New Zealand and Japan. The European headquarters are in Zug, Switzerland . The head office in Vienna is responsible for the Eastern European countries .

Main growth supplements are: Repatha ( evolocumab ), Parsabiv ( etelcalcetide ), Blincyto ( blinatumomab ), Aimovig ( erenumab ), Prolia ( denosumab ), Nplate ( romiplostim ) and Vectibix ( panitumumab ).

biotechnology

The company's success is based on the application of recombinant DNA technology, also known as biotechnology . This enables human proteins , e.g. B. to produce hormones or monoclonal antibodies with the help of microorganisms . This technology is also used by other major biotechnology companies such as AbbVie , Biogen , Genentech , Genzyme , MSD , Roche and Sanofi .

Medication

The company introduced two of the first in microorganisms produced human therapeutics , called Biologicals to market: In 1989, Epogen (Epoetin alfa) and 1991 Neupogen (filgrastim) by the Food and Drug Administration (English Food and Drug Administration , FDA). These two drugs became the first blockbusters in the biotechnology industry.

Epogen contains the hormone erythropoietin alpha as an active ingredient , which is normally formed in the interstitial cells of the tubules when the oxygen partial pressure in the kidney cortex drops and promotes the production of new erythrocytes in the bone marrow . Epogen is therefore prescribed for the treatment of anemia associated with chronic kidney malfunction in dialysis patients . It is also used - improperly - as a doping agent in sport.

Neupogen ( G-CSF or Filgrastim ) and Neulasta ( pegfilgrastim , i.e. pegylated filgrastim) , which was approved in 2002, are used, among other things, to counteract infections in the course of chemotherapy- induced neutropenia .

Enbrel ( Etanercept ), which was approved in 1998 , is a TNF ( Tumor Necrosis Factor ) antagonist that is used to treat inflammatory processes that occur, for. B. in connection with rheumatoid arthritis or psoriasis . In Germany, Enbrel is marketed by formerly Wyeth , a company that was acquired by Pfizer in 2009 .

In 2001 Aranesp ( darbepoetin alpha ) was approved for the treatment of anemia in chronic kidney failure and after chemotherapy. In the same year came with Kineret the (anakinra), the first drug of terraced antirheumatic drugs from Amgen to market. ( Enbrel joined the Amgen portfolio through the acquisition of Immunex Corporation.)

Another drug developed by Amgen is the human keratinocyte growth factor (KGF) Kepivance ( Palifermin ), which is used to treat patients with oral mucositis , an inflammation of the oral mucosa that can occur as a side effect of chemotherapy.

In 2004 Sensipar ( Cinacalcet ) was approved by the FDA. In the EU under the name Mimpara also approved since 2004, the drug decreases the release of parathyroid hormone from the parathyroid glands and is used to treat secondary hyperparathyroidism in patients with chronic kidney disease and elevated levels of calcium in the blood ( hypercalcemia ) in patients with tumors of the parathyroid gland (parathyroid ) used.

In 2009, Nplate ( romiplostim ) for the treatment of idiopathic thrombocytopenic purpura (ITP), also known as Werlhof's disease, and Vectibix ( panitumumab ) for the treatment of colon cancer were approved.

Prolia ( denosumab ) was approved in the EU in May 2010 for the treatment of osteoporosis . Shortly thereafter, the US Food and Drug Administration (FDA) approved denosumab for the US in this indication.

In November 2010, the FDA approved denosumab (trade name: XGEVA ) for the US for the prevention of skeletal-related complications in patients with bone metastases from solid tumors, followed by approval by the European Commission for the EU market in July 2011. In June 2013, Amgen received FDA approval for XGEVA for the treatment of giant cell tumors of bone. Denosumab is the first FDA-approved drug for this rare disease .

Repatha ( evolocumab ) was approved in the EU in July 2015 for the treatment of familial hypercholesterolemia ( high cholesterol levels ). The monoclonal antibody (a PCSK9 antibody) intervenes in the cholesterol metabolism and influences the LDL cholesterol . Repatha is also approved if statins are not tolerated or if they are insufficient. It can also be combined with statins or other lipid-lowering drugs.

Kyprolis ( carfilzomib ) was approved in the EU in November 2015 for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone . It was approved in the USA in July 2015.

Blincyto ( blinatumomab ) was approved in the EU in November 2015 for the treatment of specific forms of acute lymphoblastic leukemia (ALL) . It was approved in the USA in December 2014. Blinatumomab received the Breakthrough Therapy Designation from the US FDA and has been designated as an orphan drug in both the US and the EU .

Imlygic ( Talimogen laherparepvec / T-VEC / formerly Onco VEX GM-CSF ) was approved in December 2015 by the European Commission for the treatment of malignant melanoma (skin cancer) in the countries of the EU . It is the first approved oncolytic immunotherapeutic . Approval in the USA had already been granted in October 2015.

Parsabiv ( Etelcalcetide ) was approved by the European Commission for EU countries in November 2016 to lower parathyroid hormone levels in adults with high levels of this hormone due to long-term kidney disease ( secondary hyperparathyroidism ).

Amgevita ( biosimilar adalimumab ) was approved by the European Commission for the treatment of various inflammatory diseases ( rheumatoid arthritis , psoriatic arthritis , ankylosing spondylitis , chronic inflammatory bowel disease ( Crohn's disease ) and ulcerative colitis ) by the European Commission in March 2017 .

Aimovig ( erenumab-aooe ), is a human monoclonal antibody jointly developed by Amgen and Novartis that was approved in the United States in May 2018 for the prevention of migraines . The European approval took place in August 2018. In Europe, Aimovig is marketed by Novartis.

Evenity ( romosozumab ) is a monoclonal antibody that was approved in the United States in April 2019 for the prevention of osteoporosis . In October 2019, the EMA's CHMP advocated approval in the EU. In December 2019, the EMA approved the active substance for use in postmenopausal women for the treatment of overt osteoporosis when there is a significantly increased risk of fractures. (see also cooperations)

Research and Development

As the world's largest biotechnology company, the company has numerous monoclonal antibodies in clinical development (phase I-III). Drugs in phase III are e.g. B. rilotumumab ( stomach cancer ), tezepelumab (asthma) and trebananib ( ovarian cancer ).

Amgen is also dedicated to the field of biosimilars . One of the first biosimilars Amgen has in the pipeline is ABP 501, a biosimilar to adalimumab ( Humira ). In the USA it is approved under the trade name Amjevita . For the EU, the CHMP recommended approval for Amgevita in January 2017, and the approval itself in March 2017. Other biosimilars, e.g. B. to bevacizumab ( Avastin ), cetuximab ( Erbitux ), infliximab ( Remicade ), trastuzumab ( Herceptin ) and rituximab ( MabThera resp. Rituxan ) are in the pipeline.

Acquisitions and Cooperations

  • In 2007, Amgen and Cytokinetics announced that they would be jointly researching the " heart failure " indication . Amgen holds the worldwide marketing rights for an experimental compound from Cytokinetics Omecamtiv Mecarbil (CK-1827452).
  • Together with UCB , Amgen started a cooperation with NASA in 2011 to investigate the sclerostin antibody romosozumab in space with regard to bone loss . The cooperation with UCB has existed since 2004. Romosozumab was approved in Japan in January 2019 - as the first country in the world - in the indication " postmenopausal osteoporosis ". A " joint venture " exists between Amgen and Astellas Pharma to market Evenity : Amgen Astellas BioPharma KK (AABK). In January 2019, there was a positive vote for approval in the USA by the FDA. The FDA approval took place in April 2019.
  • In 2012, Amgen took over the biotechnology company Micromet, which specializes in the discovery, development and commercialization of innovative cancer therapies based on antibodies ( BiTE antibodies ). (Formerly) Micromet's lead product, blinatumomab , is now approved in both the US and the EU.
  • Amgen and AstraZeneca Plc have been jointly developing and marketing five monoclonal antibodies from Amgen's inflammation portfolio since 2012 (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827)). In May 2015, Amgen announced that it had terminated its collaboration with AstraZeneca on brodalumab.
  • The company announced in April 2012 that it would acquire Mustafa Nevzat Pharmaceuticals and in late 2012 acquired deCODE Genetics, a leader in genetics research.
  • In late August 2013, it was announced that the company would acquire Onyx Pharmaceuticals for $ 10.4 billion. Onyx owns the marketing rights for Kyprolis ( carfilzomib / multiple myeloma ).
  • In February 2014, Amgen and Merck & Co., Inc. (in Germany: MSD) announced that they would be jointly researching the indication " melanoma ". With Talimogen laherparepvec ( Imlygic ) and MSD with pembrolizumab ( Keytruda ), Amgen has an innovative drug for the treatment of melanoma in its therapeutic range.
  • In September 2016, Amgen and Servier announced an expansion of their cooperation in the field of cardiovascular diseases.
  • Amgen and Novartis announced in April 2017 that they are jointly aiming to launch the first-in-class monoclonal antibody erenumab for the treatment of migraines in the United States and Canada.
  • In 2011, Amgen and Allergan formed a cooperation for the joint development of biosimilars . First common active ingredient: biosimilar to bevacizumab ( Avastin ).
  • In October 2017, Amgen and CytomX Therapeutics announced a strategic collaboration in immune oncology .

Amgen Research (Munich) GmbH

Amgen Research (Munich) GmbH, formerly Micromet GmbH, was founded in March 2012. Over 200 employees work here in research and development, especially in the oncology area. Amgen Research (Munich) GmbH specializes in the development of " bispecific T-cell engagers " (BiTEs) for the treatment of cancer. BiTE antibodies stimulate the patient's immune cells to fight cancer.

Galenus von Pergamon Prize (Prix Galien) and criticism

In 2011, the company received the Galenus von Pergamon Prize ( Prix ​​Galien ) for two drugs : the monoclonal antibody denosumab ( Prolia ) is the winner in the Primary Care category; The winner in the Specialist Care category is the protein romiplostim ( Nplate ).

The drug Prolia was shown to be effective against bone loss. But as soon as you stop the injections, the risk of multiple vertebral fractures due to a rebound effect increases. This side effect was already suspected in the scientific literature in 2008 and 2011. The Lausanne University Hospital treats a total of 35 people with a total of 156 fractured vertebrae (as of February 16, 2018). Overall, significantly more people are affected.

literature

  • Gordon Binder (with Philip Bashe): Science Lessons: What the Business of Biotech Taught Me About Management , Harvard Business Review Press 2008

Web links

Individual evidence

  1. ↑ a b c Amgen: Amgen Fact Sheet (PDF; 334 kB) 2019. Accessed January 31, 2020.
  2. ↑ Amgen: Amgen Press Release Kevin W. Sharer / Robert Bradway . 2012. Retrieved May 31, 2012.
  3. ↑ a b c Amgen: Amgen Press Release . January 30, 2020. Accessed January 31, 2020.
  4. ^ Pfizer, Inc .: Pfizer to Acquire Wyeth, Creating the World's Premier Biopharmaceutical Company . 2009. Archived from the original on December 19, 2011. Retrieved on March 21, 2010.
  5. ↑ Prolia (R) (denosumab) Granted Marketing Authorization in the European Union , press release of May 28, 2010
  6. ↑ FDA Approves Amgen's Prolia (TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture , press release June 1, 2010
  7. ↑ FDA Approves Amgen's XGEVA (Denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors , press release of November 18, 2010
  8. ↑ XGEVA (denosumab) Granted Marketing Authorization in the European Union , press release of July 15, 2011
  9. ↑ FDA Approves Amgen's XGEVA (denosumab) For The Treatment Of Giant Cell Tumor Of Bone , press release June 13, 2013
  10. ↑ Amgen To Present Data From Four Phase 2 Studies At Upcoming American Heart Association Scientific Sessions 2012 , press release of November 2, 2012
  11. ↑ Amgen at AHA Scientific Sessions 2012 , overview on the occasion of the AHA conference
  12. ↑ European Commission Approves Amgen's New Cholesterol-Lowering Medication Repatha ™ (evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol  ( page no longer available , search in web archives )  Info: The link was automatically identified as defective marked. Please check the link according to the instructions and then remove this notice. Amgen PM on July 21, 2015, accessed July 22, 2015@1@ 2Template: Dead Link / investors.amgen.com  
  13. ↑ European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma , PM AMGEN of November 19, 2015, accessed on November 20, 2015
  14. ↑ Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe , PM AMGEN of September 25, 2015, accessed on November 9, 2015
  15. ↑ FDA approved carfilzomib (Kyprolis, Onyx Pharmaceuticals, Inc., to Amgen subsidiary) , FDA notification dated July 24, 2015, accessed November 9, 2015
  16. ↑ a b c European Commission Approves Amgen's BLINCYTO® (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia , PM AMGEN of November 24, 2015, accessed on November 24, 2015
  17. ↑ a b c Blinatumomab , FDA notification dated December 3, 2014, accessed November 24, 2015
  18. ↑ FDA Approves BLINCYTO ™ (Blinatumomab) Immunotherapy for the Treatment of Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, PM AMGEN, December 3, 2015, accessed November 24, 2015
  19. ↑ FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children , PM Amgen, July 11, 2017, accessed July 13, 2017
  20. ↑ a b European Commission Approves Amgen's IMLYGIC ™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe , PM AMGEN of December 17, 2015, accessed on December 21, 2015
  21. ↑ First oncolytic immunotherapy medicine recommended for approval , EMA report of October 21, 2015, accessed on November 8, 2015
  22. ↑ FDA Approves IMLYGIC ™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US , PM AMGEN of October 27, 2015, accessed November 8, 2015
  23. ↑ a b Amgen And Merck Announce Collaboration To Evaluate Investigational Combination Treatment For Advanced Melanoma , Amgen press release of February 5, 2014
  24. ↑ European Commission Approves Parsabiv ™ (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis , PM Amgen, November 11, 2016, accessed June 9, 2017
  25. ↑ European public assessment report (EPAR) , EMA, accessed on June 9, 2017
  26. ↑ Summary of the EPAR for the public , EMA, accessed on June 9, 2017
  27. ↑ a b European Commission Approves AMGEVITA ™ (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases , PM Amgen, March 23, 2017, accessed April 12, 2017
  28. ↑ FDA Approves Aimovig ™ (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention , PM Amgen, May 17, 2018, accessed May 19, 2018
  29. ↑ Aimovig ( Memento of the original from May 18, 2018 in the Internet Archive ) Info: The archive link was inserted automatically and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. Multimedia News Release, accessed May 19, 2018 @1@ 2Template: Webachiv / IABot / www.multivu.com
  30. ↑ Novartis and Amgen announce FDA approval of Aimovig (TM) (erenumab), a novel treatment developed specifically for migraine prevention , PM Novartis, May 18, 2018, accessed May 19, 2018
  31. ↑ Overview of Aimovig and rationale for approval in the EU , EMA, accessed on September 10, 2018
  32. ↑ Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its-kind treatment specifically designed for migraine prevention , PM Novartis of July 30, 2018
  33. ↑ a b FDA Approves EVENITY ™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture , PM Amgen, April 9, 2019, accessed April 14, 2019
  34. ↑ a b c d e Amgen Pipeline Overview of the drugs in the pipeline
  35. ↑ Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 , PM EMA of 18 October 2019, accessed on 29 October 2019
  36. ↑ Romosozumab in osteoporosis: Considerable added benefit for postmenopausal women. IQWiG, June 15, 2020, accessed on July 2, 2020 .
  37. ↑ Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype , Amgen PM, September 6, 2018, accessed September 10, 2018
  38. ↑ Amgen Announces Positive Top-Line Results From Phase 3 Study Evaluating The Efficacy And Safety Of Biosimilar Candidate ABP 501 Compared With Adalimumab In Patients With Moderate-To-Severe Plaque Psoriasis , Amgen PM October 8, 2014, accessed October 9 2014
  39. ↑ Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab , PM AMGEN of November 9, 2015, accessed on November 10, 2015
  40. ↑ Approved Products , WebSite Amgen Biosimilars, accessed June 7, 2017
  41. ↑ Adalimumab biosimilars recommended for approval , DAZ of January 27, 2017, accessed on June 7, 2017
  42. ↑ Our Pipeline , WebSite Amgen Biosimilars, accessed June 7, 2017
  43. ↑ Cytokinetics and Amgen Announce Strategic Alliance in Heart Failure , PM AMGEN, January 3, 2007, accessed November 10, 2015
  44. ↑ Amgen And Cytokinetics Announce Late-Breaking Presentation Of COSMIC-HF Trial At AHA Scientific Sessions 2015 , PM AMGEN of November 8, 2015, accessed on November 10, 2015
  45. ↑ Amgen and UCB Team Up With NASA on Final Space Shuttle Mission to Conduct Preclinical Test of Sclerostin Antibody on Bone Loss , Amgen press release of July 5, 2011
  46. ↑ EVENITY ™ (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine , Amgen PM, September 11, 2017, accessed September 13, 2017
  47. ↑ EVENITY ™ (romosozumab) Receives Approval In Japan For The Treatment Of Osteoporosis In Patients At High Risk Of Fracture , Amgen PM, January 8, 2019, accessed January 15, 2019
  48. ↑ EVENITY® SUBCUTANEOUS INJECTION 105mg SYRINGE RECEIVES THE-FIRST-IN-THE-WORLD APPROVAL IN JAPAN FOR THE TREATMENT OF OSTEOPOROSIS AT HIGH RISK OF FRACTURE , PM Astellas on January 9, 2019, accessed on January 17, 2019
  49. ↑ Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY ™ (romosozumab) , Amgen PM January 16, 2019, accessed January 17, 2019
  50. ↑ Amgen and AstraZeneca Announce Collaboration to Jointly Develop and Commercialize Clinical-Stage Inflammation Portfolio , Amgen press release of April 2, 2012
  51. ↑ Amgen to Terminate Participation in Co-development and Commercialization of Brodalumab , PM AMGEN of May 22, 2015, accessed on November 8, 2015
  52. ^ Amgen to Acquire Mustafa Nevzat
  53. ↑ Amgen to Acquire deCODE Genetics, a Global Leader in Human Genetics , Amgen press release of December 10, 2012
  54. ↑ Amgen To Acquire Onyx Pharmaceuticals For $ 125 Per Share In Cash , Amgen press release, August 25, 2013
  55. ↑ Amgen To Acquire Onyx Pharmaceuticals For $ 125 Per Share In Cash ( Memento of the original from August 29, 2013 in the Internet Archive ) Info: The @1@ 2Template: Webachiv / IABot / www.onyx.com archive link was automatically inserted and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Onyx press release from August 25, 2013
  56. ^ T-Vec: Oncolytic immunotherapy on the Pharmazeutische Zeitung market of July 1, 2016, accessed on February 3, 2017
  57. ↑ Amgen And Servier Extend Omecamtiv Mecarbil Collaboration In Chronic Heart Failure , Amgen PM, September 1, 2016, accessed June 8, 2017
  58. ↑ Amgen Announces Expanded Commercial Collaboration With Novartis For Erenumab In Migraine , Amgen PM, April 24, 2017, accessed May 11, 2017
  59. ↑ Novartis expands global collaboration with Amgen to commercialize first-in-class AMG 334 (erenumab) program in migraine prevention in the US and Canada , PM Novartis, April 24, 2017, accessed on May 11, 2017
  60. ↑ New Data Demonstrate Aimovig ™ (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies , PM Amgen, September 7, 2017, accessed September 10, 2017
  61. ↑ Amgen And Allergan Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab , PM Amgen, June 7, 2017, accessed June 7, 2017
  62. ↑ Amgen And CytomX Therapeutics Announce Strategic Collaboration In Immuno-Oncology , Amgen PM, October 3, 2017, accessed October 6, 2017
  63. ↑ Amgen Facts: Employees, Sales, Research & Development ( Memento of May 24, 2013 in the Internet Archive ), accessed on November 27, 2012
  64. ^ Amgen in Germany. (PDF; 5.4 MB) (No longer available online.) In: amgen.de. May 2015, archived from the original on March 19, 2017 ; Retrieved March 19, 2017 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.amgen.de
  65. ↑ Galenus von Pergamon Prize 2011 awarded for three top achievements in pharmacology , press release from Springer Medicine
  66. ↑ Tobias Tscherrig: University Hospital Lausanne exposes drug scandal. In: www.infosperber.ch, February 19, 2018.
  67. ↑ Drugs Commission of the German Medical Association: "From the UAW database" - Multiple vertebral body fractures after discontinuation of denosumab (Prolia ®) , in: Deutsches Ärzteblatt 2017; 114 (48): A-2309 / B-1933 / C-1887.
  68. ↑ Gordon Binder (* 1935) was Chief Financial Officer from 1982 and CEO and Chairman of Amgen from 1988 to 2000