Amgen

From Wikipedia, the free encyclopedia
Jump to: navigation, search
Amgen Inc.
Type Public
Traded as NASDAQAMGN
NASDAQ-100 Component
S&P 500 Component
SEHK4332
Industry Biotechnology
Founded 1980
Headquarters Thousand Oaks, California, U.S.
Key people Robert A. Bradway
(Chairman)
Robert A. Bradway
(President and CEO)
Products Epogen, Aranesp, Kineret, Enbrel, Neulasta, Neupogen, Nplate, Vectibix, Prolia, Xgeva and Sensipar/Mimpara.
Revenue Increase US$ 15.582 billion (2011)[1]
Operating income Decrease US$ 4.312 billion (2011)[1]
Net income Decrease US$ 3.683 billion (2011)[1]
Total assets Increase US$ 48.871 billion (2011)[1]
Total equity Decrease US$ 19.029 billion (2011)[1]
Employees 17,800 (December 2011)[1]
Website www.amgen.com

Amgen (formerly Applied Molecular Genetics) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. Located in the Conejo Valley, Amgen is the world's largest independent biotechnology firm. In 2013, the company's largest selling product lines were Neulasta/Neupogen, two closely related drugs 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.

History[edit]

AMGen Corporate Logo, 1983
Amgen's corporate Gulfstream V departs Fox Field, Lancaster, California

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 George B. Rathmann, followed by Gordon M. Binder in 1988,[2] followed by Kevin W. Sharer in 2000.[3] Robert A. Bradway became Amgen’s president and chief executive officer in May 2012 following Sharer's retirement.[4]

The company has made at least five major corporate acquisitions.

Timeline[edit]

  • 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.[5]
  • 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.[6] 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%.[7]
  • 1998. In November 1998, Amgen received approval for Enbrel (etanercept), the first rheumatoid arthritis drug targeting tumor necrosis factor alpha (TNF-alpha).[8] 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."[9] 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.[10]
  • 2010. On June 6, 2010 Amgen received FDA approval for Prolia, a protein drug for the treatment of post-menopausal osteoporosis.[11] In clinical trials, Prolia reduced the rate of vertebral fractures by 61% and the risk of hip fractures by 40%.[12]
  • 2010 In November 2010 the FDA approved Xgeva for the prevention of complications of bone metastases in patients with solid tumors.[13] 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 pled 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.[14] 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".[15] 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".[16]
  • 2012. Amgen paid $762 million after pleading guilty to criminal charges of improper promotion and sale of misbranded drugs.[17]
  • 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[18] but other assessments concluded that the change would protect seniors in rural areas and reduce overall Medicare spending.[19][20]
  • 2013. Amgen halted pediatric studies of its parathyroid drug Sensipar after the death of a 14-year-old patient in a company trial.[21] The FDA has stated that it is unclear whether the death is drug-related.[22]
  • 2013. Amgen offered to buy the shares of Onyx Pharmaceuticals for $120 per share, sending Onyx shares up by around 30% after the news was announced.[23]
  • 2014. In October the company filed a patent infringement lawsuit against Sanofis drug aventisub, and Regeneron Pharmaceuticals drug alirocumab, claiming infringement of US patents 8,563,698, 8,829,165, and 8,859,741 which describe the use of monoclonal antibodies to target proprotein convertase subtilisin/kexin type 9 (PCSK9).[24]

Acquisition history[edit]

  • 1994 – Synergen, Inc.[25]
  • 2000 – Kinetix Pharmaceuticals, Inc.[26]
  • 2002 – Immunex Corporation[27][28]
  • 2004 – Tularik, Inc.[29]
  • 2006 – Abgenix, Inc.[30][31][32]
  • 2006 – Avidia, Inc.[33]
  • 2007 – Ilypsa, Inc.[34]
  • 2007 – Alantos Pharmaceuticals Holdings, Inc.[34]
  • 2011 – BioVex Group, Inc.[35]
  • 2011 – Laboratório Químico Farmacêutico Bergamo Ltda.[36]
  • 2012 – Micromet, Inc.[37]
  • 2012 – Mustafa Nevzat İlaç[38][39]
  • 2012 – KAI Pharmaceuticals[40]
  • 2012 – deCODE genetics
  • 2013 – Onyx Pharmaceuticals Inc.[41]

Products[edit]

As of December, 2013, Amgen had twelve approved drugs or therapeutic biologicals for seventeen conditions (conditions lists are highly generalized; see each article for more detail):

Products developed and then sold off[edit]

Pipeline & Clinical trials[edit]

As of December 2013, Amgen had 11 drugs in Phase III clinical trials.[44]

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.[45] Later in the same week, the company (in conjunction with AstraZeneca) reported positive results for brodalumab in a phase ||| trial comparing the compound with ustekinumab and a placebo in treating psoriasis.[46]

See also[edit]

References[edit]

  1. ^ a b c d e f "Amgen, Form 10-K, Annual Report, Filing Date Feb 29, 2012". secdatabase.com. Retrieved Jan 8, 2013. 
  2. ^ "Amgen, Form 10-K, Annual Report, Filing Date Mar 24, 1998". secdatabase.com. Retrieved Jan 8, 2013. 
  3. ^ "Amgen, Form 10-K405, Filing Date Mar 7, 2000". secdatabase.com. Retrieved Jan 8, 2013. 
  4. ^ "Amgen, Form 8-K, Current Report, Filing Date May 24, 2012". secdatabase.com. Retrieved Jan 8, 2013. 
  5. ^ "Drugs@FDA: FDA Approved Drug Products". 
  6. ^ "Drugs@FDA: FDA Approved Drug Products". 
  7. ^ 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. 
  8. ^ "Drugs@FDA: FDA Approved Drug Products". 
  9. ^ 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. PMID 17049139. 
  10. ^ 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. 
  11. ^ "Drugs@FDA: FDA Approved Drug Products". 
  12. ^ "www.accessdata.fda.gov". 
  13. ^ "FDA approves Xgeva to help prevent cancer-related bone injury". 
  14. ^ Terhune, Chad (18 December 2012). "Amgen pleads guilty to improper marketing of anemia drug Aranesp". Los Angeles Times. Retrieved 2 February 2013. 
  15. ^ Husten, Larry. "Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp". Forbes. Retrieved 2 February 2013. 
  16. ^ "Article > Amgen's Aranesp fails in heart trial, Singapore plant planned". 
  17. ^ "Amgen Inc. pleads guilty to federal charge in Brooklyn and pays $762 million to resolve criminal liability and civil fraud allegations" (Press release). Department of Justice – Office of Public Affairs. December 19, 2012. Retrieved 3 October 2013. 
  18. ^ Lipton, Eric (19 January 2013). "Fiscal Footnote: Big Senate Gift to Drug Maker". New York Times. Retrieved 2 February 2013. 
  19. ^ "Jon Entine: New York Times Mum After Congressional Budget Office Rebukes Bungled Amgen/Medicare Investigation". Huffington Post. 26 February 2013. 
  20. ^ "CBO analysis shows keeping oral drugs out of ESRD bundle could save money | Nephrology News & Issues". 
  21. ^ "FDA halts Amgen drug trial after 14-year-old dies". CBS News. Retrieved 26 February 2013. 
  22. ^ [+++++http://www.fda.gov/Drugs/DrugSafety/ucm340551.htm "FDA Drug Safety Communication: Pediatric clinical studies of Sensipar (cinacalcet hydrochloride) suspended after report of death"]. 
  23. ^ Caroline Humer (28 June 2013). "U.S. biotech Amgen offered to buy Onyx for $120 per share: report". Reuters. 
  24. ^ http://www.genengnews.com/gen-news-highlights/amgen-files-patent-infringement-suit-against-sanofi-and-regeneron/81250484/
  25. ^ "Amgen, Form 8-K/A, Filing Date Feb 2, 1995". secdatabase.com. Retrieved Jan 8, 2013. 
  26. ^ "Amgen, Form 425, Filing Date Oct 16, 2000". secdatabase.com. Retrieved Jan 8, 2013. 
  27. ^ "Amgen, Form 8-K, Current Report, Filing Date Dec 17, 2001". secdatabase.com. Retrieved Jan 8, 2013. 
  28. ^ Amgen Completes Acquisition Of IMMUNEX
  29. ^ "Amgen, Form 8-K, Current Report, Filing Date Mar 29, 2004". secdatabase.com. Retrieved Jan 8, 2013. 
  30. ^ "Amgen, Form 8-K, Current Report, Filing Date Dec 15, 2005". secdatabase.com. Retrieved Jan 8, 2013. 
  31. ^ "Amgen, Form 8-K, Current Report, Filing Date Apr 24, 2006". secdatabase.com. Retrieved Jan 8, 2013. 
  32. ^ Amgen Completes Acquisition of Abgenix; Acquisition Provides Amgen with Full Ownership of Panitumumab and Eliminates a Denosumab Royalty
  33. ^ "Amgen, Form 8-K, Current Report, Filing Date Sep 29, 2006". secdatabase.com. Retrieved Jan 8, 2013. 
  34. ^ a b "Amgen, Form 10-Q, Quarterly Report, Filing Date Aug 9, 2007". secdatabase.com. Retrieved Jan 8, 2013. 
  35. ^ "Amgen, Form 8-K, Current Report, Filing Date Jan 25, 2011". secdatabase.com. Retrieved Jan 8, 2013. 
  36. ^ "Amgen, Form 10-Q, Quarterly Report, Filing Date May 10, 2011". secdatabase.com. Retrieved Jan 8, 2013. 
  37. ^ "Amgen, Form 8-K, Current Report, Filing Date Jan 26, 2012". secdatabase.com. Retrieved Jan 8, 2013. 
  38. ^ "Amgen, Form 8-K, Current Report, Filing Date Apr 30, 2012". secdatabase.com. Retrieved Jan 8, 2013. 
  39. ^ http://www.hurriyet.com.tr/ekonomi/20415671.asp
  40. ^ "Amgen, Form 10-Q, Quarterly Report, Filing Date May 8, 2012". secdatabase.com. Retrieved Jan 8, 2013. 
  41. ^ Guha, Malini (October 8, 2013). "Amgen swallows Onyx whole". Nature Biotechnology 31: 859—860. doi:10.1038/nbt1013-859. Retrieved November 6, 2013. 
  42. ^ a b c Amgen press office. Biovitrum Closes Product Acquisition Deal with Amgen
  43. ^ Sobi's StemGen page]
  44. ^ Amgen Phase III Pipeline, accessed December 29, 2013
  45. ^ http://www.genengnews.com/gen-news-highlights/amgen-halts-rilotumumab-trials-in-advanced-gastric-cancer/81250637/
  46. ^ http://www.genengnews.com/gen-news-highlights/brodalumab-s-no-turkey-in-phase-iii-amgen-and-astrazeneca/81250645/

External links[edit]