AstraZeneca

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AstraZeneca plc
Public limited company
Traded as LSE: AZN
OMX: AZN
NYSE: AZN
Industry Pharmaceutical
Biotechnology
Predecessor Astra AB
Zeneca Group plc
Founded April 6, 1999; 25 years ago (1999-04-06)
Headquarters London, United Kingdom
Area served
 Global
Key people
 Leif Johansson (Chairman)
Pascal Soriot (CEO)
Products Pharmaceutical products
Revenue US$24.708 billion (2015)[1]
US$4.114 billion(2015)[1]
US$2.826 billion (2015)[1]
Number of employees
 50,000 (2014)[2]
Subsidiaries MedImmune
Website www.astrazeneca.com

AstraZeneca plc[3] is a British-Swedish multinational pharmaceutical and biologics company headquartered in London, United Kingdom. It is the world's seventh-largest pharmaceutical company measured by 2012 prescription drug sales (after Pfizer, Sanofi, Novartis, Merck & Co., Roche and GlaxoSmithKline) and has operations in over 100 countries.[4]

AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.[5] The company was founded in 1999 through the merger of the Sweden-based Astra AB and the UK-based Zeneca Group[6][7] (itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993). It has made numerous corporate acquisitions, including of Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014).

AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. It has secondary listings on the New York Stock Exchange and the OMX exchange.

History

Astra AB was founded in 1913 in Södertälje, Sweden, by 400 doctors and apothecaries.[8] In 1993 the British chemicals company ICI demerged its pharmaceuticals businesses and its agrochemicals and specialties businesses, to form Zeneca Group plc.[9] Finally, in 1999 Astra and Zeneca Group merged to form AstraZeneca plc, with its headquarters in London.[9] In 1999, AstraZeneca identified as a new location for the company's US base the "Fairfax-plus" site in North Wilmington, Delaware.[10]

2000 to 2006

In 2002, its drug Iressa was approved in Japan as monotherapy for non-small cell lung cancer.[11] On 3 January 2004 Dr Robert Nolan, a former director of AstraZeneca, formed the management team of ZI Medical.[12]

In 2005, the company acquired KuDOS Pharmaceuticals, a UK biotech company, for £120m[13] and entered into an anti-cancer collaboration agreement with Astex.[14] It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation.[15]

In 2006, following a collaborative relationship begun in 2004, AstraZeneca acquired Cambridge Antibody Technology for £702 million.[16]

2007 – 2012: The patent cliff and subsequent acquisitions

In February 2007, AstraZeneca agreed to buy Arrow Therapeutics, a company focused on the discovery and development of anti-viral therapies, for $150 million.[17] AstraZeneca's pipeline, and "patent cliff", was the subject of much speculation in April 2007 leading to pipeline-boosting collaboration and acquisition activities.[18] A few days later AstraZeneca acquired American company MedImmune for about $15.2 billion to gain flu vaccines and an anti-viral treatment for infants;[19] AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune.[20]

In 2010, AstraZeneca acquired Novexel Corp, an antiobiotics discovery company formed in 2004 as a spin-off of the Sanofi-Aventis anti-infectives division. Astra acquired the experimental antibiotic NXL-104 (CEF104) (CAZ-AVI) through this acquisition.[21] [22]

In 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics business.[23]

In February 2012, AstraZeneca and Amgen announced collaboration on treatments for inflammatory diseases.[24] Then in April 2012, AstraZeneca acquired Ardea Biosciences, another biotechnology company, for $1.26 billion.[25] In June 2012, AstraZeneca and Bristol-Myers Squibb announced a two-stage deal for the joint acquisition of the biotechnology company Amylin Pharmaceuticals.[26][27] It was agreed that Bristol-Myers Squibb would acquire Amylin for $5.3 billion in cash and the assumption of $1.7 billion in debt, with AstraZeneca then paying $3.4 billion in cash to Bristol-Myers Squibb, and Amylin being folded into an existing diabetes joint-venture between AstraZeneca and Bristol-Myers Squibb.[27]

2013 restructuring and beyond

2013

In March 2013 AstraZeneca announced plans for a major corporate restructuring, including the closure of its research and development activities at Alderley Park, investment of $500 million in the construction of a new research and development facility in Cambridge and the concentration of R&D in three locations: Cambridge, Gaithersburg, Maryland (location of MedImmune, where it will work on biotech drugs), and Mölndal in Sweden, for research on traditional chemical drugs. AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016.[28][29] That announcement included the announcement that it would cut 1,600 jobs; three days later it announced it would cut an additional 2,300 jobs.[30][31] It also announced that it would focus on three therapeutic areas: Respiratory, Inflammation & Autoimmunity; Cardiovascular & Metabolic Disease; and Oncology.[32] In October 2013, AstraZeneca announced it would acquire biotech oncology company Spirogen for around $440 million.[33]

2014

On 19 May 2014 AstraZeneca rejected a "final offer" from Pfizer of £55 per share, which valued the company at £69.4 billion ($117 billion). The companies had been meeting since January 2014. If the takeover had proceeded Pfizer would have become the world's biggest drug maker. The transaction would also have been the biggest foreign takeover of a British company. Many in Britain, including politicians and scientists, had opposed the deal.[34] In July 2014 the company entered into a deal with Almirall to acquire its subsidiary Almirall Sofotec and its lung treatments including the COPD drug, Eklira. The $2.1 billion deal included an allocation of $1.2 billion for development in the respiratory franchise, one of AstraZeneca's three target therapeutic areas announced the year before. In August 2014 the company announced it had entered into a three-year collaboration with Mitsubishi Tanabe Pharma on diabetic nephropathy.[35] In September 2014 the company would join forces with Eli Lilly in developing and commercialising its candidate BACE inhibitor – AZD3292 – used for the treament of Alzheimers. The deal could yield up to $500 million for the company.[36] In November 2014 the companys biologics R&D operation, MedImmune, agreed to acquire Definiens for more than $150 million. The company also began a Phase I/II trial collaboration with Pharmacyclics and Janssen Biotech investigating combination treatments.[37] Also in November of the same year, the company agreed to sell its lipodystrophy treatment business to Aegerion Pharmaceuticals for more than $325 million.[38] In December, the company received accelerated FDA approval for Olaparib in the treatment of women with advanced ovarian cancer who have a BRCA genetic mutation. A major criterion governing the drugs approval was, on average, its ability to shrink tumours in patients for 7.9 months.[39]

2015

In February, the company announced would acquire the US and Canadian rights to Actavis' branded respiratory drug business for an initial sum of $600 million.[40] Later in the same month the company announced it would partner with Orca Pharmaceuticals to develop retinoic acid–related orphan nuclear receptor gamma inhibitors for use in the treatment of a number of autoimmune diseases, which could generate up to $122.5 million for Orca.[41] The company also announced their plan to spend $40 million creating a new subsidiary focused on small molecule anti-infectives - primarily in the research of the gyrase inhibitor, AZD0914, which is currently in Phase II for the treatment of gonorrhea.[42] In mid-March the company announced it would co commercialise naloxegol along with Daiichi Sankyo in a deal worth up to $825 million.[43] Towards the end of April the company announced a number of collaborations worth an estimated $1.8 billion; firstly, to develop and commercialise MEDI4736, with Celgene, for use against non-Hodgkin’s lymphoma, myelodysplastic syndromes, and multiple myeloma with Astra Zeneca receiving $450 million. The second of two-deals is an agreement to study a combination treatment of MEDI4736 and Innate Pharma’s Phase II anti-NKG2A antibody IPH2201 for up to $1.275 billion. The companies Medimmune arm also launched collaborative clinical trials with Juno Therapeutics, investigating combination treatments for cancer.[44] The trials will assess combinations of MEDI4736 and one of Junos CD19 directed chimeric antigen receptor T cell candidates.[45] In late June the company announced it has entered into a partnership agreement with Eolas Therapeutics on the Eolas Orexin-1 Receptor Antagonist (EORA) program for smoking cessation and other treatments.[46] In July the company announced it would sell off its rights to Entocort (budesonide) to Tillotts Pharma for $215 million.[47] In July 2015, Genzyme announced it would acquire the rare cancer drug Caprelsa (vandetanib) from AstraZeneca for up to $300 million.[48] In August, the company announced it has acquired the global rights to develop and commercialise Heptares Therapeutics drug candidate HTL-1071, which focuses on blocking the adenosine A2A receptor, in a deal worth up to $510 million.[49] In the same month the company Medimmune subsidiary acquire exclusive rights to Inovio Pharmaceuticals INO-3112 immunotherapy, currently in Phase I/II, under an agreement which could net more than $727.5 million for Inovio. INO-3112 targets Human papillomavirus types 16 and 18.[50] In September, Valeant licensed Brodalumab from the company for up to $445 million.[51][52] On the 6th of November it was reported that AstraZeneca acquired ZS Pharma for $2.7 billion.[53] In December the company announced its intention to acquire the respiratory portfolio of Takeda Pharmaceutical - namely Alvesco and Omnaris - for $575 million[54] A day later, the company announced it had taken a 55% majority stake in Acerta for $4 billion. As part of the transaction the company will gain commercial rights to Acertas irreversible oral Bruton's tyrosine kinase inhibitor, acalabrutinib (ACP-196), which is currently in Phase III development for B-cell blood cancers and in Phase I or II clinical trials in solid tumours.[55]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (a comprehensive list of AstraZeneca's subsidiary holdings can be found here):

AstraZeneca
















Astra AB
(Merged 1999)

Astra
(Founded 1913)


Tika
(Acq 1939)


Zeneca
(Merged 1999)


Zeneca
(Spun off from Imperial Chemical Industries 1993)


Salick Health Care
(Acq 1996)



Ishihara Sangyo Kaisha
(US fungicide operations, Acq 1997)







KuDOS Pharmaceuticals
(Acq 2005)





Cambridge Antibody Technology
(Acq 2006)


Aptein Inc
(Acq 1998)





Arrow Therapeutics
(Acq 2007)





MedImmune
(Acq 2007)


Definiens[56]
(Acq 2014)





Novexel Corp
(Acq 2010)





Guangdong BeiKang Pharmaceutical Company
(Acq 2011)





Ardea Biosciences
(Acq 2012)





Amylin Pharmaceuticals
(Acq 2012 jointly with Bristol-Myers Squibb )





Spirogen
(Acq 2013)





Pearl Therapeutics[57]
(Acq 2013)





Omthera Pharmaceuticals[58]
(Acq 2013)





Bristol-Myers Squibb[59]
(share of global diabetes alliance, Acq 2013)





Entasis Therapeutics[60]
(Spun off 2015)





ZS Pharma
(Acq 2015)



Operations

The AstraZeneca R&D facility in Mölndal, Sweden

AstraZeneca develops, manufactures and sells pharmaceutical and biotechnology products to treat disorders in the gastrointestinal, cardiac and vascular, neurological and psychiatric, infection, respiratory, pathological inflammation and oncology areas.

AstraZeneca has its corporate headquarters in London, England, and its research and development (R&D) headquarters are in Södertälje, Sweden and in Warsaw, Poland. The company employs over 11,000 people at research facilities in the United Kingdom, United States, Sweden, France, Canada, India, China, Brazil and Japan.

The company's largest single research and development site is at Alderley Park, a large country estate in Cheshire, England. Around 4,500 staff are based at the site.[61]

The company has a major research and development presence in Sweden, with approximately 4,000 staff employed at research facilities in Mölndal and Södertälje.[62]

Products

The following products are found on the AstraZeneca website.[63] Generic- drug names are given in parentheses following the brand name.


This list is incomplete; you can help by expanding it.

– Anesthetics

– Cardiovascular

– Diabetes

– Gastrointestinal

– Infectious diseases

– Neuroscience

  • Heminevrin (clomethiazole)
  • Mysoline (primidone; handed over to Acorus Therapeutics Ltd. in July 2004)
  • Seroquel (quetiapine)
  • Seroquel XR/Seroquel Prolong (quetiapine extended-release)

– Oncology

– Respiratory and inflammatory diseases

Orphan drugs

In April 2015 AstraZeneca's drug tremelimumab was approved as an orphan drug for the treatment of mesothelioma in the United States. [64] In February 2016, AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint.[65]

Senior management

The senior executive team is composed of David Brennan, Simon Lowth, John Patterson, Tony Zook, David Mott, Bruno Angelici, Lynn Tetrault and David Smith. As of 2008, Brennan was paid $1,574,144 for his role as chief executive officer.[66]

On 26 April 2012, it was announced that David Brennan was to retire early in the June of that year[67] In August 2012, Pascal Soriot was named CEO of AstraZeneca.[68]

"It was also announced that Leif Johansson will succeed Louis Schweitzer as Non-Executive chairman on 1 June 2012 – three months earlier than previously announced – and will become Chairman of the Nomination and Governance Committee after (the 2012) Annual General Meeting."[67]

Controversies

Seroquel

In April 2010 AstraZeneca settled a qui tam lawsuit brought by Stefan P. Kruszewski for $520 million to settle allegations that the company defrauded Medicare, Medicaid, and other government-funded health care programs in connection with its marketing and promotional practices for the blockbuster atypical antipsychotic, Seroquel.[69]

In March 2011, AstraZeneca settled a lawsuit in the United States totalling $68.5 million to be divided up to 38 states.[70]

Nexium

The company's most commercially successful medication is esomeprazole (Nexium). The primary uses are treatment of gastroesophageal reflux disease, treatment and maintenance of erosive esophagitis, treatment of duodenal ulcers caused by Helicobacter pylori, prevention of gastric ulcers in those on chronic NSAID therapy, and treatment of gastrointestinal ulcers associated with Crohn's disease. When it is manufactured the result is a mixture of two mirror-imaged molecules, R and S. Two years before the omeprazole patent expired, AstraZeneca patented S-omeprazole in pure form, pointing out that since some people metabolise R-omeprazole slowly, pure S-omeprazole treatment would give higher dose efficiency and less variation between individuals.[71] In March 2001, the company began to market Nexium, as it would a brand new drug.[72]

The (R)-entantiomer of omeprazole is metabolized exclusively by the enzyme CYP2C19, which is expressed in very low amounts by 3% of the population. Treated with a normal dose of the enantiomeric mixture, these persons will experience blood levels 5 times higher than those with normal CYP2C19 production. In contrast, esomeprazole is metabolized by both CYP2C19 and CYP3A4, providing less-variable drug exposure.[73] While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux,[74] esomeprazole is approved for doses up to 40 mg.[75]

In 2007, Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a lecturer in social medicine at the Harvard Medical School, said in Stern, a German-language weekly newsmagazine, that AstraZeneca's scientists had misrepresented their research on the drug's efficiency, saying "Instead of using presumably comparable doses [of each drug], the company's scientists used Nexium in higher dosages. They compared 20 and 40mg Nexium with 20mg Prilosec. With the cards having been marked in that way, Nexium looked like an improvement – which however was only small and shown in only two of the three studies."[76]

Bildman fraud

On 4 February 1998, Astra USA sued Lars Bildman, its former president and chief executive officer, seeking $15 million for defrauding the company.[77] The sum included $2.3 million in company funds he allegedly used to fix up three of his homes, plus money the company paid as the result of the EEOC investigation. Astra's lawsuit alleged Bildman sexually harassed and intimidated employees, used company funds for yachts and prostitutes, destroyed documents and records, and concocted "tales of conspiracy involving ex-KGB agents and competitors. This was in a last-ditch effort to distract attention from the real wrongdoer, Bildman himself." Bildman had already pleaded guilty in US District Court for failing to report more than $1 million in income on his tax returns; in addition, several female co-workers filed personal sexual-harassment lawsuits.[78]

Transfer mispricing

In 2010 AstraZeneca agreed to pay £505 million to settle a UK tax dispute related to transfer mispricing.[79]

Doping in cycling

On July 27, 2015, Fabio Taborre (Androni-Sidermec) returned a positive doping test result for the banned blood-booster FG-4592 in an out-of-competition control on June 16, 2015. FG-4592 (Roxadustat) is in phase 3 clinical trials and has not yet been commercialised. The drug was developed jointly by FibroGen and AstraZeneca. Unlike Erythropoietin (EPO), which directly stimulates the production of red blood cells, FG-4592 is taken orally, and stimulates natural production of EPO in a manner similar to altitude training.[80]

See also

Notes and references

  1. ↑ 1.0 1.1 1.2 Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ Standard practice is that the name be pronounced as "Astra Zeneca" rather than "Astrazeneca"
  4. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  5. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ 9.0 9.1 Lua error in package.lua at line 80: module 'strict' not found.
  10. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  11. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  12. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  13. ↑ AstraZeneca buys biotech company for £120m The Telegraph, 23 December 2005
  14. ↑ AstraZeneca and Astex ally for anticancer agents Business Intelligence, 1 July 2005
  15. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  16. ↑ AstraZeneca to buy CAT for £702m BBC News, 15 May 2006
  17. ↑ AstraZeneca agrees to buy Arrow Therapeutics for $150 mln Marketwatch, 1 February 2007
  18. ↑ AstraZeneca seeks a remedy for its patent pain The Telegraph, 21 April 2012
  19. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  20. ↑ AstraZeneca Buys MedImmune for $15.6 Billion The New York Times, 24 April 2007
  21. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  22. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  23. ↑ AstraZeneca to buy Chinese generics firm Healthcare News, 8 December 2011
  24. ↑ AstraZeneca and Amgen collaborate on treatments for inflammatory diseases Medcity News, 4 February 2012
  25. ↑ AstraZeneca Reaches $1.26 Billion Deal for Ardea Biosciences The New York Times, 23 April 2012
  26. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  27. ↑ 27.0 27.1 Lua error in package.lua at line 80: module 'strict' not found.
  28. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  29. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  30. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  31. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  32. ↑ AstraZeneca Press Release. 21 March 2013 AstraZeneca outlines strategy to return to growth and achieve scientific leadership
  33. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  34. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  35. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  36. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  37. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  38. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  39. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  40. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  41. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  42. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  43. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  44. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  45. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  46. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  47. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  48. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  49. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  50. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  51. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  52. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  53. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  54. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  55. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  56. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  57. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  58. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  59. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  60. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  61. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  62. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  63. ↑ AstraZeneca UK website. Retrieved 27 March 2005
  64. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  65. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  66. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  67. ↑ 67.0 67.1 AstraZeneca boss David Brennan quits under pressure from investors The Guardian, 26 April 2012
  68. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  69. ↑ Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing U.S. Department of Justice, 27 April 2010
  70. ↑ Lua error in package.lua at line 80: module 'strict' not found.[dead link][dead link]
  71. ↑ United States Patent 5,877,192 USPTO Patent Database, 11 April 1997
  72. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  73. ↑ Lemke TL, Williams DA, Roche VF, Zito SW. Foye's Principles of Medicinal Chemistry, 7th edition, Chapter 12
  74. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  75. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  76. ↑ Grill, Markus and Hansen, Hans (2007): "Vorsicht, Pharma! Wie die Industrie Ärzte manipuliert und Patienten täuscht." ('Caution, Pharma! How the industry manipulates physicians and deceives patients.') Published in the 16 August 2007 issue of Stern (Germany; pp. 100–107). Available as an e-paper here
  77. ↑ Astra hauls ex-CEO Lars Bildman into court Business Week, 4 February 1998
  78. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  79. ↑ AstraZeneca agrees to pay £505m to settle UK tax dispute, The Guardian 23 February 2010
  80. ↑ Lua error in package.lua at line 80: module 'strict' not found.

External links

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