AstraZeneca
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AstraZeneca plc[4] (LSE: AZN, NYSE: AZN, OMX: AZN) is a global pharmaceutical andbiologics company headquartered in London, United Kingdom. It is the world’s seventh largest pharmaceutical company measured by revenues and has operations in over 100 countries.[5][6] It has a portfolio of products for major disease areas including cancer, cardiovascular,gastrointestinal, infection, neuroscience, respiratory and inflammation.[3]
Its primary listing is on the London Stock Exchange and it is a constituent of the FTSE 100 Index. It has secondary listings on the New York Stock Exchange and the OMX exchange.
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[edit]History
Astra AB was founded in 1913 by 400 doctors and apothecaries in Södertälje, Sweden.[7] In 1949 the company developed Xylocaine, a local anesthetic.[clarification needed] In 1994 the company formed a joint venture with Merck to market Losec, an ulcer-treatment drug.[8]
In 1993 ICI demerged its pharmaceuticals businesses and its agrochemicals and specialties businesses, to form Zeneca Group plc.[8]
In 1999 Astra AB and Zeneca Group plc merged to form AstraZeneca plc.[8]
In 2005 the company announced an arrangement with Astex for the discovery, development and commercialisation of novel small molecule inhibitors of protein kinase B for use as anti-cancer agents.[9] In the same year it announced a collaboration with Avanir for research and licensing in the area of Reverse Cholesterol Transport (RCT) enhancing compounds for the treatment of cardiovascular disease.[10] It also announced an alliance with Schering AG for research and licensing in the area of selective glucocorticoid receptor agonists (SEGRAs).[11] It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organization.[12]
In 2006, following a collaborative relationship begun in 2004[13], AstraZeneca acquired Cambridge Antibody Technology[14][15] in a deal worth £702 million[clarification needed].
Also in 2006 it formed an alliance with Abbott Laboratories in relation to Crestor and TriCor, commencing that year and extending to at least 2009.[16]
In 2007 it reported that it had entered into an alliance with Bristol-Myers Squibb to form a global collaboration to develop and commercialise two investigational drugs (saxagliptin and dapagliflozin) beginning from 2007.[17]
Also in 2007 AstraZeneca acquired American company MedImmune for about $15.2 billion[18]. AstraZeneca consolidated its biologics portfolio in MedImmune and Cambridge Antibody Technology which was rebranded to create a dedicated biologics division known as ‘MedImmune’[19].
[edit]Operations
AstraZeneca develops, manufactures, and sells pharmaceuticals to treat disorders in the gastrointestinal, cardiac and vascular, neurologicaland psychiatric, infection, respiratory, pathological inflammation and oncology areas.
The corporate headquarters are in London, United Kingdom and research and development (R&D) headquarters are in Södertälje, Sweden. The company employs over 11,000 people at research facilities in the United Kingdom, United States, Sweden, France, Canada, India, China and Japan.
The company’s largest single research and development site is at Alderley Park (a large country estate on the east side of the A34 road north of the Monk’s Heath crossroads) in Cheshire in England. There around 4,500 staff are based.[20]
The company has a major research and development presence in Sweden, with approximately 4,000 staff employed at research facilities inLund, Mölndal and Södertälje.[21]
[edit]Products
AstraZeneca specialises in prescription medicines to fight disease in several therapeutic areas. Year-on sales information can be found through AstraZeneca annual reports.[22] The following is a list of key products found on the AstraZeneca website.[23] Generic- drug names are given in parentheses following the brand name.
This list is incomplete; you can help by expanding it.
– Anaesthetics
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-Cardiovascular
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-Gastrointestinal
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– Infection
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-Neuroscience
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-Oncology
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-Respiratory and Inflammation
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[edit]Controversies
[]Seroquel: adverse effects and trial procedures
AstraZeneca has stated that the atypical-antipsychotic drug, Seroquel, is the subject of four class-action lawsuits in Canada. Also, in the U.S., there were multiple product-liability cases alleging personal injury, namely, that Seroquel caused people to develop diabetes.
The company has indicated its intention to seek approval for Seroquel to treat psychiatric conditions such as depression and general anxiety disorder.[24]
Note as well that scientific findings regarding a new sustained-release form of the drug were announced at a conference in Madrid, Spain, in March 2007. At the time the data regarding the new drug were discussed, the drug had not been approved for sale by any health regulatory body in any country.[25]
During 2005 and 2006 clinical trials were carried out to examine the possibilities of further development of Seroquel. Test persons were recruited from research centres in Russia, Ukraine, Poland, Bulgaria and India. As part of the trials half of the test persons were given aplacebo and stopped their medication. As a result thirty-six test persons relapsed into illness. One test person committed suicide, possibly as a result of quitting his medication. AstraZeneca denied that the suicide was related to the testing procedures. Ethical concerns were raised over the issue of carrying out trials in less-developed countries because of lower requirements for getting trials approved and overall lower trial costs.
In 2008, 45% of the test persons in AstraZeneca medical trials came from Asia; Eastern- and Central Europe; and South America. The same year 13.5% of the total sales were made in these regions. In contrast 86% of total sales were made in Japan, North America and Western Europe.[26][27]
[]Late-stage trial failures
AstraZeneca has experienced a run of failures of drugs in late-stage clinical trials.[28] These include Galida for diabetes, Exanta to preventthrombosis, NXY-059[29] for acute ischemic stroke, Iressa for lung cancer, and AGI-1067 for prevention of atherosclerosis. With patents expiring on older drugs, this threatens future revenue growth.
]MedImmune takeover
After this long run of failed late-stage clinical trials, on 19 June 2007 AstraZeneca completed the acquisition of vaccine maker MedImmune, paying $15.2 billion primarily for its drug-development pipeline. Analysts have criticised this take-over, claiming that AstraZeneca paid too much[30]. AstraZeneca consolidated its biologics portfolio in MedImmune and Cambridge Antibody Technology (acquired in 2007)[31] and this biologics portfolio was rebranded to create a dedicated, global biologics organisation known as ‘MedImmune’. Amid allegations of broken promises over this consolidation[31], AstraZeneca presented the new MedImmune to investors on 7 December 2007[19].
[edit]Nexium
The company’s most successful medication is omeprazole. When it is manufactured the result is a mixture of two mirror-imaged molecules, R and S. Both are converted to the same active molecule in the body. Two years before the omeprazole patent expired AstraZeneca patented S-omeprazole in pure form, pointing that since some people metabolise R-omeprazole slowly, pure S-omeprazole treatment would give higher dose efficiency and less interindividual variation.[32] The company marketed Nexium, as it would a brand new drug. This practice is criticised because it maintains the profits of drug companies at the expense of patients and public healthcare systems.[33]
On 16 August 2007, Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a lecturer in social medicine at theHarvard Medical School, alleged in Stern, a German language, weekly newsmagazine, that AstraZeneca’s scientists had doctored their research on the drug’s efficiency:
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.
Nexium is also alleged by the authors to be “the top of the list” of medications which are marketed by pharmaceutical companies directly to doctors, who receive gifts of money and/or goods when they prescribe the medication in question. As a reason for the company’s behaviour, it is alleged that the German public healthcare system spends an additional $139.50 million at time of reporting–> per annum on Nexium as compared to using omeprazole, which however would be less profitable for the company as its patent protection has expired.[34]
]Malaria drugs
Chloroquine and Paludrine were marketed with diminutive vague health warnings inside the boxes. Rather than specifying “depression”, Zeneca used the term “changes in mood”. Also “panic attacks and anxiety” were not mentioned, only “fits and seizures”, in effect hiding information about mental effects, as it was more widely reported. As a result of these understatements, thousands of people went on holiday carrying up to 365 days dosage of these drugs, without any understanding that if they were experiencing black moods after a couple of months, the medication should be discontinued. In 1998 the University of Edinburgh department of tropical medicine conducted a study on over 100 gap-year students that had been abroad. It found that 31.8% of them that had taken the antiprophylactics for over three months complained of depression compared to 12.4% of students that had taken a holiday but not taken chloroquine or Paludrine at all. Neither Zeneca nor the U.K. National Health Service (NHS) replied to the findings of the study. The conclusion of the study was that chloroquine and Paludrine cause a slow and gradual depression, and that the NHS were widely prescribing double dosages of the drug without any health warnings.
Corporate sexual harassment
Confronted by allegations in a 13 May 1996, Business Week cover story, of widespread sexual harassment and other abuses, Astra USA Inc. suspended three top executives and launched an internal probe.[35]
On 26 June, the parent company announced that it had fired Lars Bildman, Astra USA’s president and chief executive officer, withoutseverance pay. Carl-Gustav Johansson, an Astra executive vice-president, says the investigation found that Bildman had “exhibited inappropriate behavior at company functions” and had “abused his power.” He was also accused of misappropriation of funds, diverting them for personal expenses such as “lavish trips” and “extensive renovations for his home.” Another suspended executive, George Roadman, was also fired, while a third, Edward Aarons, resigned. A senior executive in Sweden, Anders Lonner, was asked to resign for failing to report themisconduct to superiors, Astra says.[citation needed]
Astra USA agreed to pay $9.85 million to settle a lawsuit brought by at least seventy-nine women and one man against the company. The suit accused Astra’s former president and other executives of pressuring female employees for sex and replacing older workers with younger, more attractive women. It was the biggest sexual harassment settlement ever obtained by the U.S. Equal Employment Opportunity Commission (EEOC).
]Bildman fraud
On 4 February 1998, Astra USA sued Bildman, its former president and chief executive officer, seeking $15 million for defrauding thecompany.[36] 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… in a last-ditch effort to distract attention from the real wrongdoer, Bildman himself.” Bildman had already plead guilty in U.S. District Courtfor failing to report more than $1 million in income on his tax returns; in addition, several female co-workers filed personal sexual-harassment lawsuits.
]Nobel Prize investigation 2008
[clarification needed]
In 2008, the Nobel Prize in Medicine for cancer-related research on Human Papilloma Virus (HPV) by Harald zur Hausen was being looked into by the Swedish police anticorruption unit. The reason was that AstraZeneca, which has a stake in two lucrative HPV vaccines and thus stands to gain financially from the prize, had agreed to sponsor Nobel Media and Nobel Web. According to Times Online, two senior figures in the process that chose zur Hausen also had strong links with AstraZeneca.[37]
]Transfer mispricing
In 2010, AstraZeneca agreed to pay £505m to settle UK tax dispute, relating to transfer mispricing.[38]
[Senior management
The senior executive team is composed of David Brennan, Simon Lowth, John Patterson, Tony Zook, David Mott, Bruno Angelici, Lynn Tetrault, Jan Lundberg and David Smith.
Brennan is paid $1,574,144 for his role as chief executive officer.[39]