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AstraZeneca

August 15, 2023

This article is about the pharmaceutical company. For the vaccine, see Oxford–AstraZeneca COVID-19 vaccine.

AstraZeneca plc (/ˌæstrəˈzɛnəkə/) is a British-Swedish multinational pharmaceutical and biotechnology company[3][4][5] with its headquarters at the Cambridge Biomedical Campus in Cambridge, England.[6] It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.[7]

AstraZeneca plc
Corporate HQ in Cambridge, England
TypePublic limited company
ISINGB0009895292
IndustryPharmaceutical
Biotechnology
Predecessors
Founded6 April 1999; 24 years ago (1999-04-06)
HeadquartersCambridge, England, UK
Area served
Global
Key people
Leif Johansson
(Chairman)
Sir Pascal Soriot
(CEO)
ProductsPharmaceutical products
Revenue US$44.351 billion (2022)[1]
US$3.757 billion (2022)[1]
US$3.293 billion (2022)[1]
Total assets US$96.483 billion (2022)[1]
Total equity US$37.058 billion (2022)[1]
Number of employees
83,500 (2022)[2]
Subsidiaries
Websitewww.astrazeneca.com

The company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group[8][9] (itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993). Since the merger it has been among the world's largest pharmaceutical companies and has made numerous corporate acquisitions, including Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014). It has its research and development concentrated in three strategic centres: Cambridge, England; Gothenburg, Sweden and Gaithersburg in Maryland, U.S.[10]

AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index.

History

Astra AB was founded in 1913 in Södertälje, Sweden, by 400 doctors and apothecaries.[11] In 1993 the British chemicals company ICI (established from four British chemical companies) demerged its pharmaceuticals businesses and its agrochemicals and specialities businesses, to form Zeneca Group PLC.[12] Finally, in 1999 Astra and Zeneca Group merged to form AstraZeneca plc, with its headquarters in London.[12] In 1999, AstraZeneca identified a new location for the company's US base, the "Fairfax-plus" site in North Wilmington, Delaware.[13]

2000–06

In 2002, its drug Iressa (gefitinib) was approved in Japan as monotherapy for non-small cell lung cancer.[14] On 3 January 2004 Dr Robert Nolan, a former director of AstraZeneca, formed the management team of ZI Medical.[15]

In 2005, the company acquired KuDOS Pharmaceuticals, a UK biotech company, for £120 million.[16] and entered into an anti-cancer collaboration agreement with Astex[17] It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation.[18]

In 2006, following a collaborative relationship begun in 2004, AstraZeneca acquired Cambridge Antibody Technology for £702 million.[19]

2007–12: 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 US$150 million.[20] AstraZeneca's pipeline, and "patent cliff", was the subject of much speculation in April 2007 leading to pipeline-boosting collaboration and acquisition activities.[21] A few days later AstraZeneca acquired US company MedImmune for about US$15.2 billion to gain flu vaccines and an anti-viral treatment for infants;[22] AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune.[23]

In 2010, AstraZeneca acquired Novexel Corp, an antibiotics 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.[24][25]

In 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics business.[26]

In February 2012, AstraZeneca and Amgen announced a collaboration on treatments for inflammatory diseases.[27] Then in April 2012, AstraZeneca acquired Ardea Biosciences, another biotechnology company, for $1.26 billion.[28] In June 2012, AstraZeneca and Bristol Myers Squibb announced a two-stage deal for the joint acquisition of the biotechnology company Amylin Pharmaceuticals.[29][30] 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.[30]

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 in Cheshire and Loughborough in the UK and at Lund in Sweden, 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 Gothenburg in Sweden, for research on traditional chemical drugs.[10] AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016.[31][32] 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.[33][34] It also announced that it would focus on three therapeutic areas: Respiratory Inflammation & Autoimmunity, Cardiovascular & Metabolic Disease, and Oncology.[35] In October 2013, AstraZeneca announced it would acquire biotech oncology company Spirogen for around US$440 million.[36]

2014

On 19 May 2014 AstraZeneca rejected a "final offer" from Pfizer of £55 per share, which valued the company at £69.4 billion (US$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.[37] 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 US$2.1 billion deal included an allocation of US$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.[38] In September 2014 the company would join forces with Eli Lilly in developing and commercialising its candidate BACE inhibitor – AZD3292 – used for the treatment of Alzheimer's disease. The deal could yield up to US$500 million for the company.[39] In November 2014 the company's biologics R&D operation, MedImmune, agreed to acquire Definiens for more than US$150 million. The company also began a Phase I/II trial collaboration with Pharmacyclics and Janssen Biotech investigating combination treatments.[40] Also in November of the same year, the company agreed to sell its lipodystrophy treatment business to Aegerion Pharmaceuticals for more than US$325 million.[41] 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.[42]

2015

In February 2015, the company announced it would acquire the US and Canadian rights to Actavis's branded respiratory drug business for an initial sum of US$600 million.[43] 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 US$122.5 million for Orca.[44] The company also announced its plan to spend US$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.[45] The company underwrote twenty out of thirty-two seats of a new Cambridge– Gothenburg service by Sun-Air of Scandinavia.[46]

In mid-March the company announced it would co-commercialise naloxegol along with Daiichi Sankyo in a deal worth up to US$825 million.[47] Towards the end of April the company announced a number of collaborations worth an estimated US$1.8 billion; first, to develop and commercialise MEDI4736, with Celgene, for use against non-Hodgkin’s lymphoma, myelodysplastic syndromes, and multiple myeloma with AstraZeneca receiving US$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 US$1.275 billion. The company's MedImmune arm also launched collaborative clinical trials with Juno Therapeutics, investigating combination treatments for cancer.[48] The trials will assess combinations of MEDI4736 and one of Juno Therapeutics' CD19 directed chimeric antigen receptor T-cell candidates.[49] 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.[50] In July the company announced it would sell off its rights to Entocort (budesonide) to Tillotts Pharma for US$215 million.[51] In July 2015, Genzyme announced it would acquire the rare cancer drug Caprelsa (vandetanib) from AstraZeneca for up to US$300 million.[52] In August, the company announced it had 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 US$510 million.[53] In the same month the company's MedImmune subsidiary acquired exclusive rights to Inovio Pharmaceuticals' INO-3112 immunotherapy, currently in Phase I/II, under an agreement which could net more than US$727.5 million for Inovio. INO-3112 targets Human papillomavirus types 16 and 18.[54] In September, Valeant licensed Brodalumab from the company for up to US$445 million.[55][56] On 6 November it was reported that AstraZeneca had acquired ZS Pharma for US$2.7 billion.[57] In December the company announced its intention to acquire the respiratory portfolio of Takeda Pharmaceutical – namely Alvesco and Omnaris – for US$575 million[58] A day later, the company announced it had taken a 55% majority stake in Acerta for US$4 billion. As part of the transaction the company will gain commercial rights to Acerta's 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.[59] In 2015, it was the eighth-largest drug company in the world based on sales revenue.[60]

2017

In July 2017, the company's CEO Pascal Soriot said that Brexit would not affect its commitment to its current plans in the United Kingdom. However, it had slowed decision making for new investment projects waiting for a post-Brexit regulatory regime to settle down.[61]

In September 2017, the company's chairman Leif Johansson planned in taking the "first steps" in moving its research and manufacturing operations away from the United Kingdom, if there is a hard Brexit.[62]

In 2017, it was the eleventh largest drug company in the world based on sales and ranked seventh based on R&D investment.[63]

In January EVP Pam Cheng stated that AstraZeneca has ignited startup of duplicate QA testing facility in Sweden and has initiated hiring in Sweden.[64]

2018

In February 2018, AstraZeneca announced it was spinning off six early-stage experimental drugs into a new biotechnology company, known as Viela Bio, valued at US$250 million.[65]

On 6 December 2018, AstraZeneca purchased nearly 8% of the American pharmaceutical business, Moderna.[66]

2019

In March 2019, AstraZeneca announced it will pay up to US$6.9 billion to work with Daiichi Sankyo Co Ltd on an experimental treatment for breast cancer. AstraZeneca plans to use some of the proceeds of a US$3.5 billion share issue to fund the deal. The deal on the drug known as trastuzumab deruxtecan sent shares in Japan's Daiichi soaring 16%.[67]

In September 2019, the company announced that it would cease drug production at its German headquarters in Wedel, leading to the loss of 175 jobs by the end of 2021.[68][69]

In October 2019, AstraZeneca announced it would sell the global commercial rights for its drug to treat acid reflux to German pharmaceutical company Cheplapharm Arzneimittel GmbH for as much as US$276 million.[70][71]

2020

In February 2020, AstraZeneca agreed to sublicense its global rights (except Europe, Canada and Israel) to the drug Movantik, to Redhill Biopharma.[72]

In June 2020, AstraZeneca made a preliminary approach to Gilead Sciences about a potential merger, worth almost US$240 billion.[73][74] However, these plans were subsequently dropped because it would have distracted the company from its own pipeline and ongoing COVID-19 vaccine efforts.[75]

In July 2020, the business entered into its second collaboration with Daiichi Sankyo, centred around the development of DS-1062, an antibody drug conjugate. The deal could potentially be worth up to US$6 billion for Daiichi.[76]

In September 2020, AstraZeneca acquired the preclinical oral PCSK9 inhibitor program from Dogma Therapeutics.[77]

On 27 December 2020, AstraZeneca CEO Pascal Soriot said that they have “figured out the winning formula” with their two-dose system with the Oxford University’s COVID-19 vaccine.[78]

On 30 December 2020, the United Kingdom approved the emergency use of the Oxford–AstraZeneca COVID-19 vaccine.[79][80][81]

2021

In July 2021, AstraZeneca acquired Alexion Pharmaceuticals.[82][83] In October 2021, the company, through Alexion, acquired Caelum Biosciences and its monoclonal treatment (CAEL-101) for light chain (AL) amyloidosis for up to $500 million.[84][85]

2022

In July, the company announced it would acquire TeneoTwo for up to $1.3 billion, increasing its blood cancer drug offering.[86] In October 2022 it was announced that the company would acquire LogicBio Therapeutics, which was active in clinical-stage genomic medicine.[87][88]

In November 2022, it was announced AstraZeneca had acquired the Amsterdam-headquartered clinical-stage biotechnology company, Neogene Therapeutics.[89]

2023

In January, AstraZeneca announced it would acquire CinCor Pharma for $1.8 billion.[90]

Vaxzevria, AstraZeneca's COVID-19 pandemic response

Main article: Oxford–AstraZeneca COVID-19 vaccine
 
Oxford–AstraZeneca COVID-19 vaccine

The road to authorisation by the European Medicines Agency

In March 2020, the company announced that it would be donating PPE, including 9 million face masks, to help support various international health organisations mitigating the COVID-19 pandemic.[91]

In April 2020, Chief Executive Pascal Soriot, reported that the company was working with GlaxoSmithKline and the University of Cambridge to develop a new laboratory capable of conducting 30,000 COVID-19 tests per day.[92] The company also announced plans for a clinical trial to assess the potential use of Calquence in the treatment of COVID-19.[93]

In June 2020, the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020.[94] One of them, AZD1222, reached phase III trials.[95]

On 23 November 2020, Oxford–AstraZeneca announced the vaccine's successful trial, preventing 70% of people developing symptoms.[96] The researchers thought that the figure might be as high as 90% if they tweaked the dose.[97]

In January 2021, India approved the use of the Oxford–AstraZeneca vaccine, paving the way for a mass immunisation campaign in the world's second most populous country. It was announced that the Oxford–AstraZeneca shot would be made locally by the Serum Institute of India (SII) with a brand name COVISHIELD.[98]

Side-effects

On 29 January 2021, the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for AZD1222 in people from 18 years of age.[99] By mid-March 2021, The Netherlands, Denmark, Norway, Iceland, Bulgaria and Ireland had suspended the use of the AstraZeneca vaccine due to worries over six cases of a "rare combination" of blood clots with lowered blood platelets, see embolic and thrombotic events after COVID-19 vaccination. The temporary halt was against the advice of the European Union's medicines regulator who said the benefits of the vaccine still outweigh any potential risks.[100]

EMA issued a statement on 18 March 2021 stating that no association between vaccination with AstraZeneca vaccines and clot-related cases had been found, but this could not be ruled out and further investigations were being carried out. The EMA also stressed that the benefits of AstraZeneca vaccine outweigh the risks of possible side effects.[101]

Name change

On 30 March 2021, the Swedish Medicines Agency, Läkemedelsverket, announced that following the prior approval of the EMA[102] it would change the name of the vaccine to Vaxzevria, stressing that only the name of the vaccine would change, not the composition.[103][104]

Side-effects

On 6 April 2021, EMA head of vaccines Marco Cavaleri announced that it could be declared that there was a link between the Oxford–AstraZeneca COVID-19 (Vaxzevria) vaccine and rare blood clots associated with low platelet counts.[105][106] In a statement the following day, the EMA confirmed the link, but continued to recommend the vaccine, saying the benefits of the vaccine far outweigh the risks.[107][108] Later, a Scottish vaccine efficacy study confirmed the validity of this statement, showing an 88 percent reduction in the risk of hospitalization after the first dose of Vaxzevria from the fourth week onwards.[109] The European Medicines Agency also identified, over time, the development of the rare neurological disease Guillain-Barré syndrome (GBS) as a possible side effect of Vaxzevria. By the time of the EMA's decision in September 2021, Guillain-Barré syndrome was unlikely to have occurred, with only 833 cases of GBS reported in 8 months following the administration of 592 million doses of the vaccine.[110] In December 2021, the scientists from Arizona State University and Cardiff University identified “the trigger” behind blood clots. Professor Alan Parker said: “Our data confirms PF4 can bind to adenoviruses, an important step in unravelling the mechanism underlying VITT.[a] Establishing a mechanism could help to prevent and treat this disorder.”[111][112]

Lawsuits

In April 2021, the European Commission announced that it would sue Astra Zeneca for delaying the timely delivery of Vaxzevria at a time when "every vaccine counts, because every vaccine can save lives".[113][114] In September 2021, the lawsuit was finally settled with AstraZeneca agreeing to deliver 60 million doses of vaccines to EU member states by October, 75 million by the end of the year, and 65 million more by April 2022.[115]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:[116]

  • AstraZeneca
    • AstraZeneca (Merged 1999)
    • KuDOS Pharmaceuticals (Acq 2005)
    • MedImmune Biologics
    • Arrow Therapeutics (Acq 2007)
    • 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[118] (Acq 2013)
    • Omthera Pharmaceuticals[119] (Acq 2013)
    • ZS Pharma (Acq 2015)
    • Alexion Pharmaceuticals[82] (Acq 2021)
      • Proliferon Inc (Acq 2000, restructured into Alexion Antibody Technologies Inc)
      • Enobia Pharma Corp (Acq 2011)
      • Synageva BioPharma (Acq 2015)
      • Wilson Therapeutics (Acq 2018)
      • Syntimmune (Acq 2018)
      • Achillion Pharmaceuticals (Acq 2019)
      • Portola Pharmaceuticals (Acq 2020)
      • Caelum Biosciences (Acq 2021)
    • TeneoTwo (Acq 2022)
    • LogicBio Therapeutics (Acq 2022)
    • Neogene Therapeutics (Acq 2022)
    • CinCor Pharma (Acq 2023)

Operations

 
The AstraZeneca R&D facility in Gothenburg, Sweden
 
The new AstraZeneca Corporate HQ under construction in Cambridge, England

AstraZeneca develops, manufactures and sells pharmaceutical and biotechnology products to treat disorders in the oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation areas.[120]

AstraZeneca has its corporate headquarters in Cambridge, United Kingdom, and its main research and development (R&D) centres are in Cambridge (UK), Gaithersburg (Maryland, US), Gothenburg (Sweden) and Warsaw (Poland).[121]

Orphan drugs

In April 2015, AstraZeneca's drug tremelimumab was approved as an orphan drug for the treatment of mesothelioma in the United States.[122] In February 2016, AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint.[123]

Senior management

As of 2008, David Brennan was paid US$1,574,144 for his role as chief executive officer.[124]

On 26 April 2012, it was announced that Brennan was to retire in early June of that year.[125] In August 2012, Pascal Soriot was named CEO of AstraZeneca.[126]

It was also announced that Leif Johansson would succeed Louis Schweitzer as non-executive chairman on 1 June 2012, three months earlier than previously announced, and would become Chairman of the Nomination and Governance Committee after the 2012 Annual General Meeting.[125]

The company's non-executive Board directors are Philip Broadley, Euan Ashley, Michel Demaré, Deborah DiSanzo, Diana Layfield, Sheri McCoy, Tony Mok, Nazneen Rahman, Andreas Rummelt, and Marcus Wallenberg.[127]

Outreach

Political lobbying

AstraZeneca is a member of the Personalized Medicine Coalition, a medical research advocacy group that lobbies on behalf of the pharmaceutical industry.[128]

Controversies

Following 2008 Sichuan earthquake

AstraZeneca's reputation in China was tarnished following the failure of its Chinese subsidiary to timely donate to relief efforts following the 2008 Sichuan earthquake.[129]: 121  Typically, donations for disaster relief in China are made through funds established through the Chinese Ministry of Civil Affairs and its subordinate organization the Red Cross Society of China.[129]: 121  AstraZeneca had a corporate rule prohibiting foreign subsidiaries from making donations to local governments and the company construed this rule as prohibiting donations for Sichuan earthquake relief efforts.[129]: 121  AstraZeneca's Chinese subsidiary received major backlash for its failure to donate.[129]: 121  While corporate approval was ultimately given for the Chinese subsidiary to donate, the approval came after long delay.[129]: 121 

Seroquel

In April 2010, AstraZeneca settled a qui tam lawsuit brought by Stefan P. Kruszewski for US$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. According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.[130]

In March 2011, AstraZeneca settled a lawsuit in the United States totalling US$68.5 million to be divided up to 38 states.[131]

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.[132] In March 2001, the company began to market Nexium, as it would a brand new drug.[133]

The (R)-enantiomer 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 five-times higher than those with normal CYP2C19 production. In contrast, esomeprazole is metabolized by both CYP2C19 and CYP3A4, providing less-variable drug exposure.[134] While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux,[135] esomeprazole is approved for doses up to 40 mg.[136]

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 40 mg Nexium with 20 mg 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."[137]

Bildman fraud, sexual harassment and faithless servant clawback

On 4 February 1998, Astra USA sued Lars Bildman, its former president and chief executive officer, seeking US$15 million for defrauding the company.[138] The sum included US$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 US$1 million in income on his tax returns.[139] In addition, several female co-workers filed personal sexual-harassment lawsuits against Bildman.[140] In April 1998, Bildman was sentenced to 21 months in prison three months after he pled guilty to filing false Federal tax returns.[141][139]

In February 1998, AstraZenaca's U.S. affiliate Astra U.S.A. agreed to a $10 million settlement after an Equal Employment Opportunity Commission investigation which started in May 1996 found that sexual harassment against female employees.[142] 120 former female employees of Astra were interviewed during the inquiry, with about 80 of them being identified as able to file claims.[142] Astra U.S.A. also issued a statement of apology for the hostile work environment.[142]

In Astra USA v. Bildman, 914 N.E.2d 36 (Mass. 2009), applying New York's faithless servant doctrine, the court held that a company's employee who had engaged in financial misdeeds and sexual harassment must "forfeit all of his salary and bonuses for the period of disloyalty".[143] The court held that this was the case even if the employee "otherwise performed valuable services", and that the employee was not entitled to recover restitution for the value of those other services.[143][144] The decision attracted a good deal of attention by legal commentators.[145]

CAFÉ study

In 2004, University of Minnesota research participant Dan Markingson committed suicide while enrolled in an industry-sponsored pharmaceutical trial comparing three FDA-approved atypical antipsychotics: Seroquel (quetiapine), Zyprexa (olanzapine), and Risperdal (risperidone). University of Minnesota Professor of Bioethics Carl Elliott noted that Markingson was enrolled in the study against the wishes of his mother, Mary Weiss, and that he was forced to choose between enrolling in the study or being involuntarily committed to a state mental institution.[146] A 2005 FDA investigation cleared the university. Nonetheless, controversy around the case has continued. A Mother Jones article[146] resulted in a group of university faculty members sending a public letter to the university Board of Regents urging an external investigation into Markingson's death.[147]

Transfer mispricing

In 2010, AstraZeneca agreed to pay £505 million to settle a UK tax dispute related to transfer mispricing.[148]

Conflicting commitments to the UK and the EU

 
Seat of the European Commission, which negotiated a contract with AstraZeneca

In August 2020 AstraZeneca declared towards the European Commission and the EU member states:

"13.1. AstraZeneca represents, warrants and covenants to the Commission and the Participating Member States that: [...] (e) it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or would impede the complete fulfilment of its obligation under this Agreement;"[149]

However, the UK Secretary of State for Health and Social Care, Matt Hancock, declared in March 2021 that the United Kingdom had been given "exclusivity" and that the EU's treaty was "inferior".[150][151] After placing the order for AstraZeneca's vaccine, the European Commission mistakenly assumed that it had enough vaccines and initially ordered only 200 million doses from Pfizer–BioNTech when the manufacturers offered 500 million doses to the EU in November 2020.[152]

However, the contract that AstraZeneca reached with the UK was very similar to that it reached with the EU, and it also contained the phrase "best reasonable efforts"; the UK contract was signed on 28 August 2020, a day after the contract with the EU.[153] The key difference seems to be that AstraZeneca entered into a preliminary agreement with the U.K. back in May 2020 which arranged for "the development of a dedicated supply chain for the U.K."[154] The failure to produce the vaccine in the anticipated quantities contributed to the low vaccination rates of vulnerable populations of the European Union at the beginning of the outbreak of more virulent variants of SARS-CoV-2 in early 2021.[155]

China comments

In May 2023, AstraZeneca's China president said that the company aims to be a "patriotic" company in China that "loves the Communist Party."[156]

See also

Notes

  1. ^ Vaccine induced Thrombosis and Thrombocytopenia

References

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External links

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  • Official website

August 15, 2023
astrazeneca, this, article, about, pharmaceutical, company, vaccine, oxford, covid, vaccine, british, swedish, multinational, pharmaceutical, biotechnology, company, with, headquarters, cambridge, biomedical, campus, cambridge, england, portfolio, products, ma. This article is about the pharmaceutical company For the vaccine see Oxford AstraZeneca COVID 19 vaccine AstraZeneca plc ˌ ae s t r e ˈ z ɛ n e k e is a British Swedish multinational pharmaceutical and biotechnology company 3 4 5 with its headquarters at the Cambridge Biomedical Campus in Cambridge England 6 It has a portfolio of products for major diseases in areas including oncology cardiovascular gastrointestinal infection neuroscience respiratory and inflammation It has been involved in developing the Oxford AstraZeneca COVID 19 vaccine 7 AstraZeneca plcCorporate HQ in Cambridge EnglandTypePublic limited companyTraded asLSE AZNFTSE 100 componentNasdaq Stockholm AZNOMX Stockholm 30 componentNasdaq AZN ADR Nasdaq 100 componentISINGB0009895292IndustryPharmaceuticalBiotechnologyPredecessorsAstra ABZeneca Group plcFounded6 April 1999 24 years ago 1999 04 06 HeadquartersCambridge England UKArea servedGlobalKey peopleLeif Johansson Chairman Sir Pascal Soriot CEO ProductsPharmaceutical productsRevenueUS 44 351 billion 2022 1 Operating incomeUS 3 757 billion 2022 1 Net incomeUS 3 293 billion 2022 1 Total assetsUS 96 483 billion 2022 1 Total equityUS 37 058 billion 2022 1 Number of employees83 500 2022 2 SubsidiariesAlexion PharmaceuticalsMedImmuneWebsitewww wbr astrazeneca wbr comThe company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group 8 9 itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993 Since the merger it has been among the world s largest pharmaceutical companies and has made numerous corporate acquisitions including Cambridge Antibody Technology in 2006 MedImmune in 2007 Spirogen in 2013 and Definiens by MedImmune in 2014 It has its research and development concentrated in three strategic centres Cambridge England Gothenburg Sweden and Gaithersburg in Maryland U S 10 AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index Contents 1 History 1 1 2000 06 1 2 2007 12 The patent cliff and subsequent acquisitions 1 3 2013 restructuring and beyond 1 3 1 2013 1 3 2 2014 1 3 3 2015 1 3 4 2017 1 3 5 2018 1 3 6 2019 1 3 7 2020 1 3 8 2021 1 3 9 2022 1 3 10 2023 2 Vaxzevria AstraZeneca s COVID 19 pandemic response 2 1 The road to authorisation by the European Medicines Agency 2 2 Side effects 2 3 Name change 2 4 Side effects 2 5 Lawsuits 3 Acquisition history 4 Operations 5 Orphan drugs 6 Senior management 7 Outreach 7 1 Political lobbying 8 Controversies 8 1 Following 2008 Sichuan earthquake 8 2 Seroquel 8 3 Nexium 8 4 Bildman fraud sexual harassment and faithless servant clawback 8 5 CAFE study 8 6 Transfer mispricing 8 7 Conflicting commitments to the UK and the EU 8 8 China comments 9 See also 10 Notes 11 References 12 External linksHistory EditAstra AB was founded in 1913 in Sodertalje Sweden by 400 doctors and apothecaries 11 In 1993 the British chemicals company ICI established from four British chemical companies demerged its pharmaceuticals businesses and its agrochemicals and specialities businesses to form Zeneca Group PLC 12 Finally in 1999 Astra and Zeneca Group merged to form AstraZeneca plc with its headquarters in London 12 In 1999 AstraZeneca identified a new location for the company s US base the Fairfax plus site in North Wilmington Delaware 13 2000 06 Edit In 2002 its drug Iressa gefitinib was approved in Japan as monotherapy for non small cell lung cancer 14 On 3 January 2004 Dr Robert Nolan a former director of AstraZeneca formed the management team of ZI Medical 15 In 2005 the company acquired KuDOS Pharmaceuticals a UK biotech company for 120 million 16 and entered into an anti cancer collaboration agreement with Astex 17 It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation 18 In 2006 following a collaborative relationship begun in 2004 AstraZeneca acquired Cambridge Antibody Technology for 702 million 19 2007 12 The patent cliff and subsequent acquisitions Edit In February 2007 AstraZeneca agreed to buy Arrow Therapeutics a company focused on the discovery and development of anti viral therapies for US 150 million 20 AstraZeneca s pipeline and patent cliff was the subject of much speculation in April 2007 leading to pipeline boosting collaboration and acquisition activities 21 A few days later AstraZeneca acquired US company MedImmune for about US 15 2 billion to gain flu vaccines and an anti viral treatment for infants 22 AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune 23 In 2010 AstraZeneca acquired Novexel Corp an antibiotics 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 24 25 In 2011 AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company a Chinese generics business 26 In February 2012 AstraZeneca and Amgen announced a collaboration on treatments for inflammatory diseases 27 Then in April 2012 AstraZeneca acquired Ardea Biosciences another biotechnology company for 1 26 billion 28 In June 2012 AstraZeneca and Bristol Myers Squibb announced a two stage deal for the joint acquisition of the biotechnology company Amylin Pharmaceuticals 29 30 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 30 2013 restructuring and beyond Edit 2013 Edit In March 2013 AstraZeneca announced plans for a major corporate restructuring including the closure of its research and development activities at Alderley Park in Cheshire and Loughborough in the UK and at Lund in Sweden investment of 500 million in the construction of a new research and development facility in Cambridge and the concentration of R amp D in three locations Cambridge Gaithersburg Maryland location of MedImmune where it will work on biotech drugs and Gothenburg in Sweden for research on traditional chemical drugs 10 AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016 31 32 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 33 34 It also announced that it would focus on three therapeutic areas Respiratory Inflammation amp Autoimmunity Cardiovascular amp Metabolic Disease and Oncology 35 In October 2013 AstraZeneca announced it would acquire biotech oncology company Spirogen for around US 440 million 36 2014 Edit On 19 May 2014 AstraZeneca rejected a final offer from Pfizer of 55 per share which valued the company at 69 4 billion US 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 37 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 US 2 1 billion deal included an allocation of US 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 38 In September 2014 the company would join forces with Eli Lilly in developing and commercialising its candidate BACE inhibitor AZD3292 used for the treatment of Alzheimer s disease The deal could yield up to US 500 million for the company 39 In November 2014 the company s biologics R amp D operation MedImmune agreed to acquire Definiens for more than US 150 million The company also began a Phase I II trial collaboration with Pharmacyclics and Janssen Biotech investigating combination treatments 40 Also in November of the same year the company agreed to sell its lipodystrophy treatment business to Aegerion Pharmaceuticals for more than US 325 million 41 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 42 2015 Edit In February 2015 the company announced it would acquire the US and Canadian rights to Actavis s branded respiratory drug business for an initial sum of US 600 million 43 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 US 122 5 million for Orca 44 The company also announced its plan to spend US 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 45 The company underwrote twenty out of thirty two seats of a new Cambridge Gothenburg service by Sun Air of Scandinavia 46 In mid March the company announced it would co commercialise naloxegol along with Daiichi Sankyo in a deal worth up to US 825 million 47 Towards the end of April the company announced a number of collaborations worth an estimated US 1 8 billion first to develop and commercialise MEDI4736 with Celgene for use against non Hodgkin s lymphoma myelodysplastic syndromes and multiple myeloma with AstraZeneca receiving US 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 US 1 275 billion The company s MedImmune arm also launched collaborative clinical trials with Juno Therapeutics investigating combination treatments for cancer 48 The trials will assess combinations of MEDI4736 and one of Juno Therapeutics CD19 directed chimeric antigen receptor T cell candidates 49 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 50 In July the company announced it would sell off its rights to Entocort budesonide to Tillotts Pharma for US 215 million 51 In July 2015 Genzyme announced it would acquire the rare cancer drug Caprelsa vandetanib from AstraZeneca for up to US 300 million 52 In August the company announced it had 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 US 510 million 53 In the same month the company s MedImmune subsidiary acquired exclusive rights to Inovio Pharmaceuticals INO 3112 immunotherapy currently in Phase I II under an agreement which could net more than US 727 5 million for Inovio INO 3112 targets Human papillomavirus types 16 and 18 54 In September Valeant licensed Brodalumab from the company for up to US 445 million 55 56 On 6 November it was reported that AstraZeneca had acquired ZS Pharma for US 2 7 billion 57 In December the company announced its intention to acquire the respiratory portfolio of Takeda Pharmaceutical namely Alvesco and Omnaris for US 575 million 58 A day later the company announced it had taken a 55 majority stake in Acerta for US 4 billion As part of the transaction the company will gain commercial rights to Acerta s 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 59 In 2015 it was the eighth largest drug company in the world based on sales revenue 60 2017 Edit In July 2017 the company s CEO Pascal Soriot said that Brexit would not affect its commitment to its current plans in the United Kingdom However it had slowed decision making for new investment projects waiting for a post Brexit regulatory regime to settle down 61 In September 2017 the company s chairman Leif Johansson planned in taking the first steps in moving its research and manufacturing operations away from the United Kingdom if there is a hard Brexit 62 In 2017 it was the eleventh largest drug company in the world based on sales and ranked seventh based on R amp D investment 63 In January EVP Pam Cheng stated that AstraZeneca has ignited startup of duplicate QA testing facility in Sweden and has initiated hiring in Sweden 64 2018 Edit In February 2018 AstraZeneca announced it was spinning off six early stage experimental drugs into a new biotechnology company known as Viela Bio valued at US 250 million 65 On 6 December 2018 AstraZeneca purchased nearly 8 of the American pharmaceutical business Moderna 66 2019 Edit In March 2019 AstraZeneca announced it will pay up to US 6 9 billion to work with Daiichi Sankyo Co Ltd on an experimental treatment for breast cancer AstraZeneca plans to use some of the proceeds of a US 3 5 billion share issue to fund the deal The deal on the drug known as trastuzumab deruxtecan sent shares in Japan s Daiichi soaring 16 67 In September 2019 the company announced that it would cease drug production at its German headquarters in Wedel leading to the loss of 175 jobs by the end of 2021 68 69 In October 2019 AstraZeneca announced it would sell the global commercial rights for its drug to treat acid reflux to German pharmaceutical company Cheplapharm Arzneimittel GmbH for as much as US 276 million 70 71 2020 Edit In February 2020 AstraZeneca agreed to sublicense its global rights except Europe Canada and Israel to the drug Movantik to Redhill Biopharma 72 In June 2020 AstraZeneca made a preliminary approach to Gilead Sciences about a potential merger worth almost US 240 billion 73 74 However these plans were subsequently dropped because it would have distracted the company from its own pipeline and ongoing COVID 19 vaccine efforts 75 In July 2020 the business entered into its second collaboration with Daiichi Sankyo centred around the development of DS 1062 an antibody drug conjugate The deal could potentially be worth up to US 6 billion for Daiichi 76 In September 2020 AstraZeneca acquired the preclinical oral PCSK9 inhibitor program from Dogma Therapeutics 77 On 27 December 2020 AstraZeneca CEO Pascal Soriot said that they have figured out the winning formula with their two dose system with the Oxford University s COVID 19 vaccine 78 On 30 December 2020 the United Kingdom approved the emergency use of the Oxford AstraZeneca COVID 19 vaccine 79 80 81 2021 Edit In July 2021 AstraZeneca acquired Alexion Pharmaceuticals 82 83 In October 2021 the company through Alexion acquired Caelum Biosciences and its monoclonal treatment CAEL 101 for light chain AL amyloidosis for up to 500 million 84 85 2022 Edit In July the company announced it would acquire TeneoTwo for up to 1 3 billion increasing its blood cancer drug offering 86 In October 2022 it was announced that the company would acquire LogicBio Therapeutics which was active in clinical stage genomic medicine 87 88 In November 2022 it was announced AstraZeneca had acquired the Amsterdam headquartered clinical stage biotechnology company Neogene Therapeutics 89 2023 Edit In January AstraZeneca announced it would acquire CinCor Pharma for 1 8 billion 90 Vaxzevria AstraZeneca s COVID 19 pandemic response EditMain article Oxford AstraZeneca COVID 19 vaccine Oxford AstraZeneca COVID 19 vaccineThe road to authorisation by the European Medicines Agency Edit In March 2020 the company announced that it would be donating PPE including 9 million face masks to help support various international health organisations mitigating the COVID 19 pandemic 91 In April 2020 Chief Executive Pascal Soriot reported that the company was working with GlaxoSmithKline and the University of Cambridge to develop a new laboratory capable of conducting 30 000 COVID 19 tests per day 92 The company also announced plans for a clinical trial to assess the potential use of Calquence in the treatment of COVID 19 93 In June 2020 the National Institute of Allergy and Infectious Diseases NIAID confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020 94 One of them AZD1222 reached phase III trials 95 On 23 November 2020 Oxford AstraZeneca announced the vaccine s successful trial preventing 70 of people developing symptoms 96 The researchers thought that the figure might be as high as 90 if they tweaked the dose 97 In January 2021 India approved the use of the Oxford AstraZeneca vaccine paving the way for a mass immunisation campaign in the world s second most populous country It was announced that the Oxford AstraZeneca shot would be made locally by the Serum Institute of India SII with a brand name COVISHIELD 98 Side effects Edit On 29 January 2021 the European Medicines Agency EMA recommended granting a conditional marketing authorisation for AZD1222 in people from 18 years of age 99 By mid March 2021 The Netherlands Denmark Norway Iceland Bulgaria and Ireland had suspended the use of the AstraZeneca vaccine due to worries over six cases of a rare combination of blood clots with lowered blood platelets see embolic and thrombotic events after COVID 19 vaccination The temporary halt was against the advice of the European Union s medicines regulator who said the benefits of the vaccine still outweigh any potential risks 100 EMA issued a statement on 18 March 2021 stating that no association between vaccination with AstraZeneca vaccines and clot related cases had been found but this could not be ruled out and further investigations were being carried out The EMA also stressed that the benefits of AstraZeneca vaccine outweigh the risks of possible side effects 101 Name change Edit On 30 March 2021 the Swedish Medicines Agency Lakemedelsverket announced that following the prior approval of the EMA 102 it would change the name of the vaccine to Vaxzevria stressing that only the name of the vaccine would change not the composition 103 104 Side effects Edit On 6 April 2021 EMA head of vaccines Marco Cavaleri announced that it could be declared that there was a link between the Oxford AstraZeneca COVID 19 Vaxzevria vaccine and rare blood clots associated with low platelet counts 105 106 In a statement the following day the EMA confirmed the link but continued to recommend the vaccine saying the benefits of the vaccine far outweigh the risks 107 108 Later a Scottish vaccine efficacy study confirmed the validity of this statement showing an 88 percent reduction in the risk of hospitalization after the first dose of Vaxzevria from the fourth week onwards 109 The European Medicines Agency also identified over time the development of the rare neurological disease Guillain Barre syndrome GBS as a possible side effect of Vaxzevria By the time of the EMA s decision in September 2021 Guillain Barre syndrome was unlikely to have occurred with only 833 cases of GBS reported in 8 months following the administration of 592 million doses of the vaccine 110 In December 2021 the scientists from Arizona State University and Cardiff University identified the trigger behind blood clots Professor Alan Parker said Our data confirms PF4 can bind to adenoviruses an important step in unravelling the mechanism underlying VITT a Establishing a mechanism could help to prevent and treat this disorder 111 112 Lawsuits Edit In April 2021 the European Commission announced that it would sue Astra Zeneca for delaying the timely delivery of Vaxzevria at a time when every vaccine counts because every vaccine can save lives 113 114 In September 2021 the lawsuit was finally settled with AstraZeneca agreeing to deliver 60 million doses of vaccines to EU member states by October 75 million by the end of the year and 65 million more by April 2022 115 Acquisition history EditThe following is an illustration of the company s major mergers and acquisitions and historical predecessors 116 AstraZeneca AstraZeneca Merged 1999 Astra AB Founded 1913 Tika Acq 1939 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 MedImmune Biologics Cambridge Antibody Technology Acq 2006 Aptein Inc Acq 1998 MedImmune Acq 2007 Definiens 117 Acq 2014 Arrow Therapeutics Acq 2007 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 118 Acq 2013 Omthera Pharmaceuticals 119 Acq 2013 ZS Pharma Acq 2015 Alexion Pharmaceuticals 82 Acq 2021 Proliferon Inc Acq 2000 restructured into Alexion Antibody Technologies Inc Enobia Pharma Corp Acq 2011 Synageva BioPharma Acq 2015 Wilson Therapeutics Acq 2018 Syntimmune Acq 2018 Achillion Pharmaceuticals Acq 2019 Portola Pharmaceuticals Acq 2020 Caelum Biosciences Acq 2021 TeneoTwo Acq 2022 LogicBio Therapeutics Acq 2022 Neogene Therapeutics Acq 2022 CinCor Pharma Acq 2023 Operations Edit The AstraZeneca R amp D facility in Gothenburg Sweden The new AstraZeneca Corporate HQ under construction in Cambridge EnglandAstraZeneca develops manufactures and sells pharmaceutical and biotechnology products to treat disorders in the oncology cardiovascular gastrointestinal infection neuroscience respiratory and inflammation areas 120 AstraZeneca has its corporate headquarters in Cambridge United Kingdom and its main research and development R amp D centres are in Cambridge UK Gaithersburg Maryland US Gothenburg Sweden and Warsaw Poland 121 Orphan drugs EditIn April 2015 AstraZeneca s drug tremelimumab was approved as an orphan drug for the treatment of mesothelioma in the United States 122 In February 2016 AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint 123 Senior management EditAs of 2008 David Brennan was paid US 1 574 144 for his role as chief executive officer 124 On 26 April 2012 it was announced that Brennan was to retire in early June of that year 125 In August 2012 Pascal Soriot was named CEO of AstraZeneca 126 It was also announced that Leif Johansson would succeed Louis Schweitzer as non executive chairman on 1 June 2012 three months earlier than previously announced and would become Chairman of the Nomination and Governance Committee after the 2012 Annual General Meeting 125 The company s non executive Board directors are Philip Broadley Euan Ashley Michel Demare Deborah DiSanzo Diana Layfield Sheri McCoy Tony Mok Nazneen Rahman Andreas Rummelt and Marcus Wallenberg 127 Outreach EditPolitical lobbying Edit AstraZeneca is a member of the Personalized Medicine Coalition a medical research advocacy group that lobbies on behalf of the pharmaceutical industry 128 Controversies EditFollowing 2008 Sichuan earthquake Edit AstraZeneca s reputation in China was tarnished following the failure of its Chinese subsidiary to timely donate to relief efforts following the 2008 Sichuan earthquake 129 121 Typically donations for disaster relief in China are made through funds established through the Chinese Ministry of Civil Affairs and its subordinate organization the Red Cross Society of China 129 121 AstraZeneca had a corporate rule prohibiting foreign subsidiaries from making donations to local governments and the company construed this rule as prohibiting donations for Sichuan earthquake relief efforts 129 121 AstraZeneca s Chinese subsidiary received major backlash for its failure to donate 129 121 While corporate approval was ultimately given for the Chinese subsidiary to donate the approval came after long delay 129 121 Seroquel Edit In April 2010 AstraZeneca settled a qui tam lawsuit brought by Stefan P Kruszewski for US 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 According to the settlement agreement AstraZeneca targeted its illegal marketing of the anti psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder such as physicians who treat the elderly primary care physicians pediatric and adolescent physicians and in long term care facilities and prisons 130 In March 2011 AstraZeneca settled a lawsuit in the United States totalling US 68 5 million to be divided up to 38 states 131 Nexium Edit 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 132 In March 2001 the company began to market Nexium as it would a brand new drug 133 The R enantiomer 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 five times higher than those with normal CYP2C19 production In contrast esomeprazole is metabolized by both CYP2C19 and CYP3A4 providing less variable drug exposure 134 While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux 135 esomeprazole is approved for doses up to 40 mg 136 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 40 mg Nexium with 20 mg 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 137 Bildman fraud sexual harassment and faithless servant clawback Edit On 4 February 1998 Astra USA sued Lars Bildman its former president and chief executive officer seeking US 15 million for defrauding the company 138 The sum included US 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 US 1 million in income on his tax returns 139 In addition several female co workers filed personal sexual harassment lawsuits against Bildman 140 In April 1998 Bildman was sentenced to 21 months in prison three months after he pled guilty to filing false Federal tax returns 141 139 In February 1998 AstraZenaca s U S affiliate Astra U S A agreed to a 10 million settlement after an Equal Employment Opportunity Commission investigation which started in May 1996 found that sexual harassment against female employees 142 120 former female employees of Astra were interviewed during the inquiry with about 80 of them being identified as able to file claims 142 Astra U S A also issued a statement of apology for the hostile work environment 142 In Astra USA v Bildman 914 N E 2d 36 Mass 2009 applying New York s faithless servant doctrine the court held that a company s employee who had engaged in financial misdeeds and sexual harassment must forfeit all of his salary and bonuses for the period of disloyalty 143 The court held that this was the case even if the employee otherwise performed valuable services and that the employee was not entitled to recover restitution for the value of those other services 143 144 The decision attracted a good deal of attention by legal commentators 145 CAFE study Edit In 2004 University of Minnesota research participant Dan Markingson committed suicide while enrolled in an industry sponsored pharmaceutical trial comparing three FDA approved atypical antipsychotics Seroquel quetiapine Zyprexa olanzapine and Risperdal risperidone University of Minnesota Professor of Bioethics Carl Elliott noted that Markingson was enrolled in the study against the wishes of his mother Mary Weiss and that he was forced to choose between enrolling in the study or being involuntarily committed to a state mental institution 146 A 2005 FDA investigation cleared the university Nonetheless controversy around the case has continued A Mother Jones article 146 resulted in a group of university faculty members sending a public letter to the university Board of Regents urging an external investigation into Markingson s death 147 Transfer mispricing Edit In 2010 AstraZeneca agreed to pay 505 million to settle a UK tax dispute related to transfer mispricing 148 Conflicting commitments to the UK and the EU Edit Seat of the European Commission which negotiated a contract with AstraZenecaIn August 2020 AstraZeneca declared towards the European Commission and the EU member states 13 1 AstraZeneca represents warrants and covenants to the Commission and the Participating Member States that e it is not under any obligation contractual or otherwise to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or would impede the complete fulfilment of its obligation under this Agreement 149 However the UK Secretary of State for Health and Social Care Matt Hancock declared in March 2021 that the United Kingdom had been given exclusivity and that the EU s treaty was inferior 150 151 After placing the order for AstraZeneca s vaccine the European Commission mistakenly assumed that it had enough vaccines and initially ordered only 200 million doses from Pfizer BioNTech when the manufacturers offered 500 million doses to the EU in November 2020 152 However the contract that AstraZeneca reached with the UK was very similar to that it reached with the EU and it also contained the phrase best reasonable efforts the UK contract was signed on 28 August 2020 a day after the contract with the EU 153 The key difference seems to be that AstraZeneca entered into a preliminary agreement with the U K back in May 2020 which arranged for the development of a dedicated supply chain for the U K 154 The failure to produce the vaccine in the anticipated quantities contributed to the low vaccination rates of vulnerable populations of the European Union at the beginning of the outbreak of more virulent variants of SARS CoV 2 in early 2021 155 China comments Edit In May 2023 AstraZeneca s China president said that the company aims to be a patriotic company in China that loves the Communist Party 156 See also Edit London portal Companies portalPharmaceutical industry in the United Kingdom List of pharmaceutical companiesNotes Edit Vaccine induced Thrombosis and ThrombocytopeniaReferences Edit a b c d e Annual Results 2022 PDF AstraZeneca Retrieved 13 February 2022 AstraZeneca plc 2022 Annual Report Form 20 F U S Securities and Exchange Commission 21 February 2023 AstraZeneca gt GC Powerlist Sweden Teams 2019 www legal500 com Retrieved 30 December 2020 Hollingsworth Julia Renton Adam Macaya Melissa Hayes Mike 30 December 2020 UK will be able to get out of this by the spring minister says after regulator approves AstraZeneca vaccine CNN Retrieved 30 December 2020 biopharma reporter com AstraZeneca s COVID 19 vaccine gets the green light in the UK biopharma reporter com Retrieved 30 December 2020 Registered office and corporate headquarters AstraZeneca 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Launches 40M Early Stage Anti Infectives R amp Unit GEN Sweeney Kate 16 February 2015 AstraZeneca underwrites Cambridge Sweden flights Business Weekly Technology News Business news Cambridge and the East of England Business Weekly UK GEN News Highlights For Up to 825M Daiichi Sankyo Joins AstraZeneca in Co Marketing Movantik GEN 19 March 2015 GEN News Highlights AstraZeneca Inks 1 8B in Immuno Oncology Deals as Q1 Profit Dips GEN 24 April 2015 GEN News Highlights MedImmune Juno Team Up to Study Cancer Immunotherapy Combo GEN 23 April 2015 Eolas and AstraZeneca Agree to Develop Orexin 1 Receptor Antagonist for Multiple Indications GEN 30 June 2015 AstraZeneca Selling Ex U S Entocort Rights to Tillotts Pharma GEN 9 July 2015 Genzyme to Buy Caprelsa from AstraZeneca for Up to 300M GEN 27 July 2015 AstraZeneca to Develop Heptares Cancer Candidate in 510M Collaboration GEN 6 August 2015 MedImmune Licenses Inovio Cancer Vaccine for Up to 727 5M GEN News Highlights GEN GEN 10 August 2015 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the original on 11 January 2022 Retrieved 19 March 2016 Leadership Our Company AstraZeneca www astrazeneca com Retrieved 17 May 2022 Current Members Personalized Medicine Coalition Archived from the original on 6 April 2022 Retrieved 7 April 2022 a b c d e Marquis Christopher Qiao Kunyuan 2022 Mao and markets the communist roots of Chinese enterprise Kunyuan Qiao New Haven Yale University Press ISBN 978 0 300 26883 6 OCLC 1348572572 Pharmaceutical Giant AstraZeneca to Pay 520 Million for Off label Drug Marketing U S Department of Justice 27 April 2010 Drugmaker settles lawsuits over Seroquel The Des Moines Register Retrieved 1 March 2011 dead link United States Patent 5 877 192 USPTO Patent Database 11 April 1997 High Prices The New Yorker 25 October 2004 Lemke TL Williams DA Roche VF Zito SW Foye s Principles of Medicinal Chemistry 7th edition Chapter 12 Highlights of Prescribing Medicine PDF Food and Drugs Administration Highlights of Prescribing Medicine PDF Food and Drugs Administration Grill Markus Hansen Hans 16 August 2007 Vorsicht Pharma Wie die Industrie Arzte manipuliert und Patienten tauscht Caution Pharma How the industry manipulates physicians and deceives patients in German Germany Stern pp 100 107 Archived from the original on 13 October 2007 Retrieved 14 October 2011 Astra hauls ex CEO Lars Bildman into court Business Week 4 February 1998 a b The Associated Press 27 January 1998 Ex Astra Official Pleads Guilty in Tax Case The New York Times Retrieved 4 May 2021 Astra Boss Hit With 7M Fine for Sex Harassment Reps Share Memories of Bonkers CEO CBS News 6 October 2009 Retrieved 19 March 2016 Ex Astra Executive Is Sentenced To 21 Month Term for Tax Evasion The Wall Street Journal 13 April 1998 Retrieved 4 May 2021 a b c Gilpin Kenneth N 6 February 1998 Firm to Pay 10 Million In Settlement Of Sex Case The New York Times Retrieved 4 May 2021 a b Glynn Timothy P Arnow Richman Rachel S Sullivan Charles A 2019 Employment Law Private Ordering and Its Limitations Wolters Kluwer Law amp Business ISBN 9781543801064 via Google Books Carroll James R Weida Jason Collins 1 January 2010 Faithless Servants Beware Massachusetts Forfeiture Law is More Severe than Astra USA Inc v Bildman Might Suggest Boston Bar Journal Winter 2010 SSRN 1775205 Sullivan Charles A 4 March 2011 Mastering the Faithless Servant Reconciling Employment Law Contract Law and Fiduciary Duty Seton Hall Public Law Research Paper No 1777082 SSRN 1777082 a b Elliott Carl 1 September 2010 The deadly corruption of clinical trials U of M Board of Regents Markingson Letter Scribd Retrieved 14 February 2016 AstraZeneca agrees to pay 505m to settle UK tax dispute The Guardian 23 February 2010 Advance purchase agreement APA for the production purchase and supply of a COVID 19 vaccine in the European Union PDF European Union Retrieved 5 April 2021 We have exclusivity deal with AstraZeneca UK Health Secy Daiji World 25 March 2021 CORONAVIRUS EU contract with AstraZeneca is inferior to UK s says Matt Hancock The Times 25 March 2021 The Planning Disaster Germany and Europe Could Fall Short on Vaccine Supplies Spiegel 18 December 2020 AstraZeneca s vaccine contract with the UK is based on best efforts just like its deal with a frustrated EU CNN 18 February 2021 Retrieved 5 April 2021 How the UK gained an edge with AstraZeneca s vaccine commitments Politico 22 February 2021 Retrieved 5 April 2021 How the EU s vaccine rollout moved from farce into tragedy The Telegraph 22 March 2021 Archived from the original on 11 January 2022 Cash Joe Goh Brenda Cash Joe Goh Brenda 19 May 2023 AstraZeneca will seek to love the Communist Party its China boss says Reuters Retrieved 21 May 2023 External links Edit Media related to AstraZeneca at Wikimedia Commons Official website Retrieved from https en wikipedia org w index php title AstraZeneca amp oldid 1168473774, wikipedia, wiki, book, books, library,

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