AstraZeneca

Source: Wikipedia, the free encyclopedia.
This article is about the pharmaceutical company. For the vaccine, see Oxford–AstraZeneca COVID-19 vaccine.

AstraZeneca plc
ProductsPharmaceutical products
RevenueIncrease US$45.811 billion (2023)[1]
Increase US$8.193  billion (2023)[1]
Increase US$5.961 billion (2023)[1]
Total assetsIncrease US$101.119 billion (2023)[1]
Total equityIncrease US$39.166 billion (2023)[1]
Number of employees
89,900 (2023)[1]
Subsidiaries
Websiteastrazeneca.com

AstraZeneca plc (

infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.[6]

The company was founded in 1999 through the merger of the Swedish

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.[9]

AstraZeneca traces its earliest corporate history to 1913, when Astra AB was formed by a large group of doctors and apothecaries in Södertälje. Throughout the twentieth century, it grew into the largest pharmaceutical company in Sweden. Its British counterpart, Zeneca PLC was formed in 1993 when ICI divested its pharmaceuticals businesses; Astra AB and Zeneca PLC merged six years later, with the chosen headquarters in the United Kingdom.[10]

AstraZeneca's primary listing is on the London Stock Exchange and is a constituent of the FTSE 100 Index; it also has a secondary listing on the Nasdaq Stockholm. AstraZeneca has one of the highest market capitalisations of pharmaceutical companies worldwide.[11]

History

agrochemicals and specialities businesses, to form Zeneca Group PLC.[13] Finally, in 1999 Astra and Zeneca Group merged to form AstraZeneca plc, with its headquarters in London.[13] In 1999, AstraZeneca identified a new location for the company's US base, the "Fairfax-plus" site in North Wilmington, Delaware.[14]

2000–2006

In 2002, its drug

non-small cell lung cancer.[15] On 3 January 2004 Dr Robert Nolan, a former director of AstraZeneca, formed the management team of ZI Medical.[16]

In 2005, the company acquired KuDOS Pharmaceuticals, a UK biotech company, for £120 million.

Astex[18] It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation.[19]

In 2006, following a collaborative relationship begun in 2004, AstraZeneca acquired Cambridge Antibody Technology for £702 million.[20]

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 US$150 million.[21] AstraZeneca's pipeline, and "patent cliff", was the subject of much speculation in April 2007 leading to pipeline-boosting collaboration and acquisition activities.[22] 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;[23] AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune.[24]

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.[25][26]

In 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics business.[27]

In February 2012, AstraZeneca and Amgen announced a collaboration on treatments for inflammatory diseases.[28] Then in April 2012, AstraZeneca acquired Ardea Biosciences, another biotechnology company, for $1.26 billion.[29] In June 2012, AstraZeneca and Bristol Myers Squibb announced a two-stage deal for the joint acquisition of the biotechnology company Amylin Pharmaceuticals.[30][31] 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.[31]

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.[9] AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016.[32][33] 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.[34][35] It also announced that it would focus on three therapeutic areas: Respiratory Inflammation & Autoimmunity, Cardiovascular & Metabolic Disease, and Oncology.[36] In October 2013, AstraZeneca announced it would acquire biotech oncology company Spirogen for around US$440 million.[37]

2014

On 19 May 2014 AstraZeneca rejected a "final offer" from

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.[43]

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.

AZD0914, which is currently in Phase II for the treatment of gonorrhea.[46] The company underwrote twenty out of thirty-two seats of a new Cambridge– Gothenburg service by Sun-Air of Scandinavia.[47]

In mid-March the company announced it would co-commercialise

Omnaris – for US$575 million[59] 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.[60] In 2015, it was the eighth-largest drug company in the world based on sales revenue.[61]

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.[62]

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.[63]

In 2017, it was the eleventh largest drug company in the world based on sales and ranked seventh based on R&D investment.[64]

In January EVP Pam Cheng stated that AstraZeneca has ignited startup of duplicate QA testing facility in Sweden and has initiated hiring in Sweden.[65]

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.[66]

On 6 December 2018, AstraZeneca purchased nearly 8% of the American pharmaceutical business, Moderna.[67]

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%.[68]

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.[69][70]

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.[71][72]

2020

In February 2020, AstraZeneca agreed to sublicense its global rights (except Europe, Canada and Israel) to the drug Movantik, to Redhill Biopharma.[73]

In June 2020, AstraZeneca made a preliminary approach to Gilead Sciences about a potential merger, worth almost US$240 billion.[74][75] However, these plans were subsequently dropped because it would have distracted the company from its own pipeline and ongoing COVID-19 vaccine efforts.[76]

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.[77]

In September 2020, AstraZeneca acquired the preclinical oral PCSK9 inhibitor program from Dogma Therapeutics.[78]

On 27 December 2020, AstraZeneca CEO

Oxford University’s COVID-19 vaccine.[79]

On 30 December 2020, the United Kingdom approved the emergency use of the Oxford–AstraZeneca COVID-19 vaccine.[80][81][82]

2021

In July 2021, AstraZeneca acquired Alexion Pharmaceuticals.[83][84] 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.[85][86]

2022

In July, the company announced it would acquire TeneoTwo for up to $1.3 billion, increasing its blood cancer drug offering.[87] In October 2022 it was announced that the company would acquire LogicBio Therapeutics, which was active in clinical-stage genomic medicine.[88][89]

In November 2022, it was announced AstraZeneca had acquired the Amsterdam-headquartered clinical-stage biotechnology company, Neogene Therapeutics.[90]

2023

In January, AstraZeneca announced it would acquire CinCor Pharma for $1.8 billion.[91]

In November 2023, AstraZeneca launched a new global health tech business, Evinova, that focused on provide global services to CROs and pharma companies to design, run and monitor clinical trials.[92]

In December 2023, AstraZeneca announced that it would acquire an RSV vaccine developer, Icosavax for $1.1 billion.[93] Later that month, AstraZeneca agreed to acquire clinical-stage biopharmaceutical developer of cell therapies for the treatment of cancer and autoimmune diseases, Gracell Biotechnologies, in a deal valued at up to $1.2 billion.[94] Both the acquisitions were completed in February 2024.[95][96]

2024

In March 2024, AstraZeneca announced it would acquire Amolyt Pharma for $1.05 billion in cash.[97]

In March 2024, AstraZeneca announced it would acquire Fusion Pharmaceuticals Inc for $2 billion in cash.[98]

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.[99]

In April 2020, Chief Executive

Calquence in the treatment of COVID-19.[101]

In June 2020, the

AZD1222, reached phase III trials.[103]

On 23 November 2020, Oxford–AstraZeneca announced the vaccine's successful trial, preventing 70% of people developing symptoms.[104] The researchers thought that the figure might be as high as 90% if they tweaked the dose.[105]

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.[106]

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.[107] 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.[108]

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.[109]

Name change

On 30 March 2021, the Swedish Medicines Agency, Läkemedelsverket, announced that following the prior approval of the EMA[110] it would change the name of the vaccine to Vaxzevria, stressing that only the name of the vaccine would change, not the composition.[111][112]

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.

VITT.[a] Establishing a mechanism could help to prevent and treat this disorder.”[119][120]

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".[121][122] 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.[123]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:[124]

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

infection, neuroscience, respiratory and inflammation areas.[128]

AstraZeneca has its corporate headquarters in Cambridge, United Kingdom, and its main

Gaithersburg (Maryland, US), Gothenburg (Sweden) and Warsaw (Poland).[129]

Orphan drugs

In April 2015, AstraZeneca's drug tremelimumab was approved as an orphan drug for the treatment of mesothelioma in the United States.[130] In February 2016, AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint.[131]

Senior management

As of 2008, David Brennan was paid US$1,574,144 for his role as chief executive officer.[132]

On 26 April 2012, it was announced that Brennan was to retire in early June of that year.[133] In August 2012, Pascal Soriot was named CEO of AstraZeneca.[134]

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.[133]

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.[135]

Lobbying

Political lobbying

AstraZeneca is a member of the Personalized Medicine Coalition, a medical research advocacy group that lobbies on behalf of the pharmaceutical industry.[136]

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.[137]: 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.[137]: 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.[137]: 121  AstraZeneca's Chinese subsidiary received major backlash for its failure to donate.[137]: 121  While corporate approval was ultimately given for the Chinese subsidiary to donate, the approval came after long delay.[137]: 121 

Seroquel

In April 2010, AstraZeneca settled a

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.[138]

In March 2011, AstraZeneca settled a lawsuit in the United States totalling US$68.5 million to be divided up to 38 states.[139]

Nexium

The company's most commercially successful medication is

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.[140] In March 2001, the company began to market Nexium, as it would a brand new drug.[141]

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.[142] While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux,[143] esomeprazole is approved for doses up to 40 mg.[144]

In 2007,

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."[145]

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

tax returns.[147] In addition, several female co-workers filed personal sexual-harassment lawsuits against Bildman.[148] In April 1998, Bildman was sentenced to 21 months in prison three months after he pled guilty to filing false Federal tax returns.[149][147]

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.[150] 120 former female employees of Astra were interviewed during the inquiry, with about 80 of them being identified as able to file claims.[150] Astra U.S.A. also issued a statement of apology for the hostile work environment.[150]

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".[151] 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.[151][152] The decision attracted a good deal of attention by legal commentators.[153]

CAFÉ study

In 2004, University of Minnesota research participant Dan Markingson took his own life 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.[154] A 2005 FDA investigation cleared the university. Nonetheless, controversy around the case has continued. A Mother Jones article[154] 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.[155]

Transfer mispricing

In 2010, AstraZeneca agreed to pay £505 million to settle a UK tax dispute related to transfer mispricing.[156]

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;"[157]

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".[158][159] 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.[160]

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.

SARS-CoV-2 in early 2021.[163]

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."[164]

See also

Notes

  1. ^ Vaccine induced Thrombosis and Thrombocytopenia

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External links

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