Astrazeneca (COVID-19 Vaccine)
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AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. 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. The company was founded in 1999 through the merger of the Swedish
Astra AB Astra AB was a former international pharmaceutical company headquartered in Södertälje, Sweden. Astra was formed in 1913 and merged with the British Zeneca, Zeneca Group in 1999 to form AstraZeneca. Product development was focused on therapeutics ...
and the British
Zeneca Group Zeneca (officially Zeneca Group PLC) was a British multinational pharmaceutical company headquartered in London, United Kingdom. It was formed in June 1993 by the demerger of the pharmaceuticals and agrochemicals businesses of Imperial Chemi ...
(itself formed by the demerger of the pharmaceutical operations of
Imperial Chemical Industries Imperial Chemical Industries (ICI) was a British chemical company. It was, for much of its history, the largest manufacturer in Britain. It was formed by the merger of four leading British chemical companies in 1926. Its headquarters were at M ...
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 A definition is a statement of the meaning of a term (a word, phrase, or other set of symbols). Definitions can be classified into two large categories: intensional definitions (which try to give the sense of a term), and extensional definitio ...
(by MedImmune in 2014). It has its
research and development Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...
concentrated in three strategic centres: Cambridge, England;
Gothenburg Gothenburg (; abbreviated Gbg; sv, Göteborg ) is the second-largest city in Sweden, fifth-largest in the Nordic countries, and capital of the Västra Götaland County. It is situated by the Kattegat, on the west coast of Sweden, and has ...
, Sweden and
Gaithersburg Gaithersburg ( ), officially the City of Gaithersburg, is a city in Montgomery County, Maryland, United States. At the time of the 2020 U.S. Census, Gaithersburg had a population of 69,657, making it the ninth-largest location in the state. Ga ...
in Maryland, U.S. AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the
FTSE 100 Index The Financial Times Stock Exchange 100 Index, also called the FTSE 100 Index, FTSE 100, FTSE, or, informally, the "Footsie" , is a share index of the 100 companies listed on the London Stock Exchange with (in principle) the highest market ...
.


History

Astra AB Astra AB was a former international pharmaceutical company headquartered in Södertälje, Sweden. Astra was formed in 1913 and merged with the British Zeneca, Zeneca Group in 1999 to form AstraZeneca. Product development was focused on therapeutics ...
was founded in 1913 in Södertälje,
Sweden Sweden, formally the Kingdom of Sweden,The United Nations Group of Experts on Geographical Names states that the country's formal name is the Kingdom of SwedenUNGEGN World Geographical Names, Sweden./ref> is a Nordic country located on ...
, by 400 doctors and apothecaries. In 1993 the British chemicals company ICI (established from four British chemical companies)
demerged A demerger is a form of corporate restructuring in which the entity's business operations are segregated into one or more components. It is the converse of a merger or acquisition. A demerger can take place through a spin-off by distributed or ...
its
pharmaceuticals A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...
businesses and its agrochemicals and specialities businesses, to form Zeneca Group PLC. Finally, in 1999 Astra and Zeneca Group merged to form AstraZeneca plc, with its headquarters in London. In 1999, AstraZeneca identified a new location for the company's US base, the "Fairfax-plus" site in North Wilmington, Delaware.


2000–06

In 2002, its drug
Iressa Gefitinib, sold under the brand name Iressa, is a medication used for certain breast, lung and other cancers. Gefitinib is an EGFR inhibitor, like erlotinib, which interrupts signaling through the epidermal growth factor receptor (EGFR) in targe ...
(gefitinib) was approved in Japan as monotherapy for non-small cell lung cancer. On 3 January 2004 Dr Robert Nolan, a former director of AstraZeneca, formed the management team of ZI Medical. In 2005, the company acquired KuDOS Pharmaceuticals, a UK biotech company, for £120 million. and entered into an anti-cancer collaboration agreement with Astex It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation. In 2006, following a collaborative relationship begun in 2004, AstraZeneca acquired Cambridge Antibody Technology for £702 million.


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$150million. AstraZeneca's pipeline, and "patent cliff", was the subject of much speculation in April 2007 leading to pipeline-boosting collaboration and acquisition activities. A few days later AstraZeneca acquired US company MedImmune for about US$15.2 billion to gain flu vaccines and an anti-viral treatment for infants; AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune.AstraZeneca Buys MedImmune for US$ 15.6 Billion
''The New York Times'', 24 April 2007
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. In 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics business. In February 2012, AstraZeneca and Amgen announced a collaboration on treatments for inflammatory diseases. Then in April 2012, AstraZeneca acquired Ardea Biosciences, another biotechnology company, for $1.26 billion. In June 2012, AstraZeneca and
Bristol Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the lar ...
announced a two-stage deal for the joint acquisition of the biotechnology company
Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company based in San Diego, CA, that was founded in 1987. The company was engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and othe ...
. 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.


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 Alderley Park was a country estate at Nether Alderley, Cheshire, England, between Macclesfield and Knutsford. It was the residence of the Stanley family of Alderley from the 1500s. It became the headquarters of ICI Pharmaceuticals in the 1950s. I ...
in
Cheshire Cheshire ( ) is a ceremonial and historic county in North West England, bordered by Wales to the west, Merseyside and Greater Manchester to the north, Derbyshire to the east, and Staffordshire and Shropshire to the south. Cheshire's county t ...
and Loughborough in the UK and at
Lund Lund (, , ) is a city in the southern Swedish provinces of Sweden, province of Scania, across the Øresund, Öresund strait from Copenhagen. The town had 91,940 inhabitants out of a municipal total of 121,510 . It is the seat of Lund Municipali ...
in Sweden, investment of $500million 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 Gothenburg (; abbreviated Gbg; sv, Göteborg ) is the second-largest city in Sweden, fifth-largest in the Nordic countries, and capital of the Västra Götaland County. It is situated by the Kattegat, on the west coast of Sweden, and has ...
in Sweden, for research on traditional chemical drugs. AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016. 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. It also announced that it would focus on three therapeutic areas: Respiratory Inflammation & Autoimmunity, Cardiovascular & Metabolic Disease, and Oncology. In October 2013, AstraZeneca announced it would acquire biotech oncology company Spirogen for around US$440 million.


2014

On 19 May 2014 AstraZeneca rejected a "final offer" from Pfizer of £55 per share, which valued the company at £69.4billion (US$117billion). 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. 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. In September 2014 the company would join forces with Eli Lilly in developing and commercialising its candidate
BACE inhibitor Beta-secretase 1, also known as beta-site amyloid precursor protein cleaving enzyme 1, beta-site APP cleaving enzyme 1 (BACE1), membrane-associated aspartic protease 2, memapsin-2, aspartyl protease 2, and ASP2, is an enzyme that in humans is enco ...
– AZD3292 – used for the treatment of
Alzheimer's disease Alzheimer's disease (AD) is a neurodegeneration, neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in short-term me ...
. The deal could yield up to US$500 million for the company. In November 2014 the company's
biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
R&D operation, MedImmune, agreed to acquire
Definiens A definition is a statement of the meaning of a term (a word, phrase, or other set of symbols). Definitions can be classified into two large categories: intensional definitions (which try to give the sense of a term), and extensional definitio ...
for more than US$150 million. The company also began a Phase I/II trial collaboration with
Pharmacyclics Pharmacyclics LLC is an American biopharmaceutical company based in Sunnyvale, California. It is primarily focused on the development of cancer therapies. In 2017, Xynomic Pharmaceuticals acquired all global rights to Abexinostat, Pharmacyclics' p ...
and Janssen Biotech investigating combination treatments. 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. In December, the company received accelerated
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
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.


2015

In February, 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. 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. 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 DNA gyrase, or simply gyrase, is an enzyme within the class of topoisomerase and is a subclass of Type II topoisomerases that reduces topological strain in an ATP dependent manner while double-stranded DNA is being unwound by elongating RNA-pol ...
inhibitor,
AZD0914 Zoliflodacin (development codes AZD0914 and ETX0914) is an experimental antibiotic that is being studied for the treatment of infection with '' Neisseria gonorrhoeae'' (gonorrhea). It has a novel mechanism of action which involves inhibition of ...
, which is currently in Phase II for the treatment of gonorrhea. The company underwrote twenty out of thirty-two seats of a new Cambridge– Gothenburg service by Sun-Air of Scandinavia. In mid-March the company announced it would co-commercialise
naloxegol Naloxegol (INN; PEGylated naloxol; trade names Movantik and Moventig) is a peripherally acting μ-opioid receptor antagonist developed by AstraZeneca, licensed from Nektar Therapeutics, for the treatment of opioid-induced constipation. It was app ...
along with Daiichi Sankyo in a deal worth up to US$825 million. 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 Non-Hodgkin lymphoma (NHL), also known as non-Hodgkin's lymphoma, is a group of blood cancers that includes all types of lymphomas except Hodgkin lymphomas. Symptoms include enlarged lymph nodes, fever, night sweats, weight loss, and tiredness. ...
, myelodysplastic syndromes, and
multiple myeloma Multiple myeloma (MM), also known as plasma cell myeloma and simply myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies. Often, no symptoms are noticed initially. As it progresses, bone pain, an ...
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 Juno Therapeutics Inc is an American biopharmaceutical company founded in 2013 through a collaboration of the Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center and pediatrics partner Seattle Children's Research Instit ...
, investigating combination treatments for cancer. The trials will assess combinations of MEDI4736 and one of Juno Therapeutics' CD19 directed chimeric antigen receptor T-cell candidates. 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. In July the company announced it would sell off its rights to Entocort ( budesonide) to Tillotts Pharma for US$215 million. In July 2015, Genzyme announced it would acquire the rare cancer drug Caprelsa ( vandetanib) from AstraZeneca for up to US$300 million. 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 Adenosine ( symbol A) is an organic compound that occurs widely in nature in the form of diverse derivatives. The molecule consists of an adenine attached to a ribose via a β-N9-glycosidic bond. Adenosine is one of the four nucleoside building ...
A2A receptor, in a deal worth up to US$510 million. 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. In September, Valeant licensed Brodalumab from the company for up to US$445 million. On 6 November it was reported that AstraZeneca had acquired ZS Pharma for US$2.7 billion. In December the company announced its intention to acquire the respiratory portfolio of Takeda Pharmaceutical – namely Alvesco and
Omnaris Ciclesonide is a glucocorticoid used to treat asthma and allergic rhinitis. It is marketed under the brand names Alvesco for asthma and Omnaris, Omniair, Zetonna, and Alvesco for hay fever in the US and Canada. Side effects of the medication ...
– for US$575 million 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 Bruton's tyrosine kinase (abbreviated Btk or BTK), also known as tyrosine-protein kinase BTK, is a tyrosine kinase that is encoded by the ''BTK'' gene in humans. BTK plays a crucial role in B cell development. Structure BTK contains five differ ...
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. In 2015, it was the eighth-largest drug company in the world based on sales revenue.


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. In September 2017, the company's chairman
Leif Johansson Leif Johansson may refer to: * Leif Johansson (bobsleigh) (born 1950), Swedish Olympic bobsledder *Leif Johansson (businessman) (born 1951), Swedish businessman *Leif Johansson (tennis) Leif Johansson (born 1952) is a former professional tennis p ...
planned in taking the "first steps" in moving its research and manufacturing operations away from the United Kingdom, if there is a hard Brexit. In 2017, it was the eleventh largest drug company in the world based on sales and ranked seventh based on R&D investment. In January EVP Pam Cheng stated that AstraZeneca has ignited startup of duplicate QA testing facility in Sweden and has initiated hiring in Sweden.


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


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 Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan (a derivative of ...
sent shares in Japan's Daiichi soaring 16%. In September 2019, the company announced that it would cease drug production at its German headquarters in
Wedel Wedel is a town in the district of Pinneberg, in Schleswig-Holstein, Germany. It is situated on the right bank of the Elbe, approximately south of Elmshorn, and west of Hamburg. History Foundation and Middle Ages The first known mention of ...
, leading to the loss of 175 jobs by the end of 2021. 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 Cheplapharm Arzneimittel GmbH, headquartered in Greifswald, is a German pharmaceutical company that markets branded drugs, medical products, supplements and cosmetics. Cheplapharm is among the most notable small and medium-sized enterprises (S ...
GmbH for as much as US$276 million.


2020

In February 2020, AstraZeneca agreed to sublicense its global rights (except Europe, Canada and Israel) to the drug
Movantik Naloxegol (INN; PEGylated naloxol; trade names Movantik and Moventig) is a peripherally acting μ-opioid receptor antagonist developed by AstraZeneca, licensed from Nektar Therapeutics, for the treatment of opioid-induced constipation. It was ap ...
, to Redhill Biopharma. In June 2020, AstraZeneca made a preliminary approach to Gilead Sciences about a potential merger, worth almost US$240 billion. However, these plans were subsequently dropped because it would have distracted the company from its own pipeline and ongoing COVID-19 vaccine efforts. 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. In September 2020, AstraZeneca acquired the preclinical oral PCSK9 inhibitor program from Dogma Therapeutics. 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 A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...
. On 30 December 2020, the United Kingdom approved the emergency use of the Oxford–AstraZeneca COVID-19 vaccine.


2021

In July 2021, AstraZeneca acquired Alexion Pharmaceuticals. In October 2021, the company, through Alexion, acquired Caelum Biosciences and its monoclonal treatment (CAEL-101) for light chain (AL)
amyloidosis Amyloidosis is a group of diseases in which abnormal proteins, known as amyloid fibrils, build up in tissue. There are several non-specific and vague signs and symptoms associated with amyloidosis. These include fatigue, peripheral edema, weight ...
for up to $500 million.


2022

In July, the company announced it would acquire TeneoTwo for up to $1.3 billion, increasing its blood cancer drug offering. In October 2022 it was announced that the company would acquire LogicBio Therapeutics, which was active in clinical-stage genomic medicine. In November 2022, it was announced AstraZeneca had acquired the Amsterdam-headquartered clinical-stage biotechnology company, Neogene Therapeutics.


Vaxzevria, AstraZeneca's COVID-19 pandemic response


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. In April 2020, Chief Executive Pascal Soriot, reported that the company was working with
GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
and the University of Cambridge to develop a new laboratory capable of conducting 30,000 COVID-19 tests per day. The company also announced plans for a clinical trial to assess the potential use of
Calquence Acalabrutinib, sold under the brand name Calquence, is a medication used to treat various types of non-Hodgkin lymphoma, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). It may be used ...
in the treatment of COVID-19. 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. One of them, AZD1222, reached phase III trials. On 23 November 2020, Oxford–AstraZeneca announced the vaccine's successful trial, preventing 70% of people developing symptoms. The researchers thought that the figure might be as high as 90% if they tweaked the dose. 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 Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company, based in Pune. It is the world's largest manufacturer of vaccines. It was founded by Cyrus Poonawalla in 1966 and is a part of Cyrus Poonawalla Group. O ...
(SII) with a brand name COVISHIELD.


Side-effects

On 29 January 2021, the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) recommended granting a conditional marketing authorisation for AZD1222 in people from 18 years of age. 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. 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.


Name change

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


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. 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. 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. 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. In December 2021, the scientists from
Arizona State University Arizona State University (Arizona State or ASU) is a public research university in the Phoenix metropolitan area. Founded in 1885 by the 13th Arizona Territorial Legislature, ASU is one of the largest public universities by enrollment in the ...
and
Cardiff University , latin_name = , image_name = Shield of the University of Cardiff.svg , image_size = 150px , caption = Coat of arms of Cardiff University , motto = cy, Gwirionedd, Undod a Chytgord , mottoeng = Truth, Unity and Concord , established = 1 ...
identified “the trigger” behind blood clots. Professor Alan Parker said: “Our data confirms
PF4 Platelet factor 4 (PF4) is a small cytokine belonging to the CXC chemokine family that is also known as chemokine (C-X-C motif) ligand 4 (CXCL4) . This chemokine is released from alpha-granules of activated platelets during platelet aggregati ...
can bind to adenoviruses, an important step in unravelling the mechanism underlying
VITT The fishing village of Vitt lies on the German Baltic Sea island of Rügen, more precisely on the Wittow peninsula near Cape Arkona. The village is part of the municipality of Putgarten. Because of its location in a coastal gully on the cliffed ...
. Establishing a mechanism could help to prevent and treat this disorder.”


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". 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.


Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors: * AstraZeneca ** AstraZeneca (Merged 1999) ***
Astra AB Astra AB was a former international pharmaceutical company headquartered in Södertälje, Sweden. Astra was formed in 1913 and merged with the British Zeneca, Zeneca Group in 1999 to form AstraZeneca. Product development was focused on therapeutics ...
(Founded 1913) **** Tika (Acq 1939) ***
Zeneca Zeneca (officially Zeneca Group PLC) was a British multinational pharmaceutical company headquartered in London, United Kingdom. It was formed in June 1993 by the demerger of the pharmaceuticals and agrochemicals businesses of Imperial Che ...
(Spun off from
Imperial Chemical Industries Imperial Chemical Industries (ICI) was a British chemical company. It was, for much of its history, the largest manufacturer in Britain. It was formed by the merger of four leading British chemical companies in 1926. Its headquarters were at M ...
, 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 A definition is a statement of the meaning of a term (a word, phrase, or other set of symbols). Definitions can be classified into two large categories: intensional definitions (which try to give the sense of a term), and extensional definitio ...
(Acq 2014) ** Arrow Therapeutics (Acq 2007) ** Novexel Corp (Acq 2010) ** Guangdong BeiKang Pharmaceutical Company (Acq 2011) ** Ardea Biosciences (Acq 2012) **
Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company based in San Diego, CA, that was founded in 1987. The company was engaged in the discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and othe ...
(Acq 2012 jointly with Bristol-Myers Squibb) ** Spirogen (Acq 2013) ** Pearl Therapeutics (Acq 2013) ** Omthera Pharmaceuticals (Acq 2013) ** ZS Pharma (Acq 2015) ** Alexion Pharmaceuticals (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)


Operations

AstraZeneca develops, manufactures and sells pharmaceutical and biotechnology products to treat disorders in the oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation areas. AstraZeneca has its corporate headquarters in Cambridge, United Kingdom, and its main
research and development Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...
(R&D) centres are in Cambridge (UK),
Gaithersburg Gaithersburg ( ), officially the City of Gaithersburg, is a city in Montgomery County, Maryland, United States. At the time of the 2020 U.S. Census, Gaithersburg had a population of 69,657, making it the ninth-largest location in the state. Ga ...
(Maryland, US),
Gothenburg Gothenburg (; abbreviated Gbg; sv, Göteborg ) is the second-largest city in Sweden, fifth-largest in the Nordic countries, and capital of the Västra Götaland County. It is situated by the Kattegat, on the west coast of Sweden, and has ...
(Sweden) and Warsaw (Poland).


Orphan drugs

In April 2015, AstraZeneca's drug
tremelimumab Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody against CTLA-4. It is an immune checkpoint blocker. Tremelimumab was approved for unresectable hepatocellular carcinoma medical use in the United States in Oct ...
was approved as an
orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...
for the treatment of mesothelioma in the United States. In February 2016, AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint.


Senior management

As of 2008, David Brennan was paid US$1,574,144 for his role as chief executive officer. On 26 April 2012, it was announced that Brennan was to retire in early June of that year.AstraZeneca boss David Brennan quits under pressure from investors
''The Guardian'', 26 April 2012
In August 2012, Pascal Soriot was named CEO of AstraZeneca. It was also announced that
Leif Johansson Leif Johansson may refer to: * Leif Johansson (bobsleigh) (born 1950), Swedish Olympic bobsledder *Leif Johansson (businessman) (born 1951), Swedish businessman *Leif Johansson (tennis) Leif Johansson (born 1952) is a former professional tennis p ...
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. The company's non-executive Board directors are Philip Broadley,
Euan Ashley Euan Angus Ashley is a Scottish physician, scientist, author, and founder based at Stanford University in California where he is Associate Dean in the School of Medicine and holds the Roger and Joelle Burnell Chair of Genomics and Precision He ...
, Michel Demaré, Deborah DiSanzo, Diana Layfield,
Sheri McCoy Sherilyn S. McCoy (born 1959) is an American scientist and business executive. She is the former CEO of Avon Products and former vice chairman and member of the office of the chairman of Johnson & Johnson, where she was responsible for the pharmac ...
, Tony Mok, Nazneen Rahman, Andreas Rummelt, and Marcus Wallenberg.


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.


Controversies


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 Quetiapine, sold under the brand name Seroquel among others, is an atypical antipsychotic medication used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. Despite being widely used as a sleep aid due to its ...
. 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. In March 2011, AstraZeneca settled a
lawsuit - A lawsuit is a proceeding by a party or parties against another in the civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today. The term "lawsuit" is used in reference to a civil actio ...
in the United States totalling US$68.5 million to be divided up to 38 states.


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 Peptic ulcer disease (PUD) is a break in the inner lining of the stomach, the first part of the small intestine, or sometimes the lower esophagus. An ulcer in the stomach is called a gastric ulcer, while one in the first part of the intestines ...
caused by '' Helicobacter pylori'', prevention of
gastric ulcers Peptic ulcer disease (PUD) is a break in the inner lining of the stomach, the first part of the small intestine, or sometimes the lower esophagus. An ulcer in the stomach is called a gastric ulcer, while one in the first part of the intestines i ...
in those on chronic NSAID therapy, and treatment of gastrointestinal ulcers associated with
Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, abdominal distension ...
. 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. In March 2001, the company began to market
Nexium Esomeprazole, sold under the brand name Nexium among others, is a medication which reduces stomach acid. It is used to treat gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome. Effectiveness is similar to o ...
, as it would a brand new drug. 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. While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux, esomeprazole is approved for doses up to 40 mg. In 2007,
Marcia Angell Marcia Angell (; born April 20, 1939) is an American physician, author, and the first woman to serve as editor-in-chief of the ''New England Journal of Medicine''. She is currently a Senior Lecturer in the Department of Global Health and Social M ...
, 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 The stern is the back or aft-most part of a ship or boat, technically defined as the area built up over the sternpost, extending upwards from the counter rail to the taffrail. The stern lies opposite the bow, the foremost part of a ship. Ori ...
'', 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
f each drug F, or f, is the sixth letter in the Latin alphabet, used in the modern English alphabet, the alphabets of other western European languages and others worldwide. Its name in English is ''ef'' (pronounced ), and the plural is ''efs''. Hist ...
the company's scientists used Nexium in higher dosages. They compared 20 and 40 mg Nexium with 20 mg
Prilosec Omeprazole, sold under the brand names Prilosec and Losec, among others, is a medication used in the treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger–Ellison syndrome. It is also used to prevent upper g ...
. 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."


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. 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
record A record, recording or records may refer to: An item or collection of data Computing * Record (computer science), a data structure ** Record, or row (database), a set of fields in a database related to one entity ** Boot sector or boot record, ...
s, and concocted: "tales of conspiracy involving ex- KGB
agent Agent may refer to: Espionage, investigation, and law *, spies or intelligence officers * Law of agency, laws involving a person authorized to act on behalf of another ** Agent of record, a person with a contractual agreement with an insuranc ...
s 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 return A tax return is the completion of documentation that calculates an entity or individual's income earned and the amount of taxes to be paid to the government or government organizations or, potentially, back to the taxpayer. Taxation is one of ...
s. In addition, several female co-workers filed personal sexual-harassment lawsuits against Bildman. In April 1998, Bildman was sentenced to 21 months in prison three months after he pled guilty to filing false Federal tax returns. 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. 120 former female employees of Astra were interviewed during the inquiry, with about 80 of them being identified as able to file claims. Astra U.S.A. also issued a statement of apology for the hostile work environment. In ''Astra USA v. Bildman'', 914 N.E.2d 36 (Mass. 2009), applying New York's
faithless servant The faithless servant doctrine is a doctrine under the laws of a number of states in the United States, and most notably New York State law, pursuant to which employees who act unfaithfully towards their employers must forfeit to their employers a ...
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". 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. The decision attracted a good deal of attention by legal commentators.


CAFÉ study

In 2004, University of Minnesota research participant Dan Markingson
committed suicide Suicide is the act of intentionally causing one's own death. Mental disorders (including major depressive disorder, depression, bipolar disorder, schizophrenia, personality disorders, anxiety disorders), physical disorders (such as chronic f ...
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 Carl Atwood Elliott (December 20, 1913 – January 9, 1999) was a U.S. representative from the U.S. state of Alabama. He was elected to eight consecutive terms, having served from 1949 to 1965. Background Elliott was born in rural Frankli ...
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. A 2005 FDA investigation cleared the university. Nonetheless, controversy around the case has continued. A ''Mother Jones'' article 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.


Transfer mispricing

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


Conflicting commitments to the UK and the EU

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;" 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". 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. 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. 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." 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.


See also

* Pharmaceutical industry in the United Kingdom *
List of pharmaceutical companies This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry ...


Notes


References


External links

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