AstraZeneca

2021. 3. 21. 07:19ㆍ■ 건강 의학/COVID-19 Omicron외

AstraZeneca - Wikipedia

 

AstraZeneca - Wikipedia

From Wikipedia, the free encyclopedia Jump to navigation Jump to search British-Swedish pharmaceutical company AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company[2][3][4] with its headquarters at the Cambridge Bi

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AstraZeneca

설립국가분야취급품목사이트본사 주소

1913년
영국
생명공학
의약품, 의료용품, 바이오
www.astrazeneca.com
영국 케임브리지

요약 영국에 본사가 있는 세계적인 제약회사. 1999년 스웨덴의 제약회사인 아스트라와 영국의 제네카가 합병하여 설립되었다. 호흡기와 심혈관 질환, 악성 종양과 자가면역 질환 치료제, 항바이러스제와 백신 개발이 전문 분야이다. 2020년 전 세계로 확산된 코로나바이러스감염증-19의 진단 키트와 백신을 개발했다.

 

 

 

 

아스트라제네카

ⓒ 아스트라제네카 | CC BY-ND

영국에 본사가 있는 세계적인 제약회사. 1913년 스웨덴에서 설립된 아스트라(Astra) 제약회사가 1999년 영국의 제약회사인 제네카(Zeneca)와 합병하여 설립되었다. 아스트라는 독일과 스위스의 제약회사에 의해 스웨덴의 약품시장이 장악되고 있는 상황을 우려한 스웨덴의 약사와 의사 집단이 주도하여 설립했다. 외상 치료 약물과 페니실린 등의 항생제, 마취제 등을 개발하면서 1940년대에 이르러 스웨덴을 선도하는 제약회사로 자리잡았다. 아스트라는 이후 신약 개발에 힘써 심혈관 질환 치료제 등을 개발했다.

아스트라는 1960년대 초반 독일에서 개발된 진정제인 탈리도마이드를 스웨덴 시장에 공급했다가 심각한 약물 부작용 사건을 겪었다. 처방전 없이 구입할 수 있었던 약품인 탈리도마이드는 곧 선천적 기형을 유발하는 부작용으로 세계적인 문제가 되었다. 이후 아스트라는 신약 개발에 있어 더욱 신중한 입장을 택하게 되었다. 1990년대 말 신약 개발에 드는 막대한 비용으로 국제적인 제휴를 추진하다가 1998년 영국의 제약회사인 제네카와 합병을 결의했다.

제네카는 1926년 설립된 왕립화학회사(ICI)가 전신으로 1993년 제약부문을 중심으로 분리한 회사로, 주로 종양과 심장 질환 치료제를 개발했다. 1999년 두 회사는 합병후 아스트라제네카의 이름으로 변경하고 본사를 영국 런던에 두었다. 2000년대 들어 아스트라제네카는 특히 항암요법 치료제 개발에 힘썼으며 유망한 영국의 생명공학회사들을 여럿 인수합병했다.

2007년에는 항바이러스 치료제 개발 회사인 애로우제약과 독감 백신 개발회사인 미국의 메드이뮨을 인수하고, 2010년에는 항생제 개발사인 노벡셀을, 2011년에는 중국의 광동베이캉제약회사를 인수하는등 지속적인 인수합병으로 특허를 확보했다. 2013년 이후 아스트라제네카는 그동안의 지속적인 확장에 대한 경영적 압박을 받았고, 구조 조정을 거치면서 호흡기와 심혈관 질환, 악성 종양과 자가면역 질환 치료제 개발에 집중한다고 발표했다.

2016년 아스트라제네카는 본사를 케임브리지로 이전했다. 2020년 전 세계에 코로나바이러스감염증-19가 확산되어 팬데믹 상황에 이르자, 아스트라제네카는 진단 키트와 함께 옥스포드대학교 연구진과 협력하여 백신 개발에 착수했으며, 2020년 11월 바이러스 벡터 방식의 백신을 개발, 3상 임상시험 결과 90%의 예방효과를 거두었다고 발표했다.

2020년 12월 30일 영국 보건당국은 아스트라제네카와 옥스포드대학이 공동으로 개발한 코로나바이러스감염증-19 백신에 대하여, 영국 의약품건강관리제품규제청(MHRA)의 권고를 받아들여 긴급사용을 승인했으며, 2021년 1월부터 접종을 시작한다고 발표했다. 같은 날 아르헨티나와 엘살바도르도 아스트라제네카 백신의 사용을 승인했다.

2021년 1월 1일에는 인도가 아스트라제네카 백신의 사용을 승인하고 곧 접종에 착수한다고 발표했다. 1월 29일에는 유럽연합(EU) 집행위원회가 아스트라제네카 백신의 사용을 승인했으며, 2월 15일에는 세계보건기구(WHO)에서 18세 이상 성인에 대한 아스트라제네카 백신의 긴급사용을 승인했다. 아스트라제네카백신은 한국의 아스트라제네카-SK바이오 공장과 인도의 공장에서 생산되고 있으며, WHO 승인에 따라 코백스 퍼실리티를 통해 저소득 국가로 공급된다.

국내 현황

아스트라는 1980년 합작회사 형태로 한국에 진출한 이후 1992년 한국 아스트라를 설립했다. 한편 제네카는 1997년 한국제네카를 설립했다. 이 두 회사는 1999년 아스트라와 제네카가 합병되면서 한국아스트라제네카로 통합되었으며, 이후 아스트라제네카가 개발한 넥시움, 심비코트, 이레사, 크레스토, 바슬로덱스, 브릴린타, 포시가, 린파자 등의 약품을 한국에 판매했다.

2021년 1월 4일 한국 식품의약품안전처에서는 코로나바이러스감염증-19 예방용 아스트라제네카 백신에 대한 사용허가 심사에 착수, 2월 10일 65세 이상에 대한 접종 전 신중한 판단을 조건으로 18세 이상 사용을 위한 품목 허가를 결정했다. 2021년 2월 24일, 한국에서 생산한 아스트라제네카 백신의 첫 물량이 방역당국에 인도되어 2월 26일 전국의 보건소와 요양병원, 시설에서 1차 접종 대상인 만 65세 미만 입소자와 종사자등을 대상으로 접종이 시작되었고, 3월 11일에는 65세 이상에도 접종을 시행하기로 결정했다.

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AstraZeneca

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AstraZeneca plcTypeTraded asIndustryPredecessorsFoundedHeadquartersArea servedKey peopleProductsRevenueOperating incomeNet incomeTotal assetsTotal equityNumber of employeesSubsidiariesWebsite

 
Public limited company
LSE: AZN
Nasdaq Stockholm: AZN
Nasdaq: AZN
FTSE 100 Component
Pharmaceutical
Biotechnology
6 April 1999; 21 years ago
Cambridge, England
Global
Leif Johansson (Chairman)
Pascal Soriot (CEO)
Pharmaceutical products
 US$25.890 billion (2020)[1]
 US$5.162 billion (2020)[1]
 US$3.144 billion (2020)[1]
 US$66.729 billion (2020)[1]
 US$15.638 billion (2020)[1]
76,100 (2020)[1]
MedImmune
www.astrazeneca.com

AstraZeneca plc (/ˌæstrəˈzɛnəkə/) is a British-Swedish multinational pharmaceutical and biotechnology company[2][3][4] with its headquarters at the Cambridge Biomedical Campus in Cambridge, England.[5] It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation.

The company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group[6][7] (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.[8]

AstraZeneca has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. It has secondary listings on Nasdaq OMX Stockholm, Nasdaq New York, the Bombay Stock Exchange and on the National Stock Exchange of India.

 

Contents

History

Astra AB was founded in 1913 in Södertälje, Sweden, by 400 doctors and apothecaries.[9] 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.[10] Finally, in 1999 Astra and Zeneca Group merged to form AstraZeneca plc, with its headquarters in London.[10] In 1999, AstraZeneca identified a new location for the company's US base, the "Fairfax-plus" site in North Wilmington, Delaware.[11]

2000–06

In 2002, its drug Iressa (gefitinib) was approved in Japan as monotherapy for non-small cell lung cancer.[12] On 3 January 2004 Dr Robert Nolan, a former director of AstraZeneca, formed the management team of ZI Medical.[13]

In 2005, the company acquired KuDOS Pharmaceuticals, a UK biotech company, for £120 million.[14] and entered into an anti-cancer collaboration agreement with Astex[15] It also announced that it had become a Diamond Member of the Pennsylvania Bio commerce organisation.[16]

In 2006, following a collaborative relationship begun in 2004, AstraZeneca acquired Cambridge Antibody Technology for £702 million.[17]

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.[18] AstraZeneca's pipeline, and "patent cliff", was the subject of much speculation in April 2007 leading to pipeline-boosting collaboration and acquisition activities.[19] 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;[20] AstraZeneca subsequently consolidated all of its biologics operations into a dedicated biologics division called MedImmune.[21]

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.[22][23]

In 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics business.[24]

In February 2012, AstraZeneca and Amgen announced a collaboration on treatments for inflammatory diseases.[25] Then in April 2012, AstraZeneca acquired Ardea Biosciences, another biotechnology company, for $1.26 billion.[26] In June 2012, AstraZeneca and Bristol Myers Squibb announced a two-stage deal for the joint acquisition of the biotechnology company Amylin Pharmaceuticals.[27][28] 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.[28]

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.[8] AstraZeneca also announced that it would move its corporate headquarters from London to Cambridge in 2016.[29][30] 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.[31][32] It also announced that it would focus on three therapeutic areas: Respiratory Inflammation & Autoimmunity, Cardiovascular & Metabolic Disease, and Oncology.[33] In October 2013, AstraZeneca announced it would acquire biotech oncology company Spirogen for around US$440 million.[34]

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.[35] 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.[36] 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.[37] 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.[38] 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.[39] 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.[40]

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.[41] 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.[42] 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.[43] The company underwrote twenty out of thirty-two seats of a new Cambridge– Gothenburg service by Sun-Air of Scandinavia.[44]

In mid-March the company announced it would co-commercialise naloxegol along with Daiichi Sankyo in a deal worth up to US$825 million.[45] 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.[46] The trials will assess combinations of MEDI4736 and one of Juno Therapeutics' CD19 directed chimeric antigen receptor T-cell candidates.[47] 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.[48] In July the company announced it would sell off its rights to Entocort (budesonide) to Tillotts Pharma for US$215 million.[49] In July 2015, Genzyme announced it would acquire the rare cancer drug Caprelsa (vandetanib) from AstraZeneca for up to US$300 million.[50] 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.[51] 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.[52] In September, Valeant licensed Brodalumab from the company for up to US$445 million.[53][54] On 6 November it was reported that AstraZeneca had acquired ZS Pharma for US$2.7 billion.[55] In December the company announced its intention to acquire the respiratory portfolio of Takeda Pharmaceutical – namely Alvesco and Omnaris – for US$575 million[56] 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.[57] In 2015, it was the eighth-largest drug company in the world based on sales revenue.[58]

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.[59] 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.[60] In 2017, it was the eleventh largest drug company in the world based on sales and ranked seventh based on R&D investment.[61] In January EVP Pam Cheng stated that AstraZeneca has ignited startup of duplicate QA testing facility in Sweden and has initiated hiring in Sweden.[62]

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.[63]

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%.[64]

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.[65][66]

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.[67][68]

2020

In February 2020, AstraZeneca agreed to sublicense its global rights (except Europe, Canada and Israel) to the drug Movantik, to Redhill Biopharma.[69]

In June 2020, AstraZeneca made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, worth almost US$240 billion.[70][71] However, these plans were subsequently dropped because it would have distracted the company from its own pipeline and ongoing COVID-19 vaccine efforts.[72]

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.[73]

In September 2020, AstraZeneca announced it had acquired the preclinical oral PCSK9 inhibitor programme from Dogma Therapeutics for an undisclosed sum.[74]

In December 2020, AstraZeneca announced that it would acquire Alexion Pharmaceuticals in a $39 billion deal.[75] Upon completion of merger, Alexion shareholders will own approximately 15% of combined company.[76]

On 27 December 2020, the AstraZeneca chief Pascal Soriot said that they have “figured out the winning formula” with their two-dose system with the Oxford University’s COVID-19 vaccine.[77]

On 30 December 2020, the United Kingdom approved the emergency use of AstraZeneca’s Coronavirus Vaccine.[78][79][80]

COVID-19 pandemic response

Main article: Oxford–AstraZeneca COVID-19 vaccine

 

Oxford–AstraZeneca COVID-19 vaccine - Wikipedia

Vaccine against COVID-19 Oxford–AstraZeneca COVID-19 vaccineBox containing 100 COVID-19 Vaccine AstraZeneca dosesVaccine descriptionTargetSARS-CoV-2Vaccine typeViral vectorClinical dataTrade namesCOVID-19 Vaccine AstraZeneca,[1][2][3] AstraZeneca COVID-1

en.wikipedia.org

 

Oxford–AstraZeneca COVID-19 vaccine

In March 2020, the company announced that it would be donating PPEs, including 9 million face masks, to help support various international health organisations mitigating the COVID-19 pandemic.[81]

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.[82] The company also announced plans for a clinical trial to assess the potential use of Calquence in the treatment of COVID-19.[83]

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.[84] One of them, AZD1222, reached phase III trials.[85]

On 23 November 2020, Oxford–AstraZeneca announced the vaccine's successful trial, preventing 70% of people developing symptoms.[86] The researchers thought that the figure may be as high as 90% by tweaking the dose.[87]

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.[88]

On 29 January 2021, the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for AZD1222 in people from 18 years of age.[89] 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. 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.[90]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors:[91]

  • 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[93] (Acq 2013)
    • Omthera Pharmaceuticals[94] (Acq 2013)
    • ZS Pharma (Acq 2015)
    • Alexion Pharmaceuticals (Acq TBD)
      • 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)

Operations

 

The AstraZeneca R&D facility in Gothenburg, Sweden

 

The AstraZeneca Corporate HQ in Cambridge, England

 

The new AstraZeneca Corporate HQ under construction in Cambridge

AstraZeneca develops, manufactures and sells pharmaceutical and biotechnology products to treat disorders in the oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation areas.[95]

AstraZeneca has its corporate headquarters in Cambridge, United Kingdom, and its main research and development (R&D) centers are in Cambridge (UK), Gaithersburg (Maryland, US), Gothenburg (Sweden) and Warsaw (Poland).[96]

Orphan drugs

In April 2015, AstraZeneca's drug tremelimumab was approved as an orphan drug for the treatment of mesothelioma in the United States.[97] In February 2016, AstraZeneca announced that a clinical trial of tremelimumab as a treatment for mesothelioma failed to meet its primary endpoint.[98]

Senior management

As of 2008, David Brennan was paid US$1,574,144 for his role as chief executive officer.[99]

On 26 April 2012, it was announced that Brennan was to retire in early June of that year.[100] In August 2012, Pascal Soriot was named CEO of AstraZeneca.[101]

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.[100]

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. 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.[102]

In March 2011, AstraZeneca settled a lawsuit in the United States totalling US$68.5 million to be divided up to 38 states.[103]

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.[104] In March 2001, the company began to market Nexium, as it would a brand new drug.[105]

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.[106] While omeprazole is approved only at doses of up to 20 mg for the treatment of gastroesophageal reflux,[107] esomeprazole is approved for doses up to 40 mg.[108]

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."[109]

Bildman fraud 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.[110] 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; in addition, several female co-workers filed personal sexual-harassment lawsuits.[111]

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."[112] 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.[112][113] The decision attracted a good deal of attention by legal commentators.[114]

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.[115] A 2005 FDA investigation cleared the university. Nonetheless, controversy around the case has continued. A Mother Jones article[115] 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.[116]

Transfer mispricing

In 2010, AstraZeneca agreed to pay £505 million to settle a UK tax dispute related to transfer mispricing.[117]

See also

Notes and references

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아스트라제네카

위키백과, 우리 모두의 백과사전.

형태산업 분야창립국가본사 소재지사업 지역핵심 인물슬로건

 

아스트라제네카
AstraZeneca
주식회사
제약업
1999년 (인수 합병일 기준)
영국
런던
전세계
레이프 요한손(이사회 의장)
파스칼 소리오(CEO)
김상표 (한국법인 대표이사 사장)
What Science Can Do

아스트라제네카(AstraZeneca)는 과학을 기반으로 한 기업문화와 비전을 가진 스웨덴의 ‘아스트라 AB(AstraAB)’와 영국의 ‘제네카(Zeneca Group PLC)’의 인수 합병을 통해 설립된 다국적 제약회사이다.

목차

연혁[편집]

  • 1913년 스웨덴의 아스트라 에이비(Astra AB) 설립
  • 1926년 제네카(zeneca)의 전신 임페리얼 케미컬 인더스트리즈(ICI) 설립
  • 1993년 제네카 그룹과 ICI PLC가 독립 기업으로 분리
  • 1998년 아스트라AB와 제네카 합병 발표
  • 1999년 4월 스웨덴 아스트라AB(Astra AB)와 영국의 제네카(Zeneca)가 합병
  • 2007년 생명공학회사 메드이뮨(MedImmune) 인수

제품[편집]

  • 항암제 사업부: 이레사, 타그리소, 임핀지(폐암), 린파자(유방암, 난소암), 파슬로덱스(유방암)
  • 당뇨순환기 사업부: 포시가(제2형당뇨병), 브릴린타(급성관상동맥증후군 등), 아타칸 (고혈압), 베타자이드 (고혈압)
  • 호흡기·면역 사업부: 심비코트(천식, COPD), 파센라(천식)

같이 보기[편집]

외부 링크[편집]

외부 링크[편집]

전거 통제 

분류: 

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