AstraZeneca Annual Report and Form 20-F Information 2011

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Therapy Area Reviewendpoints of progression free survival and overall survival and wastherefore unlikely to benefit patients with non-metastatic CRPC. InJuly, the results from the Phase III ENTHUSE study 33, showed thatthe addition of zibotentan to docetaxel did not improve the overallsurvival for metastatic CRPC patients. The full data from both of thesestudies, in addition to the data from the Phase III ENTHUSE study 14announced in 2010 will be published in due course.In December, AstraZeneca announced its decision to discontinue thedevelopment of olaparib (AZD2281) for the maintenance treatment ofserous ovarian cancer. This followed a review of an interim analysis ofa Phase II study (study 19) which indicated that the previously reportedprogression free survival benefit was unlikely to translate into an overallsurvival benefit, the definitive measure of patient benefit in ovarian cancer.Our early oncology pipeline includes a range of novel compounds thattarget signalling pathways believed to be pivotal in cancer cell growthand survival as well as DNA repair mechanisms. AZD8931, a pan-erbkinase inhibitor, continues in Phase II trials in different segments ofmetastatic breast cancer.Selumetinib (AZD6244/ARRY-142886) is a potent MEK (mitogenactivatedprotein kinase 1) inhibitor, licensed from Array BioPharma,Inc. In October, data from a Phase II placebo-controlled study ofselumetinib in combination with docetaxel in the 2nd line treatment oflung cancer patients was reported. The study’s primary endpoint ofoverall survival demonstrated a numerically greater increase in survivalin favour of selumetinib in combination with docetaxel versus docetaxelalone, but did not reach statistical significance. The secondaryendpoints were all demonstrated with statistical significance.AZD4547 is in Phase II testing for solid tumours. AZD1480, AZD2014,AZD3514 and AZD5363 are all completing Phase I studies whileAZD1208 entered Phase I clinical trials in 2011. AZD7762 andAZD2461 were terminated in 2011 while AZD8055, a selective TORkinase inhibitor, was discontinued and effort focused on a secondcompound, AZD2014.We are also developing potential new cancer drugs using a varietyof biologics approaches. Our investigational biologics are directedtowards molecular targets with a strong role in cancer progressionand incorporate innovative technologies, providing the potential toeliminate cancer cells in more effective ways. Within biologics, wecontinue to progress a discovery and clinical pipeline that is balancedacross different anti-tumour approaches, including impacting cancercells directly (growth factor and survival signalling), modulating theblood supply that tumours need to grow (vascular modulation) andactivating a patient’s own immune system to eliminate cancer cells(immune-mediated killing).Tremelimumab is a CTLA-4 MAb and uses certain parts of theimmune system to fight diseases, including cancer. Tumours havemechanisms to evade the immune system, and blockade of CTLA-4with tremelimumab can reactivate the immune system to help fightthe cancer. AstraZeneca entered into an in-licensing agreement withPfizer for tremelimumab in October. Under the terms of thisagreement, AstraZeneca will assume global development rights totremelimumab and Pfizer will retain the rights to use tremelimumabwith specified types of combination therapies. We plan to exploretremelimumab in a number of potential cancer indications.Financial performance 2011/2010Performance 2011Reported performanceOncology sales decreased by 8% to $3,705 million, down from$4,045 million in 2010.Performance – CER growth ratesOncology sales decreased globally by 12%.In the US, sales of Arimidex decreased by 91% to $42 million.Generics now account for 97% of anastrozole prescriptions in the US.Arimidex sales in other markets decreased by 34% to $714 million.Arimidex retained market exclusivity in the major EU markets untilFebruary 2011.Casodex sales outside the US decreased by 8% to $556 million.Iressa sales increased by 32% to $554 million, with strong growthin Western Europe and Emerging Markets.Faslodex sales in the US increased by 71% to $264 million. Salesoutside the US reached $282 million, an increase of 42%, driven bythe increased adoption of the new 500mg dosage regimen.Performance 2010Reported performanceOncology sales were down 10% to $4,045 million compared with$4,518 million in the prior year.Performance – CER growth ratesOncology sales were down 12%.Sales of Arimidex were down 22%. This was mainly due to sales in theUS which were down 44% to $494 million, reflecting the inroads madeby generics since their approval at the end of June 2010. Arimidexsales outside the US were down 3% to $1,018 million.Casodex sales were down 34% with sales in the US down 89% to$16 million as a result of generic competition that began in the thirdquarter of 2009. Sales outside the US were also down 22% to$563 million.Iressa sales increased by 28% to $393 million, including $49 millionof sales in Western Europe. Sales in Japan were up 8%. Sales inEmerging Markets were up 20%, including a 23% increase in China.Faslodex sales for the full year increased by 35% in the US and grewby 32% outside the US.Our biologics pipeline also includes investigational treatments forcancers of the blood as well as for a variety of solid tumours. Wecurrently have two investigational drugs in Phase II trials and fiveinvestigational drugs in Phase I clinical trials. Additional drugcandidates are expected to progress into Phase I and Phase IItrials in 2012.72 Therapy Area Review OncologyAstraZeneca Annual Report and Form 20-F Information 2011
Respiratory & InflammationTherapy area world market(MAT/Q3/11) ($bn)21.6Market sectorsAsthmaCOPDRhinitisOther21.78.412.9In brief> Total Symbicort sales $3.1 billion, up 11%.> Total Pulmicort sales $892 million, unchanged.> In March 2011, the production of Pulmicort (budesonide) 100 and200 µg/dose HFA pMDI (pressurised metered-dose inhaler) wasdiscontinued due to complex manufacturing issues related totechnical aspects of the device, which prevented the ongoingmanufacture of the product.$64.6bnThe prescription respiratory world market value is $64.6 billion.Our marketed products> Symbicort pMDI (budesonide/formoterol in a pressurisedmetered-dose inhaler) is used for the treatment of asthma andchronic obstructive pulmonary disease (COPD), including chronicbronchitis and emphysema in the US.> Symbicort Turbuhaler (budesonide/formoterol in a dry powderinhaler) is a combination of an inhaled corticosteroid and a fastonset, long-acting bronchodilator used for the treatment ofasthma and COPD. It is also approved for maintenance andreliever therapy (SMART) in persistent asthma.> Pulmicort Turbuhaler (budesonide in a dry powder inhaler)is a corticosteroid anti-inflammatory inhalation drug that isused to help prevent the symptoms of, and improve the controlof, asthma.> Pulmicort Respules (budesonide inhalation suspension) is anebulised corticosteroid used for the treatment of asthma in bothchildren and adults. Approved use for Pulmicort Respules variesbased on territory.> Rhinocort (budesonide) is a nasal steroid used as a treatmentfor allergic rhinitis (hay fever), perennial rhinitis and nasal polyps.> Oxis Turbuhaler (formoterol) is a fast onset, long-actingbeta-agonist used for the treatment of asthma and COPD.> Accolate (zafirlukast) is an oral leukotriene receptor antagonistused for the treatment of asthma.Business ReviewAstraZeneca Annual Report and Form 20-F Information 2011Therapy Area Review Respiratory & Inflammation 73
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healthAstraZeneca Annual Reportand
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Financial summary$33.6bnSales down
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China: We announcedour decision to
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OverviewOperational overview7979 pr
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Chairman’s StatementI would like
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Chief Executive Officer’s ReviewA
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The process of getting a drug to ma
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OverviewnovationInnovation drives p
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Our Strategy and PerformanceMore pe
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Using the full range of innovative
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Our strategyMissionto make the most
Page 23 and 24: Our strategic priorities to 2014Our
Page 25 and 26: Our performance in 2011Our performa
Page 27 and 28: Business shapePeopleResponsible bus
Page 29 and 30: Strategy and PerformanceaborationIm
Page 31 and 32: Delivering our strategyOur strategy
Page 33 and 34: Development projects20112010 129342
Page 35 and 36: Investing in capabilitiesA core com
Page 37 and 38: Patent expiries for our key markete
Page 39 and 40: our Established Markets footprint i
Page 41 and 42: Product qualityWe are committed to
Page 43 and 44: We have a global approach, supporte
Page 45 and 46: ComplianceWe ensure a culture of et
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Page 51 and 52: India has the fastest growing numbe
Page 53 and 54: ProtestsAstraZeneca acknowledges th
Page 55 and 56: Also in 2011, the DIHR in collabora
Page 57 and 58: healthcollaborationRaising breast c
Page 59 and 60: Pipeline by Therapy Area at 31 Dece
Page 62 and 63: Therapy Area ReviewIn September, we
Page 64 and 65: Therapy Area ReviewGastrointestinal
Page 66 and 67: Therapy Area ReviewInfectionTherapy
Page 68 and 69: Therapy Area ReviewIn the pipelineI
Page 70 and 71: Therapy Area ReviewOur financial pe
Page 72 and 73: Therapy Area ReviewOncologyTherapy
Page 76 and 77: Therapy Area ReviewOur financial pe
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Page 80 and 81: Geographical ReviewUSAstraZeneca is
Page 82 and 83: Geographical ReviewEmerging Markets
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Page 86 and 87: Financial ReviewMeasuring performan
Page 88 and 89: Financial ReviewResults of operatio
Page 90 and 91: Financial ReviewFinancial position
Page 92 and 93: Financial ReviewCapitalisation and
Page 94 and 95: Financial ReviewResults of operatio
Page 96 and 97: Financial ReviewSensitivity analysi
Page 98 and 99: Financial Reviewover the performanc
Page 100 and 101: healthcollaborationFighting the ris
Page 102 and 103: Board of Directors and Senior Execu
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Directors’ Remuneration ReportSum
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Directors’ Remuneration ReportIn
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Directors’ Remuneration ReportPer
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Directors’ Remuneration ReportGai
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RiskManagement reporting and assura
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RiskCommercialisation and business
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RiskCommercialisation and business
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RiskSupply chain and delivery risks
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RiskEconomic and financial risks co
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Financial StatementsPreparation of
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Financial StatementsConsolidated St
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Financial StatementsConsolidated St
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Financial StatementsGroup Accountin
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Financial StatementsProperty, plant
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Financial StatementsNotes to the Gr
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Financial Statements3 Finance incom
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Financial Statements4 Taxation cont
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Financial Statements6 Segment infor
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Financial Statements9 Intangible as
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Financial Statements10 Other invest
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Financial Statements15 Financial in
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Financial Statements15 Financial in
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Financial Statements18 Post-retirem
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Financial Statements18 Post-retirem
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Financial Statements20 Share capita
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Financial Statements23 Financial ri
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Financial Statements23 Financial ri
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Financial Statements24 Employee cos
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Financial Statements25 Commitments
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Financial Statements26 LeasesTotal
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Financial StatementsIndependent Aud
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Financial StatementsCompany Account
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Financial Statements4 ReservesShare
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Financial StatementsGroup Financial
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Development PipelineNCEsPhase III/R
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Development PipelineNCEsPhases I an
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Shareholder Information> For shares
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Shareholder InformationDocuments on
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Corporate InformationHistory and de
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GlossaryThe following abbreviations
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Index2011 performance summary 23Acc
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Contact informationRegistered offic
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AstraZeneca Annual Report and Form 20-F Information 2011

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