AstraZeneca Annual Report and Form 20-F Information 2011

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OverviewLife-cycle of a medicineFind potentialmedicineIdentify the unmet medical needand market opportunity. Undertakelaboratory research to find a potentialmedicine that should be potent,selective and absorbed into andwell tolerated by the body.Begin the process of seeking patentprotection for the potential medicine.Collaborate with academia andexternal clinicians to access the bestexternal science and medical opinion.Preclinical studiesUndertake studies in the laboratoryand in animals to understand if thepotential medicine should be safe tointroduce into humans and in whatquantities.Determine likely efficacy, side effectprofile and maximum tolerable doseestimate in humans.Regulatory authorities are informedof proposed trials which are thenconducted within the framework ofthe relevant regulations.Phase I studiesStudies designed to understand how thepotential medicine is absorbed in the body,distributed around it and excreted; alsodetermine an appropriate dosage and identifyside effects. These typically take place in smallgroups of healthy human volunteers or, incertain cases, patients.Confirm the most appropriate formulation andbegin to develop manufacturing route to ensurethe manufacturing process is robust and costsare minimised.May involve external clinicians and organisationsin the design and running of these studies.Time (years)0 1 2 3 4 5 6 7 8 9Phase Discovery Preclinical ClinicalOverallprobabilityof success 1Phase I63%Phase II30%Phase III7%Phase II studiesStudies designed to evaluateeffectiveness of the medicine, typicallyusing small groups of patients.During Phase II studies, design aPhase III programme to deliver datarequired for regulatory approval andpricing and/or reimbursementthroughout the world.External advisory panels help definethe attributes to test in studies todemonstrate whether the potentialnew medicine can be differentiatedfrom the existing standard treatmentof care.Phase III studiesStudies, typically in large groupsof patients, designed to gatherinformation about effectiveness andsafety of the medicine and evaluatethe overall benefit/risk profile inthe specific disease and patientsegments in which the medicinewill be used.Create appropriate branding forthe new medicine in preparationfor launch.Regulatorysubmission andpricingSeek approval from regulatoryauthorities to manufacture, marketand sell the medicine.Submit package of clinical datawhich demonstrates the safetyprofile and efficacy of the medicineto regulatory authorities.Regulatory authorities decide whetherto grant marketing authorisationbased on the medicine’s safetyprofile, effectiveness and quality.Large numbers of national, regionaland local payers grant approval forthe pricing and/or reimbursementof the medicine.10 Life-cycle of a medicineAstraZeneca Annual Report and Form 20-F Information 2011
The process of getting a drug to market, from initial discovery,through development to approval and launch is risky, costly andtime consuming. This is a high level overview of the process.It is illustrative only. It is not intended to, nor does it, representthe life-cycle of any particular medicine or of every medicinediscovered and/or developed by AstraZeneca nor of theprobability of success or approval of any AstraZeneca medicine.OverviewLaunch new medicineRaise awareness of patient benefit and appropriate use.Market and sell medicine; continuously monitor, record andanalyse reported side effects; review need to update the sideeffect warnings to ensure that patients’ wellbeing is maintained.Clinicians begin to prescribe medicine and patients beginto benefit.Patent expiryand generic entryTypically, when patents protecting themedicine expire, generic versions ofthe medicine may enter the market.10 11 12 13 14 15 16 17 18 19 20+Approval and launchApproval3%Post-launch research anddevelopmentStudies to further understand the safety profile of the medicinein larger populations.1The line marked ‘Overall probability of success’is the probability that a compound in preclinicaldevelopment will reach each phase ofdevelopment and subsequent approval. Forexample, only 7% of preclinical compoundsenter Phase III studies. (Source: PharmaceuticalBenchmarking Forum, 2011.)Sponsors and regulatory authorities monitor the safety ofmedicines post-approval and update prescribing informationas necessary.Includes ‘life-cycle management’ activities to broadenunderstanding of the medicine’s full potential.Work with external advisory groups and regulatory authorities toconsider potential additional diseases which might be treated bythe medicine or better ways of administering the medicine.Submit data packages with requests for line extensions.Regulatory authorities review the data to assess the benefits andrisks of using the medicine in the new disease or population andissue a decision.AstraZeneca Annual Report and Form 20-F Information 2011 Life-cycle of a medicine 11
Page 1 and 2: healthAstraZeneca Annual Reportand
Page 3 and 4: Financial summary$33.6bnSales down
Page 5 and 6: China: We announcedour decision to
Page 7 and 8: OverviewOperational overview7979 pr
Page 9 and 10: Chairman’s StatementI would like
Page 11: Chief Executive Officer’s ReviewA
Page 15 and 16: OverviewnovationInnovation drives p
Page 17 and 18: Our Strategy and PerformanceMore pe
Page 19 and 20: Using the full range of innovative
Page 21 and 22: 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
Page 47 and 48: tegrityBusiness ReviewWe are dedica
Page 49 and 50: Delivering our strategyResponsible
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
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Therapy Area ReviewIn September, we
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Therapy Area ReviewGastrointestinal
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Therapy Area ReviewInfectionTherapy
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Therapy Area ReviewIn the pipelineI
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Therapy Area ReviewOur financial pe
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Therapy Area ReviewOncologyTherapy
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Therapy Area Reviewendpoints of pro
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Therapy Area ReviewOur financial pe
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healthinnovationReducing the number
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Geographical ReviewUSAstraZeneca is
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Geographical ReviewEmerging Markets
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Disciplined execution of our strate
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Financial ReviewMeasuring performan
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Financial ReviewResults of operatio
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Financial ReviewFinancial position
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Financial ReviewCapitalisation and
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Financial ReviewResults of operatio
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Financial ReviewSensitivity analysi
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Financial Reviewover the performanc
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healthcollaborationFighting the ris
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Board of Directors and Senior Execu
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Board of Directors and Senior Execu
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Corporate Governance ReportOperatio
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Corporate Governance ReportThe Boar
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Corporate Governance ReportDuring 2
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Corporate Governance ReportBusiness
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Corporate Governance ReportPolitica
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Directors’ Remuneration ReportDav
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Directors’ Remuneration ReportVar
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Directors’ Remuneration ReportAdd
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Directors’ Remuneration ReportSum
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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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