AstraZeneca Annual Report and Form 20-F Information 2011

More documents

Recommendations

Info

Delivering our strategyPipeline deliveryMilestone Product 2011 AchievementKey pipelineprogressionsMajor marketapprovalsCAZ AVINKTR-118DapagliflozinBrilinta/Brilique (ticagrelor)Caprelsa (vandetanib)Axanum (esomeprazole/ASA)Komboglyze (saxagliptin/metformin HCI)Fluenz (live attenuated, intranasalinfluenza vaccine)Nexium (esomeprazole)Faslodex (fulvestrant) 500mgInitiation of Phase III programme for CAZ AVI (a combination of ceftazidime andavibactam, formerly known as CAZ-104) for the treatment of complicated intraabdominaland complicated urinary tract infectionsInitiation of Phase III programme for treatment of opioid-induced constipationFDA acceptance of NDA file for treatment of adult patients with Type 2 diabetes;Complete Response Letter received from the FDA in January 2012 requestingadditional clinical dataRegulatory approvals in US, Canada and 64 countries in total for the preventionof cardiovascular events in patients with acute coronary syndromesFDA approval for treatment of symptomatic and progressive medullary thyroid cancerin patients with unresectable locally advanced or metastatic disease. Positive opinionreceived from CHMP regarding MAA for CaprelsaApproval by 23 EU member states as a treatment to prevent CV events in high-riskCV patients in need of low dose ASA who are at risk of gastric ulcersEuropean Commission approval as a treatment for adults with Type 2 diabetesEU marketing authorisation granted for the treatment of seasonal influenza forchildren from 24 months to less than 18 yearsApproval in Japan for acid-related conditions including NERD, reflux esophagitis,and PUDApproval in Japan for the treatment of post-menopausal women with hormonereceptor-positive metastatic breast cancer which has recurred or progressedfollowing prior endocrine therapyOur collaboration efforts have resulted in a combination of internallyand externally sourced compounds throughout our portfolio, withvarious development partnerships with biotechnology firms, researchinstitutions and other pharmaceutical companies. We previouslyannounced our intention to source up to 40% of our pipeline fromoutside our laboratories by 2014 and we are on track to deliver thatcommitment. Collaborating externally enables us to build the valueof our internally-sourced products and identify external sources ofcutting-edge science that will enhance and amend our own portfolioof compounds. External partnerships announced in 2011 include:> Tremelimumab, a late stage CTLA-4 MAb in oncology whichAstraZeneca in-licensed from Pfizer for the potential treatmentof a number of oncology indications.> A collaboration with the UK Medical Research Council (MRC) inwhich UK academic researchers are provided with access to over20 compounds developed by AstraZeneca, for investigation aspotential new treatments across a spectrum of diseases.> AMG-108, a novel MAb targeting the IL-1 pathway with potential fortreating certain inflammatory diseases, which AstraZeneca licensedfrom Amgen Inc.> A strategic collaboration with the Sarah Cannon Research Institute(SCRI), an international leader in advancing therapies for cancerpatients through clinical research, under which SCRI will lead theclinical development of a novel targeted oncology compound fromAstraZeneca.> A collaborative research agreement with Galderma Pharma S.A.,a global specialty pharmaceutical company to develop AstraZenecacompounds into new treatments for a range of skin conditionsincluding psoriasis, acne and atopic dermatitis.> A collaboration with Manchester University and GSK to establishthe Manchester Collaborative Centre for Inflammation Research(MCCIR), a translational science centre that will bring togetherindustry researchers and academia in an alliance to study chronicinflammatory diseases.> AZD4694, a late stage radiopharmaceutical imaging candidate,out-licensed to Neoprobe Corporation. AZD4694 is a fluorine-18labelled radiotracer discovered by AstraZeneca to supportdevelopment of potential treatments for Alzheimer’s disease.> Our biologics capabilities signed its first oncology researchagreement in China with the Shanghai Chest Hospital. The goalof this collaboration is to build a database of small and non-smallcell lung cancer cases.We continue to search actively for opportunities to advance scienceand public health through research collaborations and partnerships.This is demonstrated by our ongoing efforts with organisationssuch as the European Innovative Medicines Initiative (IMI) aimed atimproving tools, technologies, methodologies and knowledgemanagement and additional collaborations with the UK MRC andthe World Intellectual Property Organisation (WIPO). We have madea significant commitment to the field of neglected tropical diseases(NTDs) R&D via our founder membership of WIPO’s ‘WIPO Re:Search’consortium. This consortium promotes the formation of researchpartnerships aimed at driving the identification of solutions to NTDswhich are less commercially attractive disease targets, but haveparticularly severe effects in the world’s least developed countries.Our commitment to WIPO Re:Search includes the promise tocontribute a range of resources, technology and IP.32 Delivering our strategy Research and DevelopmentAstraZeneca Annual Report and Form 20-F Information 2011
Investing in capabilitiesA core component of our R&D strategy is strengthening four corecapabilities. In 2010, we announced an investment of more than$200 million over five years to develop capabilities in the areas ofpayer partnering, personalised healthcare, predictive science andclinical design. We are making steady progress in building theseskills both internally and through external collaborations. Examplesof our efforts in 2011 include:> Payer partnering – a new payer evidence function has beenestablished to support both our Commercial and R&D organisationsin addressing the evidence needs of payers at every stage of theproduct life-cycle. A key part of this support comes from newcapabilities in analysing observational data. We have entered aunique collaboration with HealthCore, the health outcomes researchsubsidiary of Wellpoint, Inc., to conduct real world studies, designedto determine how to most effectively and economically treatdiseases. This provides access to the largest commercially insuredpopulation data environment in the US and is fully operational,supporting both development projects and marketed brands.Building on this, in January 2012, we signed a three-year collaborationagreement with IMS Health Inc., providing AstraZeneca with accessto pre-existing anonymised health records. This information willprovide a degree of insight into how medicines that are already onthe market are working in real-world settings across Europe, and willhelp inform our discovery and clinical development programmes.> Personalised healthcare – our personalised healthcare capabilityis focused on identifying patients that are most likely to benefit fromour medicines. The proportion of our development portfolio utilisingor investigating personalised healthcare approaches such as theuse of biomarkers has increased from 25% at the end of 2010 toover 50%, including 10 projects that involve a companion diagnosticto target therapy. Our recently formed personalised healthcaregroup continues to support Iressa with initiatives to improve thespeed and quality of diagnostic testing, contributing to Iressa’sincrease in sales.> Predictive science – we are integrating modelling and simulationinto many different aspects of R&D. We recruited 25 external expertsfrom the global modelling and simulation community to acceleratethe development of our predictive science capability. Modellingand simulation is now used in the areas of biology, chemistry,formulation development, preclinical and clinical safety assessment,pharmacokinetic and pharmacodynamic evaluation and clinicaltrial simulation.> Clinical design – we implemented a range of innovative changesto drive consistency and excellence in the critically importantcapability of clinical trial design and interpretation. Almost 90%of our R&D teams have incorporated the changes and are startingto utilise a new design and interpretation framework.Our resourcesAt the end of 2011, our R&D organisation comprised approximately11,300 people at 14 principal centres in eight countries.Our R&D transformation that began in 2010 has been largelycompleted, resulting in the closure of several of our R&D facilitiesand a net reduction of 1,400 positions. The exit of R&D personneland activities from the Charnwood site in the UK and the Lund sitein Sweden was completed in 2011 and the facilities will be closed inearly 2012. Our approach to implementing such change is outlinedin the Managing change in our organisation section on page 42.In February 2012, we announced the next phase of restructuring.Further details are set out in the Our strategic priorities to 2014 sectionfrom page 21.Our R&D geographic footprint includes four main small moleculefacilities in: the UK (Alderley Park and Macclesfield); Sweden (MöIndal);and the US (Waltham, Massachusetts). Other sites with a focus onresearch are in Sweden (Södertälje), Canada (Montreal, Quebec) andFrance (Reims). We also have a clinical development facility in Osaka,Japan. Our principal sites for biologics and vaccines are in the US(Gaithersburg, Maryland and Mountain View, California) and in theUK (Cambridge). Our Wilmington, Delaware site in the US now focuseson late stage development across the portfolio. Finally, our strategicexpansion in Emerging Markets continues and includes the growth ofour ‘Innovation Centre China’ research facility in Shanghai, China aswell as our research facility in Bangalore, India.In 2011, there was Core R&D expenditure 1 of $5.0 billion in ourR&D organisation (2010: $4.2 billion; 2009: $4.3 billion). In addition,$189 million was spent on acquiring product rights (such asin-licensing) (2010: $1,017 million; 2009: $764 million) and weinvested approximately $468 million on the implementation of ourR&D restructuring strategy. The allocations of 2009-2011 spend byearly and late activities are presented below.R&D spend analysis 2011 2010 2009iMeds (%) (Discovery and early56% 73% 70%development)GMD (%) (Late stage development) 44% 27% 30%Core R&D costs ($m) 5,033 4,219 4,3341Reported expenditure in our R&D organisation was $5.5 billion (2010: $5.3 billion;2009: $4.4 billion).Business ReviewAstraZeneca Annual Report and Form 20-F Information 2011Delivering our strategy Research and Development 33
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 and 12: Chief Executive Officer’s ReviewA
Page 13 and 14: The process of getting a drug to ma
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: Development projects20112010 129342
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
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 74 and 75: Therapy Area Reviewendpoints of pro
Page 76 and 77: Therapy Area ReviewOur financial pe
Page 78 and 79: healthinnovationReducing the number
Page 80 and 81: Geographical ReviewUSAstraZeneca is
Page 82 and 83: Geographical ReviewEmerging Markets
Page 84 and 85:
Disciplined execution of our strate
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
Page 104 and 105:
Board of Directors and Senior Execu
Page 106 and 107:
Corporate Governance ReportOperatio
Page 108 and 109:
Corporate Governance ReportThe Boar
Page 110 and 111:
Corporate Governance ReportDuring 2
Page 112 and 113:
Corporate Governance ReportBusiness
Page 114 and 115:
Corporate Governance ReportPolitica
Page 116 and 117:
Directors’ Remuneration ReportDav
Page 118 and 119:
Directors’ Remuneration ReportVar
Page 120 and 121:
Directors’ Remuneration ReportAdd
Page 122 and 123:
Directors’ Remuneration ReportSum
Page 124 and 125:
Directors’ Remuneration ReportSum
Page 126 and 127:
Directors’ Remuneration ReportIn
Page 128 and 129:
Directors’ Remuneration ReportPer
Page 130 and 131:
Directors’ Remuneration ReportGai
Page 132 and 133:
RiskManagement reporting and assura
Page 134 and 135:
RiskCommercialisation and business
Page 136 and 137:
RiskCommercialisation and business
Page 138 and 139:
RiskSupply chain and delivery risks
Page 140 and 141:
RiskEconomic and financial risks co
Page 142 and 143:
Financial StatementsPreparation of
Page 144 and 145:
Financial StatementsConsolidated St
Page 146 and 147:
Financial StatementsConsolidated St
Page 148 and 149:
Financial StatementsGroup Accountin
Page 150 and 151:
Financial StatementsProperty, plant
Page 152 and 153:
Financial StatementsNotes to the Gr
Page 154 and 155:
Financial Statements3 Finance incom
Page 156 and 157:
Financial Statements4 Taxation cont
Page 158 and 159:
Financial Statements6 Segment infor
Page 160 and 161:
Financial Statements9 Intangible as
Page 162 and 163:
Financial Statements10 Other invest
Page 164 and 165:
Financial Statements15 Financial in
Page 166 and 167:
Financial Statements15 Financial in
Page 168 and 169:
Financial Statements18 Post-retirem
Page 170 and 171:
Financial Statements18 Post-retirem
Page 172 and 173:
Financial Statements20 Share capita
Page 174 and 175:
Financial Statements23 Financial ri
Page 176 and 177:
Financial Statements23 Financial ri
Page 178 and 179:
Financial Statements24 Employee cos
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Financial Statements25 Commitments
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Financial Statements26 LeasesTotal
Page 194 and 195:
Financial StatementsIndependent Aud
Page 196 and 197:
Financial StatementsCompany Account
Page 198 and 199:
Financial Statements4 ReservesShare
Page 200 and 201:
Financial StatementsGroup Financial
Page 202 and 203:
Development PipelineNCEsPhase III/R
Page 204 and 205:
Development PipelineNCEsPhases I an
Page 206 and 207:
Shareholder Information> For shares
Page 208 and 209:
Shareholder InformationDocuments on
Page 210 and 211:
Corporate InformationHistory and de
Page 212 and 213:
GlossaryThe following abbreviations
Page 214 and 215:
Index2011 performance summary 23Acc
Page 216:
Contact informationRegistered offic
show all

AstraZeneca Annual Report and Form 20-F Information 2011

Create successful ePaper yourself

Delete template?

Save as template?