The spectrumStudy 15 is part of adverse events associated with cediranibthe Phase III clinical trial program, ENTHUSE, which was broadly consistent with previous studies.  HORIZON III continues with ongoing collection of overall survival data.

On March 1, 2010,February 7, 2011 the Company and Targacept, Inc. announced the enrolment of the first patient in the Phase IIb clinical trial of TC-5214, a nicotinic channel blocker, as a “switch” monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies’ Phase III RENAISSANCE program for TC-5214 as an adjunctive treatment for MDD. The RENAISSANCE program is designed to support an NDA filing in the US planned for the second half of 2012 and a Marketing Authorization Application (MAA) filing in Europe planned for 2015. AstraZeneca and Targacept are co-developing TC-5214.

On February 23, 2011 the Company and Bristol-Myers Squibb Company announced that under the provisionsFDA has approved the inclusion of data from two clinical studies in an update to the ONGLYZA (saxagliptin) US Prescribing Information for adult type 2 diabetes patients.

On February 16, 2010,March 4, 2011 the Company and Rigel Pharmaceuticals, Inc. (“Rigel”)Bristol-Myers Squibb Company announced an exclusive worldwide license agreementthat the European Commission has approved a label update for ONGLYZA® (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment. The approved dosage for the global development and commercialization of fostamatinib disodium (R788), Rigel’s late-stage investigational product for rheumatoid arthritis (“RA”) and additional indications.  Fostamatinib disodium, which has completedpatient group is a comprehensive Phase II program, is the furthest developed oral Spleen Tyrosine Kinase (“Syk”) inhibitor being evaluated for RA. Inhibiting Syk is thought to block the intracellular signaling of various immune cells implicated in the destruction of bone and cartilage which is characteristic of RA.new once-daily 2.5 mg dose.

OnceONGLYZA will be the agreementfirst dipeptidyl peptidase-4 (DPP-4) inhibitor in Europe available for type 2 diabetes patients with moderate or severe renal impairment. ONGLYZA is effective, the Company will make an upfront paymentindicated in adult patients with type 2 diabetes mellitus to Rigel of US $100 millionimprove glycaemic control in combination with up to an additional US $345 million payable if specified development, regulatorymetformin, sulphonylurea, or thiazolidinedione, when each treatment alone, with diet and first commercial sale milestones are achieved.  Rigel will also be eligible to receive up to an additional US $800 million of specified sales-related milestone payments if the product achieves considerable levels of commercial success, as well as significant stepped double-digit royalties on net sales worldwide.  The Company is responsible for all development, regulatory filings, manufacturing and global commercialization activities in all licensed indications under the contract. Effectiveness of the agreement is contingent on expiration or termination of the waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.exercise, does not provide adequate glycaemic control.

The Company will design a global phase III program, anticipatedThis label update was granted on the basis of clinical data submitted to begin in the second half of 2010, with the goal of filing new drug applications with the US Food and Drug Administration (the “FDA”) and the European Medicines Agency (EMEA)from a 12-week, multi-centre, randomized, double-blind, placebo-controlled study to evaluate the treatment effect of ONGLYZA 2.5 mg once daily compared with placebo in 2013.  Fostamatinib disodium is being developed as a next generation oral RA therapy170 patients with Type 2 diabetes and renal impairment (creatinine clearance [CrCl] <50 mL/min). In this study, 98.2% of the patients were treated with other antihyperglycaemic medication. The results of the study, which are described in the Summary of Product Characteristics (SmPc), demonstrated that ONGLYZA 2.5 mg was safe and effective, compared with placebo, in adults with type 2 diabetes who have failedmoderate or severe renal impairment.

On March 7, 2011 the Company announced that it will discontinue the production of PULMICORT® (budesonide) 100 and 200 µg/dose HFA pMDI (pressurized metered dose inhaler) due to complex manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product. This issue is not related to the active ingredient, budesonide, or any other AstraZeneca product.

PULMICORT pMDI is manufactured using product-specific processes and components, the combination of which is not used with any other AstraZeneca respiratory products; therefore, this is a traditional disease modifying anti-rheumatic drug (DMARD)unique issue to PULMICORT pMDI.

AstraZeneca is working closely with the appropriate regulatory authorities and healthcare professionals (HCPs), and is informing manufacturers of similar asthma medications, where appropriate, to ensure all patients continue to receive the appropriate alternative treatment.

Other AstraZeneca respiratory products, including PULMICORT® Turbuhaler®, PULMICORT® Respules® and PULMICORT® Flexhaler® are not affected because they use different devices or device components. Other AstraZeneca pMDI products such as methotrexate, where a TNF biologic add-on treatment would currently be considered. Under the terms of the agreement, the Company willSYMBICORT® budesonide/formoterol fumarate dihydrate) pMDI and VANNAIR© (budesonide/formoterol) are also receive exclusive rights to Rigel’s portfolio of oral Syk inhibitors, as well as for additional indications for fostamatinib disodium beyond RA.not affected.

On February 9, 2010,March 8, 2011 the Company and Bristol-Myers Squibb Company announced that the approvalFDA has accepted for review an NDA for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. An MAA for dapagliflozin has also been validated by the European Medicines Agency (EMA). The NDA and MAA submissions for dapagliflozin were filed in December 2010. The PDUFA goal date for the FDA of CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (“CVD”) based on age (men ≥50 and women ≥60), high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.is October 28, 2011.

 

The information (including tabular data) set forth under the headings “Directors’“Corporate Governance—Corporate Governance Report—Corporate Governance—Business Organisation and Corporate Governance—Other matters—Subsidiaries and principal activities” on page 98117 and “Financial Statements—Principal Subsidiaries” on page 186,197, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.

The information (including tabular data) set forth under the headings “Directors’ Report—Reviews—“Business Review—Delivering our strategy—Research and Development—Our resources” on pages 29 to 30, “—Delivering our strategy—Supply and Manufacturing—Our resources” on page 35, “Business Review—Financial Review—Financial position including cash flow and liquidity – 2009—2010—Property, plant and equipment” and “—Financial position including cash flow and liquidity – 2008—2009—Property, plant and equipment”, on pages 3985 and 43,89, respectively, “Directors’ Report—Corporate“Corporate Governance—Risk—Principal risks and uncertainties—Legal, regulatory and compliance risks—Environmental/occupational health and safety liabilities” on page 85,102, “Financial Statements—Notes to the Financial Statements—Note 7—Property, plant and equipment” on page 153, “—Note 25—Commitments and contingent liabilities—Environmental costs and liabilities” on page 168, “—Note 7—Property, plant180 and equipment” on page 139 and ‘Additional“Additional Information—Corporate Information—Articles—Property” on page 204,216, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.

ITEM 4A -4A.  UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 5 -5.  OPERATING AND FINANCIAL REVIEW AND PROSPECTS

The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Performance—Business Environment—World pharmaceutical markets” on page 13, “Directors’ Report—Reviews—“Business Review—Financial Review” on pages 3678 to 49, “—Reviews—93, “Business Review—Geographical Review” on pages 5070 to 54, “—Reviews—74, “Business Review—Therapy Area Review—Sales by Therapy Area” (comprising(consisting of tabular data only)data) on page 55, “—Reviews—50,“—Therapy Area Review—Our financial performance” (comprising(consisting of tabular data only)data) on pages 53, 57, 61, 63, 66, 6959, 62, 65 and 72,68, “—Reviews—Therapy

Area Review—Financial performance 2009/2008”2010/2009” on pages 59, 61, 64, 67, 7055, 57, 60, 63, 66 and 74, “Directors’ Report—Performance—Resources, Skills and Capabilities—69, “Business Review—Other Businesses—Our financial performance” (consisting of tabular data) on page 75, “Business Review—Delivering our strategy—Research and Development” on pages 2226 to 27, “Directors’30, “Corporate Governance—Corporate Governance Report—CorporateBusiness organization—Portfolio Investment Board (PIB)” on page 116, “Corporate Governance—Risk—Principal risks and uncertainties—Commercialization and business execution risks—Competition, price controls and price reductions” on page 83,pages 99 to 100, “Financial Statements—Notes to the Financial Statements—Note 14—Interest-bearing loans and borrowings” on page 144,158, “—Note 15—Financial risk management objectives and policies” on pages 144 to 146, “—Note 16—Financial instruments” on pages 146158 to 152,161, “—Note 19—Capital and reserves—Other reserves” on page 153166, “—Note 23—Financial risk management objectives and policies” on pages 168 to 172 and “—Note 25—Commitments and contingent liabilities” on pages 166178 to 184,195, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.

ITEM 6 -6.  DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

The information set forth under the headings “Directors’ Report—Corporate“Corporate Governance—Business OrganisationBoard of Directors and Corporate Governance—Senior Executive Team—Board of Directors at 31 December” and “—Board of Directors and Senior Executive Team—Senior Executive Team at 31 December” on pages 88106 and 89,107, and pages 90 and 91,page 108, respectively, “Directors’ Report—Corporate“Corporate Governance—Directors’ Remuneration Report—Remuneration and terms of employment for Executive Directors and other SET members—Variable performance-related remuneration—Policy on external appointments and retention of fees” on page 110128 and “—Directors’ Remuneration Report—Directors’ emoluments in 2009—2010—Directors’ remuneration-US dollars” (last sentence only) on page 113,130, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.

The information (including graphs and tabular data) set forth under the headings “Directors’ Report—Corporate“Corporate Governance—Directors’ Remuneration Report” on pages 101119 to 119,134, “Financial Statements—Notes to the Financial Statements—Note 23—18—Post-retirement benefits” on pages 156162 to 161,166, “—Note 24—Employee costs and share option plans for employees” on pages 161173 to 165177 and “—Note 27—Statutory and other information—Key management personnel compensation”, on page 185,196, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.

The information (including tabular data) set forth under the headings “Directors’ Report—Corporate“Corporate Governance—Business OrganisationBoard of Directors and Corporate Governance—Senior Executive Team—Board of Directors at 31 December” on pages 88 and 89, “—Senior Executive Team at 31 December” on pages 90106 and 91, “—Operation of the Board”107, and page 108, respectively, “Corporate Governance—Corporate Governance Report—Leadership” on pages 92 and 93, —Board109 to 110, “—Board effectiveness” on pages 110 to 111, “—Board Committee membership” (including(consisting of tabular data) on page 112, “—Audit Committee” on pages 113 to 114, “—Remuneration Committee”, “—Nomination and Governance Committee” and “—Directors”Science Committee”, each on page 93,115, “—Operation of Board Committees”Business organization—Compliance and Group Internal Audit (GIA)” on pages 94 to 96, “—Principal corporate governance requirements—UK corporate governance requirements” on pages 96 to 97116 and “—US corporate governance requirements” on page 97, “Directors’ Report—Corporate117, “Corporate Governance—Directors’ Remuneration Report—Variable performance-related remuneration—Service contracts” and “—Non-Executive Directors”, each on page 110,128, and “—Directors’ Remuneration Report—Audit—Details of Executive Directors’ service contracts at 31 December 2009”2010” and “—Non-Executive Directors’ terms and conditions” (consisting of tabular data), each on page 111,129, in each case of the Company’s “Annual Report and Form 20-F Information 2009”2010” included as exhibit 15.1 to this Form 20-F dated March 25, 2010April 28, 2011 is incorporated by reference.