AstraZeneca Annual Report and Form 20-F Information 2011

NSAID – a non-steroidal anti-inflammatory drug.NYSE – the New York Stock Exchange.operating profit – sales, less cost of sales, less operating costs, plusoperating income.Ordinary Share – an ordinary share of $0.25 each in the sharecapital of the Company.Orphan Drug – a drug which has been approved for use in arelatively low-incidence indication (an orphan indication) and has beenrewarded with a period of market exclusivity; the period of exclusivityand the available orphan indications vary between markets.OTC – over-the-counter.Paediatric Exclusivity – in the US, a six-month period of exclusivityto market a drug which is awarded by the FDA in return for certainpaediatric clinical studies using that drug. This six-month period runsfrom the date of relevant patent expiry. Analogous provisions areavailable in certain other territories (eg European SPC paediatricextensions).Patent Term Extension (PTE) – an extension of up to five yearsin the term of a US patent relating to a drug which compensates fordelays in marketing resulting from the need to obtain FDA approval.The analogous right in the EU is a supplementary protectioncertificate (SPC).PDUFA – Prescription Drug User Fee Act.Pfizer – Pfizer, Inc.Phase I – the phase of clinical research where a new drug ortreatment is tested in small groups of people (20 to 80) to checkthat the drug can achieve appropriate concentrations in the body,determine a safe dosage range and identify side effects. This phaseincludes healthy volunteer studies.Phase II – the phase of clinical research which includes the controlledclinical activities conducted to evaluate the effectiveness of the drug inpatients with the disease under study and to determine the commonshort-term side effects and risks associated with the drug. Phase IIstudies are typically conducted in a relatively small number of patients(usually no more than several hundred).Phase III – the phase of clinical research which is performed togather additional information about effectiveness and safety of thedrug, often in a comparative setting, to evaluate the overall benefit/riskprofile of the drug. Phase III studies usually include between severalhundred and several thousand patients.PhRMA – Pharmaceutical Research and Manufacturers of America.pounds sterling, £, GBP, pence or p – references to the currency ofthe UK.Pozen – Pozen Inc.Proof of Concept – data demonstrating that a candidate drug resultsin a clinical change on an acceptable endpoint or surrogate in patientswith the disease.PSP – AstraZeneca Performance Share Plan.PUD – peptic ulcer disease.QT prolongation – a biomarker of ventricular tachyarrhythmiasmeasured by ECG.R&D – research and development.Redeemable Preference Share – a redeemable preference shareof £1 each in the share capital of the Company.Regulatory Data Protection – see the Intellectual Property sectionfrom page 34.Regulatory Exclusivity – any of the IP rights arising from generationof clinical data and includes Regulatory Data Protection (as explainedin the Intellectual Property section from page 34), Paediatric Exclusivityand Orphan Drug status.Responsible Business Plan – the plan described in theResponsible Business section from page 47, further details of whichcan be found at our website, astrazeneca.com/responsible/management-and-measurement/responsible-business-plan.Rigel – Rigel Pharmaceuticals, Inc.RSV – respiratory syncytial virus.Sarbanes-Oxley Act – the US Sarbanes-Oxley Act of 2002.SEC – the US Securities and Exchange Commission, thegovernmental agency that regulates the US securities industry/stockmarket.Seroquel – Seroquel IR and Seroquel XR unless otherwise stated.SET – the Senior Executive Team.SHE – Safety, Health and Environment.SFDA – State Food and Drug Administration of China.SG&A costs – selling, general and administrative costs.Six Sigma – a rigorous and disciplined methodology that uses dataand statistical analysis to measure and improve a company’soperational performance by identifying and eliminating defects.sNDA – a supplemental new drug application, which is an applicationmade to the FDA to seek approval to market an additional indicationfor a drug already on the market.SOP – AstraZeneca Share Option Plan.Targacept – Targacept, Inc.Teva – Teva Pharmaceuticals USA, Inc.TKI – Tyrosine Kinase Inhibitors.TSR – total shareholder return, being the total return on a share over aperiod of time, including dividends reinvested.UK – the United Kingdom of Great Britain and Northern Ireland.UK Bribery Act – means the UK Bribery Act 2010.UK Corporate Governance Code – the UK Corporate GovernanceCode published by the Financial Reporting Council in May 2010that sets out standards of good practice in corporate governancefor the UK.US – the United States of America.US dollar, US$, USD or $ – references to the currency of the US.WHO – the World Health Organization, the United Nations’ specialisedagency for health.Additional InformationAstraZeneca Annual Report and Form 20-F Information 2011Glossary 211