AstraZeneca Annual Report and Form 20-F Information 2011

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