CONFIDENTIALPharmaceuticalLife

CycleManagement(LCM)Today′sdiscussion * FootnoteSource: SourceKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissuesLifeCycleManagementLifeCycleManagementislargely

aboutbuildingbrandsovertime–

byincrementalinvestmentsinvaluecreatingactivitiestomaximize

thevalueofacompoundObjectiveBuildingabusinessbasedonagreatproductidea/brand–notjustlaunchaninnovationMindsetLCMrequiresacommercialmindsetSettingambitionlevelShape

theproductShape

themarketShapethecompanyLCMrequiresacommercialmindsetSettingambitionlevelShape

theproductEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation

(e.g.,mostimportantindications)LCMrequiresacommercialmindsetSettingambitionlevelShape

themarketShapethemarketearly

andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyLCMrequiresacommercialmindsetSettingambitionlevelShapethecompanyHaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployees

tobringproducttomarketPartnership/

communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesLCMrequiresacommercialmindsetSettingambitionlevelEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation(e.g.,mostimportantindications)HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership/

communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesShapetheproductShapethemarketearly

andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyShape

themarketShapethecompanyThelifecyclecanbedividedintothreephasesActionsoftentakenyearsearlier!YearOverallambitions0–4GainmarketshareEstablishmarketRapidsalesramp-up5–10ExpandmarketGainmarketshare11+MinimizeimpactofgenericsDevelopandlaunchline-extensionsTypicalindustrycurvePotentialcurvewithactiveLCMPhaseLaunchExtendSustainBestpracticetargetsfor”launch”phaseAmbitionsRapidgrowthinmarketshare(x%byyear4)Establishoverallmarket(fromytozbillionUSD)Rapidsalesrampup(a%ofyear4salesinyear2)AlignandanchortargetswithentireorganizationShapetheproductRapidlaunchacrossallmarketsProductlabel/positioning/brandingisconsistentanddifferentiatedCompetitormovesandstrategiesassessedandimplicationstaken–

inadvanceLCMstrategy/positioningovertimeisclearlyidentifiedShapethemarketEstablishKOLnetworkandbuildbaseforongoingrelationshipPricingstrategybalancesneedforquickapproval/penetrationandestablishingfavorablelong-termpositionMarketingmixandfocusonkeyinfluencerstoreachambitionClinical“shareofvoice”andpublicationlevelsofsufficientmagnitudeandqualityShapethecompanyCompetitiveinvestmentlevelacrossmarkets(e.g.,xperpatient)Transitionglobalteamroleandcomposition;Educate,exciteandalignlocalteamsandsalesforceCreateandmaintainmasterplanningchartoflaunchactivitiesNegotiatepossiblealliances/co-promotionarrangementtooptimizegeographicalcoverageSelectingtherightlabelrequiresaclearambitionExampleofambitionlevelstaircaseKeyinputintolabelWhatlabelisneededtogettothenextstep?Productname,projectnameProductvisionCompetitiveenvironmentMainpatientandcustomergroupsandtheirkeyunmetneedsPricingstrategyKeyclaimsforlaunchGo/nogoRelativevalueRouteofadministrationDosingregimenLabelindication(s)LaunchdateKeyissuesNogoMinimallyacceptedlevelGet““fairshare””ClassleaderExpandthemarketTrendtowardscompressedlaunchschedules––caseexample:Pfizer*Numberinparenthesesdenotesfirstlaunchdateworldwide**Includesforecastsbecausetimehorizonextendspast1998Source: FDA;pinksheets;10-K;MorganStanleyanalystreport(7/98);McKinseyanalysisWorldwidesalesUSDbillionsLipitor**(withWL)ZoloftViagra**NorvascYearsafterlaunchLipitor(97)Norvasc(90)Viagra(98)Zoloft(90)YearsafterlaunchNumberofcountries*MarketinginvestmentbecomingmoreaggressiveLipitorPravacholCumulativeUSdetailsThousandsYearsfromlaunchYearsfromlaunchSource: SalesanddetailsfromScottLevinUSCumulativeUSsalesUSDmillionsLipitor(1997)Pravachol(1991)ProjectedTrackresultsagainstsegmentbottlenecksDevelopscorecardtoevaluate

resultsfrommarketingsolutionsFocusmessageandspend

oneliminatingbottlenecksDevelopmarketingsolutionsandevaluate

eachbasedonabilitytoresolvebottleneck,easeofimplementationandcostIdentifywhichdriverscanresolve

thebottleneck(s)Howtoincreaseawareness,inducetrial,retainpatientsandphysicians,etc.?Identifykeybottlenecksformostattractiveconsumer/prescribersegments

Evaluatewhereinthepurchasefunnelmajorbottle-necksexistforhigh-valuepatientsandphysiciansManylargepharmaco’sarestillintheprocessofadoptingthistoolDynamicmarketingmodel1234PhysicianisawareofnewdrugPhysicianconsidersnewdrugPhysiciandifferen-tiatesnewdrugfromolddrugPhysiciantriesnewdrugPhysicianendorsesnewdrugsforpatientswithunresolvedsymptomsPhysicianendorsesnewdrugforallolddrugusersFew,ifany,unmetneedsNolong-termsafetyprofileBelievesthatnewdrugefficacyisnotsignificantlysuperiortothatofolddrugLackofsamplesLackofexperiencewithnewdrug;prefertrueandtesteddrugNewdrugisnotonmanyformularies/physiciandoesnotwanttodealwithMCOcallbacksPhysiciandoesnotwanttoswitchpatientwhoisstableonolddrugNotallpatientsrespondwelltonewdrugNewdrugisnotonmanyformulariesNewdrugdoesnothavefullrangeofindicationsExampleofphysiciandecisionfunnelBottle-necksILLUSTRATIVEEXAMPLEPublicationvolumeisimportantindifferentiatingdrugproductsSource: Citedreferencesciencedatabase,variousmarketing/salesdatabaseandpublicationsDiovan(Novartis)launchedin1994oneyearafterCozaar(Merck)withahigherefficacyandbettertolerateddrug;however,Cozaarwasabletoleveragea5––32xgreaterpublicationvolumetobeatDiovanSalesUSDmillionsCozaarDiovan0250500750100019929394959697982Q99Cozaar202204206201992939495969798DiovanNumberofcitationsCorrelationbetweendrugsalesandpublicationsMasterplanningchartToplevelmilestonesEXAMPLEProcessDiseaseorientatedUpdateddiseaseorientatedFinaldiseaseorientatedInitialprojectspecific––staircaseRefinedbasedonmarketresearchandtrialresults––staircaseFinalpre-launchOnlyifissues/LCM*MS1MS2TG1MS4TG2TG3TG4MS8GlobalmarketingTargetlabelPositioningBranding*UpdatedannuallyBroadinitialUpdatedasCDiselectedUpdatedbasedondevelop-mentstudiesandfocusgroupswithKOLsFinalpre-launchbasedonmarketresearchandclinicaltrialsRepositionifnecessaryInitialverypreliminaryUpdatedbasedonmarketresearchandfocusgroupsFinalpre-launchbasedoninputfrommarketsandtrialsRebrandedonlyinunusualsituationsCoverskeydimensionsProductdevelopmentGlobalmarketingProductsupplyPatentsEtc.ToplevelmilestonesandmoredetailedactivitiesBestpracticetargetsfor”extend””phaseAmbitionsMaximizegrowthoffranchiseovertimethroughshareandmarketgrowthShapetheproductDeliverstudiestoevolveproductpositioningandrespondtocompetitiveandmarketshifts–focusonincrementalsalesEvolvetheproduct(e.g.,drugdeliverymethods)andaddvalue-addedofferings(e.g.,diagnosissupport)Pursuelocalclinicalstudiesbalancingneed/demandsoflocalmarketswithdiminishingreturnsofglobalpositioningShapethemarketEvolvemarketingmixandfocusovertimeAppropriatelyfocusKOLactivitiestomaintainnetworkandrespondtonewcompetitorsIncreasethesizeofthemarketthroughinvestmentstobroadenusageandenhancediagnosisSecureoptimalgeographicalcoveragebyalliances/co-promotionShapethecompanyDevelopandretainproductteamsonglobalandlocallevelEnsuresalesforceincentivesdriveevolutionofexistingprescribersandconversionofnewprescribersExamplesofproductextensionsPatientbasedinnovationSafety/

tolerabilityprofileLineextensionsPharmaco–economicFurther/expandedindicationsNewindicationExamplesofproductextensionsWaystocreateproductextensionDescriptionExamplesNewindicationIdentifyingdiseases/symptomcurrentlypoorly/nottreatedanddevelopingnovelproductsProscar(Merck)Captopril(BMS)Reo-Pro(Centocor)Acculane(Roche)LineextensionsAdaptingproducttoavoid/delaygenericcompetitionVoltarol(Geigy)Amoxil(SB)ProcardiaXL(Pfizer)Safety/tolerability

profileFocusingproductdevelopment/marketingonaddressingsafelyissueswithincumbenttherapiesIstin/Norvasc(Pfizer)Cardizem(HMR)Zantac(GW)PharmacoeconomicDefiningp-economicprofilebye.g.,redefiningclinicalendpointsforcompetitiveadvantageRocephin(Roche)IPA/GUSTO(Genentech)Dipravan(AstraZeneca)Patient-basedInnovatingaroundthespecificneedofpatientsEasi-Breathe(3M)Novopen(NovoNordisk)Menorest(RPR)Further/expandedindicationsExpandingrelevantpatientpopulationbyredefiningdiseasesofbytreatingadditionaldiseases(formulationcombinations)Fosamax(Merck)Mevacor(Merck)Coreg(BM)Wellbutrin/Zyban(GW)CapturingbenefitsofcontinuedresearchSource:UKofficeofHealthEconomics/MarketletterJune13,200125-40%ofsalesoftopsellingdrugsinUK/USAareforindicationsdiscoveredonlyafterthedrugswerelaunchedImpactofnewindicationsExperienceshowsSubstantialspillovereffectsfrombeingfirstcompanytolaunchindicationFirstmovercangetupto10%moremarketshareevenwhereoff-labelexistsThefollower––runningthesameindications–usuallyisnotabletoimprovehismarketpositionExampleofpossibleindicationsforSSRIsMajordepressionPreventionofrelapseofdepressionPremenstrualdysphoricdisorderAnxiety–generalandpanicattacksObsessivecompulsivedisordersEatingdisorders–anorexiaandbulimiaSubstanceabuseSocialphobiaWherecancompanygainsharebypioneeringindications?Wherecancompanyleverageclasseffect?DISGUISEDEXAMPLESustainedresultswithproactiveLifeCycleManagement––

exampleVoltarenSource: IMS"Patentlife"extended10yearsafterexpirythroughproactiveproductre-launchesUSD1billionglobalsalesin1997SalesinGermanyDEMMillionsPatentexpiryGelSustainedreleaseSuppositoryPlainGlobalmarketsharePercent1993949596971982838485868788899091929304080120160IncreasingchallengetomaintainKOLnetworkdemandsfocusSponsoredSupportedCharacterization“Thoughtleaders”ProvidecriticaldataPrescribersMarketingmeasuresScientificeventsinitiatedbycompanyInvolvementinsalesforcetraining“Influencers”Heavilyinvolvedinteaching“Followers”Commandvastmajority

ofprescriptionsVeryheterogeneousandvolatilelimitedunderstanding“Laggards”LagbehindnewtherapydevelopmentsSpecialcompanyevents

toleverageOPLs,e.g.,“Semi-Annualupdate”forheavyprescribersSalesforcevisitsInformationusingmarketingmeasuresotherthansalesforcecontactOPLHighprescribersLowprescribersRetainingandmotivatingtoptalentoveryearsrequiresmorethanmoneyGreattasksDifferentiatedcompensationHightotalcompensationFreedomandautonomyJobhasexcitingchallengesCareeradvancementandgrowthGreatproductCompensationValuesandcultureWellmanagedproductCompanyhasexcitingchallengesStrongperformanceBestpracticetargetsfor””sustain”phaseAmbitionsMaintainmarketshareandprofitlevelsaslongaspossibleShapetheproductIdentifyandinvestinleverstoextendlifecycleShapethemarketReviewpricingasakeylevertomeasureproductvalueExtendsalesandmarketingactivityShapethecompanyRampupexcitementandonlocalteamstoextendthefranchiseShiftcompositionofglobalteamtomeetdemandsofsustaininglifecycleAddressinternalbarrierstosustainingfranchise5keycompetitiveleverstomaximizelatelifecycleNPVMaximize

remainingsalesIncreasesalesspendingImprovesaleseffectivenessIncreasemarketspendingImprovemarketingeffectivenessAttainadditionalindicationsCreateproductextensionsMigratetonewproprietaryproductsExclusiveproductenhancements/extensions”New”versionsofproductParsethemarketDefendsalesexclusivityLitigateManageregulatoryaffairsTakecompetitiveactionsCompetein

genericmarketProduceowngenericPartnerwithgenericsMaximizecontributionMigratetoOTCTransferownershipLicenseTradeSellKeyleversPossibleactionsInternalbarrierstoaddresslifecycleextensionsPossibleresponseDeterminewhichgenericcompetitorsarelikely

toenterStudycaseexamplesUsescenariomodelingtoquantifyimpactandassesspotentialopportunityRecognitionofthe

threatandopportunityNewproductbiasResourcecapacityconstraintsEstablishmoresophisticatedrisk/rewardmeasuresFocusontotalproductopportunityratherthanannualbudgetingforin-lineproductsLCMrevenuesimportanttosustainingperformancethrough”droughts”O(jiān)utsourcetheLCMworktoconservein-houseresources,e.g.,transferringownershipNon-traditionalskillsneededinlateLifeCycleManagementTraditionalFocus:Thisyear’sprofitplanRequiredFocus:NPVofassetClinicaldevelopmentRegulatoryaffairsSales/marketingClinicaldevelopmentRegulatoryaffairsSaleseffectivenessLicensingandacquisitioning/partneringDealstructure,negotiation

andalliancemanage-

mentLitigationstrategyandtacticsProductteamProductteamToday′′sdiscussionKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissuesDesignprinciplesDrivelifecyclemanagementaroundthemajorplanningevents(earlyonmilestonesandlaterinannualplanningcycle)CreateclearrolesandresponsibilitiesbetweenglobalandmarketsDocumentlifecyclemanagementthinkinginasimpledocumentthatpotentiallyisbroaderthanthebusinessplandocumentFocusareasandearlyrecommendationsClarifydecision-makingaroundLCMMakeLCM-plananintegralpartoftollgatedecisionsMakeLCMplanningpartofannualportfoliomanagementprocessDefinerolesandresponsibilitiesDefinewhohaswhatresponsibilitiesDefinethecompanylifecycleplanUpgradetheLCM-plantoarealannualstrategydocumentforpostlaunchDefinethecompanyLCM-plan(alignedwithmarkets)OrganizeforcreationandmanagementoftheLCM-planClarifyleadership–commercialversustechnicalCreateastanding/recurringLCMsub-teamincludingkeymarketsMakeLCMapriorityinannualplanningDefinetheroleinannualplanningDefinethecompanyminimumstandardLinkbudgetstoLCMplanningLifecyclethinkingshouldbepartoftheearlydevelopmenttollgatedecisionsChoiceoffirstindicationTargetlabelassessmentPreliminarytargetTargetlabelevolutionovertimePatent/IPstrategyChoiceofCDandbackupRoughlifecyclevisionFuturedevelopmentactivitiesEvolutionofpositioningUpdatedtargetlabelassessmentStaircaseDevelopmentprojectplanforproposedscenarioScopeScaleInvestmentforspeedUpdatedLCMplanAgreedvisionwithmarketsFuturedevelopmentinitiativesEvolutionofpositioningFuturemarketinginitiativesUpdateddevelopmentprojectplanforproposedscenarioEnsuresupplyUpdatedtargetlabelassessmentFinal““l(fā)aunch”targetlabelUpdatedLCMplanILLUSTRATIVEPre-CDCDnominationProofofconceptApprovaltolaunchAgoodLCMplanconsidersabroadrangeofstrategicinitiativesWhatisrequired

toreachvision/objectives?MarketingandsalesClinicaldevelopmentOtherMarketpenetrationprogramsGlobalpositioningandcoordinationprogramsNewmarketing/salesapproachesNewclaims/indicationsLineextensionsRepositioningofotherclassesProductionandlogisticsimprovementprogramRenegotiateallianceagreementEXAMPLECreatequalitystandardoverallandwithintheLCMplanExamplesDecisionsshouldbebasedonadeeperlevelofinsightintooverallmarketsituationthanwhatresidesinanysinglemarketAvoiddoing“alittleofeverything””Avoidmismatchbetweenglobalandlocalambition.BeclearonoverallstrategicdirectionEachplanshouldincreasethefuturevalueofproductbasedondefiningessentialactivitiesforproductgrowthEnsurethatinitiativesfocusonbothdevelopmentandmarketingleversacrosstimeUseinnovativetoolsandframeworktopushthinking

(e.g.,““wargames””,strategicstaircasesetc)ILLUSTRATIVELifecycleplan––annualportfolioreviewpostlaunchChapterContentQualityguideline1.ExecutivesummaryOutlineplanforthebrandExplaintheoverallLCMstrategyandperformanceobjectivesDescribethe3–5mainissuesthatmaysignificantlyaffecttheproductsuccessLayoutactionstoresolveissuesDoestheexecutivesummaryclearlyandconciselyarticulatehowtheproductwillwininthemarketplaceandovercomeanysignificantchallenges?2.DecisionrequiredExplainwha