的重组腺病毒Ad35商业化生产工艺

IntensificationofaPER.C6®-basedrecombinantAd35manufacturingprocesstoprepareforcommercialscaleproductionFifthAnnualOptimisingBiomanufacturingProcessesBrussels,Belgium3December2008MarceldeVocht2DisclaimerThepresentationcontainsforward-lookingstatementsthatinvolveinherentrisksanduncertainties.Wehaveidentifiedcertainimportantfactorsthatmaycauseactualresultstodiffermateriallyfromthosecontainedinsuchforward-lookingstatements.ForinformationrelatingtothesefactorspleaserefertoourForm20-F,asfiledwiththeU.S.SecuritiesandExchangeCommissiononMay7,2008,andinparticularthesectionentitled“RiskFactors”.CrucellN.V.preparesitsfinancialstatementsUnderInternationalFinancialReportingStandards(IFRS).3Agenda•Companyprofile•Crucell-AerasTBprogram•CrucellstrategyforManufacturingIntroductionintensifiedManufacturingforAdenoProduction•Conclusions•Acknowledgements4Agenda•Companyprofile•Crucell-AerasTBprogram•CrucellstrategyforManufacturingIntroductionintensifiedManufacturingforAdenoProduction•Conclusions•Acknowledgements5CrucelloverviewHeadquarters:NetherlandsTechnology:PER.C6®,AdVac®,MAbstract®,STAR®,virosomesProducts:VaccinesandantibodyproductsFacilities:Switzerland,Korea,Spain,Sweden,NetherlandsHoldings:6%GalapagosGenomicsN.V.(GLPG)20%AdImmuneCorporation(private)Listing:NYSEEuronext,NASDAQ,SWXPartners:Globaldistribution;broadbaseoftechnologylicenseesMarketCap:Approx.€700million(8September2008)66MissionCombatinginfectiousdiseases7ProductsandpipelineDevelopmentstageResearch/Pre-clinicPhaseIPhaseIIPhaseIIIMarketedCommentQuinvaxem®FullyliquidvaccineforprotectionagainstfivechildhooddiseasesHepavax-Gene®RecombinanthepatitisBvaccineMoRu-Viraten®Vaccineforprotectionagainstmeaslesandrubella(allagegroups)Epaxal®JuniorLowdosageuniquealuminum-freehepatitisAvaccine(0.25ml)Epaxal®Uniquealuminum-freehepatitisAvaccineVivotif®UniqueoraltyphoidvaccineDukoral®Internationallylicensedoralvaccineagainstcholera(andETEC)Inflexal®VVirosomaladjuvantedinfluenza(allagegroups)Flavimun®YellowFevervaccine;registrationsubmissioninCHandGERexpectedQ109InfluenzaseasonalDevelopedbysanofipasteurusingPER.C6®;plannedsubmissionin2010RabiesantibodycocktailFastTrackPartneredwithsanofipasteur;positiveresultsUSPhaseIIclinicalstudyTuberculosisPartneredwithAeras;FirstPhaseIIstudystartedMalariaPhaseItrialinUSontwosites;initialfindingsexpectedinQ109EbolaPartneredwithNIAID/NIH;grantof$30mln(+$40mln);Ebola/MarburgHIVPartneredwithHarvard;PhaseItrialstartedinApril2008FactorVL/CBloodcoagulationFactorVL/CH5N1Avianantibodies*Resultsdemonstratingpotentialpandemicpreparedness*Pandemicinfluenza78Agenda•Companyprofile•Crucell-AerasTBprogram•CrucellstrategyforManufacturingIntroductionintensifiedManufacturingforAdenoProduction•Conclusions•Acknowledgements9TuberculosisisamajorcauseofdeathworldwideEstimated8.8MMnewTBcasesin20057.4MMinsub-SaharanAfricaandAsia1.6MMpeoplediedofTBBasicFacts10Extensivelydrug-resistanttuberculosis(XDR-TB)AglobalhealththreatXDR-TBisspreading:41countriestodate**XDR-TB:germsresistanttoallmosteffectiveantiTBdrugsConcerns:futureTBepidemicwithrestrictedtreatmentoptionsBasedoninformationprovidedtoWHOStopTBdepartment11ByCalmette&Guérin1906-1921NonewTBvaccinein87yearsInventionofBCGVaccine12CurrentWidelyUsedBCGVaccine:IneffectiveAgainstTBPandemic•UnreliableprotectionagainstpulmonaryTB,whichaccountsformostTBworldwide•Despitewideuse,BCGhashadnoapparentimpactongrowingglobalTBepidemic•NotknowntoprotectagainstlatentTB•DoesreduceriskofseverepediatricTBdiseaseProfoundneedfornewTBvaccines13PotentialofaNewTBVaccineTargetsWHOandMillenniumgoals•AchieveglobalTBcontrolin15-20yearsIfnewvaccine50-70%betterthanBCGInconjunctionwithbetterdrugsanddiagnostics•MinimizeTBasaglobalthreatby2050(1case/million)TBwillnotbeeliminatedwithoutanewTBvaccinePreventTBinchildren,adolescentsandadultsProtectacrossstrains–includingMDRandXDR14ApproachtoinductionofimmunitySource:®-basedboostVaccineforthePreventionofTuberculosisPER.C6®TBSgeneAd35.TBSInfectionofPER.C6cellsTuberculosisvaccineManufacturingofAd35.TBSTransfertoAd35adenoviralvectorVaccinationAg85AAg85B10.416Agenda•Companyprofile•Crucell-AerasTBprogram•CrucellstrategyforManufacturingIntroductionintensifiedManufacturingforAdenoProduction•Conclusions•Acknowledgements17Ad35.TBSvaccinedosesneeded:~150MM/yearSource:PopulationDivisionoftheDepartmentofEconomicandSocialAffairsoftheUnitedNationsSecretariat,WorldPopulationProspects:The2006RevisionandWorldUrbanizationProspects:The2005Revision,:10:35AM.LessdevelopedregionsBirthsperyear,bothsexescombined(thousands)Mediumvariant2010-2015PeriodBirthsperyearbothsexescombined2010-2015124774LeastdevelopedcountriesBi