Strategic Changes in the Global Pharmaceutical Mar

Hale&TempestStrategicChangesintheGlobalPharmaceuticalMarketDr.BrianWTempest(UNCTAD)inadditiontobeingamemberoftheSCRIPGlobalawardspanelheisontheEditorialBoardoftheJournalofGenericMedicines.Brianspeaksatglobalconferencesandmoreinformationonthesepresentationscanbefoundonhiswebsite:Fiercebiotech22Jan2011Hale&TempestUSADOJFinesonBigPharmaSource:ChemistryWorldJan2011Hale&TempestUSABatchRecallsSource:DeutcheBank29March2011Hale&TempestApprovals&ReimbursementsSource:PharmatimesUKJuly-August2010Hale&TempestBigPharmaLosingtoLocalPlayersSourceGSKPresentationHale&TempestEmergingWorldShareofPharmaSourceEIU,OECD,WHO,IMS,RolandBergerHale&TempestTop8CosinEmergingMarkets2008Hale&TempestIncreasingPaceofEmergingMarketsAcquisitionsEmergingMarketInvestorDaysMarch16,2010December10,2009July2,2009LargeCapPharmaEnteringGenerics(Egypt,Pakistan,NearEast)(MENA,LatAm,Asia-Pac)(Algeria)Withtheslow-downofWesternmarkets,PharmaarerapidlyrepositioningtofocusonemergingmarketsforgrowthHale&TempestSalesForceJobCutsinPresssince2009Hale&TempestStructuralChangeGenericCompaniesHale&TempestAsiavs.theWesternGenericCompaniesSource:Factset,ReligareHale&TempestPricingPressuresSource:WatsonHale&TempestEuropeanGenericPricesSourceRanbaxyHale&TempestEuropeanGenericPricesSourceRanbaxyHale&TempestUSA-ANDAGrowingApprovalTimesSourceFDAChiefMHamburg,GpHAConferenceFebruary2010200516.3monthsaverage200926.7monthsaverageAround2000ANDAsawaitingapprovalFDAexplainedasaresultofstaffshortagesRegulatoryfilingfeesneededHale&TempestSeasonofWarningLetters/ImportAlertsSource:DeutcheBankJuly2011Hale&TempestUSA-LitigationSuccessRatesSourceRBCCapitalMarketsJanuary152010PatentChallengesonrise-65FTFsin2009Successrateat48%-or76%includingdeals3courtshold69%with36%successe.g.NJ4courtsneverruledagainstgenericse.g.NYAtrisklaunchesontherise–6in2009Tevahas12ofthe28atrisklaunches–2002/9Settlementsontherise–54in2009TevaaccountsforathirdofallsettlementsAuthorizedgenericsontherise–25in2009WatsonrepresentsafifthofallAGsHale&TempestGenericProfitMarginProfileindescendingordersource:DeutscheBankJuly2010Hale&TempestTop25GlobalGenericCompaniesSource:GenericsBulletin10June2011Hale&TempestNext24GlobalGenericCompaniesSource:GenericsBulletin10June2011Hale&TempestPatentExpiriesSource:SandozHale&TempestIn2016Top108willbeBiologic/RespSource:SandozEGAConference2011Hale&TempestStructuralChangesIndianPharmaCompaniesHale&TempestWHOPreQualifiedProductsHale&TempestIndianGenericFDAANDAApprovalsHale&TempestNicheTechnologySource:MAPEHale&TempestIndia–ShareofCRAMSMarketHale&TempestLotsofOpportunityforCROsinIndiaSource:clinicaltrials.gov16Feb2011Hale&TempestMacroStructuralChangesHale&TempestPfizer&HisunHale&TempestPharmaWholesalersetsupChinaJVUKCoop–theworld’slargestconsumercooperativeGBP£10bUKcompanyrunningfoodstores,banks,insurance,funeralhomes,travelagents,farmsandpharmacies3rdrankpharmacychaininUKwith800storesOwnsUKpharmaceuticalwholesalerSantsOpusMarketingJVwithDayLewisPharmacyChainoffers113productsunderProspectbrandTianjinTaslySantsManufacturingJVopened2010,“productionunderway”Jun2011WithInvestmentGBP£20m,200staffHale&TempestChinaPharmaIndustryCapexPlansSource:StravencomHale&TempestIndiaPharmaIndustryCapexPlansSource:MAPEHale&TempestFDADMFsfromIndiaHale&TempestFDADMFsfromChinaHale&TempestChineseANDAsHale&TempestEndangeredElementsSource:ChemistryWorld2011Hale&TempestANewWorldOrderisComingHale&TempestThankYoub