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Fall 2005
ISSN 0890-913X
Volume 21, Number 1

Insider Trading Around New Drug Approvals

Todd A. Finkle, The University of Akron
Laurence E. Blose, Grand Valley State University
Reinhold P. Lam, The University of North Florida
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/jpe/index.php?action=ajax&rs=GDMgetPage&rsargs[]=Fall2005 3.pdf&rsargs[]=0
JournalofPrivateEntoprise,VolumeXXI,Fall2005InsiderTradingAroundNewDrugApprovalsToddA.FinkleTheUniversityofAkronLaurenceE.BloseGrandValleyStateUniversityReinholdP.LambTheUniversityofNorthFloridaThisstudyexaminesthemarketreactiontonewdrugapprovalannouncementsbytheFoodandDrugAdministration(FDA).AccordingtotheTuftsCenterfortheStudyofDrugDevelopment(2001a),theaveragecosttodevelopanewdrugis$802millionandthetypicaltimeframebeforeitteachesthemarketis10-15years.AnewdrugthatobtainsFDAapprovaltobemarketedtothepubliccancontributebillionsofdollarstothemanufacturingpharmaceutical.Forexample,in1998,theanti-ulcerdrugPrilosecgeneratedover$4.0billioninsalesforAstraPharmaceutical.Zocor,acholesterolreducer,contributedover$2.8billiontoMerck,andClaritin,ananti-allergydrugmanufacturedbyWarner-Lambert,producedsalesofmorethan$1.3billion.Salesfortheentireindustryexceeded$102billion,andprofitsgrewbyalmost18%—fourtimesthatoftheaverageFortune500firm(Tanouye,1998).NewDrugApprovalProcessPriortomarketing,thesedrugs,whichemanatefromthepharmaceuticalandbiotechnologyindustries,mustgothrougharigorousapprovalprocesswiththeFDAthatincludespre-clinicaltestingandseveralstagesofclinicaltrials.Inordertoassesssafety,newdrugsmustundergopreclinicaltestinginanimals.ThefindingsoftheseToddA.Finkle,LaurenceE.Blose,ReinholdPLamb29
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