Astellas Pharma - Wikipedia

Astellas Pharma Inc is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of Yamanouchi Pharmaceutical Co., Ltd and ... AstellasPharma FromWikipedia,thefreeencyclopedia Jumptonavigation Jumptosearch Japanesepharmaceuticalcompany AstellasPharmaInc.TypePublic(K.K)TradedasTYO:4503TOPIXCore30ComponentTOPIX100ComponentNikkei225ComponentIndustryPharmaceuticalPredecessorsYamanouchiPharmaceuticalFujisawaPharmaceutical(Mergedin2005)Founded1 April2005;17yearsago (2005-04-01)Headquarters2-5-1,Nihonbashi-Honcho,Chūō-ku,Tokyo103-8411,JapanKeypeopleKenjiYasukawa(PresidentandCEO)ProductsPrografHarnalVesicareFunguard/MycamineProtopicandotherpharmaceuticalsRevenueUS$11,060,000,000(FY2013)NetincomeUS$1,280,000,000(¥1,139,000,000,000)(FY2013)Totalassets$14.86billion(2016)[1]Numberofemployees17,217(2016)[2]SubsidiariesAstellasUSWebsitewww.astellas.com/en/Footnotes /references[3][4][5] AstellasPharmaofficeinCanada AstellasPharmaInc.(アステラス製薬株式会社,AsuterasuSeiyakuKabushiki-gaisha)isaJapanesemultinationalpharmaceuticalcompany,formedon1April2005fromthemergerofYamanouchiPharmaceuticalCo.,Ltd.(山之内製薬株式会社,YamanouchiSeiyakuKabushiki-gaisha)andFujisawaPharmaceuticalCo.,Ltd.(藤沢薬品工業株式会社,FujisawaYakuhinKōgyōKabushiki-gaisha).OnFebruary5,2020,thecompanyannouncedmanagementchangeseffectivefromApril1,2020.[6] AstellasisamemberoftheMitsubishiUFJFinancialGroup(MUFJ)keiretsu. Contents 1History 1.1Earlyfoundations 1.2Recenttimesandmergers 1.3Acquisitionhistory 2Controversies 3Business 3.1Products 3.2Distributionagreements 4Operations 5Furtherreading 6References 7Externallinks History[edit] Earlyfoundations[edit] FujisawaShotenwasstartedin1894byTomokichiFujisawainOsaka,andwasrenamedFujisawaPharmaceuticalCo.in1943.YamanouchiYakuhinShokaiwasstartedin1923byKenjiYamanouchiinOsaka.ThecompanywasrenamedYamanouchiPharmaceuticalCo.in1940andmovedtoTokyoin1942.Bothcompaniesstartedtheiroverseasexpansionataboutthesametime,openingofficesinTaiwanin1962and1963,respectively,andintheUnitedStatesandEuropefrom1977onwards. Recenttimesandmergers[edit] FujisawaacquiredLyphomedin1990andthereafterestablisheditsUSR&DcenterinDeerfield,Illinois.Yamanouchi'sR&DcenterinLeiderdorpwasestablishedwiththeacquisitionofthepharmaceuticaldivisionofRoyalGistBrocadesin1991.FujisawaandYamanouchicombinedina"mergerofequals,"formingAstellasPharmaon1April2005.Atleastsomeofitsolderproductscontinuetobedistributedundertheoriginalbrand,ostensiblyduetohighbrand-namerecognition.[7]AstellashadacollaborationagreementwithCoMentisfrom2008to2014focusedondevelopmentofbeta-secretaseinhibitortherapeuticsforAlzheimer'sdisease.[8] In2009,thecompany'stacrolimus-containingproductsPrografandAdvagrafshowedtheywerepronetodosingerrorswithinEurope,leadingtoseriousadversereactionsamonganumberofpatients,duetodeficitsinpackagingandlabeling,deficitscorrectedafterawarningfromtheUKMHRA.[9] OnJune9,2010,AstellasacquiredOSIPharmaceuticalsfor$4.0billion.InDecember2014,Astellasexpandedits18-month-oldcollaborationwithCytokinetics,focusingontheR&Dandcommercializationofskeletalmuscleactivators.ThecompaniesannouncedtheywilladvancethedevelopmentofCK-2127107(afastskeletaltroponinactivator)intoPhaseIIclinicaltrialsforthetreatmentofspinalmuscularatrophyandpossiblyotherneuromuscularconditions.Thecollaborationwasexpectedtogeneratemorethan$600millionforCytokinetics,aswellas$75millioninmilestonepayments.[10]InNovember2015,thecompanyannounceditsmovetoacquireOcataTherapeutics(formerlyAdvancedCellTechnology)for$379million.[11]ThedealwascompletedinFebruary2016.[11][12]LaterinNovember2015thecompanyannounceditwouldsellitsdermatologybusinesstoLEOPharmafor$725million.[13]InOctober2016AstellasannounceditwouldacquireGanymedPharmaceuticalsfor$1.4billion[14] InApril2017,thecompanyannounceditwouldacquireBelgium-baseddrugdiscoveryfirmOgedaforuptoatotal€800million,strengtheningitslate-stagepipelinewithOgeda'sdrugcandidate,fezolinetant.[15]InNovember2017,thecompanyannouncedthatitexercisedanoptiontopurchaseCambridge,Massachusetts-basedMitobridge,whichisdevelopingtreatmentsforDuchennemusculardystrophyandage-relateddiseases.[16] InAugust2018,AstellasannounceditwouldacquireQuetheraLimitedfor$109million.[17][18]InDecember2018,thecompanyannounceditwouldacquirePotenzaTherapeutics,Inc.[19] InDecember2019,AstellasPharmaannounceditwouldbuyAudentesTherapeuticsIncforapproximately$3billionincash[20][21][22]aswellasacquiringXyphosBiosciences,Inclaterinthesamemonth.[23][24]AudenteswilloperateasawhollyownedsubsidiarywithinAstellas,andwillserveastheCenterofExcellenceforthenewlycreatedGeneticRegulationPrimaryFocus,providingleadershipforAAVpipelineadvancementthroughcommercialization,manufacturingexpansion,andnext-generationresearchinitiatives.[25]TheacquisitionincludesAstellasgainingXyphos’AdvancedCellularControlthroughEngineeredLigands(ACCEL)technologyplatform.[26] AstellasPharma'sSmyraf(ingredient:peficitinib)obtainedregulatoryapprovalforthetreatmentofrheumatoidarthritis,thethirdoralJanuskinase(JAK)inhibitortoreceiveapproval.[27] InOctober2020,AstellasannounceditwouldacquireiotaBiosciences,Inc.for$127.5million,withshareholderseligibletoreceiveuptoafurther$176.5millionupontheachievementofpredeterminedmilestones.[28] Acquisitionhistory[edit] Thefollowingisanillustrationofthecompany'smajormergersandacquisitionsandhistoricalpredecessors(thisisnotacomprehensivelist): Astellas                     Fujisawa Pharmaceutical Co   FujisawaPharmaceuticalCo(Est1894)     Lyphomed(Acq1990)       YamanouchiPharmaceuticalCo(Est1923)         OSIPharmaceuticals(Acq2010)           OcataTherapeutics(Acq2016)           GanymedPharmaceuticals(Acq2016)           Ogeda(Acq2017)           Mitobridge(Acq2017)           QuetheraLimited(Acq2018)           PotenzaTherapeutics,Inc.(Acq2018)           AudentesTherapeuticsInc.(Acq2019)           XyphosBiosciences,Inc.(Acq2019)           iotaBiosciences,Inc.(Acq2020)       Controversies[edit] InJune2016,theAssociationoftheBritishPharmaceuticalIndustry(ABPI)gaveAstellasayear-longsuspension,aftercomplaintsithad"purposelymisledthePMCPA."[29]Inparticular,Astellashadnotfullydisclosedthenatureofameetingwhichhadpurportedtobea"genuineadvisoryboard".[30] InMay2017,theABPIextendedthesuspensionbyafurther12months,basedonfindingsthatAstellaswasnotadequatelyoverseeingandtrainingnurses,andthatithadfailedtoprovidecompleteprescribinginformationforseveralmedicines.[31] InJune2017,Astellaswasreprimandedfor"producingalargenumberofpromotionalmaterials,whichhadbeenusedforanumberofyears,thatdidnotincludetherequiredprescribinginformationrelatedtosomeseriousorcommonadversereactions,warnings,andprecautions,foratotalofeightdrugs".[30] InDecember2018,thePrescriptionMedicinesCodeofPracticeAuthority(PMCPA)publishedtheirfindingsfollowinganallegationthatAstellashad"inappropriatelyawardedresearchfunding"toaseniorclinicianataBritishhospital,directlyresultinginthehospitaladoptingaprotocolwhichwassubsequentlyabandonedlessthanthreeyearslater"becauseofpooroutcomes".[32]ThisreportalsoreprimandedAstellasforfailingtoprovidesufficientandtimelyinformationtoinvestigators. InApril2019,AstellasagreedtopaytheUnitedStatesDepartmentofJustice$100milliontoresolveallegationsthatithadconspiredtoofferkickbacksviaMedicarecopayfoundations.[33] Business[edit] Astellas'franchiseareasareurology,immunology(transplantation),cardiology,andinfectiousdisease.PriorityareasforR&Dareinfectiousdiseases,diabetes,gastrointestinaldiseases,oncology,anddiseasesofthecentralnervoussystem. Recentlynoted,AstellasVentureManagementhasfundedOncorus,whichrecentlyraised$79.5millioninaseriesBfinancingroundtomovetwooncolyticvirusesthroughdevelopment.[34] Products[edit] SomeofthekeyproductsproducedbyAstellasinclude: Adenocard(adenosineinjection)–Pharmacologicstressagentformyocardialperfusionscan Adenoscan(adenosineinjection)–Pharmacologicstressagentformyocardialperfusionscan AmBisome(amphotericinB)–Anti-fungal–marketedwithGileadSciences. Amevive(alefacept)–plaquepsoriasis AstagrafXL(tacrolimus)–Preventionofpost-transplantorganrejection Cresemba(isavuconazole)–Anti-fungal Enfortumabvedotin–Antibody-drugconjugateforthetreatmentoflocallyadvancedormetastaticurothelialcarcinoma Flomax(tamsulosinhydrochloride)–Benignprostatichyperplasia(BPH) FlomaxMRcapsuleswerediscontinuedin2005,replacedbyFlomaxtraXL,containingthesameactiveingredient[35] Lexiscan(regadenosoninjection)–Pharmacologicstressagentformyocardialperfusionscan Macugen(pegaptanibsodium)–Anti-angiogenic–marketedwithGileadSciencesintheUSandPfizerOutsideofUS. Mycamine(micafunginsodium)–Anti-fungal Myrbetriq(mirabegron)–Overactivebladder(OAB)–USonlymarketedbyPfizerOutsideofUS. Padcev(enfortumabvedotin)-Bladdercancer Prograf(tacrolimus)–Preventionofpost-transplantorganrejection Protopic(tacrolimusointment)–Atopicdermatitis(eczema) Symoron(methadoneHCL)–Opioidreplacementtherapy Tarceva(erlotinib)–Non-smallcelllungcancerandpancreaticcancer–marketedwithHoffmann-LaRoche(Genentech). Vaprisol(conivaptan)–Hyponatremia Vesicare(solifenacinsuccinate)–Overactivebladder(OAB) Vibativ(telavancin)–bactericidallipoglycopeptide–marketedwithTheravance. Xospata(gilteritinib)–AXLreceptortyrosinekinase Xtandi(enzalutamide)–Prostatecancer–marketedwithPfizer. Distributionagreements[edit] In2007,thecompanynarrowedUKdistributionofAdvagrafandPrograftoasoledistributor,UniChem,inreactiontopharmacistcomplaintsaboutdrugavailabilityfromwholesalesources.[36]Thisnarrowdistributionwasrevisedtothreefirmsin2010,coveringallofitsproductsintheUK:AAH,AllianceHealthcare,andPhoenixHealthcareDistribution.[37] Operations[edit] Thecompany'sheadquartersareinTokyo,withresearchcentersinTsukubaandOsaka.ClinicaldevelopmentiscenteredinNorthbrook,Illinois,LaJolla,California,andLeiden,Netherlands.Combinedrevenuesofthetwopre-mergercompanieswere$7.9billionin2004.Worldwidethecompanyemploysabout17,000people.TheUnitedStatessubsidiaryofAstellasisAstellasUSLLC.[38] Thecompany'sadvertisingslogansare: English:LeadingLightforLife Japanese:Ashitawakaerareru.(明日は変えられる。

,ChangingTomorrow.)[39] Furtherreading[edit] "Onestepaheadofmanufacturers'trickyfootwork".TheChemistandDruggist(Opinion).Kent,England:CMPInformationLtd.264(6520):15.12November2005–viaInternetArchive.Manufacturershave,inthepast,talkeduptheimportanceofbioequivalencetoencourageprescribingoftheirbrand....AstellasisnowconvenientlyignoringthatargumentasitattemptstoextendthelifeofFlomaxbeyonditspatentexpiryinFebruary2006. "RidauraTiltabtocease".TheChemistandDruggist(Newsbrief).Kent,England:CMPMedica.2721(6715):6.12September2009–viaInternetArchive. References[edit] ^"AstellasPharmaontheForbesGlobal2000List".Forbes.com.Retrieved13August2018. ^"CorporateInformation–AstellasPharmaInc.GLOBALWEBSITE".Astellas.com.Retrieved13August2018. ^"CorporateProfile".AstellasPharma.ArchivedfromtheoriginalonAugust14,2012.RetrievedSeptember9,2014. ^"AnnualReport2014"(PDF).AstellasPharma.Archivedfromtheoriginal(PDF)onMarch3,2016.RetrievedSeptember9,2014. ^"AstellasPharmaSnapshot".BloombergBusinessweek.RetrievedJanuary25,2015. ^"AstellasAnnouncesManagementStructure".BioPortfolio.12March2020.Retrieved2020-04-02. ^"YamanouchiPimafucin(natamycin)productlinemanufacturedatleastupto11/2007" ^Staff(November15,2014)."AstellasEndsAlzehimer'sCollaborationwithCoMentis".Discovery&Development.Gen.Eng.Biotechnol.News(paper).Vol. 34,no. 20.p. 14. ^Wilkinson,Emma(21February2009)."MHRAwarnsofdosingerrorsinimmunedrugs".TheChemistandDruggist.271(6686):10–viaInternetArchive. ^"Astellas,CytokineticsExpandMuscleDrugCollaboration–GEN".GEN.23December2014.Retrieved13August2018. ^ab"AstellastoAcquireOcataTherapeuticsfor$379M–GEN".GEN.10November2015.Retrieved13August2018. ^"AstellasAnnouncesResultsofTenderOffertoAcquireAllOutstandingSharesofOcataTherapeuticsandChangestoSubsidiaries".Newsroom.astellas.us.Retrieved13August2018. ^"LEOPharmaBuysAstellas'DermatologyBusinessfor$725M–GEN".GEN.12November2015.Retrieved13August2018. ^"AstellastoAcquireGanymedPharmaceuticalsforUpto$1.4B–GEN".GEN.28October2016.Retrieved13August2018. ^"AstellastoBuyGPCRDrugsFirmOgedaforupto€800M–GEN".GEN.3April2017.Retrieved13August2018. ^"AstellasAcquiresMitobridgeUnderExistingCollaboration|AstellasPharmaInc.GLOBALWEBSITE".Astellas.com.Retrieved2018-02-27. ^"AstellasAnnouncesAcquisitionofQuethera".BioSpace.Retrieved2020-04-21. ^"AstellasExpandsGeneTherapyInvestment,AcquiresU.K.-basedQuetherafor$109Million".BioSpace.Retrieved2020-04-21. ^"AstellasAcquiresPotenzaTherapeutics".BioSpace.Retrieved2020-04-21. ^"AstellasBuysAudentesfor$3BilliontoExpandintoGeneTherapy".BioSpace.Retrieved2020-04-21. ^"Japan'sAstellastobuyAudentesfor$3billioninhigh-pricedgenetherapybet".Reuters.2019-12-03.Retrieved2020-04-21. ^"AstellasEntersintoDefinitiveAgreementtoAcquireAudentesTherapeutics".www.businesswire.com.2019-12-02.Retrieved2019-12-16. ^"AstellasStrengthensImmuno-oncologyPipelinewithAcquisitionofXyphosBiosciences,Inc".BioSpace.Retrieved2020-04-21. ^"AstellasrampsupM&A,buysU.S.biotechXyphosforasmuchas$665million".Reuters.2019-12-27.Retrieved2020-04-21. ^"AstellasCompletesAcquisitionofAudentesTherapeutics".BioSpace.Retrieved2020-03-04. ^"AstellashasannounceditsacquisitionofXyphosfor$665m".EuropeanPharmaceuticalReview.Retrieved2020-02-25. ^"Astellas'rheumatoidarthritisdrugSmyrafwinsregulatorynod–KoreaBiomedicalReview".www.koreabiomed.com(inKorean).2020-01-30.Retrieved2020-03-26. ^"AstellastoAcquireiotaBiosciences". ^Megaw,Nicholas(June23,2017)."DrugmakerAstellassanctionedfor'shocking'patientsafetyfailures".FinancialTimes.UnitedKingdom.RetrievedJune23,2017. ^abCohen,Deborah;Mulinari,Shai;Ozieranski,Piotr(2July2019)."ThewhistleblowingdramabehindAstellas'ssuspensionfromtheABPI".BMJ.366:l4353.doi:10.1136/bmj.l4353.PMID 31266743.S2CID 195788432. ^Helfand,Carly(June23,2017)."AstellasUKnarrowlydodgesexpulsionaftermoretroublewithBritain'spharmacops".FiercePharma.UnitedStates.RetrievedJuly3,2019. ^"AUTH/2984/10/17–HealthProfessionalvAstellasUK".PMCPA.Retrieved3July2019. ^"TwoPharmaceuticalCompaniesAgreetoPayaTotalofNearly$125MilliontoResolveAllegationsThatTheyPaidKickbacksThroughCopayAssistanceFoundations".TheUnitedStatesDepartmentofJustice(Pressrelease).Retrieved3July2019. ^"Cancer-killingvirusboostsimmuno-oncologyresponsesinmiceinAstellas-ledstudy".FierceBiotech.15January2020.Retrieved2020-03-13. ^"FlomaxMR".TheChemistandDruggist(Newsinbrief).Kent,England:CMPInformationLtd.264(6513):12.24September2005–viaInternetArchive. ^Richardson,Jennifer(17November2007)."WholesaledisbeliefatAstellassolesupplydeal".TheChemistandDruggist.Kent,England:CMPMedica.268(6622):7–viaInternetArchive.Anewsbriefappearsthefollowingweekinthepublication—"Astellasdisappointment" ^"AstellasPharma".TheChemistandDruggist(Newsbrief).London,England:UBMMedica.274(6768):10.9October2010–viaInternetArchive. ^Slatko,Joshua(December2013)."BMSchangesseniormanagementteam".PeopleontheMove:Pharma.MedAdNews.p. 27. ^"CorporatePhilosophyofAstellasPharma".AstellasPharma.ArchivedfromtheoriginalonOctober3,2014.RetrievedSeptember9,2014. 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