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IpsenAnnouncesFDAApprovalofaNewDeliveryDevicefor

SomatulineDepot(lanreotide)Injection
DeviceIncorporatesSafenSoundSyringeTechnologyandOffers
EnhancedSafetyFeatures
November06,201410:06AMEasternStandardTime
BASKINGRIDGE,N.J.(BUSINESSWIRE)IpsenBiopharmaceuticals,Inc.,anaffiliateofIpsen(Euronext:
IPNADR:IPSEY),todayannouncedthattheU.S.FoodandDrugAdministration(FDA)hasapprovedanew
devicetodeliverSomatuline Depot (lanreotide).Thedevicehasanenhanced,prefilled,lowvolume
syringethatsupportsfulldosedeliverywithnoreconstitutionrequirements.

We are continually looking for ways to better


serve those who rely upon our medications
Thesingleusesyringeisavailablein60mg,90mgand120mgdosages.Additionalsafetyfeatureshave
alsobeenincorporated,includingaretractableneedleguard,whichautomaticallyengagestohelpavoid
needlestickinjury,acommonhazardforhealthcareworkers.AccordingtotheCentersforDiseaseControl
andPrevention,eachyear385,000needlestickandsharpsrelatedinjuries,oranaverageofapproximately
1,000incidentsaday,aresustainedbyU.S.hospitalbasedhealthcarepersonnel.Theretractableneedlein
thisdevicewasdesignedwiththeNeedlestickSafetyandPreventionActandaccompanyingOccupational
Safety&HealthAdministration(OSHA)regulationsinmind.Needlesticksafetyremainsacontinuing
concernofhealthcareworkeradvocacygroupsincludingtheAmericanNursesAssociation.
Thedeviceismanufacturedwithoutlatexornaturaldryrubber,whichisimportantbecausehealthcare
workerscandevelopallergiestothesesubstancesovertime.Thesturdyconstructionincludesatransparent
syringetohelpverifysuccessfuldrugdelivery,aswellasaplungerprotectortoaidinpreventingaccidental
productloss.Whenthenewdeviceentersthemarketplace,eachshipmentofSomatuline Depotwillbe
accompaniedbyrobustinstructionsforusewhichprovidestepbystepinstructionstohealthcare
professionalsforproperadministrationoftheproduct.
TheupdateddesignhasbeenavailableintheEUsinceJanuary2012andwillbeavailableintheU.S.
beginninginJanuary2015.
Wearecontinuallylookingforwaystobetterservethosewhorelyuponourmedications,saidCynthia
Schwalm,PresidentandCEOofIpsenBiopharmaceuticals,Inc.Forpatientswhomustgetregular
injectionsofSomatulineDepot,andthehealthcareprofessionalsthatadministertheirmedication,this
updateddesign,incorporatingSafenSoundsyringetechnology,canhelpsupportfulldosedeliveryand
helppreventaccidentalneedlesticks,animportantbenefitforthoseonthefrontlinesofdeliveringcare.
AboutSomatulineDepot

Somatuline DepotInjectionisasomatostatinanalogindicatedforthelongtermtreatmentofpatientswith
acromegalywhohavehadaninadequateresponsetoorcannotbetreatedwithsurgeryand/or
radiotherapy.
TheactivesubstanceinSomatuline Depotislanreotideacetate,asomatostatinanaloguethatinhibitsthe
secretionofseveralendocrine,exocrineandparacrineaminesandpeptides.
SelectImportantSafetyInformationaboutSomatuline DepotforPatients
Somatuline Depotmaycauseserioussideeffectsincluding:

Gallstones
Changesinyourbloodsugar(highbloodsugarorlowbloodsugar)
Slowheartrate
Highbloodpressure
ThemostcommonsideeffectsofSomatuline Depotincludediarrhea,gallstones,stomacharea
(abdominal)pain,nausea,andpain,itching,oralumpattheinjectionsite.
ThesearenotallthepossiblesideeffectsofSomatuline Depot.Tellyourhealthcareprofessionalifyou
haveanysideeffectthatbothersyouorthatdoesnotgoaway.
BeforeyoureceiveSomatuline Depot,talktoyourhealthcareprofessionalaboutallofyourmedical
conditions,including:

Gallbladder,thyroid,heart,kidney,orliverproblems
Diabetes
Allergytolatexornaturaldryrubber
Pregnancyorplanstobecomepregnant
ItisnotknownifSomatulineDepotcouldharmyourunbornbaby
Breastfeedingorplanstobreastfeed
ItisnotknownifSomatulineDepotpassesintobreastmilk
Anymedicines(prescriptionandnonprescription)youaretaking,including:

Insulinorotherdiabetesmedicines
Acyclosporine(suchasGengrafTM,Neoral,orSandimmune)
Amedicinecalledbromocriptine(suchasParlodel)
Medicinesthatloweryourheartrate(suchasbetablockers)
WhileonSomatuline Depot:

Tellyourhealthcareprofessionalifyouhavesuddenpaininyourupper

rightstomach(abdominal)areaorinyourrightshoulderorbetweenyour
shoulderblades,orifyouhaveyellowingofyourskinandwhitesofyour
eyes,feverwithchills,ornauseaasthesecouldbesymptomsrelatedto
gallstones.
Ifyouhavediabetes,testyourbloodsugarasyourhealthcareprofessional
tellsyouto.Yourhealthcareprofessionalmaychangeyourdoseof
diabetesmedicineespeciallywhenyoufirststartreceivingSomatuline
DepotorifyourdoseofSomatulineDepotchanges.
Beforeeachtreatment,readthePatientInformationthatcomeswitheach
SomatulineDepotpackageastheremaybenewinformation.Talkwith
yourhealthcareprofessionalaboutyourmedicalconditionoryour
treatment.Yourhealthcareprofessionalisyourprimarysourceof
informationabouttreatment.
PleaseseethePatientInformationforSomatuline Depotat
http://somatulinedepot.com/assets/files/fpo_patient_pi.pdf.
SelectImportantSafetyInformationaboutSomatuline DepotforHealthcareProfessionals
Contraindications
Somatuline iscontraindicatedinpatientswithhypersensitivitytolanreotideorrelatedpeptides.
WarningsandPrecautions

Somatulinemayreducegallbladdermotilityandleadtogallstone
formation.Periodicmonitoringmaybeneeded.
Patientsmayexperiencehypoglycemiaorhyperglycemia.Glucoselevel
monitoringisrecommendedandantidiabetictreatmentadjusted
accordingly.
Somatulinemaydecreaseheartrate.Incardiacstudies,themost
commoncardiacadversereactionsweresinusbradycardia,bradycardia,
andhypertension.Doseadjustmentofcoadministereddrugsthatdecrease
heartratemaybenecessary.
Somatulinemaydecreasebioavailabilityofcyclosporine.Cyclosporine
dosemayneedtobeadjusted.
AdverseReactions
Themostcommonadversereactions(incidence>5%)werediarrhea(37%),cholelithiasis(20%),
abdominalpain(19%),nausea(11%),injectionsitereaction(9%),constipation(8%),flatulence(7%),
headache(7%),arthralgia(7%),vomiting(7%),andloosestools(6%).
UseinSpecialPopulations

Patientswithmoderateandsevererenalimpairmentormoderateandseverehepaticimpairment:Initial
doseis60mgevery4weeks.
PleaseseethefullPrescribingInformationforSomatulineDepotat
http://somatulinedepot.com/pdf/pi_2013november.pdf.
AboutIpsen
IpsenisaglobalspecialtydrivenpharmaceuticalcompanywithtotalsalesexceedingEUR1.2billionin
2013.Ipsen'sambitionistobecomealeaderinspecialtyhealthcaresolutionsfortargeteddebilitating
diseases.Itsdevelopmentstrategyissupportedby3franchises:neurology,endocrinologyanduro
oncology.Moreover,theGrouphasanactivepolicyofpartnerships.Ipsen'sR&Disfocusedonits
innovativeanddifferentiatedtechnologicalplatforms,peptidesandtoxins.In2013,R&Dexpendituretotaled
closetoEUR260million,representingmorethan21%ofGroupsales.Moreover,Ipsenalsohasa
significantpresenceinprimarycare.TheGrouphascloseto4,600employeesworldwide.Ipsen'sshares
aretradedonsegmentAofEuronextParis(stockcode:IPN,ISINcode:FR0010259150)andeligibletothe
"ServicedeRglementDiffr"("SRD").TheGroupispartoftheSBF120index.Ipsenhasimplementeda
SponsoredLevelIAmericanDepositaryReceipt(ADR)program,whichtradeontheoverthecounter
marketintheUnitedStatesunderthesymbolIPSEY.Formoreinformation,visitwww.ipsen.com.
ForwardLookingStatements
Theforwardlookingstatements,objectivesandtargetscontainedhereinarebasedontheGroup's
managementstrategy,currentviewsandassumptions.Suchstatementsinvolveknownandunknownrisks
anduncertaintiesthatmaycauseactualresults,performanceoreventstodiffermateriallyfromthose
anticipatedherein.AlloftheaboveriskscouldaffecttheGroup'sfutureabilitytoachieveitsfinancialtargets,
whichweresetassumingreasonablemacroeconomicconditionsbasedontheinformationavailabletoday.
Useofthewords"believes,""anticipates"and"expects"andsimilarexpressionsareintendedtoidentify
forwardlookingstatements,includingtheGroup'sexpectationsregardingfutureevents,includingregulatory
filingsanddeterminations.Moreover,thetargetsdescribedinthisdocumentwerepreparedwithouttaking
intoaccountexternalgrowthassumptionsandpotentialfutureacquisitions,whichmayalterthese
parameters.TheseobjectivesarebasedondataandassumptionsregardedasreasonablebytheGroup.
Thesetargetsdependonconditionsorfactslikelytohappeninthefuture,andnotexclusivelyonhistorical
data.Actualresultsmaydepartsignificantlyfromthesetargetsgiventheoccurrenceofcertainrisksand
uncertainties,notablythefactthatapromisingproductinearlydevelopmentphaseorclinicaltrialmayend
upneverbeinglaunchedonthemarketorreachingitscommercialtargets,notablyforregulatoryor
competitionreasons.TheGroupmustfaceormightfacecompetitionfromgenericproductsthatmight
translateintoalossofmarketshare.Furthermore,theResearchandDevelopmentprocessinvolvesseveral
stageseachofwhichinvolvesthesubstantialriskthattheGroupmayfailtoachieveitsobjectivesandbe
forcedtoabandonitseffortswithregardstoaproductinwhichithasinvestedsignificantsums.Therefore,
theGroupcannotbecertainthatfavourableresultsobtainedduringpreclinicaltrialswillbeconfirmed
subsequentlyduringclinicaltrials,orthattheresultsofclinicaltrialswillbesufficienttodemonstratethesafe
andeffectivenatureoftheproductconcerned.Therecanbenoguaranteesaproductwillreceivethe
necessaryregulatoryapprovalsorthattheproductwillprovetobecommerciallysuccessful.Ifunderlying
assumptionsproveinaccurateorrisksoruncertaintiesmaterialize,actualresultsmaydiffermateriallyfrom
thosesetforthintheforwardlookingstatements.Otherrisksanduncertaintiesincludebutarenotlimitedto,
generalindustryconditionsandcompetitiongeneraleconomicfactors,includinginterestrateandcurrency
exchangeratefluctuationstheimpactofpharmaceuticalindustryregulationandhealthcarelegislation
globaltrendstowardhealthcarecostcontainmenttechnologicaladvances,newproductsandpatents
attainedbycompetitorschallengesinherentinnewproductdevelopment,includingobtainingregulatory
approvaltheGroup'sabilitytoaccuratelypredictfuturemarketconditionsmanufacturingdifficultiesor
delaysfinancialinstabilityofinternationaleconomiesandsovereignriskdependenceontheeffectiveness
oftheGroup'spatentsandotherprotectionsforinnovativeproductsandtheexposuretolitigation,including
patentlitigation,and/orregulatoryactions.TheGroupalsodependsonthirdpartiestodevelopandmarket
someofitsproductswhichcouldpotentiallygeneratesubstantialroyaltiesthesepartnerscouldbehavein
suchwayswhichcouldcausedamagetotheGroup'sactivitiesandfinancialresults.TheGroupcannotbe

certainthatitspartnerswillfulfilltheirobligations.Itmightbeunabletoobtainanybenefitfromthose
agreements.AdefaultbyanyoftheGroup'spartnerscouldgeneratelowerrevenuesthanexpected.Such
situationscouldhaveanegativeimpactontheGroup'sbusiness,financialpositionorperformance.The
Groupexpresslydisclaimsanyobligationorundertakingtoupdateorreviseanyforwardlooking
statements,targetsorestimatescontainedinthispressreleasetoreflectanychangeinevents,conditions,
assumptionsorcircumstancesonwhichanysuchstatementsarebased,unlesssorequiredbyapplicable
law.TheGroup'sbusinessissubjecttotheriskfactorsoutlinedinitsregistrationdocumentsfiledwiththe
FrenchAutoritdesMarchsFinanciers.
SOMATULINEDEPOTisaregisteredtrademarkofIPSENPHARMAS.A.S.
SAFENSOUNDisaregisteredtrademarkofNEMERALAVERPILLIERESAS.

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RobKloppenburg,9082756388
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Email:robert.kloppenburg@ipsen.com
or
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Email:didier.veron@ipsen.com
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Email:brigitte.le.guennec@ipsen.com
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Email:ewhite@healthstarpr.com
or
FinancialCommunity:
IpsenBiopharmaceuticals,Inc.
StphaneDurantdesAulnois,+33(0)158336009
InvestorRelationsDirector
Fax:+33(0)158335063
Email:stephane.durant.des.aulnois@ipsen.com
or
ThomasPenyCoblentz,+33(0)158335636
InvestorRelationsDeputyDirector
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Email:thomas.penycoblentz@ipsen.com