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KALÉOANNOUNCES2017U.S.RETURNOFAUVI-Q®(EPINEPHRINEINJECTION,USP)AUTO-INJECTORFORLIFE-THREATENINGALLERGICREACTIONS

• Kaléo,theinventorofAUVI-Q,commitstomakingtheinnovativeepinephrineauto-injectorwithindustry-firstfeaturesavailableinthefirsthalfof2017asanalternativeforthelife-threateningallergycommunity

• New,revampedmanufacturingandqualitysystemhelpsensurereliableand

accurateepinephrinedosedeliveryRICHMOND,VA.(October26,2016)–Kaléo,aprivately-heldpharmaceuticalcompany,todayannouncedthatitwillreintroduceAUVI-Q®(epinephrineinjection,USP)auto-injectortotheU.S.marketinthefirsthalfof2017.AUVI-Qisaprescriptionmedicineusedtotreatlife-threateningallergicreactions,includinganaphylaxis,inpeoplewhoareatriskfororhaveahistoryofseriousallergicreactions.“Today’snewsrepresentsanimportantmilestoneforthelife-threateningallergycommunity,whichhassufferedfromalackofepinephrineauto-injectoroptionsforfartoolong,”saidEvanEdwards,VicePresidentofProductDevelopment&Industrializationatkaléo.“AstheinventorsofAUVI-Q,mybrotherandIhavededicatedourlivestoresearchinganddevelopinganinnovativeepinephrineauto-injectorthatwoulddoforsevereallergysuffererswhattheAEDsdidforcardiacarrestinthecommunity;namelyaproductthatcouldassistandguideevenanuntraineduserthroughalife-threateningemergency.”AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. AUVI-Q is engineered to help patients and their caregivers to confidently administer epinephrine in life-threatening allergic emergencies.AfterregainingtherightstoAUVI-Q,kaléoconductedathoroughmanufacturingassessmentandinvestedinnewtechnologyandqualitysystemstoensureaccurate,reliableandconsistentdeliveryfromtheproduct.AUVI-Qismanufacturedonanintelligent,high-tech,100%automatedroboticproductionlinewithmorethan100automatedqualitychecksoneachAUVI-Q,ensuringastreamlinedandconsistentproductionprocess.

Mark Herzog mark.herzog@kaleopharma.com 804-545-6360 ext. 318 (office) 804-677-4956 (cell)

Jennifer Corrigan auviqmedia@kaleopharma.com 212-798-9538 (office) 347-366-1444 (cell)

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“Forthemillionsaffectedbylife-threateningfoodallergies,anepinephrineauto-injectorservesasalifeline,”saidJamesR.Baker,Jr.,MD,CEOandChiefMedicalOfficeratFoodAllergyResearchandEducation(FARE).“Theselifesavingdevicesmustbeaccessibleandaffordable,andAmericansshouldhaveoptionswhenitcomestoselectingtherightauto-injectorfortheirfamily.”EricEdwardsM.D.,Ph.D,VicePresident,ProductStrategyatkaléo,added,“Asapatientandparentofchildrenwithlife-threateningallergies,Iknowhowthemomentofanallergicemergencycanunfold-withpanicandfear-andthatiswhyIbelieveandtrustinAUVI-Q,notonlyformyself,butalsoformychildrenandotherfamilieswhomighthavetodependonit.Drivenbythisreality,kaléostrivesforflawlessmanufacturingtoensureeachAUVI-Qisbuilttoexceptionalqualitystandards.”

Kaléoisawareoftheepinephrineauto-injectoraccessandaffordabilitychallengesconfrontingpatientsandisworkingtoengagewithvariousstakeholders,includingwholesalers,insurancecompanies,pharmaciesandpharmacybenefitmanagers,toensurethatallpatientsregardlessofinsurancecoverage,haveaffordableaccesstoAUVI-Q.

“Webelievethatpatientsshouldhaveoptionswhenitcomestoepinephrineauto-injectorsforlife-threateningallergicreactions”saidSpencerWilliamson,PresidentandCEOofkaléo.“WhenahealthcarepractitionerprescribesAUVI-Q,determiningthatitisbestforapatient,webelievethatthepatientshouldbeabletoobtaintheproductwithoutinsurancebarriersorbeingsubjectedtoahighout-of-pocketcost.AswepreparetomakeAUVI-QavailableonceagainintheUnitedStates,ourpriorityistoreturnAUVI-Qtothemarketasanepinephrineauto-injectoralternativethatallpatientscanafford.”“Weareveryexcitedaboutpatientsonceagainhavingachoiceinepinephrineauto-injectors,”saidEleanorGarrow-Holding,PresidentandCEOoftheFoodAllergy&AnaphylaxisConnectionTeam(FAACT).“Asfoodallergyadvocatesandfamiliespersonallyaffectedbyfoodallergies,weunderstandthateachpersonwithfoodallergieshasindividualneedsandcomfortlevels.Thoselivingwithlife-threateningallergiesdeserveinnovativeproductsandchoicesthatmeettheirindividualneeds.Assuch,wearegratefulthatpatientswillhaveoptionswhenselectingtheirpotentiallylife-savingepinephrineauto-injector."ThelatestupdatesregardingthereturnofAUVI-Qwillbeavailabletomembersofthepublicwhoregisteronlineatwww.auvi-q.com.

###AboutAnaphylaxisAnaphylaxis(pronouncedana-fuh-lak-sis)isaseriousallergicreactionthathappensquickly and may cause death. Anaphylaxis can occur as a result of exposure to

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allergens including treenuts, peanuts,milk, eggs, fish, shellfish, soy,wheat, insectbites,latexandmedication,amongotherallergens.AboutAUVI-QAUVI-Q®(epinephrineinjection,USP)Auto-injectorisaprescriptionmedicineusedtotreatlife-threateningallergicreactions,includinganaphylaxis,inpeoplewhoareatriskfororwhohaveahistoryofseriousallergicreactions.AUVI-Qcontainsepinephrine,awell-established,first-linetreatmentforsevere,life-threateningallergicreactionsthatoccurasaresultofexposuretoallergensincludingfoodsuchaspeanuts,treenuts,fish,shellfish,dairy,eggs,soyandwheat;insectstingsorbites;latexandmedication,amongotherallergensandcauses.InventedbytwinbrothersEricandEvanEdwards,aphysicianandengineerwhoeachsufferfromlife-threateningallergies,AUVI-Qisacompactepinephrineauto-injectorwithindustry-firstfeatures,includingavoicepromptsystemthatguidesauserwithstep-by-stepinstructionsthroughtheepinephrinedeliveryprocess,andaneedlethatautomaticallyretractsfollowingadministration.Inemergenciessuchasanaphylaxis,itisoftenindividualswithoutmedicaltrainingwhoneedtostepinanddeliverpotentiallylife-savingrescuetherapy.AUVI-Qwasdesigned–throughcarefulanalysisofthesituationswhereepinephrineisusedandwithsignificantinputfromtheallergycommunitythatreliesonit–toreflectHumanFactorsEngineering(HFE).HFEisaboutdesigningproductsorsystemsthatareeasytooperateand,mostimportantly,supportcorrectuse,withthegoaltoremovethepotentialforerror.IndicationAUVI-Q®(epinephrineinjection,USP)isaprescriptionmedicineusedtotreatlife-threateningallergicreactions,includinganaphylaxis,inpeoplewhoareatriskfororhaveahistoryofseriousallergicreactions.

ImportantSafetyInformationAUVI-Qisforimmediateself(orcaregiver)administrationanddoesnottaketheplaceofemergencymedicalcare.Seekimmediatemedicaltreatmentafteruse.EachAUVI-Qcontainsasingledoseofepinephrine.AUVI-Qshouldonlybeinjectedintoyourouterthigh,throughclothingifnecessary.IfyouinjectayoungchildwithAUVI-Q,holdtheirlegfirmlyinplacebeforeandduringtheinjectiontopreventinjuries.Donotinjectintoveins,buttocks,fingers,toes,hands,orfeet.IfyouaccidentallyinjectAUVI-Qintoanyotherpartofyourbody,seekimmediatemedicaltreatment.Rarely,patientswhouseAUVI-Qmaydevelopinfectionsattheinjectionsitewithinafewdaysofaninjection.Someoftheseinfectionscanbeserious.Callyourhealthcareproviderrightawayifyouhaveanyofthefollowingsymptomsataninjectionsite:rednessthatdoesnotgoaway,swelling,tenderness,ortheareafeelswarmtothetouch.

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Ifyouhavecertainmedicalconditions,ortakecertainmedicines,yourconditionmaygetworseoryoumayhavemoreorlongerlastingsideeffectswhenyouuseAUVI-Q.Besuretotellyourhealthcareprovideraboutallthemedicinesyoutake,especiallymedicinesforasthma.Alsotellyourhealthcareprovideraboutallofyourmedicalconditions,especiallyifyouhaveasthma,ahistoryofdepression,thyroidproblems,Parkinson’sdisease,diabetes,heartproblemsorhighbloodpressure,haveanyothermedicalconditions,arepregnantorplantobecomepregnant,orarebreastfeedingorplantobreastfeed.Epinephrineshouldbeusedwithcautionifyouhaveheartdiseaseoraretakingcertainmedicinesthatcancauseheart-related(cardiac)symptoms.Commonsideeffectsincludefast,irregularor‘pounding’heartbeat,sweating,shakiness,headache,paleness,feelingsofoverexcitement,nervousness,oranxiety,weakness,dizziness,nauseaandvomiting,orbreathingproblems.Thesesideeffectsusuallygoawayquickly,especiallyifyourest.Tellyourhealthcareproviderifyouhaveanysideeffectthatbothersyouorthatdoesnotgoaway.PleaseseethefullPrescribingInformationandthePatientInformationatwww.auvi-q.com.YouareencouragedtoreportnegativesideeffectsofprescriptiondrugstotheFDA.Visitwww.fda.gov/medwatchorcall1-800-FDA-1088.Aboutkaléo(kuh-LAY-oh)Kaléo is a pharmaceutical companydedicated to building innovative solutions forseriousandlife-threateningmedicalconditions.Ourmissionistoprovideinnovativesolutions that empower patients to confidently take control of their medicalconditions.Webelievepatientsandcaregiversaretheexpertsonhowtheirmedicalcondition impacts their lives,andarean integralpartofourproductdevelopmentprocess. Each kaléo product combines an established drug with an innovativedeliveryplatformwiththegoalofachievingsuperiorityandcosteffectiveness.Kaléois a privately-held company headquartered in Richmond, Virginia. For moreinformation,visitwww.kaleopharma.com.