corporate update presentation: sumatriptan alginate film (kl … · 2019-06-17 · corporate update...
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CorporateUpdatePresentation:SumatriptanAlginateFilm(KL-00119)
June,2019
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Agenda
§ Technology Description§ Sumatriptan
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An Enabling and Transformative Technology
1)Thealginatefilmisattachedtotheoralmucosa2)Filmstaysinplacefor10to30minutes3)Thedrugtransfersdirectlyintothebloodstream
Byreplacinginjectionswewillbothenableandtransformthetreatmentinmultipleindications
Filmdoesnotmelt,isnotmixedwithsalivaandswallowedlikeotheroralfilmtechnologies thatclaimtrans-mucosaldeliverybutinfactachieveoraldelivery
DrugsthatarenotorallyavailableandhavetobeinjectedcanbedeliveredwithKlaria’s FilmTechnology
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Features and Benefits of Technology
Simpleandnon-invasive
Consistent,lowvariability
Rapiddeliveryofactivesubstance
Easytomanufacture
Easytostore,ship,handle
Enabling usewhereinjectionisnotfeasibleorapooroption•Example:Naloxonefilmvsinjectionbyhealthcareprofessional•Example:Epinephrinevsinjection
Superior tonasaldelivery• Example:Sumatriptanfilmvsnasalspray
Fasterthanoraldelivery• Example:Sumatriptanfilmvstablet• Example:Cannabinoidfilmvsoraldeliverytechnologies
LowerCOGSthaninjectionsystems,nasalspraydevicesetc.• Example:Adrenalinefilmvsinjection
Broaderusagethaninjectiondevicesorinjections• Example:Adrenalinefilmvsinjection• Example:Naloxonefilmvsinjectionbyhealthcareprofessional
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§ AlginatepolymerextractedfromtheNorthSeabrownalgae(Kelp)
§ Extremelymuco-adhesivewhenformulatedusingourproprietaryprocess
§ Approvedforfoodanddruguseworldwide
§ Patentprotectedworldwide
Natural, Uniquely Efficacious, Approved and Patent Protected
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Strategy to Create Value
• Welldefinedregulatorypathwithlowerrisk,lowercosts,shortertimelinesandhigherapprovalrates
• Createmedicalvaluebyfocusingonprojectsthataddresshighunmetmedicalneedsandwhereinjectionornasalrouteispreferred
• SharebenefitsoflowerCOGS betweenstakeholders,allowingforbothlowerpriceandhighgrossmargins
• Createpricingpowerbyavoidingpharmacysubstitutionwithtablets• Clinicalstudies(ph IIsizestudies)showingsuperiorefficacyand/orsafety• Developdosesthatarebioequivalentbutnotidentical• Establishbioequivalencetonon-oralformulations
CreateCommercialValue
ClaimCommercialValue
CreateMedicalValue
Lower:Risk,Time,Cost
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Agenda
§ Technology Description§ Sumatriptan
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Migraine is Prevalent, Debilitating and Costly
§ Occursin12%ofpopulationinUSandEU§ 85%ofMigrainesufferersarewomen§ 25%ofwomensuffer4ormoreattacks/month§ 90%ofsufferersareunabletofunctionnormally
§ >2.5millionhospitalemergencyroomvisits/yearinUSandEUduetoMigraineAttacks
§ Highsocietalcost§ $70billionperyearinlostproductivityinEUandUS§ $9billionperyearintotaltreatmentcostsinEUandUS
Sources:Migraine ResearchFoundation,TheMigraine Trust,DMKG,InternationalHeadache Society
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80%1,2
ofmigrainepatientssufferfromNausea
79%willingtotryanewacutemedication2
Injectionsareriskyanddistressingtopatients
• Fearofinjection
• Difficulttoadministercorrectly
• Potentialcomplications
à
Under-treatedpatients
Nasaladministrationisapoordeliverymethod
• Highvariabilityinuptakeresultsinvariableefficacy
• Drugfallsthroughnasalcavityresultinginoraldelivery
à
Sub-optimaltreatment
1:BeckerWJ.Headache.2015;55(6):778-793.2:Lipton RB.Headache.199939(Suppl.)S20-S263:Source:Migraine ResearchFoundation
Migraine Patients are Willing to Try a New Medication- Tablet, Nasal and Injection are Poor Options
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10 Klaria Confidential
OralTablet
NasalSpray
Injection
Tabletand/orNasalSpray
Suboptimal/under
treatment UnmetMedicalNeed
80%donottoleratetabletduetonausea
NasalAdministrationisvariableandsuffersfrompoorefficacy
Patientsbouncebetweentreatmentoptions,notfinding
relief
Injectionsarepainful,causeunwantedsideeffectsandpatientsfearthem
Large Pool of Migraine Patients Currently Poorly Served
Sub-optimal treatment and under-treatment causes:- Significant patient suffering3
-High societal cost due to lost productivity and co-morbidities3
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Administration to the Vasculature around the Trigeminal Nerves to Achieve Maximum Efficacy
Placement of Film and absorption of Sumatriptan is local on the facial artery which has its terminus in the ophthalmic and maxillary regions of the facewhere migraines originate1, 2
1:Moskowitz,M.A.:Theneurobiologyofvascularheadpain.AnnNeurol1984;16:157–168.2:Goadsby,P.J.:Thepharmacologyofheadache.ProgNeurobiol2000;62:509–525.
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§ TheFilmwillclaimsignificantshareoftablet,nasalandinjectionmarket§ Theoral/tabletmarketislargeandlow-priced§ ThefilmwillbepricedsimilarlytocurrentUSmarketpricesfornasal
spraysandinjections
Sumatriptan Film is a $300+ million peak sales opportunity