corporate update presentation: sumatriptan alginate film (kl … · 2019-06-17 · corporate update...

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

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Under-treatedpatients

Nasaladministrationisapoordeliverymethod

• Highvariabilityinuptakeresultsinvariableefficacy

• Drugfallsthroughnasalcavityresultinginoraldelivery

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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

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