Novaliq

13
Bernhard Guenther CEO

Transcript of Novaliq

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Bernhard!Guenther!CEO!

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Novaliq GmbH 2

Transforming!Poorly!Soluble!Drugs!!Into!Effec?ve!Therapeu?cs!!

For!Major!Ophthalmic!Markets!!

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Value&Proposi-on&&

•  OTC:!Innova?ve!ar?ficial!tears!based!on!SFAs!!•  RX:!!Internal!development!–!poorly!soluble!APIs!–!new!therapeu?cs!!!•  Drug!delivery!partnerships!for!pharma’s!proprietary!NCEs!

BUSINESS!MODEL!

•  Unique!excipient!that!increases!solubility,!stability!and!penetra?on!of!poorly!soluble!drugs!

•  Mul?!dose,!preserva?ve!free,!nonTirrita?ng!•  Strong!Global!IP!posi?on!

INNOVATION!–!!Semi!Fluorinated!Alkanes!(SFA’s)!

•  OTC:!NovaTears®!(CE!mark)!–!NovaTears!Omega!3!(CE!mark!2015)!!•  Rx:!!Phase!2!ready:!CyclASol®!and!TacroSol®!!•  Excellent!human!data!for!OTC!and!Rx!products!!

BESTTINTCLASS!PRODUCTS!

WELL!FUNDED!&!EXPERIENCED!TEAM!

•  Heidelberg,!Germany!Based!Pharmaceu?cal!Company!•  Extensive!Ophthalmology!Experience!–!Team!and!Advisory!Board!•  $42m!capital!raised!

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Product& Indica-on& Research& Preclinic& Phase&I& Phase&II& Phase&III& Registra-on& Market&

Rx!OTC/CE!

CylASol®! Dry!Eye,!severe!

TacroSol®! Uvei?s/Allergy!

NovT143! Pain,!Cataract!Surgery!

NovaTears®! Dry!Eye,!mild!

SFA/Omega3! Dry!Eye,!moderate!

NovT236! Dry!Eye,!mild!

Research& Registra-on& Market&Clinical&Phase&

Ophthalmic&Pipeline&

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Examples&of&Substances&Directly&Soluble&in&SFAs&

aDTocopherol&(VitaminDE)!

Cyclosporin&

Latanoprost&Tacrolimus&&

Omega&3&

Lidocain&

Poorly&Soluble&Drugs&

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!CyclASol®!Phase!I!Study!

!•  No!Burning!•  No!S?nging!•  Excellent!Tolerability!•  No!Systemic!Exposure!

!NovaTears®!Observa?onal!Study!

!•  Non!Aqueous!•  Preserva?veTFree!•  No!Blurring!•  Superior!Weeng!•  Excellent!Safety!and!Efficacy!!

Clinical&Data&

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Posi-ve&Results&from&NovaTears®&Observa-onal&Study&in&Mild&to&Moderate&Evapora-ve&Dry&Eye&Disease&(DED)&!•  The!company's!first!ophthalmic!OTC!product!T!CE!Mark!

!!•  Human!Data:!Observa?onal!Study!NTT001!with!NovaTears®OTC!eye!drops!successfully!

completed!in!July!2014:!!excellent!clinical!performance!and!safety!in!pa?ents!with!hyperTevapora?ve!dry!eye!disease:!

!  Increases!tear!fluid!produc?on!!  Prolongs!tear!film!stability!(TFBUT)!!  Reduces!objec?ve!(corneal!staining)!and!subjec?ve!signs!and!!

symptoms!of!DED!!

!

OTC&

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Background&•  OmegaT3!fajy!acids!are!currently!used!systemically!(capsules)!!•  Stabiliza?on!of!the!lipid!film!with!OmegaT3!fajy!acids!&

Formula-on&•  Clear!solu?on!!•  Preserva?ve!free!mul?Tdose!units,!!•  No!irrita?ng!excipients!(e.g.!surfactants)!required!•  12!Month!stable!at!40�C/75!&

Status!•  CETmark!registra?on!expected!in!EU!for!Q1/2015!•  Partnered!with!leading!EU!ophthalmic!player,!EU!market!entry!2016!•  Available!for!partnering!outside!EU!

NovaTears®&plus&OmegaD3&&!

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OTC&

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Posi-ve&Results&From&CyclASol®&(CsA&solu-on)&Eye&Drops&Repeated&and&Ascending&Dose&Phase&1&Study:&!•  CyclASol®!(CsA!0,05%!solu?on!formula?on!in!the!semiTfluorinated!alkane!vehicle!F4H5)!!

eye!drops!are!safe!and!well!tolerated!!!•  CyclASol®!is!the!first!and!only!clear!solu?on!based!eye!drop!formula?on!in!clinical!development!for!

pa?ents!with!dry!eye!disease!!!!  Available!in!preserva?veTfree!mul?Tdose!bojles!!  Excellent!spreading!and!wejability!!  Superior!pharmacokine?cs!and!biocompa?bility!!!  Proven!longTterm!stability!!!  Broad!patent!protec?on!in!major!markets!!!

Rx&

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Novaliq’s&EyeSol®&PlaRorm&Technology&Allows&Formula-on&and&Stabilisa-on&of&Pep-des&and&Proteins&at&High&Temperatures:&&&•  Therapeu?c!pep?des,!proteins!and!monoclonal!an?bodies!show!excellent!stability!and!ac?vity!!

Stable!in!EyeSol®!formula?on!

Inac?ve!in!standard!formula?on!

Insulin&at&50�C&

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Novaliq&Offers&Access&to&EyeSol®&PlaRorm&Technology&For&Ophthalmic&Drug&Development&&

•  Combina?on!of!Novaliq’s!EyeSol®!plaqorm!technology!with!pharma’s!proprietary!NCEs!•  Technology!Access!Fee!•  Milestone!payments!for!formula?on/stablility,!licensing!op?on!•  Licensing!agreement!for!clinical!development!(Upfront,!milestones,!royal?es)!!!!!!!!

direct!and!clear!solu?ons! suspension!

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•  Novaliq!GmbH!offers!a!compelling!and!proven!drug!delivery!opportunity!to!enhance!the!performance!of!topical!eye!drops!!

•  A!new!genera?on!of!Rx!and!OTC!products!based!on!unique!and!proprietary!proper?es!of!SFA’s!as!the!delivery!vehicle!!

•  Novaliq!welcomes!invita?ons!to!enter!into!discussions!on!development!or!partnership!opportuni?es!!!!!!!

!

Summary&

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Novaliq!GmbH!Bernhard!Guenther!President!&!CEO!Im!Neuenheimer!Feld!515!69120!Heidelberg!

Phone:!+49!6221!50259T0!

Email:[email protected]!

Web:!www.novaliq.de!