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Novaliq
Novaliq GmbH develops innovative drug delivery solutions for poorly soluble drugs, focusing on ophthalmic markets. They offer proprietary formulations, including preservative-free eye drops like Novatears® and Cyclasol®, which show excellent safety and efficacy. The company has raised $42 million, holds a strong intellectual property position, and is open to partnerships for further development.
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Novaliq
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- 3. Novaliq GmbH 3 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!
- 4. Novaliq GmbH 4 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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- 6. Novaliq GmbH 6 ! 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&
- 7. Novaliq GmbH 7 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&
- 8. Novaliq GmbH 8 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&& ! ! OTC&
- 9. Novaliq GmbH 9 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&
- 10. Novaliq GmbH 10 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&
- 11. Novaliq GmbH 11 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!
- 12. Novaliq GmbH 12 • 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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