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MC2 Biotek
- 1. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style Introducing PADciclo™ - because tolerability matters Ophthalmology Innovation Summit, October 16th 2014 PAD™ Technology -‐ releasing the full poten1al of API’s 2014
- 2. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style MC2 Biotek Group at a glance § Privately held Danish company § Major investor is family behind Danfoss Group (USD 6 bn) § Long term commitment – flexible collabora1on models § PAD™ Technology – releasing full poten;al of API’s § Key to a successful drug is a label recognized by payers and clinicians as clinically superior § Focus: Clinically superior PAD™ versions of high-‐value marketed topical drugs § PADciclo™ Dry eye (phase II star1ng up) § PADcombo™ Psoriasis (phase II ongoing) § Atopic derma11s (phase I, Q1 2015) § Other PAD™ topical projects in pre-‐clinical development § Operates through a network based business model § Company loca1ons in Copenhagen and London § Project teams of highly reputed experts in the US and EU § Strategic collabora1ons with academia and hospitals
- 3. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style PADciclo™- need for 2nd generation CsA eye drop Ra;onale Challenge Solu;on by PADciclo™ Restasis® is twice daily, it s1ngs and has sub-‐op1mal label – yet a blockbuster Need for improved CsA product in the US Need for approved CsA products in EU Reduce s1nging (CsA will always s1ng in some pa1ents) § Reduce surfactant level ~30 fold § Reduce concentra1on of CsA Once daily dosing § CsA penetra1on ~4 fold be]er than Restasis® Get best in class claim for “treatment” § Novel clinical strategy
- 4. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style PAD™ droplets are robust with low level of surfactants
- 5. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style >1,000 patients treated with PADciclo™ 0.06% in the UK Collabora;on with Moorfields Pharmaceu;cals (Moorfields Eye Hospital) § Available in the UK since April 2012 as a 0.06% preserva1ve free unlicensed Special § Repeated sales to >300 hospitals, clinics, wholesalers and pharmacies § More than 1,000 pa1ents have been treated
- 6. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style MEH analysis of 129 patient files is very encouraging Safety: § PADciclo™ 0.06% is safe § No decrease in visual acuity, no effect on intraocular pressure and no vital signs Efficacy: § Qualita1ve data reported by pa1ents and ophthalmologists show improvement of clinical status of dry eye pa1ents (Be]er, Stable, Worse) Ophthalmologists Pa;ents BePer 66% 69% Stable 34% 27% Worse 0% 4% Data from dry eye pa1ent files with sufficient data
- 7. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style PADciclo™ is preferred by patients at MEH PADciclo 0.6% CsA survey (n=23) conducted by Moorfields Eye Hospital (Feb-‐April 2013) Author: Kris1n Chapman (Formulary & An1bio1c Pharmacist)
- 8. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style PADciclo™ is well tolerated and increases ocular delivery Ocular PK data support once daily ins;lla;on at strengths of 0.03% and 0.06% w/w CsA § PK studies in rabbits show superior ocular exposure of PADciclo™ compared to Restasis® § PADciclo™ once daily is sufficient for saturated delivery to cornea and conjunc1va 0 1 2 3 4 5 6 PADciclo 0.06%, 1x PADciclo 0.06%, 2x PADciclo 0.1%, 1x PADciclo 0.1%, 2x 0.05% Restasis Fold Exposure over Restasis (AUC0-‐24h) Cornea Conjunc1va Ocular Exposure rela;ve to Restasis® PADciclo is safe and very well tolerated up to 6 months § Rabbit safety and tolerability studies conducted at 0.1% strength with 2-‐4 1mes daily dosing § No treatment or administra1on-‐related effects § Systemic exposure of ciclosporin is very low
- 9. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style Large PADciclo™ phase II trial is starting up PADciclo™ has the required poten;al § Excellent pre-‐clinical data § Large scale manufacture in unit dose secured § Once daily dosing and high tolerability are key for pa1ent compliance § Experience from >1,000 pa1ents in the UK and 129 pa1ent files § Outcome of Scien1fic Advice mee1ngs support our clinical strategy Fast to market and best in class
- 10. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title style Opportuni;es using PAD™ vehicle: § Reformulate high value marketed drugs + LCM § Release the full poten1al of API’s from first formula1on PAD™ Technology - release the full potential of API’s § The right vehicle can provide the twist that makes a superior product § PAD™ Technology does not impose addi1onal risk -‐ only pharmacopeial excipients § Key differen1a1ng features of the PAD™ Technology: Penetra1on Solubility Stability Compliance Tolerability Patented
- 11. • Click to edit Master text styles – Second level • Third level – Fourth level » Fifth level Click to edit Master title styleWe welcome collaboration Thank you for your attention