Drug delivery through the oral mucosa. Stephen Carter Chief Execu;ve Officer Nick Woolf Chief Business Officer. April 2014

Transcription

1 Drug delivery through the oral mucosa Stephen Carter Chief Execu;ve Officer Nick Woolf Chief Business Officer April 2014

2 Overview SUDA (ASX: SUD) is a drug delivery company commercialising lowrisk pharmaceu>cals Worldleading technology for reformula>ng drugs into oral sprays with faster onset of ac>on Mul>ple patent families covering approx. 300 widelyused offpatent drugs Breakthrough sublingual spray for treatment of children with severe malaria completed Phase III trial Mul>ple oral sprays for large mainstream markets migraine, erec>le dysfunc>on, chemoinduced nausea Strategy for rapid commercialisa>on through trade sales or collabora>ons 2

3 Oromucosal delivery BeIer pa;ent experience Oral mucosa is the lining of the mouth, richly supplied by blood vessels Oral cavity is ideal for systemic therapy, avoids metabolism in the gut Unique advantages of oral sprays compared to tablets Faster onset of ac>on Reduc>on in dose level and dose variability Enhanced pa>ent convenience Avoids the need to swallow or be taken with water 1,2 Our oral sprays poten/ally offer improved efficacy and a be8er outcome for pa/ents 1. >40% of adults experience difficul>es swallowing 2. >50% of children (6 to 11 years) have problems swallowing tablets 3

4 Oromucosal delivery Benefits for Pharma Advantages of oral sprays to pharmaceu;cal companies Patented delivery technology protects against generic compe>>on Regulatory path can provide market exclusivity New oral spray formula>on can extend or expand exis>ng franchise Superior product profile allows for premium pricing and strong market penetra>on Improved outcome for pa>ent supports reimbursement from payers 4

5 Oromucosal delivery Lowrisk regulatory path Strategy to take advantage of faster and less expensive regulatory pathways FDA s 505(b)(2) legisla>on designed for reformula>ons of FDA approved drugs Leverage FDA s exis>ng data on safety and efficacy of original drug Simply demonstrate bioequivalence of reformula>on vs. original drug 505(b)(2) products are incen>vised with 35 years market exclusivity in USA Most countries have adopted similar regulatory pathways to the FDA 5

6 Oromucosal delivery IP & plarorm technology INTELLECTUAL PROPERTY Mul>ple patent families & more pending, covering: 300 highusage exis>ng drugs formulated into oral sprays Technology for producing micromist formula>on Pump (airac>vated) & aerosol (propellantdriven) sprays Mul>dose or singleunit containers PLATFORM TECHNOLOGY Core inhouse competence in oromucosal reformula>on Established process development and scaleup exper>se 6

7 Oromucosal delivery Strategy Supergenerics Reformulate offpatent pharmaceu>cals into highvalue patentable oral sprays Demonstrate advantages over standard of care in proofofconcept trials Outlicense inhouse programmes ader PK proof of concept Collaborate on oral spray formula>ons of APIs of interest to partners New Chemical En;;es Codevelopment with NCE innovators to enhance TPPs or extend lifecycles with oromucosal sprays 7

8 Oromucosal delivery Comparable deals Collabora>on/trade sale deals usually structured with mul>ple payments: - Upfront payment on signature - Milestone payments on clinical and regulatory events - Milestone payments on achieving sales targets and royal>es 1 on sales Objec>ve to achieve two collabora>ons/trade sales in H2 CY2014 COMPARABLE COLLABORATION/TRADE SALE DEALS Generic drug Sumatriptan Midazolam Ondansetron Zolpidem Delivery Technology Nasal spray Oral buccal spray Oral soluble film Sublingual tablet Disease Migraine Seizures Nausea/vomiAng Insomnia Licensor/Licensee OpAnose/Avanir Auralis/ViroPharma MonoSol/StraAva Orexo/MEDA Territory North America Global USA Global Upfront Payment US$20M US$15M US$3M US$13M Milestones US$90M US10M US$24M US$90M RoyalAes on Sales Yes, Aered No Yes, Aered Yes, double digit Date Signed July 2013 May 2010 Sept 2008 April Trade sale deals do not include royal>es 8

9 Lowrisk pipeline targe;ng large markets Product Ac>ve Ingredient Pre- clinical Clinical Marke>ng Approval Market Size Ar>Mist Artemether Malaria >$500m SUD001 Sumatriptan Migraine headache $3.2bn SUD002 Ondansetron Chemotherapy induced nausea & vomi>ng $2.5bn SUD003 DuroMist Sildenafil Erec>le dysfunc>on $4.1bn SUD004 Sildenafil Pulmonary arterial hypertension $2.7bn Preprocedural anxiety SUD005 Midazolam $170m 9

10 ArTiMist An;malarial sublingual spray ArTiMist sublingual artemether for children with severe malaria Completed Phase III trial versus intravenous quinine 150 children from mul>ple sites in Africa Conducted to highest standards for use in worldwide regulatory submissions Primary endpoints were achieved showing superiority to quinine >90% parasite reduc>on at 24hrs: 96% of ArTiMist pa>ents vs. 41% of quinine pa>ents Total parasite clearance: 30 hours with ArTiMist vs. 68 hours with quinine Thompson Reuters iden/fied ArTiMist as one of the world s Top5 most promising Phase III drugs in

11 ArTiMist Progressing to registra;on Successfully completed manufacturing scaleup with Canadian manufacturer Finalising regulatory dossier for first NDA filing in Africa Convened Clinical Advisory Board to design pivotal protocol for prereferral study Encouraging dialogue with Medicines for Malaria Venture Prereferral Phase III protocol to be reviewed by WHO for poten>al funding World Health Organisa>on reports 640,000 deaths annually from malaria ArTiMist has huge poten/al as an early interven/onal treatment for children with severe malaria 11

12 SUD001 Oral spray for migraine headache SUD001 is first oral spray of sumatriptan (GSK s Imitrex tablet) for rapid relief of migraine headache Migraine market is approx $3.2 billion. Sumatriptan has 50% market share Evaluated in >40 pa>ents showing safety and superiority to Imitrex tablet Significantly more effec>ve than Imitrex 50mg relief paralleling Imitrex 100mg Rapid onset of ac>on and less drug needed to achieve desired therapeu>c effect Pivotal trial could support registra>on Faster onset of ac>on provides compe>>ve advantage SUD001 has superior profile to market leading Imitrex tablet 12

13 SUD002 Oral spray for chemotherapyinduced nausea & vomi;ng SUD002 is first oral spray of ondansetron (GSK s Zofran tablet) to treat nausea & vomi>ng induced by chemotherapy or radiotherapy Global an>eme>cs market is approx. $2.5 billion SUD002 evaluated in >300 pa>ents in mul>ple trials vs. 8mg Zofran tablet SUD002 spray was safe, well tolerated and bioequivalent to tablet Faster early absorp>on of drug with 8mg SUD001 spray vs. 8mg Zofran tablet Clinical data poten>ally sufficient for NDA filing Tablets are not ideal when pa>ents are vomi>ng SUD002 has superior profile to market leading Zofran tablet 13

14 SUD003 Oral spray for erec;le dysfunc;on SUD003 (DuroMist ) is a metered oral spray of sildenafil (Pfizer s Viagra tablet) for erec>le dysfunc>on ED market is >$4 billion. Viagra is world s top selling ED drug Worldwide (exc. USA) generics launched but no oral spray formula>ons DuroMist trial in 24 males showed safety and bioequivalence vs. Viagra 20mg DuroMist spray was bioequivalent to 25mg Viagra tablet Pivotal trial could support registra>on Poten>al faster onset as direct absorp>on avoids metabolism in gut DuroMist offers ease of administra/on and poten/ally faster onset of ac/on than Viagra tablet 14

15 Westcoast Surgical Rapid growth Whollyowned subsidiary is a sales and logis>cs opera>on for medical devices and consumables based in Western Australia Experiencing rapid growth in revenue and profitability H1 FY2014 revenue of $6.2 million, approx. 200% increase from PCP H1 FY2014 net profit of $1.2 million compared to a loss in the PCP Westcoast has entered a new era in its opera/ons 15

16 Key data & financial snapshot Corporate key data ASX Code SUD: AU Current share price (Australian $) $ week range $0.024$0.086 Average volume (30day) 4.9 million Market cap $57 million Financials (Yearend: June) Revenues (H1 FY2014) Net loss (H1 FY2014) Cash & cash equivalents (31 Dec 2013) Shares on issue (m) ConverAble Notes OpAons $6.2m ($0.3m) $5.5m 925 $2.4m converable to esamated 88 million shares $0.05 exercise price 16

17 Commercialisa;on goals ANTICIPATED EVENT Founda>ons are set for first major deals in CY ANTICIPATED TIMING ACHIEVED IniAate primary research on market opportuniaes H March 2014 IniAate outreach to Pharma industry H March 2014 Finalise ArTiMist regulatory documentaaon ArTiMist trade sale or outlicensing deal First oromucosal outlicensing deal Mid 2014 H H We have established a deep pipeline of oral sprays based on our oromucosal drug delivery plauorm 1. Calendar year 17

18 Management & Directors Stephen Carter Chief Execu;ve Officer and Managing Director >25 years pharmaceu>cal industry experience with mul>na>onal pharmaceu>cal and listed public companies Joseph Ohayon Chief Financial Officer and Director >20 years experience in financial roles including 12 years within healthrelated industries Nick Woolf Chief Business Officer >20 years experience in pharma/biotech investment banking and industry with extensive BD knowledge Carol Worth Technical Manager >25 years experience in formula>ng/developing drugs and managing accredited laboratories NonExecu;ve Directors Michael Stewart NonExecu;ve Chairman Broad corporate and management background and involvement in bilateral donor funded and World Bank co- financed aid projects Ken Robson NonExecu;ve Director Background includes extensive experience as a corporate lawyer and advisor, specialising in fundraising, compliance and mergers & acquisi>ons 18

19 Summary Worldleading proprietary technology for reformula>ng drugs into highvalue oral sprays Breakthrough an>malarial spray progressing towards commercialisa>on Pipeline of oral sprays offering superior profiles (eg: faster onset) than standard of care Targe>ng large markets with short >melines for development Strategy for rapid value crea>on through collabora>ons or trade sales 19

20 Level 1, Unit 12, 55 Howe Street Osborne Park, Western Australia 6017 PO Box 1719 Osborne Park BC, WA 6916 (T) (F) (E) suda@sudaltd.com.au 20