Starpharma Holdings Limited · ASX:SPL
Starpharma — Investor Presentation (May 2007)
32 slides from Starpharma's investor presentation, May 2007
Slide 1: Starpharma Holdings Limited
ASX:SPL OTCQX:SPHRY Starpharma Holdings Limited May 2007 Dr Jackie Fairley CEO
Slide 2: Forward-looking statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set
Slide 3: Company Overview
Company Overview World leader in developing dendrimer nanotechnology products for pharmaceutical and life-sciences Lead product VivaGel™ is being developed (with >$20M NIH support) under IND as a microbicide to prevent HIV and Genital Herpes Other core projects in drug delivery and drug develo
Slide 4: Investment Summary
Investment Summary 9 Deep pipeline of pharmaceutical and non-pharmaceutical products, balancing risk and timeframes to market 9 Topical Microbicides have strong consumer demand and payor support 9 Starpharma has a leading microbicide (VivaGel™) in development for prevention of HIV and genital herpes
Slide 5: Company Structure
Company Structure Starpharma Holdings 8.6% Limited ASX:SPL USOTC:SPHRY 100% 100% Dendritic Nanotechnologies Starpharma Pty Ltd Inc. (DNT) 36 employees based in Melbourne, Australia Wholly owned subsidiary based in Michigan, Leading developer of dendrimers as USA (16 employees) pharmaceuticals
Slide 6: Shareholding and OTCQX:SPHRY
Shareholding and OTCQX:SPHRY Dow Major shareholders include: Other US 8.6% – The Dow Chemical Company (NASDQ:DOW) Inves tors 10.9% – Acorn Capital – Biotech Capital Retail – Queensland Investment Corporation 51.5% – Irrewarra/ GoldmanSachs-JBW Ins titutions 29.0% Strong Level 1 ADR program – >72
Slide 7: Starpharma: 06/07 Highlights
Starpharma: 06/07 Highlights Acquisition of DNT SPL acquires US company DNT Dow becomes SPL’s largest holder Integration of SPL and DNT complete Richard Hazelton appointment Retired Dow Corning Chairman/CEO appointed to SPL Board VivaGelTM clinical trial progress Expanded safety trial in men complet
Slide 8: Starpharma: Technology Overview
Starpharma: Technology Overview Unique Characteristics of Dendrimers: Precisely defined, synthetic macromolecules (1-10nm) e.g VivaGel™ active Precisely defined surface topology with anti-viral activity Can be designed to optimize potency, pharmacokinetics and localization; heat stable or biod
Slide 9: Starpharma's Pipeline: Balanced for Risk
Starpharma’s Pipeline: Balanced for Risk Proof of Pharmaceutical & Medical Products Concept Lead Clinical Trials Sales VivaGel™ ► HSV-2 prevention ► HIV prevention ► condoms coating & other line extensions ADME Engineering™ ► Therapeutic protein PK optimisation Drug Delivery - Small Molecules ► Canc
Slide 10: VivaGel
VivaGe/l™ & starpharma
Slide 11: VivaGel – Lead Product for Prevention of STIs
VivaGelTM – Lead Product for Prevention of STIs VivaGel™is a vaginal microbicide being developed to HIV prevent sexually transmitted infections in women Major health burden in both developed – Currently being developed under two INDs for the and developing countries prevention of HIV and genital
Slide 12: VivaGel – Product Features and Performance
VivaGelTM – Product Features and Performance Market research indicates significant (international) user and payor demand for microbicide gels VivaGel™Offers Several Key Compelling HSV-2 &HIV efficacy; Contraceptive activity (in animals) Advantages Significant NIH support for development Viru
Slide 13: Commercial Opportunity for Microbicides
Commercial Opportunity for Microbicides Large, addressable markets Estimated Market for microbicides in Developed Countries – HIV primarily in developing countries Market Average Frequency of Use Per Annum – HSV-2 in both developing and developed countries Penetration 25x 50x 100x US$M US$M US$M
Slide 14: VivaGel – Development and Commercial Strategy
VivaGelTM – Development and Commercial Strategy One of the most advanced 2nd generation microbicides for HIV&HSV Significant non-dilutive NIH support Broad application; chronic-use product Partnering/commercial strategies likely to differ between developed VivaGel™ (OTC/Pharma) markets and d
Slide 15: VivaGel: Development stage and plan
VivaGel™ : Development stage and plan PRODUCT TYPE Therapeutic In vitro In vivo In vivo Market Phase I Phase 2 Phase 3 efficacy efficacy safety entry Agent Preventative Expanded Population In vitro In vivo In vivo Market Phase I Safety Based “Drug” efficacy efficacy safety studies Efficacy entry (Vi
Slide 16: Product Pipeline
Product Pipeline
Slide 17: Early Commercial Opportunities
Early Commercial Opportunities Marketed Dendrimer PrioFect™ siRNA Materials Science / Products Transfection Reagents Industrial Applications Value Transfection Reagents Capture Current Licensed to EMD 2007 / 08 Horizon Biosciences* Existing product sales and Transfection reagent market: Sector Discu
Slide 18: PrioFect: siRNA Transfection Reagent
PrioFect™ : siRNA Transfection Reagent “The discovery of RNA interference (RNAi) may well be one of the transforming events in biology in the past decade” Nature The discovery of RNAi has already had an immense impact on biomedical research and will most likely lead to novel medical applications in
Slide 19: PrioFect: siRNA Transfection Reagent
PrioFect™ : siRNA Transfection Reagent Commercial opportunities: 1. Research reagent ($200 million market) • Licensed to EMD Biosciences • Agreement includes royalties and PrioFect™ Competitive Advantages: milestones • Superior efficacy through size control • First products to market in 2007 • Cell-
Slide 20: Pipeline: Commercialisation Strategy
Pipeline: Commercialisation Strategy Product/ Projected / Category Approach actual Income Stage Application type Late stage partnering deal to retain Milestones VivaGel™ Clinical value Royalties “In house” Milestones Other Drugs, Pharmaceutical Preclinical out-license Pre-clincial e.g cancer therape
Slide 21: Partnerships and Collaborators
Partnerships and Collaborators Industry Collaborators Research/ University Collaborators NICHD NIAID 21
Slide 22: Key Management
Key Management Over 15 years international business development and general Dr Jackie Fairley, CEO management experience in pharmaceuticals and biotechnology Former senior roles with CSL and Faulding (Mayne Pharma) Significant experience in marketing and business development in Dr Paul Barrett
Slide 23: Board of Directors
Board of Directors Significant international executive exp.: Coles Myer, Fosters Brewings Peter Bartels, Chairman* Pharmaceutical experience at DHA Pharmaceuticals, Abbot Laboratories Founding CEO of Starpharma Dr John Raff, Dep. Chairman* Highly respected industry and government participant
Slide 24: Key Investment Highlights
Key Investment Highlights Compelling competitive advantages VivaGel™: A Unique Lead Significant funding and support received from NIH Product (>US$20M) Only microbicide in development for genital herpes HIV and genital herpes at epidemic proportions Significant Commercial (Europe ~ 15-20%; U
Slide 25: Starpharma Holdings Limited ASX:SPL OTCQX:SPHRY
Starpharma Holdings Limited ASX:SPL OTCQX:SPHRY SPL US$M Market Capitalisation 60 NIH Support 26 Cash on Hand (Mar07) ~ 10 Further information: www.starpharma.com Jackie Fairley CEO +613 85322704 [email protected]
Slide 26: Supplementary Information
Supplementary Information @ starpharma
Slide 27: VivaGel: Animal Efficacy results
VivaGel™: Animal Efficacy results SHIV/HIV Protection HSV Protection VivaGel™: animals protected from HSV-2 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 5% w/w 3% w/w Placebo gel PBS SPL7013 gel SPL7013 gel Approximately Advantage: VivaGel™ is NOT a surfactant Approximately4545million millionAmerican
Slide 28: VivaGel: Potent Contraceptive Activity in Rabbits
VivaGel™ : Potent Contraceptive Activity in Rabbits Recent study has shown that SPL7013, the active ingredient in its VivaGel™, exhibits a potent contraceptive effect in rabbits Independent study undertaken at Johns Hopkins University under an NIH grant Fertility was reduced by more than 75% b
Slide 29: VivaGel: Significant Advantages Over Competitors
VivaGelTM : Significant Advantages Over Competitors Competitor Category Key Disadvantages VivaGel™ Advantages HSV-2 VivaGel™ is the only microbicide being developed to prevent genital herpes Surfacants/Detergents Ulceration possible No surfactant properties Potential increased risk of Non-ir
Slide 30: Portfolio of Opportunities
Portfolio of Opportunities Multiple Near-Term Future High-Value Commercial Commercial Opportunities Opportunities Pharmaceutical Industrial Products Life-science Applications Applications siRNA, siRNA,DNA DNAtransfection transfection VivaGel™ Industrial Industrial Reagents VivaGel™ Chemicals Reagent
Slide 31: Pipeline: Drug Delivery & PK Modification of Protein Therapeutics
Pipeline: Drug Delivery & PK Modification of Protein Therapeutics Plasma concentration-time profile in male SD rats for PEGylated poly-L-lysine dendrimers 100000 plasma dendrimer (ng equiv/ml) O O Lys16(PEG2000)32 O O t½ = 0.6h O O O O Therapeutic Protein O O 10000 t½ = 0.7h O O N N N N O N O N t½ =
Slide 32: RNAi therapeutics
RNAi therapeutics Company Clinical Development Pre-clinical development Acuity Ph II AMD & DME anti-inflammatories & anti-infectives Alnylam Ph 1 2006 (RSV) pandemic flu, spinal cord injury, Parkinson’s, cystic fibrosis, hypercholesterolemia, neuropathic pain Sirna Ph II AMD (w/ Allergan) Asthma, RS
Starpharma Holdings — Investor Presentation (May 2007) on 6ix