Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Investor Presentation (October 2005)
33 slides from Neuren Pharmaceuticals's investor presentation, October 2005
Slide 1: Neuren Pharmaceuticals Market Update October 2005
Neuren Pharmaceuticals Market Update October 2005
Slide 2: Corporate Overview
| | "i neuren pharmaceuticals —_————=> 1 Corporate Overview
Slide 3: Corporate Snapshot
Corporate Snapshot Register Neuren is a biotech development company targeting Neuronz Ltd: 12.4% neuroprotection, metabolism and cancer NZ Seed Fund Management Ltd: 11.4% Neuren’s lead products protect against brain damage Macquarie Bank Tech Funds: 9.6% Glypromate® has been accelerated into Phase-3
Slide 4: Value Proposition: Why Invest in Neuren?
Value Proposition: Why Invest in Neuren? • News flow over next 6 – 12 months should lead to a significant re-rating in stock – Glypromate® enters Phase-3 trials in CY2006: Only a very small number of Australian Biotechs are testing Phase-3 products – NNZ-2566 currently being tested by the US in the
Slide 5: Recent Events and Accolades
Recent Events: • Initiated Phase 2a trial with Glypromate® • Accelerated Glypromate® to Phase 3 following productive meeting with FDA: Expected to enter Phase 3 in CY2006 • NNZ-2566 (follow up compound to Glypromate®) delivered positive results in testing with WRAIR: Expected to enter Phase 1 in ear
Slide 6: Product Development
i neuren pharmaceuticals © 2 Product Development
Slide 7: Lead Products are Key Value Drivers
Lead Products are Key Value Drivers • Naturally occurring compound that protects against neuronal damage • Many medical conditions result from damage to nervous tissue in the brain Glypromate® • Key Features: Exhibited potent neuroprotective activity; Small enough to cross blood-brain barrier, long
Slide 8: Discovery Pipeline Offers Excellent Potential
Discovery Pipeline Offers Excellent Potential Diketopiperazines • Small molecules that are both neuroprotectant and stimulate neurite growth for (DKPs) neurodegenerative diseases • Most advanced compound, NNZ-2591, is currently being tested in animals Growth Hormones • Growth hormone program is focu
Slide 9: Lead Development Pipeline
Development Pipeline io n od y n ac at II tio . ox mm se I fic lis Il I uc se lT rm Lead se Ef cia ha ha ca ha Ma ical Pr lP er n ery i lP lP tio lin d ca lin ial ate ula ca ov e -C ca e -C ini ter ini sc Co ini lid Cl Pr Cl Di Cl Va Pr Fo • Glypromate® • NNZ-2566 (acute/sub-acute) CNS Product Portf
Slide 10: Glypromate and Clinical Development
3 Glypromate® and Clinical Development
Slide 11: Glypromate - Lead compound
Glypromate® - Lead compound • Molecule derived from the IGF-1 growth factor, but with distinct properties • Naturally occurring • Exceptional neuroprotection characteristics 11
Slide 12: Glypromate and the FDA
Glypromate® and the FDA • Pre-investigational new drug meeting with the US FDA • Poised to commence Phase 3 clinical trial in 2006 (originally planned for 2008) - directly from Phase 2a • 400-500 patient multi site trial • Approximate cost <AUD$10 million • Completion within 18 months Commercial Ben
Slide 13: Clinical Strategy
Clinical Strategy • Elective procedure 1 • Recruitment and Pre-selection CABG • Simple clinical signal (Glypromate®) • Administer drug at time of injury • Large potential market with no current Acute TBI treatment Indications (NNZ-2566) • Significant market 2 • No current treatment Stroke Glypromate
Slide 14: Key Short-Term Milestones (CY2005)
Key Short-Term Milestones (CY2005) Glypromate® NNZ-2566 Completion of Phase 2a Q4 CY2005 In-vivo efficacy results Q3 CY2005 trial Oral development results Q4 CY2005 Pre-clinical toxicology Q4 CY2005 completed 14
Slide 15: Key Medium-Term Milestones (CY2006)
Key Medium-Term Milestones (CY2006) Glypromate® NNZ-2566 Other Compounds Results of Phase 2a Q1 Third-stage contract Q1 NRP in vivo Q3 Trial with US Dep’t of programme CY2006 CY2006 CY2006 Defence completes Commence Phase 3 Q3 Commence Phase 1 Q1 DKP’s – Lead Q2 Trial Trial candidate selection CY200
Slide 16: Why Do Drugs Fail?
Why Do Drugs Fail? • Why do drugs fail? – Safety Neuren’s Glypromate®and 2566 – Manufacturing The reason that 2/3 of Development Program has drugs fail effectively mitigated against these – Toxicology development risks – Efficacy • The Glypromate® Development Program: – Look at competitive space and
Slide 17: Jain Report Criteria: Why have other neuroprotection drugs failed?
Jain Report* Criteria Why have other neuroprotection drugs failed? N e u ro p ro te c tio n fo r S tro k e (h ig h h u rd le ) • P o o r T h e ra p e u tic R a tio s ** √ • C ro s s B B B √ • S m a ll M o le c u le √ • D ru g A d m in is te re d 4 p lu s h o u rs √ • S a fe ty P ro file √ • IV A d m
Slide 18: Commercialisation and Market Metrics
4 Commercialisation and Market Metrics
Slide 19: Commercialisation Strategy
Commercialisation Strategy 1. Build World-Class Partnerships Early – Joint development (e.g. Pfizer, WRAIR, Metabolic Pharmaceuticals) – External verification (FDA IND) 2. Move Quickly into Clinical Trials – Acute CNS (CABG, TBI…) followed by chronic CNS diseases 3. Maintain Multiple Products and Pa
Slide 20: Large and Growing Market with Unmet Needs
Large and Growing Market with Unmet Needs Indication Cases per Market Size Effective Year (USA) US$ Treatment Neuroprotection Bypass Surgery 400,000 $2.0b N Traumatic Brain Injury 1,000,000 $1.0b N Stroke 800,000 $3.5b N Parkinson’s Disease 3,000,000 $2.0b Y/N Alzheimer’s Disease 4,500,000 $2.5b Y/N
Slide 21: Limited Competition
Limited Competition Acute Neuroprotection • No drug currently on the market • Trials ongoing for CABG (Medicure, Alexion, NIH) • Trials ongoing for stroke, TBI • Neuren’s products have superior profile Chronic Neuroprotection • Limited effectiveness of current offerings and Neuroregeneration • Neure
Slide 22: Board and Senior Management
5 Board and Senior Management
Slide 23: Experienced Board with Direct Experience in Commercialising Drugs
Experienced Board with Direct Experience in Commercialising Drugs • Neuren’s Board has Board of Directors extensive experience and Dr Robin Congreve (PHD) Leading NZ international businessman expertise in drug Chairman Partner in Oceania and Eastern Group development, regulatory David Clarke (ME, MB
Slide 24: Management and Scientists
Management and Scientists Management and Scientists Prof Peter Gluckman (MB, DSc, FRS) Pediatrician, endocrinologist, Director of Liggins Institute CSO Former Dean, University of Auckland Medical School World authority in neuroscience and endocrinology Dr Mike Bickerdike (Phd ) Formerly private UK b
Slide 25: Conclusion
i neuren pharmaceuticals 6 Conclusion
Slide 26: Investment Highlights
Investment Highlights • Stage of Development: Glypromate® enter Phase 3 in CY2006 – FDA verification…Safety and need – Further CY2006 milestones focused on increasing investor value • Breadth and quality of portfolio – World class partners: Pfizer, US Department of Defence, Metabolic – Not a one pro
Slide 27: David Clarke, Neuren Pharmaceuticals
David Clarke Neuren Pharmaceuticals 1800 259 181 dclarke@neurenpharma.com 27
Slide 28: Appendices
i neuren pharmaceuticals Appendices
Slide 29: Neuren's Core CNS Biology
Neuren’s Core CNS Biology Inflammation Cause of Cell Death Acute - Stroke Necrosis - CABG - Head Trauma Delayed Primary Neuronal Cell Death Apoptosis Death Chronic - Alzheimer’s Disease Opportunity for - Parkinson’s Disease Rescue Therapy - Multiple Sclerosis Therapeutic “Window” Cell Damage Event 1
Slide 30: Neuronal Regeneration Peptides
Neuronal Regeneration Peptides B • Promote neurite and axonal growth • Promote neural stem cell proliferation, migration and differentiation • Optimal Attributes for a Neural Recovery Drug 30
Slide 31: GH – Implication in Breast Cancer
GH – Implication in Breast Cancer Without Growth Hormone • Cells that do not express GH remain non aggressive and non invasive With Growth Hormone • Cells made to express GH become aggressive, proliferative and invasive 31
Slide 32: Collaborations with WRAIR and Metabolic
Collaborations with WRAIR and Metabolic US Army Stage 2 Metabolic Deal WRAIR • TBI Stage 1 results confirmed • Faster Development • US Army confirmed 2nd Stage • Less Costs • Move to Pre-Clinical – Share Costs – MBP 2:1 – Save 50% • Government Grant A$585,000 • “Goal… advanced drug for brain injury”
Slide 33: Executive Staff Experience
Executive Staff Experience Drugs to market in USA: 100+ years experience, Multiple IND’s • Atrovent for common cold, Atrovent nasal for allergic rhinitis, Combivent for COPD, Asasantin for TIAs, pameprexole for Parkinson’s, Meloxicam as a NSAID for osteoarthritis, Spiriva for COPD, Nevirapine for HI
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