Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2007)
20 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 2007
Slide 1: Neuren Pharmaceuticals CEO Presentation AGM May 2007
Neuren Pharmaceuticals CEO Presentation AGM May 2007
Slide 2: Summary - progress
Summary - progress Major progress has been made… Phase 3 Glypromate® US FDA trial underway Major focus for the Company over the last year FDA validation... highest hurdle Very cost effective trial First to market Phase 1a NNZ-2566 complete Safe and well tolerated Phase 1b NNZ-2566 un
Slide 3: More…
More… Cancer technology significantly progressed – Significant interest Partnering programme developed – Under Due Diligence – Multiple CDA and MTA agreements signed Strong Trial infrastructure built – COO appointed... Dr Parmjot Bains – Other CD Staff appointed… 36 years experience in US FDA
Slide 4: Our strategy
Our strategy The Glypromate® Phase 3 trial is on target to complete in 18 months – Examining other potential applications – Created significant US interest The NNZ-2566 TBI trials (2) planned to commence near term – Efficiency signals in next 18 months – US army support and Fast track/Orphan Sta
Slide 5: Development pipeline
Development pipeline y gy ac n o lo n if c ctio xi c at io f 1 2 3 ad E od u lT o e e se l is Le al ha s ha s ha ia ry ic Pr ca rc ve ed E lin ia l in i P P P e o at M C er Cl al al al m is c lid AD e- t e- n ic n ic n ic om D Va Pr M a P r C l i C l i C l i C Glypromate® - MCI 1H2007 Glypromate® –
Slide 6: Multiple out-licensing opportunities
Multiple out-licensing opportunities NEU has an extensive pipeline as a result of its “Right to Own” agreement with the University of Auckland NEU has focused on developing four + product lines such that they are attractive out-licensing or further investment opportunities NNZ-2566 / NRP: NNZ-49
Slide 7: Glypromate®
Glypromate® Safe, non-toxic and in Phase 3
Slide 8: Glypromate® Phase 3 - Why is this important?
Glypromate® Phase 3 - Why is this important? Excellent drug design… pharmacology, safety profile, long therapeutic time window – Typical of naturally occurring compounds; evolution as an effective drug discovery strategy – Multiple modes of action = multiple opportunities for effect – Single actio
Slide 9: Glypromate® Phase 3 - Why this trial?
Glypromate® Phase 3 - Why this trial? Adequately powered to detect an effect – Many trials have been underpowered (e.g., Pharmos dexanabinol) – FDA have agreed to ADAPTIVE DESIGN... at 300 patients it will be opened and patient numbers increased to ensure adequate trial power if needed Resources
Slide 10: Commercial strength
Commercial strength We believe this combination of – Drug properties and – Trial design has a better combination than all others we know in this space and is very well matched to the endpoint… And we have FDA validation… – everyone has to go to the FDA eventually!!! Affordable trial, A$10 mill
Slide 11: Phase 3 Executive Committee
Phase 3 Executive Committee Comprising a number of global leading clinicians and researchers in neurology, cardiology, cardiothoracic surgery and anaesthesiology. The members of the Executive Committee are: Professor Harvey White (Auckland Hospital, Professor of Cardiology, Chair), Professor Ala
Slide 12: NNZ-2566
NNZ-2566 About to enter Phase 2 for TBI
Slide 13: NNZ-2566 TBI Program
NNZ-2566 TBI Program Completed – Complex pharmacology - multiple modes of action in multiple pathways – Obtained Consistent effects in multiple models - stroke, closed-head injury, penetrating head injury – Drug CMC logistics completed Flexible clinical trial strategy – Separate moderate from se
Slide 14: NNZ-2591
NNZ-2591 Oral treatment for Chronic CNS
Slide 15: NNZ-2591 – Oral treatment for multiple diseases
NNZ-2591 – Oral treatment for multiple diseases Meets all requirements for a CNS drug candidate – 100% oral bioavailability – Safe, non-toxic, crosses into brain, therapeutic window – Stable, low cost of goods Key Results – Parkinson's disease: long-term disease modifying effects as well as shor
Slide 16: NNZ-8000
NNZ-8000 A treatment for solid tumours
Slide 17: Cancer programme
Cancer programme Neuren has developed unique IP in a set key molecules involved in many cancers The presence of these factors , called TFF’s , lead to tumor growth and spread We have strong laboratory evidence reinforced by strong clinical evidence In vitro and in vivo proof of principle est
Slide 18: Tumor volume in xenograft model of human breast cancer
Tumor volume in xenograft model of human breast cancer (polyclonal antibody; MCF-7 cell line)
Slide 19: Our strategy
Our strategy Hasn’t changed…. – Well developed clinical trial programme and out-licensing strategy – A great deal of effort over the last year in preparing for Phase 3 US FDA trial A leader in the area of reducing acute brain damage – Large markets, high unmet need and limited competition – Well
Slide 20: Thank you for your continued support…
Thank you for your continued support…
Neuren Pharmaceuticals — Shareholder Meeting (May 2007) on 6ix