Neuren Pharmaceuticals Limited · ASX:NEU
Neuren Pharmaceuticals — Shareholder Meeting (May 2011)
24 slides from Neuren Pharmaceuticals's shareholder meeting presentation, May 31, 2011
Slide 1: Neuren Pharmaceuticals Annual General Meeting May 2011
For personal use only Neuren Pharmaceuticals Annual General Meeting May 2011
Slide 2: Forward Looking Statement
Forward Looking Statement For personal use only This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations reflected in the forward looking statements are reasonable at this time, Neuren can give no assurance that these expec
Slide 3: Neuren is…
Neuren is… For personal use only • A biopharmaceutical company—not pure biotech, not pure small molecules • With scientific origins in one of the leading research institutions in the world • Always science driven, knowing that great science is where it all begins • Also knowing that great science is
Slide 4: Neuren's people are…
Neuren’s people are… For personal use only • A small group of incredibly dedicated professionals • Average of 20+ years of global experience in drug development, clinical trials, regulatory affairs, business development, corporate finance • All key staff have been with Neuren for >5 years • A team i
Slide 5: 2010: Significant progress on all programmes
2010: Significant progress on all programmes • Initiated the INTREPID-2566 Phase 2 trial of NNZ-2566 For personal use only • Completed manufacturing process development and validation • Completed the Phase I safety/PK trial in female volunteers • Initiated the oral formulation development program fo
Slide 6: Product Pipeline
Product Pipeline For personal use only Discovery Validated Lead Formulation Phase I Phase III Pre-Clinical Manufacturing Pre-Clinical Phase II Commercialization Efficacy Toxicology Motiva™ (nefiracetam) Apathy and depression (post-stroke, Parkinson’s, Alzheimer’s) NNZ-2566 (IV) Traumatic brain injur
Slide 7: Two dynamic clinical programs
Two dynamic clinical programs For personal use only NNZ-2566 • Phase II INTREPID-2566 trial initiated in Q2 2010 for moderate to severe traumatic brain injury • Fast Track designation • Oral formulation development initiated Q2 2010 for mild TBI and other indications • Partnership with US Army since
Slide 8: NNZ-2566: Innovation in the Treatment of Brain Injury and Neurodegeneration
For personal use only NNZ-2566 Innovation in the Treatment of Brain Injury and Neurodegeneration
Slide 9: NNZ-2566: Therapeutic and Regulatory Strategy
NNZ-2566: Therapeutic and Regulatory Strategy For personal use only Therapeutic strategy: rescue brain cells from the effects of acute and chronic neurodegeneration • Synthetic analogue of naturally occurring neuroprotective peptide—the brain’s response to injury • Prevents secondary brain injury—da
Slide 10: NNZ-2566 targets multiple inflammatory processes
NNZ-2566 targets multiple inflammatory processes For personal use only Gene expression Protein expression 10
Slide 11: NNZ-2566 prevents post-injury seizures
NNZ-2566 prevents post-injury seizures For personal use only Excitoxicity Inflammation Neuronal Death • NMDA • Pro-inflammatory • Necrosis activation cytokine elevation • Apoptosis • Ca influx • Free radical production 0 hr 6 hr 24 hr 72 hr NNZ-2566 # of NCS/rat/hour Time post pMCAo (hours)
Slide 12: NNZ-2566: Risk profile supports optimism
NNZ-2566: Risk profile supports optimism For personal use only Pharmacokinetics • Blood-brain barrier penetration • Linear pharmacokinetics (PK) • Comparable PK in healthy volunteers and patients • Oral bioavailability Miscellaneous • Manufacturing—fully validated; suitable for Phase III; simple
Slide 13: NNZ-2566—a growing franchise
NNZ-2566—a growing franchise For personal use only Intravenous administration Stroke Cardiac arrest Perinatal asphyxia Penetrating brain injury Non-convulsive seizures in other CNS injuries/conditions Oral administration Mild TBI Post-stroke recovery Prophylaxis following transient ichaemic attack C
Slide 14: Rett Syndrome and autism spectrum disorders (ASDs)
Rett Syndrome and autism spectrum disorders (ASDs) ASDs are disorders of connections between brain cells (neurons) For personal use only • Rett Syndrome has too few connections • Fragile X Syndrome has too many connections • Autism has ~ 70% patients with too many and ~ 30% patients with too few Ret
Slide 15: Motiva (nefiracetam): A Safe Drug for a Difficult to Treat Indication
For personal use only Motiva®(nefiracetam) A Safe Drug for a Difficult to Treat Indication with Unmet Need
Slide 16: Apathy Syndrome: Apathy is not depression
Apathy Syndrome: Apathy is not depression Symptoms of apathy For personal use only Loss of motivation and initiation Lack of persistence Emotional indifference or diminished emotional reactivity Post Decreased social engagement Stroke Symptoms of depression 35% Dysphoria, sadness Alzheimer’s Hopeles
Slide 17: Motiva: Efficacy data in stroke patients (Japan)
Motiva: Efficacy data in stroke patients (Japan) For personal use only 3 Phase IIa open- • 165 patients; dosing up to 16 weeks label studies • Endpoint: Global Improvement Rating (GIR) • GIR results: Min = 12.5%; Max = 58.8% (450 mg/day x 16 weeks) • 321 patients; 3 doses for 8 weeks; 150, 300, 450
Slide 18: Motiva: Efficacy data in stroke patients (US/Canada)
Motiva: Efficacy data in stroke patients (US/Canada) For personal use only Phase IIb (US IND) Study results • Sponsored by Daiichi • HAM-D: not statistically significant overall • Led by Robert Robinson (U of Iowa), Sergio 1. Statistically significant benefit in most severely Starkstein (U of Wester
Slide 19: Perseis Therapeutics Ltd.
For personal use only Perseis Therapeutics Ltd. Targeting Trefoil Factors to Treat Breast and Other Cancers
Slide 20: Perseis Therapeutics: Profile
Perseis Therapeutics: Profile Developing antibodies for the treatment of breast and other cancers For personal use only • Founded in 2009 by Neuren Pharmaceuticals and the NZ Breast Cancer Research Trust • Targeting Trefoil Factors which play a significant role in the growth and spread of solid tumo
Slide 21: Recent publications
Recent publications For personal use only Double-Blind Treatment of Apathy in Patients with Poststroke Depression Using Nefiracetam (Robert G. Robinson, M.D., Ricardo E. Jorge, M.D., Kathleen Clarence-Smith, M.D., Ph.D., Sergio Starkstein, M.D.) (The Journal of Neuropsychiatry and Clinical Neuroscie
Slide 22: Recent commentary
Recent commentary For personal use only • Statement by the Director of Defense Medical R&D Program before the US Congress (September 2010) “Currently, the only promising therapy for TBI in large clinical trials is progesterone and NNZ 2566.” • Thomson Reuters. The Ones to Watch (April – June 2010) •
Slide 23: Where Are We Now?
Where Are We Now? Key programmes fully funded through significant milestones For personal use only NNZ-2566 • Cohort 1 completed; Cohort 2 underway; 18 sites lined up; new IND for EFIC • Oral development on track for Phase I in Q4 2011, Phase II in mild TBI in Q2 2012 • Development for Rett Syndrome
Slide 24: Further Information
Further Information For personal use only Larry Glass, CEO +1 (301) 941 1830 lglass@neurenpharma.com New Zealand Level 2, 57 Wellington Street Freemans Bay 1011, Auckland New Zealand +64 (9) 3700 200 1 800 259 181 (Australia Freephone) USA 3 Bethesda Metro Center, Suite 700 Bethesda, Maryland 20814
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