Amarin Corporation plc · NASDAQ:AMRN
Amarin — Investor Presentation (July 2006)
31 slides from Amarin's investor presentation, July 2006
Slide 1: Amarin Corporate Presentation
www.amarincorp.com THE FUTURE IN uN
Slide 2: Safe Harbour
Safe Harbour DISCLOSURE NOTICE: The information contained in this document is as of July, 2006. Amarin assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. This document contains forward-looking sta
Slide 3: Corporate Focus
Corporate Focus A Neuroscience Company Focused on the Research Development and Commercialization of Novel Drugs for the Treatment of Central Nervous System Disorders 3
Slide 4: Investment Highlights
Investment Highlights • Focused growth strategy managing risk • Miraxion for Huntington’s disease in Late Phase III 9Orphan Drug Status 9FDA Fast Track Designation 9Special Protocol Assessment • Robust Pipeline in CNS Diseases • Melancholic depression • Parkinson’s disease • Seasoned CNS Management
Slide 5: Amarin Strategy
Amarin Strategy • Develop & commercialize neurodegenerative disease pipeline for U.S. Market • In-License Neurology Products for U.S. • Out-license/Partner Outside U.S. 5
Slide 6: Global CNS market
Global CNS market Source: NeuroInsights Market Analysis & Strategic Investment Guide 6
Slide 7: Core Pipeline with Large Market Potential
Core Pipeline with Large Market Potential Pre-Clinical Phase I Phase II Phase III Miraxion in HD File 2007 U.S. Miraxion in HD File 2007 Europe Miraxion for Depression Apomorphine for PD Miraxion for PD* Combinatorial Lipids *Phase II to commence H2 2006 7
Slide 8: Miraxion for Huntington's Disease Market Size $500M+
Miraxion for Huntington’s Disease • Fatal Genetic Disease • No current cure or treatment • Clinical diagnosis with CAG>36 • 65-70% of all HD patients have CAG < 44 • 10-25 Years Life Expectancy • Severe Movement Disorder • Psychosis & Dementia 400,000 at risk Market Size $500M+ 70,000 diagnosed 8
Slide 9: Miraxion for HD - Scientific Rationale
Miraxion for HD - Scientific Rationale • Miraxion is a semi-synthetic, highly purified derivative of eicosapentaenoic acid (ethyl-EPA) • Patent protected ~97% purity is key attribute • Consistent predictable metabolism and functioning in brain • Minimization of impurities • Mechanism of action • Reg
Slide 10: Safety Profile - Low Risk
Miraxion Safety Profile - Low Risk Epadel on Market in Japan No serious side effects No major complications 95% pure EPA * Prescribed for 2 Million Patients 15 years 10 * Miraxion is approximately 97% pure EPA
Slide 11: Miraxion for HD – Initial Phase III Trial Design
Miraxion for HD – Initial Phase III Trial Initial Phase III Trial Design Patient Entry Criteria All comers Powering 135 patients Clinical Sites 6 centres Duration 12 months Clinical Evaluations 3 evaluations 11
Slide 12: HD – Initial Phase III Trial Results
Miraxion for HD – Initial Phase III Trial Initial Phase III Trial Results Group Patients Significance Intent To Treat 135 No Per Protocol 83 Near CAG Score <44 * 67 YES ic s ub-gr ou p * Positive CAG data consistent across centres Genet identified 12
Slide 13: Initial Phase III Trial: Intent To Treat CAG < 44
Miraxion for HD – Initial Phase III Trial TMS-4 N = 67 40 P = .029 35 15.2% difference (3.5) Placebo 30 25 20 15 Baseline 6 month 12 month Intent To Treat: CAG < 44 Group 13
Slide 14: Initial Phase III Trial: Per Protocol CAG < 44
Miraxion for HD – Initial Phase III trial TMS-4 N = 44 40 P = .006 35 28.4% Difference (5.1) 30 Placebo 25 20 15 Baseline 6 month 12 month Per Protocol: CAG < 44 Group 14
Slide 15: HD – Phase III Trial Design
Miraxion for HD – Phase III Trial Design Current Phase III Trial Patient Entry Criteria CAG ≤ 44 : Less severe Detect TMS-4 change of Powering: 540 pts; 90% 3.2 in US and 3.5 in EU Clinical Centers 70 centers, 6 month trial, 6 month extension Regulatory Agencies Expert involvement SPA 15
Slide 16: Miraxion for HD - Milestones (US)
Miraxion for HD - Milestones (US) Potential NDA Filing Last patient out FDA Response First Last Data patient in patient in available Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ‘05 ‘06 ‘07 Orphan Drug, SPA and Fast Track 16
Slide 17: Melancholic Depression Market Size $2-4B+
Miraxion for Melancholic depression • Approx 40 million people suffer from depressive disorders in US and EU • Approx 20 million suffer from Major Depression • 25% suffer from melancholic depression – the most severe form Approx 20 million suffer from major depression globally Market Size $2-4 B+ Ap
Slide 18: Miraxion for Melancholic Depression
Miraxion for Melancholic Depression • Clear unmet need • Potential 1st-to-market therapy specifically for MD • Six Phase IIa trials completed – proof of concept achieved • Effective and fast-acting (2-3 weeks); no sexual dysfunction, weight gain, or other significant side effects • Potential mechani
Slide 19: Statistical Significance Achieved in Melancholic Depression Patients
Miraxion for MD • Three Sponsor Led Trials: 262 Depression Patients • 137 Patients with Melancholic Symptoms No. with Melancholic Investigators Trial Details Melancholic Scale Data Features Analysis N=70 1, 2 or 4g/d or placebo N= 28 Amarin HDRS p<0.05 for 12 wks More severely ill (Peet & Horrobin )
Slide 20: Change in HDRS
Miraxion for MD Change in HDRS from Baseline in Recurrent Unipolar Depressive Disorder (Nemets) 20 Patients were randomised 0 on a double blind basis to -2 receive Miraxion or Change in HDRS -4 matching placebo at a dose 20 Patients were randomised on a -6 of 2g/day for 4 weeks. Placebo double blind
Slide 21: Miraxion for MD
Miraxion for MD Hypothalamic- • Depressed patients show significantly higher cortisol / ACTH Pituitary- Adrenal Axis • Corticotropin-releasing factor (CRF) is elevated in depression Implicated in Depression • Several pipeline Rx targeting CRF inhibition (e.g. CRH antagonists) Miraxion Down • Compete
Slide 22: Miraxion for PD
Miraxion for PD • Research supports role for Miraxion in PD •Neuro-protective and neuro anti-inflammatory effects in Neurodegenerative models •Improved cell viability and the slowing of neuronal apoptosis (cell death) associated with the symptoms of PD •Enhanced learning performance, improved motor
Slide 23: Miraxion - Intellectual Property Portfolio
Miraxion - Intellectual Property Portfolio Orphan designation (US) Patent 40390 (US&EU) HD Patent 45429 2nd Generation Patent 40266 (US&EU) Patent 40390 (US&EU) Depr Patent 48245 2nd Generation 2005 2010 2020 2030 23
Slide 24: Apomorphine for Parkinson's Disease Market Size $100M+
Apomorphine for Parkinson’s Disease • 30% of patients have advanced Parkinson’s disease • Characterized by frequent “off” periods of semi-paralysis • Current injectable apomorphine – frequent, painful & granulomas • Completing development of final novel oral formulation • Commence final-stage clinic
Slide 25: Combinatorial Lipid Program
Combinatorial Lipid Program • Proprietary technology platform • Uses chemical linkage to attach a range of bioactive lipids to other lipids or other drugs • Results in novel single chemical entities with predictable properties offering clinically relevant advantages • A range of candidates currently
Slide 26: Out-licensing / Partnering Opportunities
Out-licensing /Partnering Opportunities 9 LAX-202 for MS Fatigue to MultiCell • Miraxion for Depressive Disorders • Miraxion for HD in Remaining EU Markets • LAX-201 for Depression • Apomorphine for PD in EU Markets • Other IP 26
Slide 27: Management Team Experience
Management Team Experience 27
Slide 28: Financials
Financials Capitalization 03/ 31/06 Cash position $33.3m Debt None Common Shares 81.3m Options 5.4m Warrants (avge exercise price 10.2m $1.56) 28
Slide 29: Twelve-Month Milestones
Twelve-Month Twelve-Month Milestones Milestones 9 Complete Enrollment of US Phase III trial in HD • Complete Enrollment of EU Phase III trial in HD • Advance Studies of Apomorphine in PD • In-license other synergistic neurology products • Partner Miraxion for Depression • Partner Other Pipeline Oppo
Slide 30: Investment Highlights
Investment Highlights Focused strategy managing risk Lead Product in Late Phase III Robust Pipeline in CNS Diseases Seasoned CNS Management Team Large Market Opportunities in CNS Diseases Strong Financials: $33 million in cash - No Debt 30
Slide 31: www.amarincorp.com
www.amarincorp.com THE FUTURE IN uN