Amarin Corporation plc · NASDAQ:AMRN
Amarin — Amarin Corp Plc\uk — Investor Presentation (September 2006)
34 slides from Amarin's investor presentation, Sep 28, 2006
Slide 1: www.amarincorp.com
www.amarincorp.com
Slide 2: Safe Harbour
Safe Harbour DISCLOSURE NOTICE: The information in this document is as of September,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 statement
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
Slide 4: Investment Highlights
Investment Highlights • Focused growth strategy managing risk • Miraxion for Huntington’s disease in Late Phase III ü Orphan Drug Status ü FDA Fast Track Designation ü Special Protocol Assessment • Robust Pipeline in CNS Diseases • Melancholic depression • Parkinson’s disease • Seasoned CNS Manageme
Slide 5: Core Pipeline with Large Market Potential
Miraxion in HD Miraxion in HD Miraxion for Depression Miraxion for PD* Apomorphine for PD Combinatorial Lipids File 2007 File 2007 Core Pipeline with Large Market Potential U.S. Europe Pre-Clinical Phase I Phase II Phase III *Phase II to commence H2 2006
Slide 6: 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.
Slide 7: Huntington's Disease
Miraxion for Huntington’s Disease Market Size $500M+ 70,000 diagnosed 400,000 at risk • 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
Slide 8: Safety Profile - Low Risk
Miraxion Safety Profile - Low Risk Epadel on Market in Japan 95% pure EPA No serious side effects No major complications Prescribed for 2 Million Patients years * Miraxion is approximately 97% pure EPA
Slide 9: 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: HD – Initial Phase III Trial
Miraxion for HD – Initial Phase III Trial Significance Intent To Treat No Per Protocol Near CAG Score < 44 * YES Initial Phase III Trial Results Patients Group * Positive CAG data consistent across centres
Slide 11: HD – Initial Phase III Trial
Miraxion for HD – Initial Phase III Trial Baseline month month Placebo Intent To Treat: CAG < 44 Group N = P = .029 TMS-4 15.2% difference (3.5)
Slide 12: HD – Initial Phase III trial
Miraxion for HD – Initial Phase III trial Baseline month month Placebo Per Protocol: CAG < 44 Group TMS-4 N = P = .006 28.4% Difference (6.5)
Slide 13: Neuro imaging in Phase III Trial
Neuro imaging in Phase III Trial
Slide 14: Neuro-imaging in Phase III Trial
Neuro-imaging in Phase III Trial Baseline months Contrast Healthy Brain
Slide 15: Neuro-imaging in Phase III Trial
Neuro-imaging in Phase III Trial Huntington’s disease patient brain
Slide 16: Neuro imaging in Phase III Trial
Neuro imaging in Phase III Trial Placebo patient - Lateral ventricular enlargement
Slide 17: Neuro imaging in Phase III Trial
Neuro imaging in Phase III Trial Miraxion patient - Ventricular shrinkage
Slide 18: HD – Phase III Trial Design
Miraxion for HD – Phase III Trial Design Powering: pts; 90% Clinical Centers Patient Entry Criteria CAG ≤ : Less severe Detect TMS-4 change of 3.2 in US and 3.5 in EU centers, 6 month trial, month extension Regulatory Agencies Expert involvement Current Phase III Trial
Slide 19: HD - Milestones (US)
Miraxion for HD - Milestones (US) Potential NDA Filing Last patient out FDA Response Data available Last patient in First patient in Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 ‘05 ‘06 ‘07 Q3 Q4 Orphan Drug, SPA and Fast Track
Slide 20: Melancholic depression
Miraxion for Melancholic depression Market Size $2-4 B+ Approx 25% with melancholic depression Approx 20 million suffer from major depression globally • Approx 40 million people suffer from depressive disorders in US and EU • Approx 20 million suffer from Major Depression • 25% suffer from melanchol
Slide 21: 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 22: MD Investigators
Miraxion for MD Investigators Trial Details No. with Melancholic Features Scale Melancholic Data Analysis Amarin (Peet & Horrobin ) N=70 1, 2 or 4g/d or placebo for wks adjunct N= More severely ill HDRS p<0.05 Amarin N=115 1g/d or placebo for wks adjunct N= More severely ill HDRS p<0.05 Amarin N=77
Slide 23: MD Patients
Miraxion for MD Patients were randomised on a double blind basis to receive placebo or 1g, 2g or 4g per day of LAX-101 for 12 weeks. The primary end point was change on the 17 item Hamilton Depression Rating Scale (HDRS). Secondary end points were changes on the Montgomery-Asberg Depression rating s
Slide 24: CRF
Miraxion for MD • CRF significantly up-regulated by IL-1 in the CNS • Depression is major side effect of INF-α / IL-2 therapy • Cytokines are key promoter of pro-inflammatory prostaglandins Cytokines Have a Clear Role in HPA Axis Control • Competes with arachidonic acid at cyclooxygenase, inhibiting
Slide 25: Research
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 mot
Slide 26: Miraxion - Intellectual Property Portfolio
Orphan designation (US) Patent 40390 (US&EU) Patent 45429 2 nd Generation Patent 40266 (US&EU) Patent 40390 (US&EU) Patent 48245 2 nd Generation Miraxion - Intellectual Property Portfolio HD Depr
Slide 27: Apomorphine for Parkinson's Disease
Apomorphine for Parkinson’s Disease Market Size $100M+ 700,000 advanced patients experience frequent “off” episodes > million diagnosed with Parkinson’s • 30% of patients have advanced Parkinson’s disease • Characterized by frequent “off” periods of semi-paralysis • Current injectable apomorphine –
Slide 28: 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 29: Out-licensing /Partnering Opportunities
Out-licensing /Partnering Opportunities ü 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
Slide 30: CardinalHealth
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Slide 31: Capitalization Financials
Warrants (avge exercise price $1.56) Options Common Shares Debt Cash position 10.2m 5.4m 81.3m None $29m 06/ 30/06 Capitalization Financials
Slide 32: Twelve-Month Milestones
Twelve-Month Milestones ü Complete Enrollment of US Phase III trial in HD ü Complete Enrollment of EU Phase III trial in HD • Commence Neuro-imaging Studies in PD • Commence Phase IIb study in Depression • Advance Phase II Studies of Apomorphine in PD • In-license Other Synergistic Neurology Product
Slide 33: Investment Highlights
Lead Product in Late Phase III Focused strategy managing risk Seasoned CNS Management Team Large Market Opportunities in CNS Diseases Strong Financials: $29 million in cash - No Debt Robust Pipeline in CNS Diseases Investment Highlights
Slide 34: www.amarincorp.com
www.amarincorp.com
Amarin Corp Plc\uk — Investor Presentation (September 2006) on 6ix