Via Pharmaceuticals Inc · OTC:VIAP
Via Pharmaceuticals — Investor Presentation (July 2009)
48 slides from Via Pharmaceuticals's investor presentation, Jul 9, 2009
Slide 1: Investor Presentation July 2009
Investor Presentation July 2009 V 7.2; 7 8 09
Slide 2: Safe Harbor
SAFE HARBOR This presentation contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that ma
Slide 3: Executive Summary
Executive Summary VIA is Developing Drugs Targeting Novel Mechanisms in Cardiometabolic Disease - Large Unmet Medical Need Despite Successful Treatments Our Lead Product, VIA-2291, Targets Reduction of Inflammation in Atherosclerosis Phase 2 Data on VIA-2291 Have Achieved Goals, Supporting Further D
Slide 4: Residual Risk of Major Adverse Cardiac Events (MACE)
Residual Risk of Major Adverse Cardiac Events (MACE) Lipitor Zocor Pravachol Published Clinical Trial Results Plavix 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% IDEAL Prove IT HPS 4S LIPID CARE CAPRIE Risk not addressed Reduction in MACE 70-80% of Risk Unaddressed Despite Current Standard of Care Re
Slide 5: Inflammation Will Be the Target of the Next Generation of Therapeutics for Atherosclerosis
Inflammation Will Be the Target of the Next Generation of Therapeutics for Atherosclerosis 5
Slide 6: Inflammation Causes Plaque Rupture and MACE
6 Stable plaque MACE Inflammation Causes Plaque Rupture and MACE Thin fibrous cap Large fatty core Thick fibrous cap Small fatty core Reducing inflammation to stabilize plaque: A new paradigm for treating CV disease Unstable plaque Leukotrienes Proteases Cytokines Necrotic Core
Slide 7: Inflammation in Atherosclerosis is a Focus of Pharma
Pharma Companies with Programs in Inflammation and CV Disease - AstraZeneca - Merck - GSK - Boehringer-Ingelheim - Roche - Novartis - Lilly - Bristol Myers Squibb GSK has Announced Major Financial Commitments to Develop an Anti- inflammatory Drug for Atherosclerosis Darapladib inhibits one pathway f
Slide 8: Leukotrienes are Key Mediators of Plaque Inflammation
Leukotrienes are Key Mediators of Plaque Inflammation VIA's Science & Data Human gene expression shows up-regulation of leukotriene pathway in plaques Physiol. Genomics (2005) 23:103-118. Gene expression studies in animal models shows up-regulation of leukotriene pathway in plaques Physiol. Genomics
Slide 9: 5-LO Catalyzes Key Step in the Production of Leukotrienes
5-LO Catalyzes Key Step in the Production of Leukotrienes Leukotrienes are Potent Chemoattractants for Inflammatory Cells and Increase Vascular Permeability 5-LO Catalyzes the Rate Determining Step 5-LO is a Pharmaceutically Validated Target in Asthma VIA-2291 is a Potent and Specific Inhibitor of 5
Slide 10: VIA-2291 - Potent and De-risked Drug
VIA-2291 - Potent and De-risked Drug Diligence of 35 Compounds Identified ABT-761 at Abbott Laboratories Once daily oral dosing Highly potent and specific inhibitor of 5-LO Significant patient experience at doses up 300 mg Furthest in development of all 5-LO inhibitors Strong Development Program at
Slide 11: VIA-2291 Market Exclusivity is Assured by Multiple Mechanisms
VIA-2291 Market Exclusivity is Assured by Multiple Mechanisms Composition of Matter Patent Expires November 6th 2012 in United States (US 5,288,751) November 5th 2013 in EU (France, Germany, UK, Italy, Spain) (667,855) Extension of up to 5 years of patent life in the US under Patent Term Restoration
Slide 12: Comprehensive Phase 2 Program in CV Disease
Comprehensive Phase 2 Program in CV Disease With Significant Data Reported at AHA & ATVB Acute Coronary Syndrome (ACS) Trial Carotid Endarterectomy (CEA) Trial 12
Slide 13: 5-LO Inhibition Reduced Vascular Inflammation Hypothesis
5-LO Inhibition Reduced Vascular Inflammation Increased Plaque Stability Reduction in MACE 5-LO Hypothesis Development of a drug with a novel mechanism requires parallel development of both the compound and the surrogate markers 13
Slide 14: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Population Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively T
Slide 15: VIA-2291 Phase 2 Clinical Strategy
VIA-2291 Phase 2 Clinical Strategy ACS FDG-PET 191 patients 12 weeks Dose - 25, 50, or 100mg Biomarkers Safety Coronary Imaging (MDCT) Sub-Study Additional 12 weeks Tx Genomic Sub-study 50 patients 12 weeks Dose -100mg Biomarkers Plaque Tissue Histology Safety 50 Patients 24 weeks Dose - 100mg Bioma
Slide 16: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Population Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively T
Slide 17: VIA-2291 is a Potent Inhibitor of Both LTB4 and LTE4
VIA-2291 is a Potent Inhibitor of Both LTB4 and LTE4 Urinary LTE4 Whole Blood LTB4 Data shown from ACS trial; analogous results obtained in CEA trial Placebo VIA-2291 25mg VIA-2291 50mg VIA-2291 100mg Ex vivo In vivo 17
Slide 18: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Population Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively T
Slide 19: ACS Trial - hsCRP
ACS Trial - hsCRP 24 Week % Change from Baseline 40 20 hsCRP % Change from Baseline Placebo VIA-2291 VIA-2291 VIA-2291 25mg 50mg 100mg ti p<0.01 p< p<0.001 19 vid
Slide 20: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Population Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively T
Slide 21: VIA-2291 Reduces Genes Up-regulated in Unstable Plaques
VIA-2291 Reduces Genes Up-regulated in Unstable Plaques 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 IL-6 Osteopontin IL-10 MMP-9 Fold change Relative to Placebo 0 1 1.5 2 2.5 3 3.5 4 4.5 IL-6 Osteopontin IL-10 MMP-9 Fold change Relative to Placebo 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 IL-6 Osteopontin IL-10 MMP-9 Fold ch
Slide 22: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Population Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively T
Slide 23: VIA-2291 Decreases Necrotic Core in Unstable Plaques
VIA-2291 Decreases Necrotic Core in Unstable Plaques Histology - Morphometry n=6 n=3 n=4 n=7 *p<0.02 *p<0.02 Results of 12 Weeks of Treatment 23 Necrotic Core Carotid Lumen Plaque Thickness 0 0.2 0.4 0.6 0.8 1 Stable Unstable Ratio Necrotic Core Thickness/Plaque Thickness Placebo VIA-2291
Slide 24: MDCT: Plaque Burden and New Lesions
MDCT: Plaque Burden and New Lesions p <0.01 24
Slide 25: MDCT Analysis - Non-Calcified Plaque Burden
MDCT Analysis - Non-Calcified Plaque Burden * White arrows indicate location of lesion * 25
Slide 26: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 Explore Dose Range of Leukotriene Inhibition in Cardiovascular Patients Demonstrate Effect on Inflammatory Biomarker Show Ability to Down Regulate Inflammatory Genes in Plaque Show Improvement in Plaque Morphology Show Safety in Cardiovascular Patients Intensively Tre
Slide 27: VIA-2291 Safety Profile
VIA-2291 Safety Profile All Trials Monitored by Data Safety Monitoring Board (DSMB) VIA-2291 Was Generally Well-tolerated at All Doses Tested No Drug-related Serious Adverse Events (SAEs) Reported Reversible Laboratory Findings in VIA-2291 Treated Patients DSMB: Safety Findings Support Further Devel
Slide 28: Phase 2 Objectives for VIA-2291
Phase 2 Objectives for VIA-2291 1. Explore Dose Range of Leukotriene Inhibition in Cardiovascular Patients 2. Demonstrate Effect on Inflammatory Biomarker 3. Show Ability to Down Regulate Inflammatory Genes in Plaque 4. Show Improvement in Plaque Morphology 5. Show Safety in Cardiovascular Patients
Slide 29: Ongoing Clinical Studies
Ongoing Clinical Studies FDG-Positron Emission Tomography (FDG-PET) Serial images of carotid vessels at 0 and 24 weeks Permits assessment of inflammatory activity in plaques Fully enrolled Results due 2H 2009 Genomic Analysis ACS Phase 2 Sub-Study Genomic analysis of patient DNA from ACS trial Marke
Slide 30: Weight of the Clinical Evidence Supports the 5-LO Hypothesis
5-LO Inhibition Reduced Vascular Inflammation Increased Plaque Stability Reduction in MACE Weight of the Clinical Evidence Supports the 5-LO Hypothesis ACS CEA MDCT FDG-PET LTB4 & LTE4 Inhibition LTB4 & LTE4 Inhibition Reduction of hsCRP Reduction of hsCRP Reduction of Cytokines Reduction of Proteas
Slide 31: Key Data Correlate With Clinical Outcomes
5-LO Inhibition Reduced Vascular Inflammation Increased Plaque Stability Reduction in MACE Key Data Correlate With Clinical Outcomes ACS CEA MDCT FDG-PET LTB4 & LTE4 Inhibition LTB4 & LTE4 Inhibition Reduction of hsCRP Reduction of hsCRP Reduction of Cytokines Reduction of Proteases Reduction of Nec
Slide 32: Clinical Outcome Correlations - hsCRP and Plaque Burden
Clinical Outcome Correlations - hsCRP and Plaque Burden 32 Result Clinical Significance Reference Reductions in hsCRP Reductions in hsCRP levels correlate with reduced incidence of MACE in both healthy patients (primary prevention - JUPITER) and those that have experienced a previous MACE (secondary
Slide 33: hsCRP and LDL-C - Treat to Dual Target Goals
hsCRP and LDL-C - Treat to Dual Target Goals 33 JUPITER Trial Primary prevention patients with LDL-C ^ 130 and hsCRP ^ 2 received rosuvastatin Those achieving LDL-C < 70 and hsCRP < 1 had a 79% decrease in MACE Only 15% of the patients achieved hsCRP < 1 VIA ACS Trial Secondary prevention patients n
Slide 34: VIA-2291 End of Phase 2a Meeting
VIA-2291 End of Phase 2a Meeting Safety and Biological Data Reviewed from ACS and CEA Clinical Studies Guidance from the FDA Will be Incorporated into the VIA-2291 Registration and Phase 3 Program VIA intends to Submit the Phase 3 Plan to FDA Including a Request for a Special Protocol Assessment (SP
Slide 35: Development Strategy
Development Strategy 35 Phase 2 Data Demonstrate Safety, Confirm Mechanism, and Show Changes That Correlate with Clinically Significant Endpoints Phase 3 Cardiovascular Outcome Trial will Assess the Effect of VIA-2291 in Preventing MACE Patient Population Event Rate Drug Effect Size Definition of MA
Slide 36: Potential Commercial Market for Launched Drug is Large
Potential Commercial Market for Launched Drug is Large 36 Research for Commercial Market Plan done by Inventiv Health Target Secondary Prevention in post-ACS Patients Primary Research included: Potential Prescribing Physicians Third Party Payors Pharmacists Cardiology Key Opinion Leaders Research Su
Slide 37: ACS Market Remains Significant and Growing
ACS Market Remains Significant and Growing 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 US 1516843 1535550 1555111 1570590 1613888 1629950 1671694 1688330 1705131 1722099 1739235 1756540 EU5 1019796 1027160 1056142 1062110 1088003 1094150 1115051 1121350 1127684 1134053 1140458 114689
Slide 38: Target Product Sales Estimated to Surpass $7.5 Billion by 2023
Target Product Sales Estimated to Surpass $7.5 Billion by 2023 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 TPP 84112878 804972543 1464086319 2136223723 2750406770 3307002374 3806312557 4250773346 4666156045 5055989653 Lower Efficacy 76466253 731793221 1330987563 1942021567 2500369791 300636579
Slide 39: New NCE Assets Address Cardiometabolic Diseases
New NCE Assets Address Cardiometabolic Diseases 39
Slide 40: Expanding Product Pipeline
Expanding Product Pipeline Compound/Target Area of Focus Research Pre-Clinical Phase 1 Phase 2 Phase 3 VIA-2291 / 5-LO Secondary Prevention for ACS Patients Thyroid Hormone Receptor-^ (THR-^) Agonist Hypercholesterolemia, insulin sensitization Diacylglycerol acyl Transferase-1 (DGAT-1) Inhibitor Met
Slide 41: Thyroid Hormone Receptor Beta Agonist (THR-β)
Thyroid Hormone Receptor Beta Agonist (THR-^) IND Ready Candidate with Target Product Profile of: Oral, once a day, small molecule drug Clinically validated target Multiple potential indications include - - Hypercholesterolemia - - Type 2 diabetes / insulin sensitization Potential Anti-diabetic Effi
Slide 42: Diacylglycerol Acyl Transferase-1 (DGAT-1) Inhibitor
Diacylglycerol Acyl Transferase-1 (DGAT-1) Inhibitor Compounds Target Multiple Potential Indications: Dyslipidemia Diabetes Obesity Potential Anti-diabetic Efficacy with Cardiovascular Benefit Pre-clinical Studies Demonstrated: Positive effects on body weight Improvement in insulin sensitivity: - -
Slide 43: Milestones, Management, and Advisors
Milestones, Management, and Advisors 43
Slide 44: Accomplishments & Upcoming Milestones
Accomplishments & Upcoming Milestones 2007 - 2008 Accomplishments VIA launched as public company Initiated FDG-PET Phase 2 Expanded clinical advisory board and KOL network Addition of Dr. Rebecca Taub - Sr. VP R&D Reported positive results from CEA and ACS trials at AHA NCE assets acquired from Roch
Slide 45: Experienced Leadership Team
Personnel Position Experience Larry Cohen, PhD CEO Zyomyx, Progenitor, Somatix, Therion, Harvard Medical Becky Taub, MD SVP R&D Roche, Bristol-Myers Squibb, Dupont, U Penn-HHMI Brendan Rae, PhD, JD SVP Bus Dev Roche, Purdue Pharma Jim Stewart SVP CFO ACT, CN Biosciences, Ventro, E&Y Tom Quertermous,
Slide 46: Advisory Boards
Advisory Boards Scientific Advisory Board Israel Charo, MD, PhD UCSF Marco Conti, MD Stanford Medical School Garret FitzGerald, MD University of Pennsylvania Colin Funk, PhD Queens University Christopher Glass, MD, PhD UCSD Todd Klingler, PhD XDx, Inc. Thomas Quertermous, MD Stanford Medical School
Slide 47: Executive Summary
Executive Summary VIA is Developing Drugs Targeting Novel Mechanisms in Cardiometabolic Disease - Large Unmet Medical Need Despite Successful Treatments Our Lead Product, VIA-2291, Targets Reduction of Inflammation in Atherosclerosis Phase 2 Data on VIA-2291 Have Achieved Goals, Supporting Further D
Slide 48: VIA Pharmaceuticals
—= VIA pharmaceuticals VIA
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