Stakeholder Opinions

Introduction

At the forefront of novel technologies; momentum is steadily building for the development of stem cell products to address cardiovascular disease. The most active areas are those with high clinical unmet need heart failure, cardiomyopathy and ishemic heart disease.

Scope

• Analysis of the current unmet needs in cardiovascular disease markets
• Opinion leader commentary on key clinical trials and market landscape
• Review of the clinical and commercial status of stem cell therapy for cardiovascular disease
• Review of the clinical and commercial status of gene therapy for cardiovascular disease

Highlights

• Datamonitor's analysis demonstrates how the most innovative drugs offer the greatest growth potential for their respective markets. In the mature cardiovascular market, commercial success must be derived from innovative approaches with unique clinical benefits.
• The array of innovative gene and cell products emerging from young companies exposes investment opportunities for venture capitalists, Big Pharma, as well as partnering opportunities for technology companies that can offer compatible catheters, or cell delivery devices.
• There awaits an outstanding commercial opportunity for innovators who address clinical unmet need in this market, as a number of companies will see their key revenue generators melt away as they lose patent protection.

Reasons to Purchase

• Understand the need for innovation in the cardiovascular market.
• Up to date insight into the commercial and clinical status of cardiovascular gene and cell therapies
• Understand the barriers to commercialization of novel therapies, with expert commentary

• ABOUT DATAMONITOR HEALTHCARE
• About the Cardiovascular and Diabetes pharmaceutical analysis team:
• CHAPTER 1 EXECUTIVE SUMMARY
  • Objective of the analysis
  • Datamonitor Key insights
  • Related reports
  • Acknowledgements
• CHAPTER 2 BACKGROUND
  • Business Implications
  • Introduction
  • Scope
  • Definition of unmet needs
  • Clinical unmet needs in cardiovascular markets
  • Commercial Unmet Needs in cardiovascular markets
  • Commercial opportunities across cardiovascular indications
  • Response to the unmet need
  • Summary
• CHAPTER 3 NOVEL DRUG TARGETS IN CV MEDICINE
  • Business Implications
  • Introduction
  • Bridging the innovation gap
• Cardiovascular drug targets
• New technologies allow expansion into novel targets
• A lack of commercially viable drug targets
• Biologics drive market growth
• Monoclonal antibodies (MAbs)
• Application of MAbs in cardiovascular disease
• ReoPro (abciximab) profile
• MAbs in the cardiovascular pipeline
• BI-204 for atherosclerosis
• TB-402 for thrombosis
• Therapeutic vaccines
• The need for therapeutic vaccines for chronic cardiovascular disease
• Angiotensin vaccines for hypertension
• Protherics's Angiotensin Therapeutic Vaccine
• Cytos Biotechnology's CYT006-AngQ
• Outlook for angiotensin vaccines
• CHAPTER 4 STEM CELLS FOR USE IN CV MEDICINE
  • Business Implications
  • Introduction
  • The biology of stem cells
  • Derivation
  • Embryonic stem cells (ESCs)
  • Adult stem cells (ASCs)
  • The use of embryonic versus adult stem cells
  • Proliferation
  • Differentiation and pluripotency
  • Allogeneic versus autologous stem cells
  • The development timeline for stem cell technology
  • The exploitation of stem cells
  • Stem cell therapy
  • Use in regenerative medicine and tissue engineering
  • Stem cell transplantation
  • Stem cells for use in drug discovery
  • Screening arrays of compounds
  • Predictive toxicology
  • Stem cell therapy in cardiovascular medicine
  • Current status
  • The need for cardiovascular regeneration
  • Myocardial infarction and myocardial ischemia
  • Heart failure
  • Stem cell suitability for cardiovascular regeneration
  • Embryonic stem cells (ESCs)
  • Adult stem cells (ASCs)
  • Clinical development of stem cells for cardiovascular disease
  • Current clinical trial focus
  • Clinical trial results
  • Summary and future focus
  • Future clinical trial focus
  • Commercial landscape
  • International markets
  • Key players and products
  • Company Profiles
  • Aastrom Biosciences
  • Advanced Cell Technology
  • Angioblast Systems
  • Athersys
  • BioHeart
  • Cardio3BioSciences
  • Osiris Therapeutics
  • Development hurdles for stem cell therapy
  • Commercial risk associated with small companies
  • Research capacity
  • Regulation
  • Ethics and the perception of stem cells
  • Reimbursement
  • Intellectual property
• CHAPTER 5 GENE THERAPY FOR USE IN CV MEDICINE
  • Business Implications
  • Introduction
  • Key definitions
  • Genomics
  • Gene therapy
  • The evolution of gene therapy
  • Discovery timeline
  • Approaches to gene therapy
  • In vivo versus ex vivo gene therapy
  • Gene delivery strategies
  • The use of vectors
  • Vector types
  • Delivery modalities
  • Systemic delivery
  • Non-systemic delivery
  • Disease targets for gene therapy
  • Research activity by indication
  • Cancer
  • Inherited diseases
  • Other targets
  • Gene therapy targets in cardiovascular disease
  • Therapeutic angiogenesis
  • Coronary artery disease (CAD) and myocardial ischemia
  • Peripheral arterial disease (PAD)
  • Heart failure
  • The beta-adrenergic (beta-AR) receptor signaling pathway
  • SERCA2a
  • Hypertension
  • ACE gene linked to high blood pressure in men
  • Targets in dyslipidemia
  • LDL-cholesterol and triglycerides
  • HDL-cholesterol
  • Other dyslipidemic targets
  • Gene therapies in the drug development pipeline
  • Current status
  • Current status of clinical trials of gene therapy
  • Gene therapy for coronary artery disease
  • Gene therapy for peripheral arterial disease
  • Gene therapy for heart failure
  • The beta-adrenergic receptor (beta-AR) signaling pathway
  • SERCA2a
  • Gene therapy for dyslipidemia
  • Gene therapy for hypertension
  • Future perspectives in gene therapy
  • Summary of preclinical and clinical research
  • Restenosis
  • Commercial landscape
  • International markets
  • Key players and products
  • Cardium Therapeutics
  • Development hurdles for gene therapy
  • Research and informatics
  • APPENDIX
  • Bibliography
  • About Datamonitor
  • About Datamonitor Healthcare
  • About the Cardiovascular Disease analysis team
  • Report methodology
  • Disclaimer
• List of Tables
  • Table 1: Summary of clinical unmet needs across the main cardiovascular indications, 2008
  • Table 2: Family classification of drug targets
  • Table 3: ReoPro: Overview
  • Table 4: Key clinical trials using stem cells in acute myocardial infarction, 2008
  • Table 5: Key clinical trials using stem cells in heart failure, 2008
  • Table 6: Key unknowns in cardiovascular stem cell therapy
  • Table 7: Stem cell products currently in development for cardiovascular indications, 2008
  • Table 8: Stem cell companies developing products for cardiovascular indications (Listed)
  • Table 9: Stem cell companies developing products for cardiovascular indications (Non-listed)
  • Table 10: Comparison of different gene vectors used for gene transfer
  • Table 11: Potential delivery methods for different vectors in cardiovascular disease
  • Table 12: Genetic targets in cardiovascular disease
  • Table 13: Effects of overexpressing SR Ca2+ pump in myocytes isolated from failing human hearts
  • Table 14: Key clinical trials in gene therapy for CAD
  • Table 15: Key clinical trials in gene therapy for PAD
• List of Figures
  • Figure 1: Chapter 2 - Business Implications
  • Figure 2: The $ sales plateau in the cardiovascular market, 2006-2016
  • Figure 3: US patent expiries of the top 10 cardiovascular brands, 2006-2016
  • Figure 4: Summary of unmet needs in cardiovascular indications, 2008
  • Figure 5: Chapter 3 - Business Implications
  • Figure 6: Technological advances expand the conceptual 'druggable' space
  • Figure 7: Key characteristics influencing pharmaceutical commercial attractiveness
  • Figure 8: The mechanism through which the renin-angiotensin-aldosterone system induces systemic hypertension
  • Figure 9: Chapter 4 - Business Implications
  • Figure 10: Definition of terms in the stem cell differentiation process
  • Figure 11: US and UK milestones in the development of stem cell technology, 1950-2008
  • Figure 12: Summary of current focus of stem cell technology in cardiovascular disease, 2008
  • Figure 13: Expert comment: maximizing useful progenitor cells per sample volume is an important consideration
  • Figure 14: Development hurdles for embryonic stem cells
  • Figure 15: Expert comment: future clinical trial focus for stem cell therapy in cardiovascular disease
  • Figure 16: Cardiovascular stem cell therapies in clinical development, 2008
  • Figure 17: Proposed research, development and marketing protocol for stem cell therapies
  • Figure 18: Chapter 5 - Business Implications
  • Figure 19: Timeline of key developments in gene therapy
  • Figure 20: In vivo versus ex vivo gene transfer
  • Figure 21: Reserch activity in gene therapy, according to number of clinical trials, by indication
  • Figure 22: Summary of current focus of gene therapy research in cardiovascular disease, 2008
  • Figure 23: Reserch activity in gene therapy, according to number of clinical trials, by location
  • Figure 24: Cardiovascular stem cell therapies in clinical development, 2008