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High Growth Reported for the Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine

Lack of market prospects for biologics expose an opportunity for cell and gene therapies

LONDON, UNITED KINGDOM -- (Marketwire) -- 08/19/08 -- Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine - Lack of market prospects for biologics expose an opportunity for cell and gene therapies

http://www.reportlinker.com/p091762/Stakeholder-Opinions-Novel-Therapeutic-Approaches-in-Cardiovascular-Medicine---Lack-of-market-prospects-for-biologics-expose-an-opportunity-for-cell-and-gene-therapies.html

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 2

About the Cardiovascular and Diabetes pharmaceutical analysis team: 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Objective of the analysis 3

Datamonitor Key insights 3

Related reports 5

Acknowledgements 5

CHAPTER 2 BACKGROUND 8

Business Implications 8

Introduction 8

Scope 9

Definition of unmet needs 10

Clinical unmet needs in cardiovascular markets 10

Commercial Unmet Needs in cardiovascular markets 16

Commercial opportunities across cardiovascular indications 19

Response to the unmet need 22

Summary 23

CHAPTER 3 NOVEL DRUG TARGETS IN CV MEDICINE 24

Business Implications 24

Introduction 24

Bridging the "innovation gap" 25

Cardiovascular drug targets 25

New technologies allow expansion into novel targets 27

A lack of commercially viable drug targets 28

Biologics drive market growth 29

Monoclonal antibodies (MAbs) 30

Application of MAbs in cardiovascular disease 30

ReoPro (abciximab) profile 30

MAbs in the cardiovascular pipeline 31

BI-204 for atherosclerosis 31

TB-402 for thrombosis 33

Therapeutic vaccines 34

The need for therapeutic vaccines for chronic cardiovascular disease 34

Angiotensin vaccines for hypertension 34

Protherics's Angiotensin Therapeutic Vaccine 36

Cytos Biotechnology's CYT006-AngQ 36

Outlook for angiotensin vaccines 37

CHAPTER 4 STEM CELLS FOR USE IN CV MEDICINE 39

Business Implications 39

Introduction 39

The biology of stem cells 40

Derivation 41

Embryonic stem cells (ESCs) 42

Adult stem cells (ASCs) 42

The use of embryonic versus adult stem cells 43

Proliferation 43

Differentiation and pluripotency 44

Allogeneic versus autologous stem cells 44

The development timeline for stem cell technology 46

The exploitation of stem cells 47

Stem cell therapy 47

Use in regenerative medicine and tissue engineering 47

Stem cell transplantation 47

Stem cells for use in drug discovery 48

Screening arrays of compounds 48

Predictive toxicology 48

Stem cell therapy in cardiovascular medicine 48

Current status 48

The need for cardiovascular regeneration 49

Myocardial infarction and myocardial ischemia 49

Heart failure 50

Stem cell suitability for cardiovascular regeneration 50

Embryonic stem cells (ESCs) 51

Adult stem cells (ASCs) 51

Clinical development of stem cells for cardiovascular disease 54

Current clinical trial focus 54

Clinical trial results 57

Summary and future focus 66

Future clinical trial focus 67

Commercial landscape 69

International markets 70

Key players and products 70

Company Profiles 83

Aastrom Biosciences 83

Advanced Cell Technology 86

Angioblast Systems 88

Athersys 89

BioHeart 91

Cardio3BioSciences 93

Osiris Therapeutics 94

Development hurdles for stem cell therapy 96

Commercial risk associated with small companies 97

Research capacity 97

Regulation 100

Ethics and the perception of stem cells 101

Reimbursement 102

Intellectual property 102

CHAPTER 5 GENE THERAPY FOR USE IN CV MEDICINE 105

Business Implications 105

Introduction 106

Key definitions 106

Genomics 106

Gene therapy 107

The evolution of gene therapy 108

Discovery timeline 108

Approaches to gene therapy 110

In vivo versus ex vivo gene therapy 110

Gene delivery strategies 112

The use of vectors 112

Vector types 112

Delivery modalities 115

Systemic delivery 115

Non-systemic delivery 116

Disease targets for gene therapy 116

Research activity by indication 117

Cancer 117

Inherited diseases 118

Other targets 119

Gene therapy targets in cardiovascular disease 119

Therapeutic angiogenesis 124

Coronary artery disease (CAD) and myocardial ischemia 124

Peripheral arterial disease (PAD) 125

Heart failure 125

The beta-adrenergic (beta-AR) receptor signaling pathway 125

SERCA2a 126

Hypertension 127

ACE gene linked to high blood pressure in men 127

Targets in dyslipidemia 128

LDL-cholesterol and triglycerides 128

HDL-cholesterol 130

Other dyslipidemic targets 131

Gene therapies in the drug development pipeline 132

Current status 132

Current status of clinical trials of gene therapy 133

Gene therapy for coronary artery disease 133

Gene therapy for peripheral arterial disease 137

Gene therapy for heart failure 140

The beta-adrenergic receptor (beta-AR) signaling pathway 140

SERCA2a 140

Gene therapy for dyslipidemia 141

Gene therapy for hypertension 141

Future perspectives in gene therapy 142

Summary of preclinical and clinical research 142

Restenosis 142

Commercial landscape 143

International markets 143

Key players and products 144

Cardium Therapeutics 146

Development hurdles for gene therapy 148

Research and informatics 148

APPENDIX 150

Bibliography 150

About Datamonitor 154

About Datamonitor Healthcare 154

About the Cardiovascular Disease analysis team 155

Report methodology 155

Disclaimer 156

List of Tables

Table 1: Summary of clinical unmet needs across the main cardiovascular

indications, 2008 12

Table 2: Family classification of drug targets 26

Table 3: ReoPro: Overview 31

Table 4: Key clinical trials using stem cells in acute myocardial

infarction, 2008 58

Table 5: Key clinical trials using stem cells in heart failure, 2008 63

Table 6: Key unknowns in cardiovascular stem cell therapy 69

Table 7: Stem cell products currently in development for cardiovascular

indications, 2008 72

Table 8: Stem cell companies developing products for cardiovascular

indications (Listed) 77

Table 9: Stem cell companies developing products for cardiovascular

indications (Non-listed) 81

Table 10: Comparison of different gene vectors used for gene transfer 113

Table 11: Potential delivery methods for different vectors in cardiovascular

disease 116

Table 12: Genetic targets in cardiovascular disease 121

Table 13: Effects of overexpressing SR Ca2+ pump in myocytes isolated from

failing human hearts 127

Table 14: Key clinical trials in gene therapy for CAD 134

Table 15: Key clinical trials in gene therapy for PAD 138

List of Figures

Figure 1: Chapter 2 - Business Implications 8

Figure 2: The $ sales plateau in the cardiovascular market, 2006-2016 17

Figure 3: US patent expiries of the top 10 cardiovascular brands, 2006-2016

18

Figure 4: Summary of unmet needs in cardiovascular indications, 2008 23

Figure 5: Chapter 3 - Business Implications 24

Figure 6: Technological advances expand the conceptual 'druggable' space 27

Figure 7: Key characteristics influencing pharmaceutical commercial

attractiveness 29

Figure 8: The mechanism through which the renin-angiotensin-aldosterone

system induces systemic hypertension 35

Figure 9: Chapter 4 - Business Implications 39

Figure 10: Definition of terms in the stem cell differentiation process 41

Figure 11: US and UK milestones in the development of stem cell technology,

1950-2008 46

Figure 12: Summary of current focus of stem cell technology in

cardiovascular disease, 2008 49

Figure 13: Expert comment: maximizing useful progenitor cells per sample

volume is an important consideration 54

Figure 14: Development hurdles for embryonic stem cells 56

Figure 15: Expert comment: future clinical trial focus for stem cell therapy

in cardiovascular disease 68

Figure 16: Cardiovascular stem cell therapies in clinical development, 2008

71

Figure 17: Proposed research, development and marketing protocol for stem

cell therapies 99

Figure 18: Chapter 5 - Business Implications 105

Figure 19: Timeline of key developments in gene therapy 109

Figure 20: In vivo versus ex vivo gene transfer 111

Figure 21: Reserch activity in gene therapy, according to number of clinical

trials, by indication 119

Figure 22: Summary of current focus of gene therapy research in

cardiovascular disease, 2008 132

Figure 23: Reserch activity in gene therapy, according to number of clinical

trials, by location 144

Figure 24: Cardiovascular stem cell therapies in clinical development, 2008

145



To order this report:

Stakeholder Opinions: Novel Therapeutic Approaches in Cardiovascular Medicine - Lack of market prospects for biologics expose an opportunity for cell and gene therapies

http://www.reportlinker.com/p091762/Stakeholder-Opinions-Novel-Therapeutic-Approaches-in-Cardiovascular-Medicine---Lack-of-market-prospects-for-biologics-expose-an-opportunity-for-cell-and-gene-therapies.html

More market research reports here!

Contacts:
Reportlinker.com
Nicolas
US: (805) 652-2626 or Int: +1-805-652-2626
Email: nbo@reportlinker.com


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