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Cardiovascular Drug Delivery - Technologies, Markets and Companies

NEW YORK, Nov. 30, 2011 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Cardiovascular Drug Delivery - technologies,markets and companies


Drug delivery to the cardiovascular system is different from delivery to other systems because of the anatomy and physiology of the vascular system; it supplies blood and nutrients to all organs of the body. Drugs can be introduced into the vascular system for systemic effects or targeted to an organ via the regional blood supply. In addition to the usual formulations of drugs such as controlled release, devices are used as well. This report starts with an introduction to molecular cardiology and discusses its relationship to biotechnology and drug delivery systems.

Drug delivery to the cardiovascular system is approached at three levels: (1) routes of drug delivery; (2) formulations; and finally (3) applications to various diseases. Formulations for drug delivery to the cardiovascular system range from controlled release preparations to delivery of proteins and peptides. Cell and gene therapies, including antisense and RNA interference, are described in full chapters as they are the most innovative methods of delivery of therapeutics. Various methods of improving systemic administration of drugs for cardiovascular disorders are described including use of nanotechnology.

Cell-selective targeted drug delivery has emerged as one of the most significant areas of biomedical engineering research, to optimize the therapeutic efficacy of a drug by strictly localizing its pharmacological activity to a pathophysiologically relevant tissue system. These concepts have been applied to targeted drug delivery to the cardiovascular system. Devices for drug delivery to the cardiovascular system are also described.

Role of drug delivery in various cardiovascular disorders such as myocardial ischemia, hypertension and hypercholesterolemia is discussed. Cardioprotection is also discussed. Some of the preparations and technologies are also applicable to peripheral arterial diseases. Controlled release systems are based on chronopharmacology, which deals with the effects of circadian biological rhythms on drug actions.A full chapter is devoted to drug-eluting stents as treatment for restenosis following stenting of coronary arteries.Fifteen companies are involved in drug-eluting stents.

New cell-based therapeutic strategies are being developed in response to the shortcomings of available treatments for heart disease. Potential repair by cell grafting or mobilizing endogenous cells holds particular attraction in heart disease, where the meager capacity for cardiomyocyte proliferation likely contributes to the irreversibility of heart failure. Cell therapy approaches include attempts to reinitiate cardiomyocyte proliferation in the adult, conversion of fibroblasts to contractile myocytes, conversion of bone marrow stem cells into cardiomyocytes, and transplantation of myocytes or other cells into injured myocardium.

Advances in molecular pathophysiology of cardiovascular diseases have brought gene therapy within the realm of possibility as a novel approach to treatment of these diseases. It is hoped that gene therapy will be less expensive and affordable because the techniques involved are simpler than those involved in cardiac bypass surgery, heart transplantation and stent implantation. Gene therapy would be a more physiologic approach to deliver vasoprotective molecules to the site of vascular lesion. Gene therapy is not only a sophisticated method of drug delivery; it may at time need drug delivery devices such as catheters for transfer of genes to various parts of the cardiovascular system.

The cardiovascular drug delivery markets are estimated for the years 2010 to 2020 on the basis of epidemiology and total markets for cardiovascular therapeutics. The estimates take into consideration the anticipated advances and availability of various technologies, particularly drug delivery devices in the future. Markets for drug-eluting stents are calculated separately. Role of drug delivery in developing cardiovascular markets is defined and unmet needs in cardiovascular drug delivery technologies are identified.

Selected 80 companies that either develop technologies for drug delivery to the cardiovascular system or products using these technologies are profiled and 74 collaborations between companies are tabulated. The bibliography includes 200 selected references from recent literature on this topic. The report is supplemented with 27 tables and 7 figures


0. Executive Summary 11

1. Cardiovascular Diseases 13

Introduction 13

History of cardiovascular drug delivery 13

Overview of cardiovascular disease 14

Coronary artery disease 14

Angina pectoris 14

Limitations of current therapies for myocardial ischemic disease 14

Cardiomyopathies 14

Cardiac arrhythmias 15

Congestive heart failure 15

Peripheral arterial disease 15

Current management 16

Atherosclerosis 16

The endothelium as a target for cardiovascular therapeutics 16

Molecular cardiology 17

Cardiogenomics 17

Cardioproteomics 17

Personalized cardiology 18

Pharmacogenomics of cardiovascular disorders 18

Modifying the genetic risk for myocardial infarction 19

Management of heart failure 19

Management of hypertension 20

Pharmacogenomics of diuretic drugs 20

Pharmacogenomics of ACE inhibitors 20

Management of hypertension by personalized approach 21

Pharmacogenetics of lipid-lowering therapies 21

Polymorphisms in genes involved in cholesterol metabolism 21

Role of eNOS gene polymorphisms 22

Important advances in cardiovascular therapeutics 22

Drug delivery, biotechnology and the cardiovascular system 23

Role of cardiovascular imaging in cardiovascular therapeutics 23

Chronopharmacotherapy of cardiovascular diseases 23

2. Methods for Drug Delivery to the Cardiovascular System 25

Introduction 25

Routes of drug delivery to the cardiovascular system 25

Local administration of drugs to the cardiovascular system 25

Intramyocardial drug delivery 25

Drug delivery via coronary venous system 26

Intrapericardial drug delivery 26

Formulations for drug delivery to the cardiovascular system 27

Sustained and controlled release 27

Programming the release at a defined time 28

Dosage formulation of calcium channel blockers 28

Sustained and controlled release verapamil 28

Methods of administration of proteins and peptides 28

Delivery of peptides by subcutaneous injection 29

Depot formulations and implants 29

Poly(ethylene glycol) technology 29

Microencapsulation for protein delivery 30

Localized delivery of biomaterials for tissue engineering 30

Oral delivery of proteins and peptides 30

DDS to improve systemic delivery of cardiovascular drugs 32

Nanotechnology-based drug delivery 32

Controlled delivery of nanoparticles to injured vasculature 33

Nanoparticles for cardiovascular imaging and targeted drug delivery 34

Nanofiber-based scaffolds with drug-release properties 34

Targeted drug delivery to the cardiovascular system 34

Immunotargeting of liposomes to activated vascular endothelial cells 35

PEGylated biodegradable particles targeted to inflamed endothelium 36

Devices for cardiovascular drug delivery 36

Local drug delivery by catheters 37

Microneedle for periarterial injection 38

Nanotechnology-based devices for the cardiovascular system 39

Liposomal nanodevices for targeted cardiovascular drug delivery 39

Nanotechnology approach to the problem of "vulnerable plaque" 40

Drug delivery in the management of cardiovascular disease 40

Drug delivery in the management of hypertension 40

Transnasal drug delivery for hypertension 41

Transdermal drug delivery for hypertension 41

Oral extended and controlled release preparations for hypertension 42

Long-acting hypertensives for 24 h blood pressure control 43

Drug delivery to control early morning blood pressure peak 43

Role of drug delivery in improving compliance with antihypertensive therapy 44

Drug delivery for congestive heart failure 44

Oral human brain-type natriuretic peptide 44

Nitric oxide-based therapies for congestive heart failure 44

Automated drug delivery system for cardiac failure 45

DDS in the management of ischemic heart disease 45

Intravenous emulsified formulations of halogenated anesthetics 46

Injectable peptide nanofibers for myocardial ischemia 46

Delivery of angiogenesis-inducing agents for myocardial ischemia 47

Drug delivery for cardioprotection 47

Drug delivery for cardiac rhythm disorders 48

Drug delivery in the treatment of angina pectoris 49

Sustained and controlled-release nitrate for angina pectoris 49

Transdermal nitrate therapy 49

Controlled release calcium blockers for angina pectoris 51

Vaccines for hypertension 51

Drug delivery in the management of pulmonary hypertension 51

Prostacyclin by inhalation 52

Endothelin receptor antagonist treatment of PAH 52

Anticoagulation in cardiovascular disease 52

Oral heparin 52

Low molecular weight heparin-loaded polymeric nanoparticles 53

Transdermal anticoagulants 53

Thrombolysis for cardiovascular disorders 53

Use of ultrasound to facilitate thrombolysis 54

Delivery of alteplase through the AngioJet rheolytic catheter 54

Drug delivery for peripheral arterial disease 54

Delivery of thrombolytic agent to the clot through a catheter 55

Delivery of growth factors to promote angiogenesis in ischemic limbs 55

Immune modulation therapy for PAD 55

NO-based therapies for peripheral arterial disease 55

Drug delivery in the management of hypercholesterolemia 56

Controlled/sustained release formulations of statins 56

Combinations of statins with other drugs to increase efficacy 56

Controlled release fenofibrate 57

Extended release nicotinic acid 58

Intravenous infusion of lipoprotein preparations to raise HDL 59

Innovative approaches to hypercholesterolemia 59

Single dose therapy for more than one cardiovascular disorder 59

3. Cell Therapy for Cardiovascular Disorders 61

Introduction 61

Inducing the proliferation of cardiomyocytes 61

Role of stem cells in repair of the heart 61

Cell-mediated immune modulation for chronic heart disease 61

Cell therapy for atherosclerotic coronary artery disease 62

Transplantation of myoblasts for myocardial infarction 62

MyoCell™ (Bioheart) 63

Transplantation of cardiac progenitor cells for revascularization of myocardium 64

Methods of delivery of cells to the heart 64

Cellular cardiomyoplasty 64

IGF-1 delivery by nanofibers to improve cell therapy for MI 65

Intracoronary infusion of bone marrow-derived cells for AMI 65

Non-invasive delivery of cells to the heart by Morph®guide catheter 65

Transplantation of stem cells for myocardial infarction 66

Transplantation of embryonic stem cells 66

Transplantation of hematopoietic stem cells 66

Transplantation of cord blood stem cells for myocardial infarction 66

Intracoronary infusion of mobilized peripheral blood stem cells 67

Human mesenchymal stem cells for cardiac regeneration 67

Cytokine preconditioning of human fetal liver CD133+ SCs 68

Transplantation of expanded adult SCs derived from the heart 68

Transplantation of endothelial cells 68

Transplantation of genetically modified cells 69

Transplantation of cells secreting vascular endothelial growth factor 69

Transplantation of genetically modified bone marrow stem cells 69

Cell transplantation for congestive heart failure 69

Myoblasts for treatment of congestive heart failure 69

Injection of adult stem cells for congestive heart failure 70

Role of cell therapy in cardiac arrhythmias 70

Atrioventricular conduction block 71

Ventricular tachycardia 71

ESCs for correction of congenital heart defects 72

Cardiac progenitors cells for treatment of heart disease in children 72

Stem cell therapy for peripheral arterial disease 72

Targeted delivery of endothelial progenitor cells labeled with nanoparticles 73

Clinical trials of cell therapy in cardiovascular disease 73

A critical evaluation of cell therapy for heart disease 75

Publications of clinical trials of cell therapy for CVD 75

Future directions for cell therapy of CVD 76

4. Gene Therapy for Cardiovascular Disorders 79

Introduction 79

Techniques of gene transfer to the cardiovascular system 80

Direct plasmid injection into the myocardium 80

Catheter-based systems for vector delivery 80

Ultrasound microbubbles for cardiovascular gene delivery 81

Vectors for cardiovascular gene therapy 81

Adenoviral vectors for cardiovascular diseases 81

Plasmid DNA-based delivery in cardiovascular disorders 82

Intravenous rAAV vectors for targeted delivery to the heart 82

Hypoxia-regulated gene therapy for myocardial ischemia 82

Angiogenesis and gene therapy of ischemic disorders 83

Therapeutic angiogenesis vs. vascular growth factor therapy 83

Gene painting for delivery of targeted gene therapy to the heart 84

Gene delivery to vascular endothelium 84

Targeted plasmid DNA delivery to the cardiovascular system with nanoparticles 84

Gene delivery by vascular stents 85

Gene therapy for genetic cardiovascular disorders 85

Genetic disorders predisposing to atherosclerosis 85

Familial hypercholesterolemia 86

Apolipoprotein E deficiency 87

Hypertension 87

Genetic factors for myocardial infarction 88

Acquired cardiovascular diseases 88

Coronary artery disease with angina pectoris 88

Ad5FGF-4 88

Ischemic heart disease with myocardial infarction 89

Angiogenesis for cardiovascular disease 90

Myocardial repair with IGF-1 therapy 90

miRNA gene therapy for ischemic heart disease 91

Congestive heart failure 91

Rationale of gene therapy in CHF 91

?-ARKct gene therapy 92

Intracoronary adenovirus-mediated gene therapy for CHF 92

AAV-mediated gene transfer for CHF 92

AngioCell gene therapy for CHF 93

nNOS gene transfer in CHF 93

Gene therapy for cardiac arrhythmias 93

Gene transfer for biological pacemakers 94

Management of arrhythmias due to myoblast transplantation 95

Genetically engineered cells as biological pacemakers 95

Gene therapy and heart transplantation 96

Gene therapy for peripheral arterial disease 96

Angiogenesis by gene therapy 96

HIF-1? gene therapy for peripheral arterial disease 96

HGF gene therapy for peripheral arterial disease 97

Ischemic neuropathy secondary to peripheral arterial disease 97

Maintaining vascular patency after surgery 97

Antisense therapy for cardiovascular disorders 98

Antisense therapy for hypertension 99

Antisense therapy for hypercholesterolemia 99

RNAi for cardiovascular disorders 100

RNAi for hypercholesterolemia 100

microRNA and the cardiovascular system 101

Role of miRNAs in angiogenesis 101

Role of miRNAs in cardiac hypertrophy and failure 101

Role of miRNAs in conduction and rhythm disorders of the heart 102

miRNA-based approach for reduction of hypercholesterolemia 102

miRNAs as therapeutic targets for cardiovascular diseases 103

Future prospects of miRNA in the cardiovascular therapeutics 103

Future prospects of gene therapy of cardiovascular disorders 103

Companies involved in gene therapy of cardiovascular disorders 104

5. Drug-Eluting Stents 107

Introduction 107

Percutaneous transluminal coronary angioplasty 107

Stents 107

Restenosis 107

Pathomechanism 108

Treatment 108

Nitric oxide-based therapies for restenosis 109

Carbon monoxide inhalation for preventing restenosis 109

Antisense approaches for prevention of restenosis after angioplasty 110

miRNA-based approach for restenosis following angioplasty 111

Gene therapy to prevent restenosis after angioplasty 111

Techniques of gene therapy for restenosis 112

NOS gene therapy for restenosis 113

Nonviral gene therapy to prevent intimal hyperplasia 113

HSV-1 gene therapy to prevent intimal hyperplasia 114

Drug delivery devices for restenosis 114

Local drug delivery by catheter 114

Stenosis associated with stents 115

Absorbable metal stents 115

Drug-eluting stents 115

Various types of DES 116

CYPHER® sirolimus-eluting coronary stent 116

Dexamethasone-eluting stents 116

NO-generating stents 117

Paclitaxel-eluting stents 117

Sirolimus-eluting vs paclitaxel-eluting stents 118

Novel technologies for DES 118

Absorbable DES 118

Bio-absorbable low-dose DES 119

Drug-eluting stents coated with polymer surfaces 119

Endeavour DES 119

Stents for delivery of gene therapy 120

Stem cell-based stents 121

VAN 10-4 DES 121

Nanotechnology-based stents 122

Drugs encapsulated in biodegradable nanoparticles 122

Magnetic nanoparticle-coated DES 122

Magnetic nanoparticles encapsulating paclitaxel targeted to stents 123

Nanocoated DES 123

Nanopores to enhance compatibility of DES 124

The ideal DES 124

Companies developing drug-eluting stents 124

Clinical trials of drug-eluting stents 125

Measurements used in clinical trials of DES 125

TAXUS paclitaxel-eluting stents 126

XIENCE™ V everolimus-eluting coronary stent 127

COSTAR II clinical trial 127

Endeavor RESOLUTE zotarolimus-eluting stent system 128

CUSTOM I clinical trial 128


LEADERS trial 129

Comparison of DES in clinical trials 130

Comparison of DES with competing technologies 130

DES versus coronary artery bypass graft 130

DES versus bare metal stents 131

Guidelines for DES vs BMS 133

DES vs BMS for off-label indications 133

Role of DES in cases of bare-metal in-stent restenosis 134

DES versus balloon catheter coated with paclitaxel 134

DES versus intracoronary radiation therapy for recurrent stenosis 134

Cost-effectiveness of DES 135

Safety issues of DES 136

Adverse reactions to DES 136

Endothelial vascular dysfunction due to sirolismus 136

Risk of clotting with DES 136

Clopidogrel use and long-term outcomes of patients receiving DES 138

Prasugrel as antiplatelet agent 138

Effect of blood clot on release of drug from DES 139

Use of magnetized cell lining to prevent clotting of DES 139

Long-term safety studies of DES 139

Regulatory issues of DES 140

Future prospects for treatment of restenosis by DES 142

Future role of DES in management of cardiovascular diseases 142

Stent cost and marketing strategies 142

Improvements in stent technology 143

Bioabsorbale stent 143

DES vs drug-eluting balloons 143

6. Markets for Cardiovascular Drug Delivery 145

Introduction 145

Epidemiology of cardiovascular disease 145

Cost of care of cardiovascular disorders 146

Cardiovascular markets according to important diseases 147

Antithrombotics 147

Anticholesterol agents 147

Antihypertensive agents 148

Drugs for congestive heart failure 148

Markets for innovative technologies for cardiovascular disorders 148

Markets for cell therapy of cardiovascular disorders 148

Markets for gene therapy of cardiovascular disorders 149

Markets for drug-eluting stents 149

Major players in DES market 149

Impact of safety issues on future markets for DES 149

DES market in Asia 150

Patenting and legal issues of DES 151

The financial impact of DES on cardiovascular markets 151

Unmet needs for cardiovascular drug delivery 152

Role of DDS in developing cardiovascular markets 153

Markets for cardiovascular devices 153

Marketing of innovative cardiovascular drug delivery devices 153

Direct to consumer advertising of DES 154

Future trends in the integration of drug delivery with therapeutics 154

Future prospects of cardiovascular drug delivery 154

7. Companies involved in Cardiovascular Drug Delivery 155

Profiles of companies 155

Collaborations 241

8. References 245

List of Tables

Table 1 1: Landmarks in the historical evolution of cardiovascular drug delivery 13

Table 1 2: Gene polymorphisms that alter cardiovascular response to drugs 18

Table 2 1: Routes of drug delivery used for treatment of cardiovascular disorders 25

Table 2 2: Formulations for drug delivery to the cardiovascular system 27

Table 2 3: Improved methods of systemic drug delivery of cardiovascular drugs 32

Table 2 4: Targeted delivery of therapeutic substances to the cardiovascular system 35

Table 2 5: Classification of devices for drug delivery to the cardiovascular system 36

Table 2 6: Various methods of delivery of therapeutic agents for hypertension 41

Table 2 7: Marketed controlled/ extended release preparation for hypertension 43

Table 2 8: Drug delivery in ischemic heart disease 45

Table 2 9: Methods of delivery of nitrate therapy in angina pectoris 49

Table 2 10: Drug delivery for peripheral arterial disorders 54

Table 3 1: Clinical trials of cell therapy in cardiovascular disease 73

Table 4 1: Cardiovascular disorders for which gene therapy is being considered. 79

Table 4 2: Catheter-based systems for vector delivery to the cardiovascular system 80

Table 4 3: Potential applications of antisense in cardiovascular disorders 99

Table 4 4: Companies involved in gene therapy of cardiovascular diseases 104

Table 5 1: Treatment of restenosis 108

Table 5 2: Devices used for drug delivery in restenosis 114

Table 5 3: Companies involved in drug-eluting stents 124

Table 6 1: Prevalence of cardiovascular disorders in major markets: US 2010-2020 146

Table 6 2: Prevalence of cardiovascular disorders in major markets: Europe 2010-2020 146

Table 6 3: Prevalence of cardiovascular disorders in major markets: Japan 2010-2020 146

Table 6 4: Values of cardiovascular DDS in major markets 2010-2020 147

Table 6 5: Markets for innovative technologies for cardiovascular disorders 2010-2020 148

Table 7 1: Top 5 companies in cardiovascular drug delivery 155

Table 7 2: Collaborations in cardiovascular drug delivery 241

List of Figures

Figure 1 1: Drug delivery, biotechnology and cardiovascular diseases 23

Figure 2 1: MicroSyringe for periarterial injection 39

Figure 5 1: Vicious circle of vascular occlusion following angioplasty and stenting 109

Figure 5 2: Measurement of in-stent stenosis 115

Figure 5 3: Medtronic's Endeavour drug-eluting stent 120

Figure 5 4: Magnetic nanoparticle-coated stent 122

Figure 6 1: Unmet needs for cardiovascular drug delivery 152

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Nicolas Bombourg
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