Drug Delivery Technology: Revolutionizing Cardiovascular Treatment
Revolutionizing Cardiovascular Treatment
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| “The ability to deliver therapeutics site specifically,safely and efficiently remains a major challenge for the treatment of cardiovascular diseases. Additional drug delivery hurdles will need to be overcome as pharma companies and medical device manufacturers target specific areas of the vasculature. These advances will help to develop a new generation of medicines and devices to tackle the world’s leading killer.” Dr Cheryl Barton Cardiovascular disease (CVD) is the leading cause of death in the world, killing almost 17 million people each year. Types of CVD include coronary heart disease, hypertension, dyslipidemia and stroke - stroke is now the third leading cause of death, and the leading cause of disability in the western world (source: American Heart Association, AHA). Each year these conditions account for almost half of all deaths and are a tremendous financial burden on the healthcare system estimated to cost the US around US$560 billion annually (Source: Buxton, 2007). The following report summarizes some of the latest developments in CV drug development and devices and analyzes some of the most promising solutions which drug delivery companies and device manufacturers are providing in order to address this unmet clinical need. |
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| Keywords: active targeted delivery, autologous cell platforms, allogenic cell platforms, biocompatible, biodegradable, cardiovascular drug delivery sales (CDDS), cell therapy, drug eluting stents, gene therapy | |
 
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By Dr Cheryl Lee Barton / Publication Date: 9th July 2007
Contents:
The cardiovascular market and drug delivery technology opportunities5
1.1 Introduction5
1.2 Overview of the market.6
1.2.1 Market size6
1.2.2 Key pharma players8
1.2.3 Growth areas for drug delivery10
1.3 Product pipeline10
1.3.1 Cardiovascular pipeline products11
2 Market drivers and opportunities for drug delivery technologies12
3 Key drug delivery companies and academic researchers in cardiovascular research15
4 Current drug delivery issues and opportunities in the cardiovascular arena20
4.1 Oral, passive, targeted and controlled release technologies20
4.2 Invasive and non-invasive targeted regenerative therapeutic delivery20
4.3 Minimally invasive biocompatible and bioerodible technologies20
5 Oral, passive, targeted and controlled release technologie21
5.1 Oral drug delivery23
5.1.1 Case Study: Elaprin® (Emisphere Technologies23
5.2 Encapsulated microbubble drug delivery25
5.2.1 Case Study: MRX-801 microbubbles (ImaRx Therapeutics26
5.3 Liposomal drug delivery27
5.3.1 Case Study: Liposome nanoparticles (CWRU28
5.4 Polymer-based drug delivery29
5.4.1 Case Study: SynBiosys™ Polymers (Innocore Technologies29
5.5 Antibody-based drug delivery30
5.5.1 Case Study: PECAM-1 scFV lmw-scuPA (University of Pennsylvania30
5.6 Controlled-release delivery31
5.6.1 Case Study: BioSilicon™ Nanoparticles (pSivida31
5.7 Our opinion on passive, targeted and controlled-release drug delivery technologies33
6 Invasive and non-invasive cell-based regenerative therapeutic delivery34
6.1 Cell sources34
6.2 Cell delivery technologies35
6.3 Autologous cell platforms37
6.3.1 Case Study: Celution™ System (Cytori Therapeutics37
6.3.2 Case Study: TGI 1200™ System (Tissue Genesis/Bioheart39
6.3.3 Case Study: Myosix technology (MG Biotherapeutics/Myosix40
6.4 Allogenic cell platforms41
6.4.1 Case Study: Provacel™ (Osiris Therapeutics/Boston Scientific Corporation42
6.4.2 Mesenchymal precursor cell technology (Angioblast43
6.4.3 Case Study: GRNCM1 (Geron Corporation45
6.4.4 Case Study: ACTCellerate (Advanced Cell Technology46
6.5 Our opinion on cell-based delivery technologies48
7 Invasive and non-invasive gene-based regenerative therapeutic delivery49
7.1 Non-viral gene therapy delivery51
7.2 Physical Delivery Technologies51
7.2.1 eNOS non-viral gene loading (MaxCyte/Northern Therapeutics51
7.3 Chemical Delivery Technologies53
7.3.1 Case Study: AMG0001 (Vical/AnGes MG/Daiichi Pharma53
7.3.2 Case Study: compacted DNA nanoparticles (Copernicus Therapeutics54
7.3.3 Case Study: Mirus’ Pathway IV ™ delivery technology (Mirus Bio Corporation55
7.3.4 Case Study: ALN-PCS01 (Alnylam Pharmaceuticals/Protiva Biotherapeutics57
7.3.5 Case Study: Resten CytoPorter™ (AVI BioPharma/ Cook Medical58
7.4 Viral gene therapy delivery60
7.4.1 Case Study: Viral and non-viral conjugate vectors (Genome Media/[AnGes MG]) 61
7.4.2 Case Study: Mydicar™ (Targeted Genetics/Celladon Corporation62
7.4.3 Growth factor AV delivery and GAM (Cardium Therapeutics63
7.4.4 Trinam® (Ark Therapeutics65
7.4.5 Viral vector manufacturing (MaxCyte65
7.5 Our opinion on gene-based delivery technologies67
8 Drug delivery for stents68
8.1 Stents75
8.2 Bare metal stents76
8.3 Drug Eluting Stents77
8.3.1 Case Study: Dynalink-E everolimus-eluting coronary stent (Abbott Vascular79
8.3.2 Case Study: BVS-everolimus eluting stent (Abbott Vascular80
8.3.3 Case Study: Microporous sirolimus-eluting stent (MIV Therapeutics/UCB81
8.3.4 Case Study: CoStar® Stent (Conor Medsystems/[J&J83
8.3.5 ProGenic Pimecrolimus Drug Eluting Stent (Biotronik AG) 84
8.3.6 Genous™ Bio-engineered R stent (OrbusNeich85
8.4 Our opinion on drug eluting stent technologies87
9 Market trends in drug delivery in cardiovascular88
9.1 Key drug delivery players in the cardiovascular arena89
9.2 Recent partnerships and acquisitions93
9.2.1 Specialist technology providers93
9.2.2 Emerging specialty pharma companies93
9.2.3 Strategic partnerships and joint ventures93
9.2.4 Acquisitions94
9.3 Market trends now 2006-201297
9.3.1 Historical drug delivery market 2000-200597
9.3.2 Global drug delivery market 2006-201298
9.3.3 Global advanced cardiovascular drug delivery and devices market 2006-201298
9.3.4 Pharma drivers and drug delivery trends by 2012102
9.4 Market by 2020102
9.4.1 Global advanced drug delivery market by 2020103
9.4.2 Global advanced cardiovascular drug delivery products and devices by 2020103
9.4.3 Pharma drivers and drug delivery trends by 2020103
9.3.4 Drug delivery trends by 2020104
10 Summary & Conclusions105
11 Bibliography107
12 Acknowledgements109
List of Tables:
List of Figures
Figure 1.1: Global cardiovascular market sales 20066
Figure 1.2: Leading cardiovascular brands 20067
Figure 1.3: Global stent market 20068
Figure 1.4: Global cardiovascular market players 20068
Figure 1.5: Global cardiovascular pharma pipelines 20069
Figure 1.6: Global cardiovascular device manufacturers 2006 9
Figure 1.7: Acute and chronic cardiovascular conditions for therapeutic intervention10
Figure 1.8: Cardiovascular medicines in development 200611
Figure 2.1: Drug delivery opportunities in cardiovascular diseases13
Figure 2.2: Projected number of deaths due to non-communicable diseases13
Figure 5.1: Proposed mechanism of oral drug delivery with carrier agent24
Figure 5.2: Heparin SC versus oral heparin/SNAC solution and soft gel capsules25
Figure 5.3: Schematic of SonoLysis mode of action26
Figure 5.4: Nanoparticle liposome for targeted CV delivery28
Figure 5.5: Molecular composition of SynBiosys 29
Figure 5.6: Schematic for PECAM-1 scFV lmw-scuPA mechanism of action30
Figure 5.7: Cross section of a porous BioSilicon™ membrane31
Figure 6.1: Schematic of cell-based therapy administration to the myocardium35
Figure 6.2: Adipose tissues source of stem and regenerative cells37
Figure 6.3: Myostar™ catheter38
Figure 6.4: Schematic of TGI/Biohearts TGI 1200™ system39
Figure 6.5: Schematic of autologous cell generation for the MAGIC tria40
Figure 6.6: Provacel™ preclinical data41
Figure 6.7: Stem cell therapeutic applications44
Figure 6.8: GRNCM1 Cardiomyocytes in Heart Failure45
Figure 6.9: ACTCellerate Technology46
Figure 7.1: MaxCyte GT ™ non-viral cell loading system51
Figure 7.2: Mechanism of uptake of compacted DNA nanoparticles53
Figure 7.3: Mirus’ Pathway IV ™ delivery technology54
Figure 7.4: Application of RNAi therapeutics in hypercholesterolemia56
Figure 7.5: Application of HVJ-technology systems60
Figure 7.6: Schematic of the Gene Activated Matrix (GAM63
Figure 7.7: Schematic of Trinam® method of use64
Figure 7.8: MaxCyte GT ™ viral vector manufacturing64
Figure 8.1: Dynalink-E everolimus stent elution profile from Abbott Vascular70
Figure 8.2: BVS bioabsorbable stent from Abbott Vascular72
Figure 8.3: MIVT’s HAp Coated Stent74
Figure 8.4: Schematic representation of a Conor MedStent™ well76
Figure 8.5: Schematic ProGenic Pimecrolimus Drug Eluting Stent76
Figure 8.6: Schematic representation of the Genous™ Bioengineered R stent77
Figure 9.1: Progression of cardiovascular products and devices fuelled by drug delivery by 201294
Figure 9.2: Progression of cardiovascular products and devices fuelled by drug delivery by 202096
List of Tables
Table 2.1: US patent expiration of leading cardiovascular brands14
Table 3.1: Leading drug delivery technology companies in the cardiovascular arena15
Table 3.2: Leading academic research laboratories in cardiovascular drug delivery technology19
Table 5.1: Leading drug delivery companies and academic institutes evaluating non-invasive cardiovascular drug delivery22
Table 5.2: ImaRx product pipeline27
Table 5.3: Homing beacons for site specific cardiovascular delivery28
Table 6.1: Leading companies and academic institutes evaluating cell-based cardiovascular therapies36
Table 6.2: Provacel™ 6 month clinical data43
Table 6.3: Advantages of mesenchymal-precursor cells44
Table 7.1: Leading companies and academic institutes in cardiovascular gene therapy49
Table 7.2: Gene targets for cardiovascular conditions50
Table 7.3: Viral vector delivery systems60
Table 7.4: Differential distribution of growth factors in the cardiovascular system63
Table 8.1: Leading cardiovascular device manufacturers and academic institutes evaluating cardiology devices and delivery technologies....68
Table 8.2: Leading approved bare metal stents77
Table 8.3: Approved and developmental drug eluting stents78
Table 8.4: ABSORB trial data81
Table 8.5: e-HEALING post-marketing data86
Table 9.1: Summary of leading cardiovascular-focused drug delivery companies89
Table 9.2: Summary of recent alliances, agreements and acquisitions with drug delivery companies evaluating cardiovascular agents and devices95
Table 9.3: Forecast of global pharmaceutical market and drug delivery market (2000-200597
Table 9.4: Forecast of global drug delivery market 2006-201298
Table 9.5: Forecasts of approved drug delivery driven cardiovascular products 2006-2012 (US$ million99
Table 9.6: Forecasts of approved drug delivery driven cardiovascular medical devices 2006-2012 (US$ million100
Table 9.7: Forecasts of pipeline drug delivery driven cardiovascular products and drug-eluting stents 2006-2012 (US$ million101
Table 9.8: Forecast of drug delivery market 2012-2020 (US$ billion103