Drug Delivery Technology: Revolutionizing Cardiovascular Treatment

July 2007 | 109 pages | ID: D0E1AF2AABFEN
PharmaVision

Abstracts

Use the incisive analysis, commentary, opinions and forecasts provided in this note to:

• gain an in-depth understanding of the technology landscape for CV devices including active & passive targeting platforms, cell- & gene-based therapeutic delivery platforms & biomaterials for medical devices including drug-eluting stents
• assess the options available for delivering existing & novel cardiovascular agents now & in the future
• gauge the current & future technology requirements of pharma, biotech & medical device companies developing cardiovascular products & devices
• analyze how the market is evolving & the influence that drug delivery may have on pharma cardiovascular pipelines
• identify key pharma & delivery companies focusing on the improved delivery of existing & novel cardiovascular agents
• highlight alliances between delivery companies & pharma & device manufacturers and recent market activity
• evaluate where progress has been made in the delivery of potential new cardiovascular products & devices

KEY FINDINGS:

• 2006 global cardiovascular market worth over US$75 billion.
• attracted attention of specialty pharma and big pharma players such as Amgen, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., Novartis, Pfizer, sanofi-aventis and Schering-Plough.
• >270 products in clinical development however; 3 key challenges remain - ensuring efficient, targeted and con-trolled-release of mono and combination therapies, improve delivery of novel regenerative therapies and improve the biocompatibility & biodegradability of medical devices.
• Analysis of historic (2000-2005) market trends of the cardiovascular pharmaceutical sales and advanced drug delivery sales.
• Forecasts for near-term (2006-2012) and the future (2020) market growth based on the technology platforms evaluated in the report.
• Plus, sales forecasts for approved and pipeline cardiovascular products and medical devices used as a basis for our cardiovascular drug delivery sales (CDDS) forecasts.
• Drug delivery companies applying a plethora of platforms, including controlled-release, targeted systems, to overcome the above challenges.
• Many new classes of drugs and combinations will reach the market over the next 6 years, driving future market growth. Their success is analyzed in detail and case studies provided to highlight the progress of each technology.
• As the cardiovascular market evolves new approaches to treatment will emerge targeting the reversal of cardiovascular conditions utilizing cutting edge cell- and gene based therapies. Several Biotherapeutics companies are working towards this goal including: Advanced Cell Technology, Angioblast Systems, Cytori Therapeutics, Geron Corporation, MG Biotherapeutics, Osiris Therapeutics and Tissue Genesis. A number of delivery options are currently being evaluated to optimize the clinical utility of these regenerative therapies and are analyzed in detail in the report.
• The medical devices market is going through a transition period as novel biomaterials are evaluated that may have wide ranging utility in medical devices including drug eluting stents. Competition in this market is fierce where Abbott Laboratories, Boston Scientific Corporation, Johnson & Johnson and Medtronic dominate but newer players such as MIV Therapeutics are venturing into the arena. The latest development in drug-eluting stents and biomaterials are analyzed in detail in the report.

“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.

EIGHT QUESTIONS THIS NOTE ANSWERS:

1. How will the drug delivery technology drivers change in the cardiovascular arena during the next decade and beyond?
2. What are the key delivery technologies and devices in the cardiovascular field?
3. When are products and medical devices which utilize these key delivery technolo-gies likely to reach the market?
4. Which drug delivery specialists are forming strategic alliances with the pharma industry in the cardiovascular arena?
5. Which companies are the winners in each technology category?
6. How are drug delivery technologies evolving to meet the demands of the cardiovas-cular market?
7. Where are the market opportunities now and in the future?
8. What do we predict will be the value of the cardiovascular drug delivery and medical devices market each year until 2012, in 2015 and in 2020?

Contents

1. THE CARDIOVASCULAR MARKET AND DRUG DELIVERY TECHNOLOGY OPPORTUNITIES

1.1 Introduction
1.2 Overview of the market.
1.2.1 Market size
1.2.2 Key pharma players
1.2.3 Growth areas for drug delivery
1.3 Product pipeline
1.3.1 Cardiovascular pipeline products

2 MARKET DRIVERS AND OPPORTUNITIES FOR DRUG DELIVERY TECHNOLOGIES

3 KEY DRUG DELIVERY COMPANIES AND ACADEMIC RESEARCHERS IN CARDIOVASCULAR RESEARCH

4 CURRENT DRUG DELIVERY ISSUES AND OPPORTUNITIES IN THE CARDIOVASCULAR ARENA

4.1 Oral, passive, targeted and controlled release technologies
4.2 Invasive and non-invasive targeted regenerative therapeutic delivery
4.3 Minimally invasive biocompatible and bioerodible technologies

5 ORAL, PASSIVE, TARGETED AND CONTROLLED RELEASE TECHNOLOGIE

5.1 Oral drug delivery
5.1.1 Case Study: Elaprin® (Emisphere Technologies)
5.2 Encapsulated microbubble drug delivery
5.2.1 Case Study: MRX-801 microbubbles (ImaRx Therapeutics)
5.3 Liposomal drug delivery
5.3.1 Case Study: Liposome nanoparticles (CWRU)
5.4 Polymer-based drug delivery
5.4.1 Case Study: SynBiosys™ Polymers (Innocore Technologies)
5.5 Antibody-based drug delivery
5.5.1 Case Study: PECAM-1 scFV lmw-scuPA (University of Pennsylvania)
5.6 Controlled-release delivery
5.6.1 Case Study: BioSilicon™ Nanoparticles (pSivida)
5.7 Our opinion on passive, targeted and controlled-release drug delivery technologies

6 INVASIVE AND NON-INVASIVE CELL-BASED REGENERATIVE THERAPEUTIC DELIVERY

6.1 Cell sources
6.2 Cell delivery technologies
6.3 Autologous cell platforms
6.3.1 Case Study: Celution™ System (Cytori Therapeutics)
6.3.2 Case Study: TGI 1200™ System (Tissue Genesis/Bioheart)
6.3.3 Case Study: Myosix technology (MG Biotherapeutics/Myosix)
6.4 Allogenic cell platforms
6.4.1 Case Study: Provacel™ (Osiris Therapeutics/Boston Scientific Corporation)
6.4.2 Mesenchymal precursor cell technology (Angioblast)
6.4.3 Case Study: GRNCM1 (Geron Corporation)
6.4.4 Case Study: ACTCellerate (Advanced Cell Technology)
6.5 Our opinion on cell-based delivery technologies

7 INVASIVE AND NON-INVASIVE GENE-BASED REGENERATIVE THERAPEUTIC DELIVERY

7.1 Non-viral gene therapy delivery
7.2 Physical Delivery Technologies
7.2.1 eNOS non-viral gene loading (MaxCyte/Northern Therapeutics)
7.3 Chemical Delivery Technologies
7.3.1 Case Study: AMG0001 (Vical/AnGes MG/Daiichi Pharma)
7.3.2 Case Study: compacted DNA nanoparticles (Copernicus Therapeutics)
7.3.3 Case Study: Mirus’ Pathway IV ™ delivery technology (Mirus Bio Corporation)
7.3.4 Case Study: ALN-PCS01 (Alnylam Pharmaceuticals/Protiva Biotherapeutics)
7.3.5 Case Study: Resten CytoPorter™ (AVI BioPharma/ Cook Medical)
7.4 Viral gene therapy delivery
7.4.1 Case Study: Viral and non-viral conjugate vectors (Genome Media/[AnGes MG])
7.4.2 Case Study: Mydicar™ (Targeted Genetics/Celladon Corporation)
7.4.3 Growth factor AV delivery and GAM (Cardium Therapeutics)
7.4.4 Trinam® (Ark Therapeutics)
7.4.5 Viral vector manufacturing (MaxCyte)
7.5 Our opinion on gene-based delivery technologies

8 DRUG DELIVERY FOR STENTS

8.1 Stents
8.2 Bare metal stents
8.3 Drug Eluting Stents
8.3.1 Case Study: Dynalink-E everolimus-eluting coronary stent (Abbott Vascular)
8.3.2 Case Study: BVS-everolimus eluting stent (Abbott Vascular)
8.3.3 Case Study: Microporous sirolimus-eluting stent (MIV Therapeutics/UCB)
8.3.4 Case Study: CoStar® Stent (Conor Medsystems/[J&J])
8.3.5 ProGenic Pimecrolimus Drug Eluting Stent (Biotronik AG)
8.3.6 Genous™ Bio-engineered R stent (OrbusNeich)
8.4 Our opinion on drug eluting stent technologies

9 MARKET TRENDS IN DRUG DELIVERY IN CARDIOVASCULAR

9.1 Key drug delivery players in the cardiovascular arena
9.2 Recent partnerships and acquisitions
9.2.1 Specialist technology providers
9.2.2 Emerging specialty pharma companies
9.2.3 Strategic partnerships and joint ventures
9.2.4 Acquisitions
9.3 Market trends now 2006-2012
9.3.1 Historical drug delivery market 2000-2005
9.3.2 Global drug delivery market 2006-2012
9.3.3 Global advanced cardiovascular drug delivery and devices market 2006-2012
9.3.4 Pharma drivers and drug delivery trends by 2012
9.4 Market by 2020
9.4.1 Global advanced drug delivery market by 2020
9.4.2 Global advanced cardiovascular drug delivery products and devices by 2020
9.4.3 Pharma drivers and drug delivery trends by 2020
9.3.4 Drug delivery trends by 2020

10 SUMMARY & CONCLUSIONS

11 BIBLIOGRAPHY

12 ACKNOWLEDGEMENTS

List Of Figures

LIST OF FIGURES

Figure 1.1: Global cardiovascular market sales 2006
Figure 1.2: Leading cardiovascular brands 2006
Figure 1.3: Global stent market 2006
Figure 1.4: Global cardiovascular market players 2006
Figure 1.5: Global cardiovascular pharma pipelines 2006
Figure 1.6: Global cardiovascular device manufacturers 2006
Figure 1.7: Acute and chronic cardiovascular conditions for therapeutic intervention
Figure 1.8: Cardiovascular medicines in development 2006
Figure 2.1: Drug delivery opportunities in cardiovascular diseases
Figure 2.2: Projected number of deaths due to non-communicable diseases
Figure 5.1: Proposed mechanism of oral drug delivery with carrier agent
Figure 5.2: Heparin SC versus oral heparin/SNAC solution and soft gel capsules
Figure 5.3: Schematic of SonoLysis mode of action
Figure 5.4: Nanoparticle liposome for targeted CV delivery
Figure 5.5: Molecular composition of SynBiosys
Figure 5.6: Schematic for PECAM-1 scFV lmw-scuPA mechanism of action
Figure 5.7: Cross section of a porous BioSilicon™ membrane
Figure 6.1: Schematic of cell-based therapy administration to the myocardium
Figure 6.2: Adipose tissues source of stem and regenerative cells
Figure 6.3: Myostar™ catheter
Figure 6.4: Schematic of TGI/Biohearts TGI 1200™ system
Figure 6.5: Schematic of autologous cell generation for the MAGIC tria
Figure 6.6: Provacel™ preclinical data
Figure 6.7: Stem cell therapeutic applications
Figure 6.8: GRNCM1 Cardiomyocytes in Heart Failure
Figure 6.9: ACTCellerate Technology
Figure 7.1: MaxCyte GT ™ non-viral cell loading system
Figure 7.2: Mechanism of uptake of compacted DNA nanoparticles
Figure 7.3: Mirus’ Pathway IV ™ delivery technology
Figure 7.4: Application of RNAi therapeutics in hypercholesterolemia
Figure 7.5: Application of HVJ-technology systems
Figure 7.6: Schematic of the Gene Activated Matrix (GAM)
Figure 7.7: Schematic of Trinam® method of use
Figure 7.8: MaxCyte GT ™ viral vector manufacturing
Figure 8.1: Dynalink-E everolimus stent elution profile from Abbott Vascular
Figure 8.2: BVS bioabsorbable stent from Abbott Vascular
Figure 8.3: MIVT’s HAp Coated Stent
Figure 8.4: Schematic representation of a Conor MedStent™ well
Figure 8.5: Schematic ProGenic Pimecrolimus Drug Eluting Stent
Figure 8.6: Schematic representation of the Genous™ Bioengineered R stent
Figure 9.1: Progression of cardiovascular products and devices fuelled by drug delivery by 2012
Figure 9.2: Progression of cardiovascular products and devices fuelled by drug delivery by 2020

List Of Tables

LIST OF TABLES

Table 2.1: US patent expiration of leading cardiovascular brands
Table 3.1: Leading drug delivery technology companies in the cardiovascular arena
Table 3.2: Leading academic research laboratories in cardiovascular drug delivery technology
Table 5.1: Leading drug delivery companies and academic institutes evaluating non-invasive cardiovascular drug delivery
Table 5.2: ImaRx product pipeline
Table 5.3: Homing beacons for site specific cardiovascular delivery
Table 6.1: Leading companies and academic institutes evaluating cell-based cardiovascular therapies
Table 6.2: Provacel™ 6 month clinical data
Table 6.3: Advantages of mesenchymal-precursor cells
Table 7.1: Leading companies and academic institutes in cardiovascular gene therapy
Table 7.2: Gene targets for cardiovascular conditions
Table 7.3: Viral vector delivery systems
Table 7.4: Differential distribution of growth factors in the cardiovascular system
Table 8.1: Leading cardiovascular device manufacturers and academic institutes evaluating cardiology devices and delivery technologies....
Table 8.2: Leading approved bare metal stents
Table 8.3: Approved and developmental drug eluting stents
Table 8.4: ABSORB trial data
Table 8.5: e-HEALING post-marketing data
Table 9.1: Summary of leading cardiovascular-focused drug delivery companies
Table 9.2: Summary of recent alliances, agreements and acquisitions with drug delivery companies evaluating cardiovascular agents and devices
Table 9.3: Forecast of global pharmaceutical market and drug delivery market (2000-2005)
Table 9.4: Forecast of global drug delivery market 2006-2012
Table 9.5: Forecasts of approved drug delivery driven cardiovascular products 2006-2012 (US$ million)
Table 9.6: Forecasts of approved drug delivery driven cardiovascular medical devices 2006-2012 (US$ million)
Table 9.7: Forecasts of pipeline drug delivery driven cardiovascular products and drug-eluting stents 2006-2012 (US$ million)
Table 9.8: Forecast of drug delivery market 2012-2020 (US$ billion)

COMPANIES MENTIONED:

Abbott Vascular, Actelion Pharmaceuticals, Advanced Cell Technology, Alltracel Technologies, Alnylam Pharmaceuticals, ALZA , Amgen, AnGes MG, Angioblast Systems, Ark Therapeutics, AVI BioPharma Inc, Bard Inc, Bioavail Pharmaceuticals, Bioheart, Biophan Technologies, Biosense Webster, BioSensors International, Biosync Scientific Corporation, Biotechnology Research Corporation of Hong Kong, Biotronik AG, Boston Scientific Inc, Bristol-Myers Squibb, Cardium Therapeutics, Celladon Corporation, Clearstream, Conor Medsystems Inc, Cook Medical, Copernicus Therapeutics, Cordis Corporation, Cytori Therapeutics, Diachii-Sankyo, Dendritic Nanotechnologies, DepoMed Inc, EMD BioSciences (Merck KGaA), Emisphere Technologies, EndoTex Interventional Systems, Endovasc, GlaxoSmithKline, Geron Corporation, Guidant Corporation, ImaRx Therapeutics, Infigen Inc., Innocore Technologies, Invitrogen, Johnson & Johnson, Kereos, Maxcyte, Medtronic Inc, Merck & Co., MG Biotherapeutics, Micell Technologies, Miravant Medical Technologies, Mirus Bio Corporatiom, MIV Therapeutics, Myosix, Mytogen Inc., Nastech Pharmaceutical, NaturalNano Inc, Northern Therapeutics, Novartis, OBS Medical, OrbusNeich, Osiris Therapeutics, Otsuka, Pacific Northwest National Laboratory, Penwest Pharma, Phosphagenics Ltd, Pfizer, PolyNovo, Protiva Biotherapeutics, pSivida, Remon Medical Technologies Inc, Resverlogix Corporation, sanofi-aventis, Schering-Plough, SCOLR Pharma, StarPharma, SurModics Inc, Tissue Genesis Inc, TyRx Pharma, UCB, Vical Inc, Volcano Corporation, X-Cell Medical Inc.