Nucleic Acid Drug Delivery Technologies:
Players, products & prospects to 2015
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| Overview: | |
| Although the nucleic acid delivery market is still in its infancy there are currently 1,300 clinical trials underway worldwide. The majority of these are in early clinical development (c. 67%) with just over 2% on Phase II trials. This indicates that relatively few nucleic acid candidates are likely to reach the market in the short term but the potential of the sector is significant. Our market analysis indicates that relatively few nucleic acid based products have been approved for human prescription. Those that have, rely on novel delivery technologies. The report estimates the nucleic acid market is worth around US$65 million globally in 2007. By 2015, nucleic acid products in development from ten key companies could generate additional sales of around US$1.1 billion. These products utilise a range of delivery platforms including viral to non-viral delivery systems and cover gene therapies, gene agents and DNA vaccines for a variety of targets including cancer, cardiovascular disease and infectious diseases. Drivers and dampeners of growth. The future of nucleic acid based therapies and gene therapies hangs in the balance whilst regulators and researchers weigh up the unmet clinical need for curative/preventative therapies versus the safety issues (immunogenicity, pathogenicity) associated with the delivery of some of these agents. Whilst the majority of gene therapy trials under evaluation incorporate the use of viral vectors there has been a shift in opinion in favour of non-viral delivery. However, significant opportunities exist for future commercial development within the pharmaceutical industry. These include: Development of new polymers and biopolymers that may be utilised in the safe and efficient delivery of genetic material to host cells The development of viral and non-viral vectors that can be regulated and incorporate high DNA payloads. Targeted delivery of nucleic acid drugs to increase the specificity of treatment Cost-effective production and application of safe and efficient vectors for the delivery of nucleic acid-based therapies Identification and delivery of polygenic genes for the treatment of multi-gene based diseases e.g. cancer. Improvements in DNA vaccine delivery and immune stimulation. Which companies and products will succeed in the nucleic acid delivery sector? What technical and regulatory hurdles must they overcome? This volume will tell you! |
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By Dr Cheryl Lee Barton / Publication Date: 17th November 2007
List of Tables:
Contents
Executive Summary 1
Competitor Ratio Analysis Summary 4
Introduction 6
Nucleic acid delivery: motivators & resistors 7
Motivators 8
Resistors 8
NUCLEIC ACID DELIVERY TECHNOLOGIES 9
Types of nucleic acid based products under development by the pharma industry 9
Viral vector delivery of nucleic acids 9
Figure 1: Schematic of gene therapy utilising an AAV vector 9
Figure 2: Schematic of gene therapy utilising HVJ envelope - virosome 10
Non-viral vector delivery of nucleic acids 11
Figure 3: Stable nucleic acid-lipid particles 12
Figure 4: Targeted nanoparticles 12
Figure 5: Schematic of Macroflux Technology 13
Figure 6: Schematic of PMED Technology and delivery 14
Table 1: Advantages and disadvantages of nucleic acid platforms 15
Current therapeutic applications for the viral and non-viral delivery of nucleic acids 15
Leading nucleic acid based products in development 16
Table 2: Nucleic acid-based approved/filed drugs 16
Table 3: Selection of nucleic acid-based developmental drugs 17
Future commercial applications & opportunities 18
STRATEGIES OF DRUG DELIVERY COMPANIES 19
Leading nucleic acid drug delivery companies 19
Table 4: Leading nucleic acid drug delivery specialists 19
Partnerships & acquisitions 21
Strategic developmental & commercialisation partnerships 21
Mergers & acquisitions 22
Table 5: Recent partnerships & acquisitions in the nucleic acid field 22
Intellectual Property 24
Table 6: Nucleic acid patents 24
THE viral and non-viral vector Delivery MARKET 25
Now 2007 25
Table 7: Approved nucleic acid product sales 25
Future 2015 25
Table 8: Global controlled-release product sales 26
Table 9: Novel nucleic acid product sales 26
COMPETITOR ANALYSIS 27
Movers & Shakers: Cutting edge or losing their grip 27
Table 10: Movers & shakers in nucleic acid drug delivery systems 28
COMPANY PROFILES 29
AlphaVax, Inc. (www.alphavax.com 29
Figure 7: The alphavaccine platform system 29
Table 11: AlphaVax product pipeline 31
Table 12: AlphaVax’ sales forecasts (US$ million 31
Altea Therapeutics, Inc. (www.alteatherapeutics.com 33
Table 13: Altea Therapeutics’ product pipeline 34
AP Pharma, Inc (www.appharma.com 36
Table 14: AP Pharma’s product pipeline 37
Aradigm, Inc (www.aradigm.com 38
Table 15: Aradigm’s product pipeline 39
BioDelivery Sciences International (www.biodeliverysciences.com 40
Figure 8: Bioral Technology 40
Figure 9: Direct membrane fusion 41
Table 16: BDSI’s product pipeline 42
Calando Pharmaceuticals (www. Calandopharma.com 43
Figure 10: Schematic of cyclodextrin polymeric nanoparticles 43
Table 17: Calando’s product pipeline 44
Table 18: Calando’s sales forecasts 44
Copernicus Therapeutics (www.cgsys.com 45
Figure 11: Uptake and trafficking of condensed nanoparticle DNA 45
Table 19: Copernicus’ product pipeline 46
Table 20: Copernicus’ sales forecasts 47
Diatos SA (www.diatos.com 48
Table 21: Diatos’ product pipeline 49
DOR BioPharma, Inc (www.dorbiopharma.com 50
Table 22: DOR’s product pipeline 51
Expression Genetics, Inc (www.egencorp.com 52
Figure 12: TheraPlas Technology Platform 52
Table 23: EGEN’s product pipeline 53
Table 24: EGEN’s sales forecasts 54
Inovio Biomedical Corporation (www.inovio.com 55
Figure 13: Inovio’s gene delivery platform 55
Table 25: Inovio’s product pipeline 57
Table 26: Inovio’s sales forecasts 58
Macroflux Corporation (www.macroflux.com 59
Table 27: Macroflux’ product pipeline 59
Maxcyte, Inc (www.maxcyte.com 61
Figure 14: MaxCyte’s GT ex-vivo cell loading system 61
Table 28: MaxCyte’s product pipeline 63
Mirus Bio Corporation (www.mirusbio.com 64
Figure 15: PolyConjugates – siRNA delivery system 64
Table 29: Mirus’ product pipeline 65
Table 30: Mirus’ sales forecasts 66
Nanotherapeutics Inc. (www.nanotherapeutics.com 67
Table 31: Nanotherapeutics’ product pipeline 68
NeoPharm (www.neopharm.com 70
Table 32: NeoPharm’s product pipeline 71
Novagali Pharma SA (www.novagali.com 72
Table 33: Novagali’s product pipeline 73
PCI Biotech (www.pcibiotech.com 74
Table 34: PCI’s product pipeline 74
PowderMed Inc (www.powdermed.com 76
Table 35: PowderMed’s product pipeline 77
Table 5.2.25: PowderMed’s sales forecasts 77
Protiva Biotherapeutics, Inc (www.protivabio.com 78
Table 37: Protiva’s product pipeline 79
Table 38: Protiva’s sales forecasts 79
Silence Therapeutics plc (www.silence-therapeutics.com 80
Table 39: Silence Therapeutics’ product pipeline 81
Table 40: Silence Therapeutics’ sales forecasts 81
Supratek Pharma Inc. (www.supratek.com 82
Table 40: Supratek’s product pipeline 83
Tekmira Pharmaceuticals Corporation (www.tekmirapharm.com 84
Table 42: Tekmira’s product pipeline 85
Table 43: Tekmira’s sales forecasts 85
Vical Inc. (www.vical.com 87
Table 44: Vical’s product pipeline 88
Table 45: Vical’s sales forecasts 89
APPENDIX 1 90
Table 46: Global nucleic acid approved drugs sales 2006A-20015E 90
APPENDIX 2 91
APPENDIX 3 93
Competitor Ratio Analysis Criteria 93
Table 48: Key nucleic acid delivery companies by 2015 94
BIBLIOGRAPHY 95
GLOSSARY 96
ACRONYM S 99
FOOTNOTE REFERENCES 101