Some of biotech’s most celebrated successes include: clotting factors anticoagulants modern insulins growth hormone follicle-stimulating hormone hematopoietic growth factors interferons interleukins What do they have in common'They are therapeutic proteins, a market segment that had $34 billion in sales in 2004 and will have a projected $52.2 billion in sales in 2010*. As patents on first-generation proteins wind down, their owners naturally seek to protect their markets against interlopers. And in current and future battles for market share, protein delivery technologies are major weapons of offense and defense. It is a safe bet that if a therapeutic protein is bringing in big money and its patent is nearing expiration, someone somewhere with a clever technology is planning a market invasion based on improving how the protein is delivered.Delivery Technologies for Therapeutic Proteins: Assessment and Outlook analyzes and assesses protein delivery technologies developed by companies that are targeting:improved insulin delivery improved erythropoietin delivery improved interferon delivery improved growth hormone delivery The report also analyzes and assesses noninjection delivery technologies, including technologies for:transdermal protein delivery oral protein delivery pulmonary protein delivery nasal protein delivery
Delivery Technologies for Protein Therapeutics: Assessment and Outlook
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Delivery Technologies for Protein Therapeutics: Assessment and
Outlook
Published on March 2007
Report Summary
Some of biotech’s most celebrated successes include: clotting factors anticoagulants modern insulins growth hormone
follicle-stimulating hormone hematopoietic growth factors interferons interleukins What do they have in common'
They are therapeutic proteins, a market segment that had $34 billion in sales in 2004 and will have a projected $52.2 billion in sales in
2010*. As patents on first-generation proteins wind down, their owners naturally seek to protect their markets against interlopers. And
in current and future battles for market share, protein delivery technologies are major weapons of offense and defense. It is a safe bet
that if a therapeutic protein is bringing in big money and its patent is nearing expiration, someone somewhere with a clever technology
is planning a market invasion based on improving how the protein is delivered.
Delivery Technologies for Therapeutic Proteins: Assessment and Outlook analyzes and assesses protein delivery technologies
developed by companies that are targeting:improved insulin delivery improved erythropoietin delivery improved interferon delivery
improved growth hormone delivery The report also analyzes and assesses noninjection delivery technologies, including technologies
for:transdermal protein delivery oral protein delivery pulmonary protein delivery nasal protein delivery
Table of Content
Chapter 1 - INTRODUCTION: TRENDS IN TECHNOLOGY FOR DELIVERING PROTEIN THERAPEUTICS
1.1. Why Better Delivery For Therapeutic Proteins Is Needed
Alternatives to Injection
1.2. Organization of this Report
1.3. Protein Engineering Technologies
1.4. Non-Injection Technologies
1.5. Insulin: El Dorado of Protein Delivery Tech
Multiple Products, Multiple Mechanisms
1.6. Business and Market Outlook
Competition Among Noninjection Technologies
1.7. When Will Tech Trends Merge'
Chapter 2 - ENGINEERING THERAPEUTIC PROTEINS FOR LONGER HALF-LIFE
2.1. Introduction
PEGylated Interferons
2.2. Increasing Half-life by PEGylation
Releasable PEGylation
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2.3. Increasing Half-life by Site-specific PEGylation
ReCODE Technology
2.4. Increasing Half-life by Conjugation with Polysialic Acid
PolyXen Technology
2.5. Increasing Half-life by Albumin Gene Fusion
2.6. Increasing Half-life by Albumin Conjugation
DAC and PC-DAC Technologies
2.7. Increasing Half-life by Albumin-binding Fatty Acids
2.8. Increasing Half-life by Albumin-binding Peptides
2.9. Increasing Half-life with the Streptococcal Albumin-binding Domain
2.10. Increasing Half-life by Transferrin Gene Fusion
2.11. Increasing Half-life by Hyperglycosylation
2.12 Increasing Half-life by Glycosylation Completion and GlycoPEGylation
2.13. Increasing Half-life by Humanized Glycosylation
2.14. Increasing Half-life by Protease-resistant Point Mutations
Chapter 3 - OTHER PROTEIN ENGINEERING TECHNOLOGIES TO IMPROVE PROTEIN DELIVERY
3.1. Reducing Immunogenicity through Bioinformatics
Epibase Software
3.2. Reducing Protein Aggregation through Bioinformatics
AggreSolve Algorithms
3.3. Refolding Protein Aggregates through High Pressure Technology
PreEMT Technology
Chapter 4 - TECHNOLOGIES FOR TRANSDERMAL DELIVERY OF PROTEINS
4.1. Introduction
4.2. Delivery by Radio Frequency (RF) Microelectrode Array
4.3. Active Delivery by Ultrasound
U-Strip Ultrasound Module
4.4. Passive Delivery by Ultrasound
SonoPrep Device
4.5. Delivery by Thermal Burst
PassPort System
4.6. Delivery by Iontophoresis
Actyve Patches
4.7. Delivery by Transfersomes
Chapter 5 - Technologies for Oral Delivery of Proteins
5.1. Introduction
5.2. Oral Protein Delivery using Carrier Molecules
Eligen Technology
5.3. Oral Protein Delivery using Crystallization Technology
Crystalomics
5.4. Oral Protein Delivery by Calcium Phosphate Nanoparticles
BioOral System
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5.5. Oral Protein Delivery by Buccal Mouth Spray
RapidMist and Oral-lyn
5.6. Oral Protein Delivery using Amphiphilic Oligomers
HIM2 to IN-105
Chapter 6 - TECHNOLOGIES FOR PULMONARY AND NASAL DELIVERY OF PROTEINS
6.1. Pulmonary Delivery using Dry Powder Inhalers
Milestone: Exubera
6.2. Other Protein Inhaler Technologies
Competing Products in Clinical Trials
6.3. Pulmonary Delivery using Antibody Transcytosis Fusion Proteins
FcRn Pathway
6.4. Nasal Delivery using Mucosal Absorption Enhancers, Part 1
IntraVail Technology
Pro Tek Excipients
6.5. Nasal Delivery using Mucosal Absorption Enhancers, Part 2
6.6. Nasal Delivery via Tight Junction Modulation
Chapter 7 - EXPERT INTERVIEWS
7.1. Abe S. Abuchowski, PhD, CEO, Prolong Pharmaceuticals
7.2. Ajay K. Banga, PhD, Professor and Chair, Department of Pharmaceutical Sciences, Mercer University
7.3. Eric Tomlinson, DSc, PhD, President and CEO, Altea Therapeutics
7.4. Manuel Vega, PhD, CEO Nautilus Biotech
Tables
Table 1.1. Companies Targeting Improved Insulin Delivery
Table 1.2. Companies Targeting Improved Erythropoietin Delivery
Table 1.3. Companies Targeting Improved Growth Hormone Delivery
Table 1.4. Companies Targeting Improved Interferon Delivery
Table 1.5. Companies Targeting Improved Parathyroid Hormone Delivery
Table 2.1. Technologies for Extending Therapeutic Protein Half-life
Table 2.2. FDA-Approved Therapeutic Proteins Engineered for Extended Half-life
Figures
Figure 2.1. Multiple Benefits of Extending Half-life
Figure 2.2. PEG Mechanisms for Drug Delivery
Figure 2.3. SWOT Analysis for Releasable Pegylation
Figure 2.4. ReCODE: Biosynthetic Incorporation of Chemically Specified Amino Acids
Figure 2.5. SWOT Analysis for Site-specific Pegylation
Figure 2.6. Polysialic Acid Protects Against Proteases
Figure 2.7. Extending Therapeutic Protein Half-Life with Human Serum Albumin Fusion Technology
Figure 2.8. SWOT Analysis for Albumin Gene Fusion
Figure 2.9. SWOT Analysis for Albumin Conjugation
Figure 2.10. Structure of Insulin Detemir
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Figure 2.11. SWOT Analysis for Albumin-binding peptides
Figure 2.12. Tertiary Structure of an Affibody Molecule
Figure 2.13. Peptide Fused via a Peptide Linker to the N Terminus of Transferrin
Figure 2.14. SWOT Analysis for Hyperglycosylation
Figure 2.15. Glycolylation Pattern Depends on Expression System
Figure 2.16. Enzymes Add Missing Sugars
Figure 2.17. PEGylation of a Protein on a Carbohydrate Chain
Figure 2.18. SWOT Analysis for Glycopegylation
Figure 2.19. SWOT Analysis for Humanized Glycosylation in Yeast
Figure 2.20. SWOT Analysis for Pretease-Resistant Point Mutations
Figure 3.1. Typical Effects of PreEMT System Pressure on Protein Aggregates
Figure 4.1. Micro Processor
Figure 4.2. Delivery of Insulin in Humans
Figure 4.3. SWOT Analysis for Transdermal Delivery of Proteins via RF-Microchannels
Figure 4.4. SWOT Analysis for Active Delivery by Ultrasound
Figure 4.5. SWOT Analysis for Passive Delivery by Ultrasound
Figure 4.6. Transdermal Delivery by Charge Repulsion
Figure 4.7. Dosage Patterns for Actyve
Figure 4.8. SWOT Analysis for Delivery by Iontophoresis
Figure 4.9. SWOT Anslysis for Delivery by Transferomes
Figure 5.1. Oral Delivery by Carrier Molecules
Figure 5.2. SWOT Analysis for Oral Protein Delivery Using Carrier Molecules
Figure 5.3a. Toxic Metabolites in the Blood Before Therapy
Figure 5.3b. Metabolite Gradient Set in Motion by Protein Crystals
Figure 5.4. SWOT Analysis for Oral Protein Delivery by Protein Crystalization
Figure 5.5. Calcium-PEG-Insulin-Casein
Figure 5.6. SWOT Analysis for RapidMist Buccal Protein Delivery
Figure 5.7. SWOT Analysis for Protein Delivery with Amphiphilic Oligomers
Figure 6.1. SWOT Analysis of Pulmonary Protein Delivery Using Dry Powder Inhalers
Figure 6.2. Epithelial Pinocytosis of Fc Therapeutic Fusion Proteins
Figure 6.3. Structures of Syntonix Therapeutic Fusion Proteins
Figure 6.4. SWOT Analysis of Pulmonary Protein Delivery Using Antibody Transcytosis Fusion Proteins
Figure 6.5. SWOT Analysis of Intranasal Protein Delivery Using Aegis Therapeutics' Mucosal Absorption Enhancers
Figure 6.6. SWOT Analysis of Intranasal Protein Delivery Using Bentley Pharmaceuticals' Mucosal Absorption Enhancers
Figure 6.7. Junctions Between Epithelial Cells
Figure 1A. Respondents by Sector
Figure 2A. Focus of Respondents
Figure 3A. Delivery Technologies and New Indications for Drugs
Figure 4A. Technologies and Competitiveness
Figure 5A. PEGylation Dominance in the Marketplace
Figure 6A. Trend in Increasing Half-Life of Therapeutic Proteins
Figure 7A. Competitors' Use of Longer Half-Life Proteins
Figure 8A. Alternatives to Injection
Figure 9A. Competitors and Injection
Figure 10A. Noninjection and Patient Compliance
Figure 11A. Improved Technologies and Prices of Treatments
Figure 12A. Involvement with Approved Therapies
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Figure 13A. Oral Protein Delivery vs. Transdermal
Figure 14A. '. vs. Pulmonary
Figure 15A. '. Nasal
Figure 16A. Specialist vs. Primary Care
Figure 17A. Longer Half-Lives vs. Injection
Figure 18A. Noninjection Monoclonal Antibodies
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