Drug Delivery Technology: Revolutionizing Diabetes Treatment
Revolutionizing Diabetes Treatment
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| "The efficient delivery of insulin remains one of the key therapeutic problems in the management of diabetes. Treatment of Type 1, and up to one-third of Type 2 cases require insulin however, until recently the only route of administration was via subcutaneous injection. Whilst there have been marginal improvements in injectable devices – insulin “pens” – the recent approval of inhalable insulin is the first step to opening new opportunities in the non-invasive delivery of this life-giving macromolecule. Clearly, there has been a major opportunity for new product development in the insulin delivery field, and a great deal of R&D activity is now beginning to bear fruit. It is noteworthy that all three lead products in the inhaled insulin category have involved collaboration between the top insulin companies and smaller concerns specializing in delivery devices: Alkermes, Aradigm and Nektar Therapeutics. Inhalable insulin formulations are also being developed by companies including Mannkind and Baxter. Other non-invasive routes to exploit for insulin delivery include ansdermal patches utilizing some form of active transport to drive the sizeable insulin molecule through the skin, and delivery via the buccal mucosa. Generex is one company investigating the buccal route, and Altea and Alza are working with the transdermal approach. We believe there are significant opportunities for the improved delivery of insulin, and examples are provided on research programmes which are now underway. There is less need for development of drug delivery technologies in the area of oral hypoglycaemics, since all the leading drugs in this category are well absorbed orally and the current generation all have adequate long half-lives. There is, however, an emerging (potential) opportunity for optimizing the delivery of newer drug treatments, including incretin mimetics (the current products are given by injection) and GLP-1 agonists which are thought to have the same limitation. In addition, PPAR agonists may benefit from the utilization of delivery platforms. |
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| Keywords: buccal, gene therapy, injectable, insulin pumps, liquid dose inhaled insulin, jet injectors, nasal, needle free, oral, pens, pulmonary, solid dose inhaled insulin, stem cells, transdermal, transplants | |
 
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By Dr Paul Evers / Publication Date: 20th September 2007
Contents:
Diabetes market and drug delivery technology opportunities
1.1 Introduction 7
1.1.1 Regulation of sugar7
1.1.2 Insulin7
1.1.3 Type 1 diabetes 8
1.1.4 Type 2 diabetes8
1.1.5 Other types of diabetes 8
1.2 Overview of the market9
1.2.1 Market aize9
1.2.2 Insulin9
1.2.3 Oral hypogycaemic agents12
1.2.4 Other hypoglycemics13
1.2.5 Key pharma players14
1.3 Product pipeline14
1.3.1 Growth areas for drug delivery in diabetes15
2 Market drivers and opportunities for drug delivery technologies16
2.1 The diabetes market and its drivers16
2.1.1 Opportunities for growth16
2.1.2 Factors determining market size17
2.2 Translating demographics into market projections17
2.2.1 Cost18
2.2.2 Conservatism18
2.2.3 Evolving treatment patterns18
2.3 Opportunities for drug delivery technology19
2.3.1 Insulin19
2.3.2 Conclusions20
2.4 Hypoglycemics20
3 Key drug delivery companies in diabetes research22
4 Current drug delivery issues and opportunities in diabetes25
4.1 Insulin by injection26
4.1.1. Syringe-and-needle administration26
4.1.2 Insulin pen devices26
4.1.3 Insulin pumps274.2 Non-invasive insulin delivery29
4.2.1 Jet injectors29
4.2.2 Pulmonary inhalation31
4.2.3 Transdermal delivery of insulin32
4.2.4 Buccal and nasal absorption of insulin33
5 Drug delivery platform: insulin by injection34
5.1 Delivery technology: new-generation insulin pens34
5.2 Delivery technology: needle-free injectors34
5.2.1 Case Study: SQ-Pen (The Medical House34
5.3 Delivery technology: insulin pumps36
5.3.1 Case Study: Paradigm (Medtronic36
5.3.2 Case Study: OmniPod (Insulet Corporation37
5.4 Our opinion on insulin injection technologies39
6 Drug delivery platform: insulin by inhalation42
6.1 Exubera: a brief recap and critique42
6.2 Delivery technology: solid insulin dosage form for inhalation43
6.2.1 Case Study: AIR Insulin System (Eli Lilly& Co/Alkermes Inc43
6.2.2 Case Study: Technosphere (Mannkind Corporation44
6.2.3 Case Study: Promaxx (Baxter45
6.3 Delivery technology: liquid insulin dosage form for inhalation47
6.3.1 Case Study: AERx (Aradigm/Novo Nordisk47
6.3.2 Case Study: Insulair (B&O Medicom48
6.3.3 Case Study: KI-02-212 (Kos Pharmceuticals49
6.4 Our opinion on insulin inhalation technologies51
7 Delivery platform: other insulin delivery routes53
7.1 Delivery technology: buccal insulin delivery53
7.1.1 Case Study: Oral-lyn buccal spray (Generex53
7.1.2 Case Study: Oral spray (Hubei Huagong Biochemical Engineering54
7.2 Delivery technology: oral insulin54
7.2.1 Case study: Oral insulin cobalamin-coated nanoparticles (Access Pharmaceuticals54
7.2.2 Case Study: Oral insulin (Emisphere Technologies56
7.2.3 Case Study: Oradel (Apollo Life Sciences57
7.3 Delivery Technology: transdermal insulin delivery58
7.3.1 Case Study: ALT 1391 (Altea Therapeutics58
7.3.2 Case Study: TPM-02/insulin (Phosphagenics59
7.3.3 Case Study: ViaDerm (TransPharma59
7.4 Delivery technology: nasal insulin administration61
7.4.1 Case Study: CPE-215 (Bentley Pharmaceuticals61
7.5 Our opinion on buccal, oral, transdermal and nasal insulin delivery routes62
8 Delivery platform: delivery of non-insulin drugs65
8.1 Delivery technology: injectable formulations65
8.1.1 Case Study: Byetta LAR (Amylin/Eli Lilly/Alkermes65
8.1.2 Case Study: CJC113 (ConjuChem66
8.1.3 Case Study: BIM 51077 (Roche/Ipsen66
8.1.4 Case Study: Liraglutide (Novo Nordisk67
8.2 Delivery technology: oral formulations68
8.2.1 Case Study: Eligen technology (Emisphere Technologies68
8.2.2 Case Study: Oradel (Apollo Life Sciences68
8.3 Our opinion on delivery of non-insulin drugs70
9 Future developments in delivery of novel antidiabetic therapies72
9.1 Transplantation72
9.1.1 Islet cell transplants72
9.1.2 Case Study: Transition Therapeutics73
9.2 Development of the "artificial pancreas75
9.3 Stem cell developments76
9.3.1 Case Study: University of Texas at Galveston76
9.3.2 Case Study: University of São Paulo, Ribeirão Preto, Brazil, and the Northwestern University
Feinberg School of Medicine, Chicago77
9.4 Gene therapy78
9.4.1 Case Study: New exon-skipping technology, Esprit (AVI BioPharma78
9.4.2 Case Study: Nanoparticle insulin gene delivery (enGene Inc78
9.5 Our opinion on novel anti-diabetic therapies80
10 Market trends in diabetes drug delivery82
10.1 Demographics drive the market82
10.1.1 Leading therapy groups 82
10.1.2 Leading companies83
10.2 Drug delivery: role and market trends to 201185
10.2.1 The insulin injection problem85
10.2.2 Present achievements in insulin delivery86
10.2.3 Insulin pumps86
10.2.4 Jet injectors86
10.3 Other delivery problems and opportunities in diabetes87
10.4 Diabetes pharma drivers and drug delivery trends by 201287
10.4.1 Current and future insulin delivery market segmentation88
10.5 The Diabetes Market by 2020 90
10.5.1 Pharma drivers and drug delivery trends by 2020 90
11 Summary & conclusions 92
12 Bibliography 93
13 Biography 94
List of Tables:
Figure 1.1: Global diabetes market (20079
Figure 1.2: Leading insulin brand sales (200710
Figure 1.3: Global injectable and oral anti-diabetic market (200713
Figure 1.4: Leading players in the diabetes market (200714
Figure 5.1: SQ-Pen Medical House35
Figure 5.2: MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System36
Figure 5.3: Insulin pump therapy reduces HbA1c levels vs. multiple injections with long-acting37
Figure 5.4: OmniPod insulin pump and personal diabetes manager Insulet Corporation38
Figure 6.1: Exubera’s delivery system43
Figure 6.2: AIR insulin delivery system44
Figure 6.3: MedTone Inhaler45
Figure 6.4: PROMAXX inhalable formulation 46
Figure 6.5: AERx strip and delivery device47
Figure 6.6: Insulair48
Figure 6.7: KI-02-212 inhalation device50
Figure 7.1: Oral-lyn aerosol applicator53
Figure 7.2: Cobalamin-coated nanoparticles55
Figure 7.3: Cobalamin-insulin nanoparticles glucose response curve 55
Figure 7.4: Proposed delivery mechanism of Eligen technology57
Figure 7.5: Insulin transdermal patch profile58
Figure 7.6: TransPharma Medical’s Diabetes Suite -ViaDerm, ViaDerm Mini and Viaderm Micro60
Figure 9.1: Schematic summarizing I.N.T function73
Figure 9.2: An electron micrograph of an Islet Sheet appears74
List of Tables
Table 1.1: Leading brands and types of insulin11
Table 1.2: Oral diabetes treatments12
Table 2.1: Five year forecast for diabetes therapy market21
Table 3.1: Leading drug delivery specialists in diabetes research22
Table 4.1: Advantages and disadvantages of delivery technologies use to deliver insulin25
Table 7.1: Leading drug delivery specialists in buccal, oral, transdermal and nasal diabetes delivery research63
Table 10.1: Global prevalence of diabetes (200682
Table 10.2: Global diabetes sales and annual growth rates (2006, 201283
Table 10.3: Global diabetes pharmaceutical franchises (200683
Table 10.4: Leading insulin brands (200684
Table 10.5: Leading oral and injectable hypoglycemics (200684
Table 10.6: Global sales of insulin drug delivery technologies (2006 & 201288
Table 10.7: Sales forecast for new insulin and non-insulin formulations (2006-201289
Table 10.8: Diabetes therapy market by 202090