Drug Delivery Technology: Revolutionizing Diabetes Treatment

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Publication Date: 2007-09-01

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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 transdermal 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. The authors of this report 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 paltforms.

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


• Gain an in-depth understanding of the technology landscape for diabetes devices and delivery platforms including syringe/pens & pumps, jet injectors, pulmonary, transdermal, buccal & nasal
• Assess the options available for delivering insulin now & in the future
• Assess the potential delivery options available for emerging non-insulin products
• Gauge the current & future technology requirements of pharma, biotech & medical device companies developing diabetes products & devices
• Analyze how the market is evolving & the influence that drug delivery may have on pharma anti-diabetes pipelines
• Identify key pharma & delivery companies focusing on the improved delivery of existing & novel anti-diabetes agents
• Evaluate where progress has been made in the delivery of potential new anti-diabetes products & devices



• 2006 global diabetes market worth around US$22 billion.
• This attracted attention of specialty pharma and big pharma players such as Bayer, Daiichi-Sankyo, GlaxoSmithKline, Eli-Lilly, Merck & Co., Novartis, Novo Nordisk, Pfizer, sanofi-aventis and Takeda.
• Challenges remain to ensure the efficient delivery ofinsulin by invasive and non-invasive delivery methods to provide flexible, reproducible and cost-effective methods of managing diabetes.
• Specialists are applying a plethora of platforms to deliver insulin, including jet injectors, pulmonary, transdermal buccal & nasal delivery systems.
• Many new classes of drugs will reach the market over the next 6 years, driving future market growth. Their success is analyzed in detail and case studies provided to  ighlight the progress of each technology.

• Medical devices continue to evolve with the aim to develop an “artificial pancreas”, one which is capable of delivering & monitoring insulin blood levels on a minute by minute basis. A number of devices are evaluated in this report.

• As the diabetes market evolves new approaches totreatment of diabetes are emerging utilizing islet cell transplantation plus cell- and gene-based therapies. Several Biotherapeutics companies are working towards this goal including: AVI BioPharma, enGENE & Transition Therapeutics. 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.

Table of Contents

Table of Contents

1 Diabetes market and drug delivery technology opportunities

1.1 Introduction
1.1.1 Regulation of sugar
1.1.2 Insulin
1.1.3 Type 1 diabetes
1.1.4 Type 2 diabetes
1.1.5 Other types of diabetes
1.2 Overview of the market
1.2.1 Market size
1.2.2 Insulin
1.2.3 Oral hypogycaemic agents
1.2.4 Other hypoglycemics
1.2.5 Key pharma players
1.3 Product pipeline
1.3.1 Growth areas for drug delivery in diabetes

2 Market drivers and opportunities for drug delivery technologies

2.1 The diabetes market and its drivers
2.1.1 Opportunities for growth
2.1.2 Factors determining market size
2.2 Translating demographics into market projections
2.2.1 Cost
2.2.2 Conservatism
2.2.3 Evolving treatment patterns
2.3 Opportunities for drug delivery technology
2.3.1 Insulin
2.3.2 Conclusions
2.4 Hypoglycemics

3 Key drug delivery companies in diabetes research

4 Current drug delivery issues and opportunities in diabetes

4.1 Insulin by injection
4.1.1. Syringe-and-needle administration
4.1.2 Insulin pen devices
4.1.3 Insulin pumps
4.2 Non-invasive insulin delivery
4.2.1 Jet injectors
4.2.2 Pulmonary inhalation
4.2.3 Transdermal delivery of insulin
4.2.4 Buccal and nasal absorption of insulin

5 Drug delivery platform: insulin by injection

5.1 Delivery technology: new-generation insulin pens
5.2 Delivery technology: needle-free injectors
5.2.1 Case Study: SQ-Pen (The Medical House)
5.3 Delivery technology: insulin pumps
5.3.1 Case Study: Paradigm (Medtronic)
5.3.2 Case Study: OmniPod (Insulet Corporation)
5.4 Our opinion on insulin injection technologies

6 Drug delivery platform: insulin by inhalation

6.1 Exubera: a brief recap and critique
6.2 Delivery technology: solid insulin dosage form for inhalation
6.2.1 Case Study: AIR Insulin System (Eli Lilly& Co/Alkermes Inc.)
6.2.2 Case Study: Technosphere (Mannkind Corporation)
6.2.3 Case Study: Promaxx (Baxter)
6.3 Delivery technology: liquid insulin dosage form for inhalation
6.3.1 Case Study: AERx (Aradigm/Novo Nordisk)
6.3.2 Case Study: Insulair (B&O Medicom)
6.3.3 Case Study: KI-02-212 (Kos Pharmceuticals)
6.4 Our opinion on insulin inhalation technologies

7 Delivery platform: other insulin delivery routes

7.1 Delivery technology: buccal insulin delivery
7.1.1 Case Study: Oral-lyn buccal spray (Generex)
7.1.2 Case Study: Oral spray (Hubei Huagong Biochemical Engineering)
7.2 Delivery technology: oral insulin
7.2.1 Case study: Oral insulin cobalamin-coated nanoparticles (Access Pharmaceuticals)
7.2.2 Case Study: Oral insulin (Emisphere Technologies)
7.2.3 Case Study: Oradel (Apollo Life Sciences)
7.3 Delivery Technology: transdermal insulin delivery
7.3.1 Case Study: ALT 1391 (Altea Therapeutics)
7.3.2 Case Study: TPM-02/insulin (Phosphagenics)
7.3.3 Case Study: ViaDerm (TransPharma)
7.4 Delivery technology: nasal insulin administration
7.4.1 Case Study: CPE-215 (Bentley Pharmaceuticals)
7.5 Our opinion on buccal, oral, transdermal and nasal insulin delivery routes

8 Delivery platform: delivery of non-insulin drugs

8.1 Delivery technology: injectable formulations
8.1.1 Case Study: Byetta LAR (Amylin/Eli Lilly/Alkermes)
8.1.2 Case Study: CJC113 (ConjuChem)
8.1.3 Case Study: BIM 51077 (Roche/Ipsen)
8.1.4 Case Study: Liraglutide (Novo Nordisk)
8.2 Delivery technology: oral formulations
8.2.1 Case Study: Eligen technology (Emisphere Technologies)
8.2.2 Case Study: Oradel (Apollo Life Sciences)
8.3 Our opinion on delivery of non-insulin drugs

9 Future developments in delivery of novel antidiabetic therapies

9.1 Transplantation
9.1.1 Islet cell transplants
9.1.2 Case Study: Transition Therapeutics
9.2 Development of the "artificial pancreas"
9.3 Stem cell developments
9.3.1 Case Study: University of Texas at Galveston
9.3.2 Case Study: University of São Paulo, Ribeirão Preto, Brazil, and the Northwestern Universit
9.4 Gene therapy
9.4.1 Case Study: New exon-skipping technology, Esprit (AVI BioPharma)
9.4.2 Case Study: Nanoparticle insulin gene delivery (enGene Inc.)
9.5 Our opinion on novel anti-diabetic therapies

10 Market trends in diabetes drug delivery

10.1 Demographics drive the market
10.1.1 Leading therapy groups
10.1.2 Leading companies
10.2 Drug delivery: role and market trends to 2011
10.2.1 The insulin injection problem
10.2.2 Present achievements in insulin delivery
10.2.3 Insulin pumps
10.2.4 Jet injectors
10.3 Other delivery problems and opportunities in diabetes
10.4 Diabetes pharma drivers and drug delivery trends by 2012
10.4.1 Current and future insulin delivery market segmentation
10.5 The Diabetes Market by 2020
10.5.1 Pharma drivers and drug delivery trends by 2020

11 Summary & conclusions
12 Bibliography
13 Biography

List of Figures

Figure 1.1: Global diabetes market (2007)
Figure 1.2: Leading insulin brand sales (2007)
Figure 1.3: Global injectable and oral anti-diabetic market (2007)
Figure 1.4: Leading players in the diabetes market (2007)
Figure 5.1: SQ-Pen Medical House
Figure 5.2: MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System
Figure 5.3: Insulin pump therapy reduces HbA1c levels vs. multiple injections with long-acting
Figure 5.4: OmniPod insulin pump and personal diabetes manager Insulet Corporation
Figure 6.1: Exubera’s delivery system
Figure 6.2: AIR insulin delivery system
Figure 6.3: MedTone Inhaler
Figure 6.4: PROMAXX inhalable formulation
Figure 6.5: AERx strip and delivery device
Figure 6.6: Insulair
Figure 6.7: KI-02-212 inhalation device
Figure 7.1: Oral-lyn aerosol applicator
Figure 7.2: Cobalamin-coated nanoparticles
Figure 7.3: Cobalamin-insulin nanoparticles glucose response curve
Figure 7.4: Proposed delivery mechanism of Eligen technology
Figure 7.5: Insulin transdermal patch profile
Figure 7.6: TransPharma Medical’s Diabetes Suite -ViaDerm, ViaDerm Mini and Viaderm Micro
Figure 9.1: Schematic summarizing I.N.T function
Figure 9.2: An electron micrograph of an Islet Sheet appears

List of Tables

Table 1.1: Leading brands and types of insulin
Table 1.2: Oral diabetes treatments
Table 2.1: Five year forecast for diabetes therapy market
Table 3.1: Leading drug delivery specialists in diabetes research
Table 4.1: Advantages and disadvantages of delivery technologies use to deliver insulin
Table 7.1: Leading drug delivery specialists in buccal, oral, transdermal and nasal diabetes delivery research
Table 10.1: Global prevalence of diabetes (2006)
Table 10.2: Global diabetes sales and annual growth rates (2006, 2012)
Table 10.3: Global diabetes pharmaceutical franchises (2006)
Table 10.4: Leading insulin brands (2006)
Table 10.5: Leading oral and injectable hypoglycemics (2006)
Table 10.6: Global sales of insulin drug delivery technologies (2006 & 2012)
Table 10.7: Sales forecast for new insulin and non-insulin formulations (2006-2012)
Table 10.8: Diabetes therapy market by 2020

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