REPORT CONTENTS SUMMARY
An analysis of diabetes prevalence and trends worldwide, plus current treatment options
An assessment of 7 insulin/insulin analogues currently available and continuing research to identify alternative methods of administration
Pipeline analysis of:
Development strategies for Type I diabetes
Featuring
Unique 5-point assessment and scoring for each product examining key areas such as product novelty, clinical data and competition
Sales forecasts by year to 2013 for key launched and pipeline products
The withdrawal of Pfizer’s Exubera and safety concerns over the thiazolidinediones has not reduced interest in this fast growing global sector. New products, drug delivery technologies and therapeutic approaches continue apace.
It is estimated that around 250 million people are living with diabetes today and this number will increase to around 380 million by 2025.
Diabetes has become a major cause of premature illness and death in most countries, mainly through the increased risk of cardiovascular disease. In 2005, an estimated 1.1 million people around the world died directly from diabetes. The number of people whose death was recorded as heart disease or kidney failure where diabetes was a contributory factor is, however, considerably higher. Each year, diabetes related causes account for 3.8 million deaths; equivalent to one death every ten seconds and claiming the lives of as many people as HIV/AIDS.
The economic impact...
The prevention and treatment of diabetes and its complications cost around US$232 billion in 2007. By 2025, the cost is likely to exceed US$302.5 billion. In the US, the total economic cost of diabetes was estimated to be US$174 billion in 2007, of which US$116 billion was medical expenditure; US$27 billion was for diabetes care, US$58 billion was for chronic complications related to diabetes, and US$31 billion was attributed to general medical costs. In the UK, around 10% of the NHS budget is spent on treating diabetes and its complications. This equates to around £9 billion (US$16.2 billion). In Japan, general medical expenditure on diabetes amounted to ¥1,116.5 billion (US$10.7 billion) in 2005.
Understand the prospects for this US$26.3 billion sector
We estimate the global diabetes therapy market at around US$26.3 billion in 2009. By 2013, the market is expected to grow to around US$34.5 billion
Oral diabetes drugs account for around 39% of the total market value. Metformin is the recommended first-line therapy for Type II diabetes and accounts for around 11-12% of the total market by value. Other oral agents include sulphonylureas, thiazolidinediones (TZDs or glitazones), glinides and alpha-glucosidase inhibitors. Many of these are widely available generically; sales of leading proprietary oral agents amounted to US$7 billion in 2007.
Hope still for novel drug delivery
Despite the commercial failure of Pfizer’s inhaled insulin, Exubera, alternative methods of delivering insulin to patients remain of interest to developers. Of particular interest are Mannkind’s Afresa, an inhaled insulin product that has recently completed Phase III trials, and Generex Oral-lyn from Generex Biotechnology, a buccal spray formulation in Phase III in the US, which has recently been approved for marketing in Ecuador, India and Lebanon.
New approaches introduced: GLP-1 agonists and DPP-4 inhibitors
Two new classes of drugs have recently entered the market, both of which work on the incretin system: injectable glucagon-like peptide-1 (GLP-1) agonists and oral dipeptidyl peptidase-4 (DPP-4) inhibitors. GLP-1 agonists, also known as incretin mimetics, stimulate insulin secretions from beta cells in the pancreas in response to food intake, in a glucose dependent manner. DPP-4 inhibitors inhibit the DPP-4 enzyme, which results in an increase in circulation of the incretin hormone, GLP-1.
Key questions answered include:
An analysis of diabetes prevalence and trends worldwide, plus current treatment options
An assessment of 7 insulin/insulin analogues currently available and continuing research to identify alternative methods of administration
Pipeline analysis of:
- Thiazolidinediones
- GLP-1 agonists
- DPP-4 inhibitors
- SGLT-2 inhibitors
Development strategies for Type I diabetes
Featuring
Unique 5-point assessment and scoring for each product examining key areas such as product novelty, clinical data and competition
Sales forecasts by year to 2013 for key launched and pipeline products
The withdrawal of Pfizer’s Exubera and safety concerns over the thiazolidinediones has not reduced interest in this fast growing global sector. New products, drug delivery technologies and therapeutic approaches continue apace.
It is estimated that around 250 million people are living with diabetes today and this number will increase to around 380 million by 2025.
Diabetes has become a major cause of premature illness and death in most countries, mainly through the increased risk of cardiovascular disease. In 2005, an estimated 1.1 million people around the world died directly from diabetes. The number of people whose death was recorded as heart disease or kidney failure where diabetes was a contributory factor is, however, considerably higher. Each year, diabetes related causes account for 3.8 million deaths; equivalent to one death every ten seconds and claiming the lives of as many people as HIV/AIDS.
The economic impact...
The prevention and treatment of diabetes and its complications cost around US$232 billion in 2007. By 2025, the cost is likely to exceed US$302.5 billion. In the US, the total economic cost of diabetes was estimated to be US$174 billion in 2007, of which US$116 billion was medical expenditure; US$27 billion was for diabetes care, US$58 billion was for chronic complications related to diabetes, and US$31 billion was attributed to general medical costs. In the UK, around 10% of the NHS budget is spent on treating diabetes and its complications. This equates to around £9 billion (US$16.2 billion). In Japan, general medical expenditure on diabetes amounted to ¥1,116.5 billion (US$10.7 billion) in 2005.
Understand the prospects for this US$26.3 billion sector
We estimate the global diabetes therapy market at around US$26.3 billion in 2009. By 2013, the market is expected to grow to around US$34.5 billion
Oral diabetes drugs account for around 39% of the total market value. Metformin is the recommended first-line therapy for Type II diabetes and accounts for around 11-12% of the total market by value. Other oral agents include sulphonylureas, thiazolidinediones (TZDs or glitazones), glinides and alpha-glucosidase inhibitors. Many of these are widely available generically; sales of leading proprietary oral agents amounted to US$7 billion in 2007.
Hope still for novel drug delivery
Despite the commercial failure of Pfizer’s inhaled insulin, Exubera, alternative methods of delivering insulin to patients remain of interest to developers. Of particular interest are Mannkind’s Afresa, an inhaled insulin product that has recently completed Phase III trials, and Generex Oral-lyn from Generex Biotechnology, a buccal spray formulation in Phase III in the US, which has recently been approved for marketing in Ecuador, India and Lebanon.
New approaches introduced: GLP-1 agonists and DPP-4 inhibitors
Two new classes of drugs have recently entered the market, both of which work on the incretin system: injectable glucagon-like peptide-1 (GLP-1) agonists and oral dipeptidyl peptidase-4 (DPP-4) inhibitors. GLP-1 agonists, also known as incretin mimetics, stimulate insulin secretions from beta cells in the pancreas in response to food intake, in a glucose dependent manner. DPP-4 inhibitors inhibit the DPP-4 enzyme, which results in an increase in circulation of the incretin hormone, GLP-1.
Key questions answered include:
- Which markets will see the most significant growth in diabetes incidence?
What drug delivery approaches are showing promise and who is developing them?
What commercial impact are safety issues having on GSK’s Avandia?
How did sanofi-aventis boost sales of Lantus in 2008?
To what degree will Novartis’ Galvus be able to compete with Merck’s Januvia in the DPP-4 inhibitor battle?
The rapidly increasing patient pool and high unmet clinical need will translate into a continuing increase in revenue for several years to come
CURRENT & PIPELINE PRODUCTS EVALUATED
INSULIN & INSULIN ANALOGUES
Humulin (insulin human [rDNA origin])
Humalog (insulin lisprone)
Lantus (insulin glargine)
Apidra (insulin glulisine)
Levemir (insulin detemir)
Novorapid/NovoLog (insulin aspart)
NovoMix/NovoLog Mix
Afresa (insulin)
Generex Oral-lyn (insulin)
THIAZOLIDINEDIONES
Avandia (rosiglitazone)
Actos (pioglitazone)
Balaglitazone
Rivoglitazone
GLP-1 AGONISTS
Byetta (exenatide)
Liraglutide
AVE0010
Taspoglutide
DPP-4 INHIBITORS
Januvia (sitagliptin)
Galvus (vildagliptin)
Saxagliptin
Alogliptin
Ondero (BI 1356)
SGLT-2 INHIBITORS
Dapagliflozin
OTHER STRATEGIES FOR TYPE I DIABETES
Otelixizumab
Teplizumab
DiaPep277
Diamyd
FOREWORD
EXECUTIVE SUMMARY
WHAT IS DIABETES?
A Global Problem
Where in the World?
The Economic Burden
Unhealthy Lifestyles; a Worrying Trend
Additional Health Risks for Young People
THE DIABETES THERAPY MARKET
DIABETES MANAGEMENT
Current Treatment Options
Initial Therapy
Metformin
Additional Therapies
Insulin
Sulphonylureas
Thiazolidinediones
Glinides
Alpha-glucosidase inhibitors
Amylin agonist
GLP-1 inhibitors
DPP-4 inhibitors
What’s in the Pipeline?
Further Development of Launched Products
Potential New Drugs
Competitor Ratio Analysis
INSULIN & INSULIN ANALOGUES
Humulin (insulin human [rDNA origin])
Sales Forecast
Humalog (insulin lispro)
Patents
Sales Forecast
Lantus (insulin glargine)
Patents
Sales Forecast
Clinical Trials
INTENSIVE
GINGER
LACE
ELEONOR
OPAL
TULIP
LANMET
INSIGHT
AT.LANTUS
Apidra (insulin glulisine)
Patents
Clinical Trials
GINGER
LACE
ELEONOR
OPAL
Levemir (insulin detemir)
Patents
Clinical Trials
Levemir head-to-head with Lantus
PREDICTIVE
NovoRapid/NovoLog (insulin aspart)
Patents
NovoMix/NovoLog Mix
Patents
Clinical Trials
PREFER
Recent Developments in Insulin Drug Delivery
Buccal Spray
Intranasal Insulin
Intranasal insulin may lower food intake in men and improve memory function in women
Oral Insulin
Insulin Suppository
Afresa (Technosphere Insulin System)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Study 102 - comparable decreases in HbA1c levels
Study 030 - no adverse effect on lung function
Study 009
Generex Oral-lyn
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Generex Oral-lyn compared with insulin analogues
Phase II
THIAZOLIDINEDIONES
Update on the use of TZDs in the consensus algorithm
Cardiovascular safety concerns
Long-term TZD use doubles women's fracture risk
Researchers map molecular regulation of adipocyte genetics
Avandia (rosiglitazone)
Patents and Generic Competition
Sales Forecast
Safety Issues
Public Citizen petitions for Avandia ban
Diabetic macular oedema
Clinical Trials
APPROACH
ACCORD
RECORD
ADOPT
DREAM
RESULT
Rosiglitazone+atorvastatin
Rosiglitazone+fenofibrate
Actos (pioglitazone)
Patents and Generic Competition
Sales Forecast
Safety Issues
Heart failure warning
Fracture risk
Clinical Trials
Research supports Actos’ Cardiovascular safety profile
Pioglitazone in NASH
CHICAGO
PROactive
COMPLEMENT
Balaglitazone
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Rivoglitazone
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
GLP-1 AGONISTS
Byetta (exenatide)
Patents
Sales Forecast
Safety Issues
Pancreatitis
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Exenatide versus sitagliptin
Exenatide versus biphasic insulin aspart
Exenatide as adjunctive therapy with thiazolidinedione
Long-acting release (LAR) formulation
Liraglutide
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical trial results
LEAD 6
LEAD 4
LEAD 3
Phase IIb
AVE0010
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase IIb
Phase IIa
Taspoglutide
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
DPP-4 INHIBITORS
Januvia (sitagliptin)
Patents
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Januvia in combination therapy
Pooled analysis: safety and tolerability
Sitagliptin versus glipizide
Sitagliptin as monotherapy
Sitagliptin with metformin
Januvia with pioglitazone
Dose adjustment in patients with renal impairment
Galvus (vildagliptin)
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
GALLANT
Pooled analysis of Phase III studies
Saxagliptin
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Saxagliptin+metformin
Treatment-naïve Type II diabetes patients
Alogliptin
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase III
Early-phase data
Ondero (BI 1356)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
SGLT-2 INHIBITORS
Dapagliflozin
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
DEVELOPMENT STRATEGIES FOR TYPE I DIABETES
Otelixizumab
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II study
Teplizumab
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase I/II
DiaPep277
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase III interim analysis
Phase II
Diamyd
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
ABBREVIATIONS
SOURCES
Espicom Sources
Others
LIST OF TABLES
Prevalence of Diabetes Worldwide by Region, 2000-2030 (000s)
Prevalence of Diabetes in Top 25 Countries, 2000-2030 (000s)
Summary of Treatments for Type II Diabetes
Launched Products in Development
Novel Drugs in Development
Competitor Ratio Analysis Summary
Leading Insulins and Insulin Analogues by Sales Value, 2006-2007 (US$ million)
Humulin Sales, 2003-2008 (US$ million)
Humalog Sales, 2003-2008 (US$ million)
Humalog US Patents
Lantus Sales, 2003-2007 (EUR & US$ million)
Lantus US Patents
Apidra US Patent
Levemir Sales, 2005-2008 (DKr & US$ million)
Levemir US Patents
NovoRapid/NovoLog Sales, 2005-2008 (DKr & US$ million)
NovoLog US Patents
NovoLog Mix US Patents
Thiazolidinedione Sales, 2006-2007 (US$ million)
Avandia Sales, 2003-2007 (£ million and US$ million)
Avandia US Patents
Actos Sales, 2004-2008 (¥ billion and US$ million)
Actos US Patents
Byetta Sales, 2005-2008 (US$ million)
Byetta US Patents
Januvia US Patents
LIST OF FIGURES
Diabetes in the Top Ten Countries, 2000
Diabetes in the Top Ten Countries, 2030
UK Diabetes Therapy Market, 2007 (%)
Novel Drugs in Clinical Development
Humulin Sales, 2003A-2013E (US$ million)
Humalog Sales, 2003A-2013E (US$ million)
Lantus Sales, 2003A-2013E (US$ million)
Avandia Product Family Sales, 2003A-2013E (US$ million)
Actos Sales, 2003A-2013E (US$ million)
Byetta Sales, 2005A-2013E (US$ million)
Liraglutide Sales, 2009E-2013E (US$ million)
AVE0010 Sales 2011E-2015E (US$ million
Taspoglutide Sales 2011E-2015E (US$ million
Januvia/Janumet Sales, 2006A-2013 (US$ million)
Galvus Sales, 2008A-2013E (US$ million)
Saxagliptin Sales, 2009E-2013E (US$ million)
Alogliptin Sales, 2009E-2013E (US$ million)
EXECUTIVE SUMMARY
WHAT IS DIABETES?
A Global Problem
Where in the World?
The Economic Burden
Unhealthy Lifestyles; a Worrying Trend
Additional Health Risks for Young People
THE DIABETES THERAPY MARKET
DIABETES MANAGEMENT
Current Treatment Options
Initial Therapy
Metformin
Additional Therapies
Insulin
Sulphonylureas
Thiazolidinediones
Glinides
Alpha-glucosidase inhibitors
Amylin agonist
GLP-1 inhibitors
DPP-4 inhibitors
What’s in the Pipeline?
Further Development of Launched Products
Potential New Drugs
Competitor Ratio Analysis
INSULIN & INSULIN ANALOGUES
Humulin (insulin human [rDNA origin])
Sales Forecast
Humalog (insulin lispro)
Patents
Sales Forecast
Lantus (insulin glargine)
Patents
Sales Forecast
Clinical Trials
INTENSIVE
GINGER
LACE
ELEONOR
OPAL
TULIP
LANMET
INSIGHT
AT.LANTUS
Apidra (insulin glulisine)
Patents
Clinical Trials
GINGER
LACE
ELEONOR
OPAL
Levemir (insulin detemir)
Patents
Clinical Trials
Levemir head-to-head with Lantus
PREDICTIVE
NovoRapid/NovoLog (insulin aspart)
Patents
NovoMix/NovoLog Mix
Patents
Clinical Trials
PREFER
Recent Developments in Insulin Drug Delivery
Buccal Spray
Intranasal Insulin
Intranasal insulin may lower food intake in men and improve memory function in women
Oral Insulin
Insulin Suppository
Afresa (Technosphere Insulin System)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Study 102 - comparable decreases in HbA1c levels
Study 030 - no adverse effect on lung function
Study 009
Generex Oral-lyn
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Generex Oral-lyn compared with insulin analogues
Phase II
THIAZOLIDINEDIONES
Update on the use of TZDs in the consensus algorithm
Cardiovascular safety concerns
Long-term TZD use doubles women's fracture risk
Researchers map molecular regulation of adipocyte genetics
Avandia (rosiglitazone)
Patents and Generic Competition
Sales Forecast
Safety Issues
Public Citizen petitions for Avandia ban
Diabetic macular oedema
Clinical Trials
APPROACH
ACCORD
RECORD
ADOPT
DREAM
RESULT
Rosiglitazone+atorvastatin
Rosiglitazone+fenofibrate
Actos (pioglitazone)
Patents and Generic Competition
Sales Forecast
Safety Issues
Heart failure warning
Fracture risk
Clinical Trials
Research supports Actos’ Cardiovascular safety profile
Pioglitazone in NASH
CHICAGO
PROactive
COMPLEMENT
Balaglitazone
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Rivoglitazone
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
GLP-1 AGONISTS
Byetta (exenatide)
Patents
Sales Forecast
Safety Issues
Pancreatitis
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Exenatide versus sitagliptin
Exenatide versus biphasic insulin aspart
Exenatide as adjunctive therapy with thiazolidinedione
Long-acting release (LAR) formulation
Liraglutide
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical trial results
LEAD 6
LEAD 4
LEAD 3
Phase IIb
AVE0010
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase IIb
Phase IIa
Taspoglutide
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
DPP-4 INHIBITORS
Januvia (sitagliptin)
Patents
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Januvia in combination therapy
Pooled analysis: safety and tolerability
Sitagliptin versus glipizide
Sitagliptin as monotherapy
Sitagliptin with metformin
Januvia with pioglitazone
Dose adjustment in patients with renal impairment
Galvus (vildagliptin)
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
GALLANT
Pooled analysis of Phase III studies
Saxagliptin
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Saxagliptin+metformin
Treatment-naïve Type II diabetes patients
Alogliptin
Sales Forecast
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase III
Early-phase data
Ondero (BI 1356)
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
SGLT-2 INHIBITORS
Dapagliflozin
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
DEVELOPMENT STRATEGIES FOR TYPE I DIABETES
Otelixizumab
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II study
Teplizumab
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase I/II
DiaPep277
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase III interim analysis
Phase II
Diamyd
Competitor Ratio Analysis
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace
Risks associated with drug development in therapeutic class
Clinical Trials
Phase II
ABBREVIATIONS
SOURCES
Espicom Sources
Others
LIST OF TABLES
Prevalence of Diabetes Worldwide by Region, 2000-2030 (000s)
Prevalence of Diabetes in Top 25 Countries, 2000-2030 (000s)
Summary of Treatments for Type II Diabetes
Launched Products in Development
Novel Drugs in Development
Competitor Ratio Analysis Summary
Leading Insulins and Insulin Analogues by Sales Value, 2006-2007 (US$ million)
Humulin Sales, 2003-2008 (US$ million)
Humalog Sales, 2003-2008 (US$ million)
Humalog US Patents
Lantus Sales, 2003-2007 (EUR & US$ million)
Lantus US Patents
Apidra US Patent
Levemir Sales, 2005-2008 (DKr & US$ million)
Levemir US Patents
NovoRapid/NovoLog Sales, 2005-2008 (DKr & US$ million)
NovoLog US Patents
NovoLog Mix US Patents
Thiazolidinedione Sales, 2006-2007 (US$ million)
Avandia Sales, 2003-2007 (£ million and US$ million)
Avandia US Patents
Actos Sales, 2004-2008 (¥ billion and US$ million)
Actos US Patents
Byetta Sales, 2005-2008 (US$ million)
Byetta US Patents
Januvia US Patents
LIST OF FIGURES
Diabetes in the Top Ten Countries, 2000
Diabetes in the Top Ten Countries, 2030
UK Diabetes Therapy Market, 2007 (%)
Novel Drugs in Clinical Development
Humulin Sales, 2003A-2013E (US$ million)
Humalog Sales, 2003A-2013E (US$ million)
Lantus Sales, 2003A-2013E (US$ million)
Avandia Product Family Sales, 2003A-2013E (US$ million)
Actos Sales, 2003A-2013E (US$ million)
Byetta Sales, 2005A-2013E (US$ million)
Liraglutide Sales, 2009E-2013E (US$ million)
AVE0010 Sales 2011E-2015E (US$ million
Taspoglutide Sales 2011E-2015E (US$ million
Januvia/Janumet Sales, 2006A-2013 (US$ million)
Galvus Sales, 2008A-2013E (US$ million)
Saxagliptin Sales, 2009E-2013E (US$ million)
Alogliptin Sales, 2009E-2013E (US$ million)
