Report: Diabetes Drug Discoveries 2009: what the future holds TOC

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-naive 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)

Diabetes Drug Discoveries 2009: what the future holds

Table of Contents

List of Tables

List of Figures