Diabetes Drug Discoveries 2009: what the future holds

Summary

This strategic report from Espicom puts the spotlight on current and future drugs that will be used in the treatment of Type I and Type II diabetes, providing industry and investors with a comprehensive overview of the market in the medium term.

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

Contents

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