Diabetes Drug Discoveries 2009: what the future holds

Published by	Espicom Business Intelligence
Published	February, 2009	Product code	81800
Content info	Pages: 160
Price	US $ 1390 Hard Copy US $ 1390 PDF by E-mail (Single user license) US $ 1390 Web Access (Single user license)

Introduction
Related Reports

Diabetes Drug Discoveries 2009: what the future holds published by Espicom Business Intelligence in February, 2009. This report consists of Pages: 160 and the price starts from US $ 1390.

Introduction

Abstract

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.

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.

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.....

About the Author

The report has been researched and written by Espicom' s Senior Market Analyst, Karen Holmes. Karen has over 12 years pharmaceutical and healthcare market analysis experience.

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