Diabetes Drug Discoveries 2009: what the future holds

Date: February 22, 2009
Pages: 160
Price:
US$ 1,390.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: D6920CCDFA1EN
Leaflet:

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Diabetes Drug Discoveries 2009: what the future holds
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:
  • 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)
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