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Pipeline Insight: Non-insulin antidiabetics - Incretin mimetics - leaders in a diverse pipeline

Published by: Datamonitor

Published: May. 28, 2008 - 294 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the Non-insulin antidiabetics disease market

Key metrics

Datamonitor pipeline assessment summary

Related reports

Upcoming report

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Non-insulin antidiabetics: a diverse pipeline

Huge increase in development candidates as Western World focuses on diabetes

Market dominated by Big Pharma and single candidate companies

Current leaders - Pipeline management

Takeda

GlaxoSmithKline

Sanofi-Aventis

Others

CHAPTER 3 NON-INSULIN ANTIDIABETIC OVERVIEW - MARKET POTENTIAL

Definition of diabetes

Segmentation of diabetes

Type 1 diabetes

Type 1.5 diabetes

Type 2 diabetes

Epidemiology of diabetes

Current prevalence of type 1 and type 2 diabetes

Methodology

Epidemic rise in incidence of Type 2 diabetes

Etiology

Mechanisms of development of diabetes

Genetic or acquired causes

Risk factors

Obesity

Type 2 diabetes epidemic hand-in-hand with obesity epidemic

Race

Type 2 diabetes more prevalent in Hispanics and African Americans than in Caucasians

Family history

Type 2 diabetes in first-degree relatives is a strong prognostic indicator

Advanced age

Gender and other factors

Gestational diabetes mellitus

Unmet need in diabetes

Unmet market needs

Unmet market need 1: routine screening for the detection of type 2 diabetes mellitus

Unmet market need 2: greater patient awareness

Unmet market need 3: greater guideline awareness in physicians

Unmet clinical needs

Unmet clinical need 1: greater efficacy of non-insulin antidiabetics

Unmet clinical need 2: durability of therapy

Unmet clinical need 3: better tolerability of non-insulin antidiabetics

CHAPTER 4 R&D APPROACH

Therapy overview in type 1 and type 2 diabetes

Type 1 diabetes

Type 2 diabetes

Comparator therapies

Thiazolidinediones

Weight gain associated with TZD therapy

Actos (pioglitazone)

Avandia (rosiglitazone)

Sulfonylureas

Amaryl (glimepiride)

Glucotrol XL (glipizide)

Biguanides

Glucophage (metformin)

Alpha glucosidase inhibitors

Basen (voglibose)

Other classes

Classification of pipeline products

Incretin mimetics

Glucagon-like peptide-1 (GLP-1)

Dipeptidyl peptidase IV (DPP-IV) inhibition

PPAR agonists

PPAR-ã agonists

Dual PPAR agonists and PPAR pan agonists

Sodium glucose co-transporter 2 (SGLT-2) inhibitors

Other classes of agents in development

Glucokinase activation

Inhibitors of glycogenolysis and gluconeogenesis

11â-Hydroxysteroiddehydrogenase-1 inhibitors

Non-insulin antidiabetic pipeline

Incretin mimetics

DPP-IV inhibitors

GLP-1 agonists

GLP-1 fusion proteins

GPR119 agonist

Liver and muscle insulin sensitizers

PPAR system

Insulin sensitizers

Glucose excretion

Sodium dependent glucose transport-2 inhibitor

Fatty acid digestion and metabolism

Bile acid sequestrants

Carnitine palmitoyltransferase inhibitor

Farnesoid X receptor agonist

PPAR-á agonist

PPAR-ä agonist

HM74a agonist

Phase I candidates

Glucose metabolism

Fructose 1,6 bisphosphatase inhibitor

Glucagon receptor agonist

Glucokinase activators

Glucagon receptor antisense oligonucleotide

Glycogen phosphorylase inhibitor

Autoimmune dysfunction

CD-3 monoclonal antibodies

Recombinant glutamic acid decarboxylase

Heat shock protein modulators

Cell adhesion molecule modulator

Steroid hormones and the stress response

11â-Hydroxysteroid dehydrogenase type 1 inhibitors

Glucocorticoid receptor antagonist

Biotech therapies

Alginate encapsulated pancreatic islet product

Human islet allografts

Plasmid gene therapy

Cell based therapy

Insulin vaccine

Autonomic and central nervous system

Dopamine D2 agonist

Cannabinoid (CB) -1 antagonist

Anti-inflammatory agents

Vascular cell adhesion molecule -1 (VCAM-1) gene expression inhibitor

Cyclooxygenase inhibitor

IL-1â antagonist/TNF-á antagonist/IL-6 antagonist

IL-1â antagonist

NF-êB pathway inhibitor

Insulin release stimulators

ATP dependent potassium channel inhibitor

Unknown mechanisms

Insulin signaling modulators

Protein tyrosine phosphatase -1B (PTP-1B) antisense oligonucleotide

Adenosine monophosphate (AMP) protein kinase modulator

Undisclosed insulin modulator

Combination therapies

PPAR-á agonist based therapies

PPAR-ã agonist and statin

GABA agonist and appetite suppressant

Gastrin agonist based therapies

Muscarinic acetyl choline receptor agonist and a mucolytic

Other therapeutic modes of action

Angiotensin converting enzyme inhibitors

NAD dependent deacetylase sirtuin-1 stimulator

Amyloid protein deposition inhibitor

Unknown mechanisms

Clinical trial issues in diabetes

Efficacy

Control of average blood glucose levels

Insulin

Blood markers

Weight loss

Safety and side effects

Weight gain

Cardiovascular endpoints

Comparators: add-on versus replacement therapy

Future trends

FDA guidance February 2008

Safety

Regulatory divergence - FDA versus EMEA

Combinations

Clinical endpoint selection

CHAPTER 5 NON-INSULIN ANTIDIABETIC LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for non-insulin antidiabetics

Pipeline summary

Comparative forecasts

Definition of current comparator therapy

DPP-IV and SGLT-2 inhibitors

Saxagliptin

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

Alogliptin

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

BI-1356

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

Dapagliflozin

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

GLP-1 agonists

Byetta LAR

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

Liraglutide

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

PPAR modulators

Balaglitazone

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

MBX-102

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

Rivoglitazone

Drug overview

Forecasts to 2017

Datamonitor drug assessment summary

Marketing factors

Patient potential

Satisfaction of unmet needs

Clinical trial data

Intellectual property status

Autoimmune antibody

Teplizumab

Drug overview

Forecasts to 2017

Datamonitor drug assessment

Abstract

Introduction

Datamonitor expects incretin mimetics to emerge as a major new therapeutic class in non-insulin antidiabetics, driven by an explosion in the patient population, safety fears surrounding established therapies and significant unmet patient needs.

Scope

Comprehensive analysis of the current non-insulin antidiabetic pipeline detailing the broad range of developmental classes. A detailed clinical and commercial assessment of all key emerging therapies. Sales based sales forecasts for key late-stage developmental non-insulin antidiabetics agents in the seven major markets to 2017.

Highlights

Incretin mimetics, GLP-1 agonists and DPP-IV inhibitors, are likely to be the most successful candidates in the pipeline. Pipeline incretin candidates are forecast to generate sales of $7,905m in the seven major markets in 2017 A huge number of molecules are in development as non-insulin antidiabetics to meet the increase in patient population and disease unmet needs. 137 candidates from 60 different mechanisms of action are in development Big Pharma dominate the non-insulin antidiabetic pipeline as the disease is one of the few growth areas in the cardiovascular and metabolic disease areas. Sixteen of the top twenty drug companies have a non-insulin antidiabetic pipeline and between them are developing 52% of the pipeline

Reasons to Purchase

Quantify the future drugs in the non-insulin antidiabetic market. Identify licensing opportunities based on company portfolio and market needs. Assess the remaining market opportunity, where established therapies and other developmental compounds fail to address key unmet clinical needs.

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