Market Report Source

Overview

Introduction

Datamonitor expects the continuously growing prevalence of diabetes to drive growth in diabetes drug spending, benefiting market uptake of newly developed, efficacious therapies. A variety of novel, non-insulin antidiabetic agents are poised to become available to patients in the next decade, with two DPP-4 inhibitors likely to launch in 2007 and two GLP-1 agonists entering the market by 2010.

Scope

*Assessment of the patient potential for developmental non-insulin agents in the type 2 diabetes setting of over the period 2006-15 *Overview of the non-insulin antidiabetics R&D pipeline, with detailed information on the classes in development and comparator drugs *Commercial analysis of key compounds in development regarding their ability to satisfy key unmet needs, supported by the views of key opinion leaders *Sales forecasts for key late-stage developmental non-insulin antidiabetics in the seven major markets to 2015

Highlights

The diabetes market is worthy of investment because of the endemic size of its patient pool which is set to grow further, and the nature of its unmet clinical needs. This situation is reflected in the R&D pipeline for non-insulin antidiabetics, comprising a diverse collection of 76 novel agents in clinical development.

Datamonitor has identified five late-stage candidate drugs likely to be launched in the diabetes market within the next five years. These are the DPP-4 inhibitors Galvus and Januvia, the GLP-1 agonists Byetta LAR and liraglutide, the PPAR-gamma modulator metaglidasen. Apart from metaglidasen, all four agents have blockbuster potential.

Despite the fact that pipeline products will impact the diabetes market greatly in the next five years, there are currently no agents in late-stage clinical development that are likely to fully replace current mainstays of antidiabetic therapy. Type 2 diabetes is therefore likely to remain an add-on market rather than develop into a switch market.

Reasons to Purchase

*Understand the key factors that will contribute to the success of the next generation of anti-diabetes drugs *View independent sales forecasts for products in late stage development for therapy of type 2 diabetes *Understand physician sentiment on clinical trial endpoints and late-stage candidate drugs for the diabetes market

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the cardiovascular pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the market for non-insulin antidiabetic pharmacotherapies

The R&D pipeline for non-insulin antidiabetics is a mechanistically diverse collection of 77 novel agents at the clinical stages of drug development and dominated by a set of five pharmaceutical companies

The diabetes market is characterized primarily by significant unmet clinical needs but also by some unmet market needs

Datamonitor has identified two unmet market needs in the setting of diabetes.

Datamonitor has identified two unmet clinical needs in the setting of diabetes.

Datamonitor has identified five late-stage candidate drugs likely to be launched into the diabetes market within the next five years-the DPP-4 inhibitors Galvus (vildagliptin) and Januvia (sitagliptin), the GLP-1 agonists Byetta LAR (exenatide LAR) and liraglutide, and the specific PPAR-? modulator metaglidasen.

GLP-1 agonists

DPP-4 inhibitors

Metaglidasen

CHAPTER 2 PIPELINE OVERVIEW

Pipeline overview

Non-insulin antidiabetic pipeline is mechanistically diversified

Non-insulin antidiabetic pipeline is rich in Phase I and Phase II candidates

The R&D landscape is dominated by five companies: GSK, Roche, Sanofi-Aventis, Merck & Co. and Novo Nordisk

CHAPTER 3 PATIENT 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

Future prevalence of type 2 diabetes

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: 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

Glucotrol XL

Biguanides

Glucophage (metformin)

Other classes

Classification of pipeline products

Incretin mimetics

Gastric inhibitory polypeptide (GIP)

Glucagon-like peptide-1 (GLP-1)

Dipeptidyl PeptidaseIV (DPP-4 Inhibition

PPAR agonists

PPAR-? agonists

Dual PPAR agonists and PPAR pan agonists

Sodium glucose co-transporter 2 (SGLT2) inhibitors

Other classes of agents in development

Inhibitors of glycogenolysis

Glucokinase activation

Clinical trial issues in diabetes

Efficacy

Control of average blood glucose levels (HbA1c)

Bioavailability of non-invasive insulin

Control of postprandial glucose levels

Safety and side effects

Incidence of hypoglycemic events

Delivery-related complications

Weight gain

Patient compliance

CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS: NON-INSULIN ANTIDIABETICS

Overview of pharmacotherapies in late-stage development for type 2 diabetes

Pipeline summary

DPP-4 inhibitor class

Januvia (sitagliptin, MK-0431)

Drug overview

Clinical data

Galvus (vildagliptin, LAF-237)

Drug overview

Clinical data

Competitive environment of the DPP-4 inhibitor class

Comparison with currently marketed oral antidiabetics

Comparison with other late-stage pipeline agents

Inter-class comparison of key clinical trial data of sitagliptin (Januvia) with vildagliptin (Galvus)

SWOT analysis: Januvia (sitagliptin)

SWOT analysis: Galvus (vildagliptin)

Forecast: Galvus and Januvia

Datamonitor comment

GLP-1 class

Byetta LAR (exenatide LAR)

Drug overview

Parent product: Byetta (exenatide), Byetta BID

Clinical data

Liraglutide (NN-2211)

Drug overview

Clinical data

Competitive environment of the GLP-1 class

Points of consideration: Byetta LAR

Points of consideration: Liraglutide

SWOT-Analysis: Byetta LAR (exenatide LAR)

SWOT-Analysis: Liraglutide

Forecast: Byetta LAR and liraglutide

Datamonitor comment

Metaglidasen (MBX-102)

Drug overview

Clinical data

Phase II

Competitive environment

SWOT-Analysis: metaglidasen

Forecast: metaglidasen

Datamonitor comment

Datamonitor does not believe non-injectable insulins to be able to compete with non-insulin antidiabetics

Datamonitor drug assessment summary

CHAPTER 6 OTHER NON-INSULIN ANTIDIABETICS

625019

Drug overview

677954

Drug overview

825964

Drug overview

189075

Drug overview

Ro-0730699

Drug overview

DRF-2593 (Balaglitazone)

Drug overview

PHX-1149

Drug overview

AMG-221

Drug overview

APD-668

Drug overview

Arimoclomol (BRX-345)

Drug overview

Anti-CD3

Drug overview

Phase I/II clinical trials

AVE-0847

Drug overview

AVE-2268

Drug overview

AVE-5376

Drug overview

AVE-8134

Drug overview

AZD-6610

Drug overview

AZD-8677

Drug overview

AVE-0010 (ZP-10)

Drug overview

Clinical data

Phase IIa

Phase IIb

BAY-73-7977

Drug overview

BI-1356-BS

Drug overview

BIM-51077 (ITM-077)

Drug overview

BLX-1002

Drug overview

Clinical data

Phase I

Phase IIa

CJC-1134-PC

Drug overview

Phase I/II

CKD-501

Drug overview

CS-917 (MB-6322)

Drug overview

Denagliptin (Redona, 823093)

Drug overview

Clinical data

Diamyd (GAD-65)

Drug overview

Clinical data

Phase II: 47 patients with latent autoimmune diabetes in adults (LADA)

Phase II: 70 patients with recent onset type 1 diabetes

Phase II/III: 160 patients with Latent Autoimmune Diabetes in Adults (LADA)

DiaPep277 (AVE-0277)

Drug overview

Clinical data

Phase II: 35 patients with newly diagnosed type 1 diabetes

DIO-901

Drug overview

DIO-902

Drug overview

Clinical data

Phase II

EMD-387008

Drug overview

EN-122004

Drug overview

GRC-8200

Drug overview

Phase I

716155 (albugon)

Drug overview

K-111

Drug overview

KRP-104

Drug overview

ISIS-113715

Drug overview

Clinical data

Phase I

Phase II

MB-07803

Drug overview

MBX-2044

Drug overview

MK-0533

Drug overview

MK-0893

Drug overview

MK-0941

Drug overview

MP-513

Drug overview

Naveglitazar (LY-818, LY519818)

Drug overview

iPlex (mecasermin rinfabate)

Drug overview

Clinical data

Phase II: type 1 diabetes

Phase II: type 1 diabetes

Phase II: type 2 diabetes

Phase II: type 2 diabetes

Netoglitazone (MCC-555)

Drug overview

NN-0606

Drug overview

NN-9101

Drug overview

ONO-5129

Drug overview

PLX-204

Drug overview

PSN-010

Drug overview

PSN-357

Drug overview

PSN-9301 (P93/01)

Drug overview

Clinical data

Phase IIa

Phase IIa