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Diabetes Drug Discoveries: What the Future Holds

Published by: Espicom Healthcare Intelligence

Published: Jan. 26, 2007 - 128 Pages


Table of 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

Insulin

Metformin

Sulphonylureas

Thiazolidinediones

Glinides

Alpha-glucosidase inhibitors

Amylin agonists

GLP-1 agonists

DPP-IV inhibitors

What’s in the pipeline?

Further development of launched products

Potential new drugs

Competitor ratio analysis

Insulin and insulin analogues

Humulin (insulin human [rDNA origin])

Sales forecast

Humalog (insulin lispro)

Sales forecast

Lantus (insulin glargine)

Sales forecast

Clinical trials

LANMET

INSIGHT

AT.LANTUS

Apidra (insulin glulisine [rDNA origin])

Further development

Sales forecast

Clinical trial resu40

Novo Nordisk’s insulin analogues

Sales forecast

Levemir (insulin detemir)

Clinical trial resu43

PREDICTIVE

NovoRapid/NovoLog (insulin aspart [rDNA origin])

NovoMix/NovoLog Mix

Clinical trial resu46

PREFER

Exubera (insulin human [rDNA origin]) inhalation powder

Sales forecast and assumptions

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 resu51

Ongoing studies in Type I and Type II diabetes

Diabetes patients with respiratory infections/exposure to cigarette smoke

Type I diabetes

Type II diabetes

AERx iDMS (NN1998)

Sales forecast and assumptions

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

AERx iDMS compared to sc insulin aspart and sc human regular insulin

AIR Insulin System

Clinical trial resu58

Technosphere Insulin

Clinical trial resu61

Phase III

Phase II

Oral-lyn

Metformin and sulphonylureas

Glucophage (metformin)

EASD/ADA consensus recommends metformin at diagnosis of Type II diabetes

Sales forecast

Recent Research

Metformin effective for non-obese Type II diabetes patients

Generic competition

Amaryl (glimepiride)

Sales forecast

Generic competition

Thiazolidinediones

Avandia (rosiglitazone)

Sales forecast

Clinical trial results

ADOPT

DREAM

RESULT

Rosiglitazone+atorvastatin

Rosiglitazone+fenofibrate

Safety issues

Actos (pioglitazone)

Sales forecast

Safety issues

Clinical trial results

Pioglitazone in NASH

CHICAGO

PROactive

COMPL 86

Patent challenges/generic competition

GLP-1 agonists

Byetta (exenatide)

Sales forecast and assumptions

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

Exanatide versus biphasic insulin aspart

Exenatide as adjunctive therapy with thiazolidinedione

Long-acting release (LAR) formulation

Liraglutide

Sales forecast and assumptions

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

Phase IIb

AVE0010

Sales forecast and assumptions

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

DPP-IV inhibitors

Januvia (sitagliptin)

Sales forecast and assumptions

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

Januvia as monotherapy

Januvia versus glipizide

Januvia with metformin

Januvia with pioglitazone

Dose adjustment in patients with renal impairment

Galvus (vildagliptin)

Sales forecast and assumptions

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

Saxagliptin

Sales forecast and assumptions

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

Cannabinoid type 1 blockers

Acomplia (rimonabant)

Sales forecast and assumptions

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

SERENADE

RIO-Diabetes

Towards greater understanding; a future cure?

Advances in islet transplantation therapy

MicroIslet moves towards clinical trials

Northfield Laboratories preclinical study

Clinical trial of islet transplantation

Key to insulin metabolism discovered?

New research shows immune response spreads from one protein to another in Type I diabetes

Beta cell regeneration

Researchers find enzymatic regulator of insulin pathways

Insulin-making protein identified in beta cells

TCF7L2 polymorphisms linked to progression of Type II diabetes

Insulin signalling defects linked to lipid metabolism

Potential cure for recent-onset Type I diabetes?

Encouraging preliminary results from animal pancreatic xenotransplantation studies

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)

Leading insulins and insulin analogues by sales value, 2004-2005 (US$ million)

Thiazolidinedione sales, 2004-2005 (US$ million)

Launched products in development

Novel drugs in development

Competitor ratio analysis summary

Humulin sales, 2001-2005 (US$ million)

Humalog sales, 2001-2005 (US$ million)

Lantus sales, 2001-2005 (EUR million & US$ million)

Novo Nordisk insulin analogue sales, 2001-2005 (DKr million & US$ million)

Glucophage sales, 2001-2005 (US$ million)

FDA ANDA approvals for generic Glucophage

FDA ANDA approvals for generic Glucophage XR

FDA ANDA approvals for generic Glucovance

Amaryl sales, 2001-2005 (EUR million & US$ million)

FDA ANDA approvals for Glimepiride

Avandia family sales, 2001-2005 (£ million and US$ million)

Actos sales, 2002-2006 (¥ billion and US$ million)

List of Figures

Diabetes in the top ten countries, 2000

Diabetes in the top ten countries, 2030

UK diabetes therapy market, 2005 (%)

Novel drugs in clinical development by activity

Humulin projected sales, 2005-2012 (US$ million)

Humalog projected sales, 2005-2011 (US$ million)

Lantus projected sales, 2005-2011 (US$ million)

Apidra projected sales, 2006-2011 (US$ million)

Levemir/NovoLog projected sales, 2005-2011 (US$ million)

Exubera projected sales, 2006-2011 (US$ million)

AERx iDMS projected sales, 2009-2014 (US$ million)

Glucophage family projected sales, 2006-2011 (US$ million)

Amaryl projected sales, 2005-2011 (US$ million)

Avandia family projected sales, 2005-2011 (US$ million)

Actos projected sales, 2005-2011 (US$ million)

Byetta projected sales, 2005-2011 (US$ million)

Liraglutide projected sales, 2009-2014 (US$ million)

AVE0010 projected sales, 2009-2014 (US$ million)

Januvia projected sales, 2007-2012 (US$ million)

Galvus projected sales, 2007-2012 (US$ million)

Saxagliptin projected sales, 2008-2013 (US$ million)

Acomplia projected sales, 2007-2012 (US$ million)

Abstract

The diabetes market will grow significantly over the next 5 years to US$31.4 billion - who are the companies and what are the market trends and products that will drive growth?

This report will tell you!

A growing and valuable market There are a number of drivers in the diabetes market that are fuelling growth:

Product innovation
New classes of drugs such as GLP-l agonists and DPP-lV inhibitors have already been launched and the pipeline is well stocked. Combination therapies will play their part in the future as will novel drug delivery technology.

Emerging markets = rapid growth Some of the fastest growing markets for diabetes are in emerging economies - India, China and Indonesia are in the top 5 for disease prevalence. The impact for both branded and generic drugs is considerable.

Unmet clinical need will keep developed markets strong While the number of patients diagnosed has gone up it is estimated millions are still to be identified. In the UK alone, it is estimated that up to a million Type II sufferers are undiagnosed.

Strong annual growth expected for the next five years With many new products yet to realise their full potential, and the high incidence of Type II diabetes expected in emerging markets, prospects for the sector look strong. Estimated at US$22 billion in 2007, it is forecast to grow to US$31.4 billion by 2011, with generics performing strongly as time moves on.

THIS REPORT ANSWERS KEY QUESTIONS What revenue is Pfizer’s novel Exubera forecast to achieve by 2011 in the hotly-contested insulin market?

What are the strengths and weaknesses of Merck & Co’s Januvia and Novartis’ Galvus in the new DDP-IV inhibitor sector?

Which markets are showing the highest growth in terms of disease prevalence?

What impact might combination therapies have in the future?

How well will Bristol-Myers Squibb and Merck KgaA be able to protect future Glucophage (metformin) revenues from generic competition?

CURRENT TREATMENT OPTIONS

Insulin
Metformin
Sulphonylureas
Thiazolidinediones
Glinides
Alpha-glucosidase inhibitors
Amylin agonists
GLP-l agonists
DPP-lV inhibitors

OUTLOOK FOR CURRENT AND EXPECTED THERAPIES TO 2011
Insulin and insulin analogues
Humulin (Eli Lilly)
Humalog (Eli Lilly)
Novolin, Velosulin etc (Novo Nordisk)
Lantus (sanofi-aventis)
Levemir (Novo Nordisk)
NovoRapid/NovoLog (Novo Nordisk)
Apidra (sanofi-aventis)
Exubera (Pfizer)
AERx iDMS (Novo Nordisk/Aradigm)
Metformin and sulphonylureas
Glucophage (BMS/Merck)
Amaryl (sanofi-aventis)
Thiazolidinediones
Avandia (GSK)
Actos (Takeda)
GLP-l agonists
Byetta (Eli Lilly)
Liraglutide (Novo Nordisk)
AVE0010 (sanofi-aventis)
DPP-IV inhibitors
Januvia (Merck & Co)
Galvus (Novartis)
saxagliptin (BMS/AstraZeneca)
Cannabinoid Type I receptor blockers
Acomplia (sanofi-aventis)


NOVEL COMPETITOR RATIO ANALYSIS PUTS PRODUCTS INTO A WIDER MARKET CONTEXT
For a number of new and future drugs, Espicom has provided a competitor ratio analysis, based on our assessment of the following five criteria:

Novelty/rationale for mechanism of action;
Proof of concept/clinical data;
Management expertise;
Competition within the marketplace;
Risks associated with drug development in therapeutic class.

Each of these criteria attracts a maximum of ten points, resulting in a maximum score of 50 overall and allowing you to compare and contrast the prospects for each product.

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