Market Report Source

Overview

Introduction
Datamonitor predicts a somewhat enthusiastic uptake of two agents currently in development by 2015. However, reimbursement is critical to the uptake of new medication, due to the high cost of therapy. If the reimbursable status is not achieved, the expansion of the market will not match the rate of growth of the obese population and the great potential of the obesity market will remain untapped.

Scope
Assessment of the patient potential for developmental anti-obesity agents over the period 2006-15
Overview of the anti-obesity 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 take away market share from the currently available drugs
Sales forecasts for key late-stage developmental anti-obesity agents in the seven major markets to 2015

Highlights
The obesity ““epidemic”“ is taking place to a certain extent in all the major markets, and the rate of obesity prevalence growth is not showing any signs of slowing down in the near future.

The anti-obesity market growth does not follow the growth of obesity prevalence. The major cause for the lack of growth in most of the major markets is lack of reimbursement for pharmacological management of obesity.

The drugs currently available in the major markets for treatment of obesity have significant unmet needs and do not meet the expectations of obese patients. The pipeline drugs will be able to expand the market. However, the growth of the market will still be marginal in comparison to the growth of obesity prevalence.

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

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the Analysis

Datamonitor insight into the Obesity market

The obesity “epidemic” is taking place to a certain extent in all the major markets, and the rate of obesity prevalence growth is not showing any signs of slowing down in the near future

The anti-obesity market growth does not follow the growth of obesity prevalence. The major cause for the lack of growth in most of the major markets is lack of reimbursement for pharmacological management of obesity

The drugs currently available in the major markets for treatment of obesity have significant unmet needs and do not meet the expectations of obese patients

The pipeline drugs will be able to satisfy some of the unmet needs and will be able to expand the market. However, the growth of the market will still be marginal in comparison to the growth of obesity prevalence

Key metrics

CHAPTER 2 PATIENT POTENTIAL

Definition of obesity

Segmentation of obesity

Causes of obesity

Genetic factors

Environmental factors

Psychological factors

Other causes

Obesity as a Risk Factor

Obesity and overweight prevalence

Obesity and overweight prevalence methodology

US

Japan

France

Germany

Italy

Spain

UK

Overview of guidelines

NHLBI Guidelines

American College of Physicians guidelines

PRODIGY

Unmet needs in obesity

More cost-effective care

Increased patient knowledge and physician awareness

Safe and tolerable drugs

Drugs with greater efficacy

Improved patient compliance

CHAPTER 3 MARKET ANALYSIS

Overview of the global anti-obesity drug market

Lack of reimbursement is the key market resistor.

Overview of the US anti-obesity drug market

Reimbursement

DTC advertising

National organizations and Awareness campaigns

FDA’s Obesity Working Group

The United States Department of Health and Human Services

Trust for America’s Health

2001-2006 – The VERB Youth Media

2003 – Steps to a HealthierUS

2004 – Preventing Childhood Obesity: Health in the Balance

2004 – The Calories Count initiative

2004 – The Obesity and the Built Environment: Improving Public Health Through Community Design conference

2005 – Dietary Guidelines for Americans, 2005

2005 – “We Can!”

2006 – Perspectives on Marketing, Self- Regulation, and Childhood Obesity

2006 – Food Marketing to Children and Youth: Threat or Opportunity?

2006 – Shape of the Nation

Overview of the anti-obesity drug market in Japan

Overview of the anti-obesity drug market in Europe

France

Germany

Italy

Spain

UK

UK-specific awareness campaigns

TOAST

The British Dietetic Association’s Food First Program

National Obesity Forum

The International Obesity Taskforce

Other European initiatives

Food & Nutrition Action Plan

The European Childhood Obesity Group

EU platform for action “diet, physical activity and health”

Green Paper: “Promoting healthy diets and physical activity”

Anti-Obesity Charter

Global market forecast

CHAPTER 4 OBESITY PIPELINE ANALYSIS

The anti-obesity pipeline is mechanistically diversified

The anti-obesity pipeline is rich in Phase I and Phase II candidates

Numerous companies have their stake in the R&D landscape

CHAPTER 5 R&D APPROACH

Classification of pipeline products

Cannabinoid (CB1) antagonists

5-HT (Serotonin) Receptors

SNRIs

Lipase inhibitors

Alpha MSH (alpha-melanocyte-stimulating hormone) modulator

Clinical trial design

Clinical endpoints

Insulin sensitivity and prevention of type 2 diabetes

HDL and LDL cholesterol levels

Critique of clinical trial design in obesity

Strategies for achieving reimbursement

Sanofi-Aventis raises the bar

CHAPTER 6 DRUG ANALYSIS – DRUGS ON THE MARKET

Xenical analysis

Drug overview

Marketing support

The XENDOS study shows orlistat reduces risk of type 2 diabetes

The FDA approves the use of orlistat in adolescents

The European Commission approves label extension

Xenical may slow cancer growth

Chugai discontinues clinical development of orlistat in Japan

The European Commission approves the use of orlistat in obese adolescents

FDA gives conditional approval for OTC use of orlistat

Public Citizen petitions FDA to remove orlistat from the market

Trials with Orlistat (60 mg) prove efficacy and improved tolerability in weight loss and reduction in LDL cholesterol.

Marketing strategies

Promotion of long-term efficacy and safety

Promotion of Xenical use in obese adolescents and the reduced risk of developing type 2 diabetes

Provide more patient support to increase patient compliance

Xenical forecasts to 2015

Launch of Acomplia

Orlistat goes OTC

Loss of Patent Protection

Launch of Contrave

Launch of Qnexa

Launch of Lorcaserin

Launch of Cetilistat

Meridia analysis

Drug overview

Behavior therapy and sibutramine for the treatment of adolescent obesity

STORM trial shows weight-maintenance success after weight loss is positively influenced by sibutramine and leisure-time activity.

Sibutramine has a positive effect on clinical and metabolic parameters in obese patients with polycystic ovary syndrome (PCOS)

Sibutramine effective in the treatment of binge-eating disorder

No benefits shown in health-related quality of life study in sibutramine-treated obese patients with type 2 diabetes

Eisai announces the start of phase III trials in Japan

SCOUT study

Marketing strategies

Increase patient support strategies to improve patient compliance

Invest in more clinical trials for new indications

Conduct more trials focusing on the safety of Meridia

Meridia forecasts to 2015

Launch of Acomplia

Launch of Sibutramine in Japan

Disclosure of SCOUT results

Patent expiry

Launch of Contrave

Launch of Qnexa

Launch of Lorcaserin

Launch of Cetilistat

Acomplia analysis

Drug overview

Results of RIO-Lipids presented

Results of RIO-Diabetes presented

FDA issues approvable letter for obesity

EU CHMP recommends approval of rimonabant for obesity

Germany classifies rimonabant as lifestyle drug

Results of SERENADE presented

Marketing strategies

Conduct more safety studies focusing on depression

Promote the improvement of multiple risk factors for CV disease

Conduct an outcome study with prevention of diabetes as primary end point

Acomplia forecasts to 2015

Launch of Acomplia

Potential for a black box warning

Launch of Contrave

Launch of Qnexa

Launch of Lorcaserin

Launch of Cetilistat

CHAPTER 7 DRUG ANALYSIS – LATE STAGE AGENTS

Phase III

Pipeline summary

Contrave (bupropion+ naltrexone)

Drug Overview

Clinical Trial Data

Datamonitor Comments

Forecasts to 2015

Lorcaserin (APD356)

Drug overview

Clinical Trial Data

Datamonitor Comments

Forecasts to 2015

MK0557 (L-000753721)

Drug Overview

Clinical Trial Data

Datamonitor Comments

MK0364 (c5093)

Drug Overview

Clinical Trial Data

CP945598

Phase II – Pipeline summary

Phase II – most promising compounds

Cetilistat (ATL962)

Drug Overview

Datamonitor Comments

Forecasts to 2015

Qnexa (phentermine + topiramate; VI0521)

Drug Overview

Clinical Trial Data

Datamonitor Comments

Forecasts to 2015

Phase II – other compounds

Excalia (zonisamide +bupropion)

Drug Overview

Clinical Trial Data

Datamonitor Comments

AOD9604

Drug Overview

Clinical Trial Data

Datamonitor Comments

Surinabant (SR 147778)

Drug Overview

Clinical Trial Data

Datamonitor Comments

Recombinant Methionyl human leptin

Drug Overview

Clinical Trial Data

Datamonitor Comments

Pramlintide (AC137)

Drug Overview

Clinical Trial Data

Datamonitor Comments

S2367

Drug Overview

Clinical Trial Data

Datamonitor Comments

Oleoyl-estrone

Drug Overview

Clinical Trial Data

Teglicar (ST1326)

N5984 (KRP204)

CP741952

MK0916

AVE1625

C2735

MK0493 (c2624)

Sergliflozin (KGT1251, 869682)

Tesofensine (NS2330)

CHAPTER 8 DRUG ANALYSIS – EARLY STAGE AGENTS

KB2115

SLV319

PROTEIN TYROSINE PHOSPHATASE 1B INHIBITORS, SERONO

856464

AC162352

ANDROGEN RECEPTOR AGONISTS, GTX

AMG076

QRX431

BDC03

RESVERATROL (SRT501)

PRX07034

TM30338

GT389255

PEPTIDE YY [3-36] (OBESITY, INTRANASAL), NASTECH

ID1101

RADAFAXINE

FLUASTERONE

NGD4715

BVT74316

APPENDIX A

Contributing experts

Interviewed in 2004