Understand the state of play with Orexigen’s Contrave
Review the prevalence and impact of obesity
Evaluate the therapeutic approaches being undertaken
Critically assess and compare the approach and potential of products in clinical research with our unique product scoring

Around one in three of the global adult population and more than 20 million children under five are overweight according to the World Health Organization. Around 10% of adults are obese. In the US, an estimated 44.2% of males and 48.3% of females have a body mass index (BMI) of 30 or more and are classified as obese.

Orexigen’s Contrave: possibly a new chapter – but when?
In December 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted positively in favour of Orexigen’s naltrexone sustained-release (SR) and bupropion SR combination, Contrave. The market was then surprised when the FDA did not approve the drug, asking instead for further clinical trials. If Contrave had been approved, it would have been the first new pharmacological treatment for obesity for more than a decade and would have immediately doubled the choice of available therapies; currently the only prescription drug that remains approved for obesity in the US and EU is Roche’s Xenical (orlistat), a low-dose OTC version of which is marketed by GlaxoSmithKline as alli.

Report contents summary
Executive summary
Current market
Future market
Background information
Product analysis by phase of development

EXECUTIVE SUMMARY

On 31st January 2011, the FDA issued a complete response letter regarding the NDA for Orexigen’s naltrexone sustained-release (SR) and bupropion SR combination, Contrave. The FDA noted concern about the cardiovascular safety of the drug used long-term in overweight and obese subjects and requested a new clinical trial.

The FDA’s decision was the latest in a series of setbacks for obesity product developers and a significant disappointment for Orexigen and its partner, Takeda, particularly since it followed a majority vote from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in December in favour of approval.

Other recent developments included the withdrawal of Abbott’s Meridia/Reductil (sibutramine) from the EU in January 2010 and from the US and Canada in October, following safety concerns. Also in October, there were negative responses from the FDA regarding the NDAs for Vivus’ Qnexa (phentermine+topiramate) and Arena Pharmaceuticals’ lorcaserin. In 2009, sanofi-aventis’ Acomplia (rimonabant) was withdrawn from the EU.

Contrave had been expected to be the first new pharmacological treatment for obesity for more than a decade and would have immediately doubled the choice of available therapies; currently the only prescription drug that remains approved for obesity in the US and EU is Roche’s Xenical (orlistat), a low-dose OTC version of which is marketed by GlaxoSmithKline as alli. There is certainly no shortage of people who could potentially benefit from a wider choice of medicines in the battle to lose weight and maintain weight loss. Around one in three of the global adult population and more than 20 million children under five are overweight according to the World Health Organization. Around 10% of adults are obese. In the US, an estimated 44.2% of males and 48.3% of females have a body mass index (BMI) of 30 or more and are, therefore, classified as obese.

While the proportion is not quite so high in European countries, there is a clear upward trend in overweight and obesity.

People who are overweight or obese have a substantially increased risk of developing chronic conditions and illnesses such as hypertension, dyslipidaemia, Type II diabetes, coronary artery disease, stroke, gall bladder disease, osteoarthritis, sleep apnoea, non-alcoholic steatohepatitis and respiratory problems, as well as cancers of the endometrium, breast, prostate and colon. The risk of premature mortality also increases with rising weight.

The battle against overweight and obesity may be seen as one of the biggest challenges facing departments of health in the 21st Century. For doctors and patients alike, the desire for safe and effective pharmacological interventions is likely to increase as lifestyle changes alone continue to fail for a growing number of people. While the market for pharmaceuticals in this segment has remained fairly static for some time, there is undoubtedly significant opportunity for growth.Following the FDA’s decision on Orexigen’s Contrave, the question is: Will a successful obesity drug market ever develop?

FOREWORD

EXECUTIVE SUMMARY

MARKET ANALYSIS

CURRENT MARKET
Sibutramine
Rimonabant
Orlistat

FUTURE MARKET
Research and Development
Endogenous Hormones
Monoamine Neurotransmission Modulation
Neuropeptide Signalling Modulators
Peripheral Modulators of Metabolism
Regulation of Fat Metabolism and Food Intake: a Novel Approach?

BACKGROUND INFORMATION
What is Obesity?
What Causes Obesity
Obesity Health Risks
Controlling Energy Balance
Achieving Weight Loss
Lifestyle Modifications
Behaviour Therapy
Pharmacotherapy
Surgery
Why are New Treatments Needed?
The Prevalence of Obesity
Childhood Obesity

PRODUCT ANALYSIS

ESTABLISHED PRODUCT
Orlistat
Mode of Action
Current Status
Approvals/Filings
Development
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
Low-dose Orlistat
Xenical in Adolescents
Diabetes Prevention in Obese Subjects

RECENTLY WITHDRAWN PRODUCT
Sibutramine
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Clinical Trial Results

FILED PRODUCTS
Bupropion+naltrexone
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Patent Expiry
Competitor Ratio Analysis
Clinical Trial Results
Contrave Obesity Research (COR)

Lorcaserin
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Patent Expiry
Competitor Ratio Analysis
Clinical Trial Results
BLOSSOM
BLOOM
BLOOM-DM
Abuse Potential

Phentermine+topiramate
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Patent Expiry
Competitor Ratio Analysis
Clinical Trial Results
Long-Term Date Show Significant and Sustained Weight Loss Over Two Years
EQUIP (OB-302) and CONQUER (OB-303) Obesity Studies
EQUATE Obesity Study
Sleep Apnoea Phase II Study

PHASE III
Cetilistat
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
Phase IIb

Liraglutide
Mode of Action
Current Status
Approvals/Filings
Development
Proof of Concept/Clinical Data
Diabetes
Obesity
Development Risks
Company Expertise
Competition within the Market-place
Data Exclusivity
Patent Expiry
Competitor Ratio Analysis
Clinical Trial Results
Type II Diabetes

PHASE II
Betahistine
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Competitor Ratio Analysis
Clinical Trial Results
BET 209
Obesity
Pramlintide+metreleptin
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
Phase II
SLx-4090
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
Phase II - Dyslipidaemia
Phase I - Dyslipidaemia
Phase I - Safety and Tolerability

Tesofensine
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
TIPO-5
TIPO-4
TIPO-2
TIPO-1
Cardiovascular Safety Study

TM30339
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Clinical Trial Results
Phase I

Velneperit
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Competitor Ratio Analysis
Clinical Trial Results
Phase II

Zonisamide+bupropion
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Competitor Ratio Analysis
Clinical Trial Results
Phase IIb
Post hoc analyses
Phase IIb results at 48 weeks
Phase IIb results at 24 weeks
PHASE I/II

BMS-830216
Mode of Action
Current Status
Proof of Concept/Clinical Data

Obinepitide
Mode of Action
Current Status
Proof of Concept/Clinical Data
Development Risks
Company Expertise
Competition within the Market-place
Patents
Clinical Trial Results
Phase I/II

METHODOLOGY
Competitor Ratio Analysis Criteria

List of Tables
Competitor Ratio Analysis Summary
Drugs in Clinical Development for Obesity
Relative Risks of Health Problems Associated with Obesity
The Benefits of 10kg Weight Loss

List of Figures
Global Prevalence of Obesity, 2010
Adult Male BMI kg/m2 in Selected Countries, 2010 (%)
Adult Female BMI kg/m2 in Selected Countries, 2010 (%)
Weight Loss Achieved With Orlistat

Pharmaceutical Market Research

Will Anyone Crack the Obesity Drug Market?

Will Anyone Crack the Obesity Drug Market?

Contents

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