Obesity Drug Discoveries: what the future holds

Published by: Espicom Healthcare Intelligence

Published: Aug. 22, 2007 - 116 Pages

Table of Contents

FOREWARD

EXECUTIVE SUMMARY

WHAT IS OBESITY

Defining obesity

What causes obesity?

What effects does obesity have?

Figure 1: Effects of obesity on health

Table 1. Relative risks of health problems associated with obesity

The scale of the problem

Prevalence.of.obesity

Figure 2. Estimated global prevalence of obesity

Highest prevalence of obesity

Prevalence in the US

Prevalence in the UK

Prevalence in Europe

Prevalence in Asia

Prevalence in developing countries

Figure 3. Percentage of households having both underweight and overweight members in seven countries

Figure 4. Country comparison - percentage of adults with normal BMI

childhood.and.future.obesity

Figure 5. Percentage of population that is overweight

Figure 6. Predicted prevalence of obesity by 2025

The economic burden

US

UK

Europe

Developing Countries

THE OBESITY THERAPY MARKET

Competitor ratio analysis

Table 2. Competitor ratio analysis summary

OBESITY MANAGEMENT

Controlling energy balance

Achieving weight loss

Table 3. The benefits of a 10kg weight loss

Lifestyle modifications

Behaviour therapy

Pharmacotherapy

Surgery

Approved drugs for obesity management

Table 4. History of drug treatments for obesity

Table 5. Anti-obesity drugs approved for short-term use

Table 6. Anti-obesity drugs approved for long-term use

acomplia

Approval History

Key Markets

Key Agreements

Clinical Trial Data

Safety Issues

Further Development

Sales

Sales Forecast

Figure 7. Acomplia reported and projected sales, 2006A-2012E (EUR million)

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

meridia/reductil

Approval History

Key Markets

Key Agreements

Clinical Trial Data

Table 7. Percentage change in subject's body weight at varying doses of sibutramine

Table 8. Health profile of subjects losing at least 5 per cent of body weight

Safety Issues

Further Development

xenical/alli

Approval History

Key Markets

Key Agreements

Patent History

Clinical Trial Data

Safety Issues

Further Development

Sales

Sales Forecast

Figure 8. Reported and projected sales of Xenical 2001A-2011E

Regulatory authority guidelines for drug approval

Approval for additional indications

Potential new drugs

Table 9. Novel drugs in development by Phase

Table 10. Novel drugs in development by company

DRUGS IN CLINICAL DEVELOPMENT

Figure 9. Estimated launch dates for profiled drugs

Beta3 adrenergic receptor modulators

Table 11. Beta3 adrenergic receptor modulators in development

krP-204.(n-5984)

Safety Issues

Competitors

Launch Prediction

Cannabinoid receptor modulators

Table 12. Cannabinoid receptor modulators in development:

cP-945,598

Safety Issues

Competitors

Launch Prediction

taranabant

Safety Issues

Competitors

Launch Prediction

ave1625

Safety Issues

Competitors

Launch Prediction

slv319

Key Agreements

Safety Issues

Competitors

Launch Prediction

Digestive inhibitors/lipid metabolism modulators

Table 13. Digestive inhibitors/lipid metabolism modulators in development

cetilistat

Key Agreements

Clinical Trial Data

Safety Issues

Further Developments

Launch Prediction

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

869682

Safety Issues

Competitors

Launch Prediction

Histaminergic system modulators

Table 14. Histaminergic system modulators in development

obe101

Table 15. Properties of OBE101 and histamine compared

Key Agreements

Clinical Trial Data

Safety Issues

Table 16. Adverse effects of OBE101 when compared to anti-obesity medications currently in use

Patent History

Further Development

Competitors

Launch Prediction

Hormone analogues

Table 17. Hormone analogues in development

pramlintide

Clinical Trial Data

Further Development

Safety Issues

Launch Prediction

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

liraglutide

Clinical Trial Data

Safety Issues

Launch Prediction

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

obinepitide

Patent History

Clinical Trial Data

Further Development

Safety Issues

Competitors

Launch Prediction

Pyy3-36

Key Agreements

Patent History

Clinical Trial Data

Further Development

Safety Issues

Competitors

Launch Prediction

Monoamine reuptake inhibitors/5-HT receptor modulators

Table 18. Monoamine reuptake inhibitors/5-HT receptor modulators in development

lorcaserin

Patent History

Clinical Trial Data

Table 19. Incidence of FDA-defined valvulopathy

Further Development

Safety Issues

Launch Prediction

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

tesofensine

Clinical Trial Data

Further Development

Safety Issues

Launch Prediction

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

Neuropeptide receptor modulators

Table 20. Neuropeptide receptor modulators in development

s-2367

Clinical Trial Data

Safety Issues

Launch Prediction

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

Combination drugs

Table 21. Combination drugs in development

contrave

Patent History

Clinical Trial Data

Further Developments

Safety Issues

Launch Prediction

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

Qnexa

Clinical Trial Data

Further Development

Safety Issues

Launch Prediction

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

pramlintide+phentermine/sibutramine

Safety Issues

Competitors

Launch Prediction

empatic

Patent History

Clinical Trial Data

Table 22. Percentage change in body weight at week 24

Safety Issues

Launch Prediction

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

RECENTLY-TERMINATED PROGRAMMES

amg

aod9604

Clinical Trial Data

cP-741952

cyt009-ghrQb

Clinical Trial Data

oleoyl-estrone

Patent History

Clinical Trial Data

Further Development

PF-431499

THE FUTURE OF OBESITY TREATMENT

Towards an all-encompassing cure; targeting the metabolic syndrome?

Recent advances and future developments

cd36

targeting.ghrelin

vaccines

gene.therapy

rna.interference

CONCLUSIONS

SOURCES

Espicom sources

Others

Abstract

While only recently identified as a major health concern, obesity levels have been growing steadily and the condition threatens to rank among the biggest causes of premature death in both the industrialised and emerging economies. With only three products approved worldwide for long-term treatment, and growing unmet clinical need, the treatment of obesity could present a major opportunity area for pharma companies.

Key areas addressed

• Sales forecasts for major launched products
• Obesity prevalence and trends
• Detailed appraisal of 20 therapies in research
• Estimation of launch

Emerging trends and developments

• Focus on leading strategies
• Beta3 adrenergic receptor modulators
• Cannabinoid receptor modulators
• Digestive inhibitors/lipid metabolism modulators
• Histaminergic system modulators
• Hormone analogues
• Monoamine reuptake inhibitors/5-HT receptor modulators
• Neuropeptide receptor modulators
• Combination therapies.

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