Obesity has reached epidemic proportions worldwide. With 2005 estimates of approximately 1.6 billion adults (aged 15 years and over) overweight and at least 400 million adults obese, the World Health Organization predicts that by 2015, approximately 2.3 billion adults will be overweight and more than 700 million will be obese. These estimates do not even take into account a lower overweight threshold set for Asians. In the US and Canada half of all adults are likely to be obese within eight years, with only one in five people of healthy weight.
The market for weight-loss drugs in the US, Europe and Japan totalled around US$600 million in 2005, and is expected to rise globally to approximately US$2 billion by 2010. Current long-term treatments include: Abbott's Meridia/Reductil (sibutramine), a monoamine reuptake inhibitor that is approved in the US and Europe; Roche's Xenical (orlistat), a gastric lipase inhibitor that is approved in the US and Europe; and sanofi-aventis' Acomplia (rimonabant), a cannabinoid type 1 receptor blocker that is approved only in Europe.
No single major company dominates the obesity drug market, although sanofi-aventis, GSK, Merck & Co and Pfizer all have several compounds in development. The rewards are high for those who can bring effective treatments to market, but questions remain...
What are the strengths and weaknesses for current therapy approaches?
Which research approach is likely to achieve best clinical and commercial results and when are the resulting drugs likely to reach the market?
What are the development and regulatory challenges companies must overcome?
The answers to these and many other questions can be found in this new 120+ page strategic management report Obesity Drug Discoveries: What the future holds (published August 2007). The web edition of the report includes, Obesity Tracker, an online news service for those needing to monitor this developing area. The report is also available in print and pdf formats.
The race is on among competing research strategies.
Obesity offers pharmaceutical companies a marketplace characterised by rapid and continuing growth, long-term unmet clinical need and a wide prevalence profile. The recognition of obesity as a serious global issue is relatively recent, and rising concern and interest has outpaced the industry’s ability to nurture products through the lengthy regulatory process.
Health payers will have to balance the cost of obesity treatment with the very real health benefits of reducing related conditions, such as diabetes and cardiovascular disease. With pressure to contain rising drug costs, arguments about paying for this “lifestyle” illness are bound to rage.
Furthermore, patient demand for drug-based intervention, even for those with a questionable clinical need, could significantly boost the market value.
Although 25 companies have products in clinical development, much interest lies in the research and prospects of big pharma companies such as GSK, sanofi-aventis, Merck & Co and Pfizer. However, in such a fledgling market, the opportunities for innovation to win through are better than in established and more exploited therapy areas.
UNIQUE COMPETITIVE ASSESSMENT SCORE
For each product reviewed, the report provides a critical competitor ratio analysis, based on our assessment of the following five criteria:
Products analysed and their developers
Product
Developer
869682
GSK
AVE1625
sanofi-aventis
cetilistat
Alizyme/Takeda
Contrave
OREXIGEN Therapeutics
CP-945,598
Pfizer
Empatic
OREXIGEN Therapeutics
KRP-204
Kyorin
liraglutide
Novo Nordisk
lorcaserin
Arena Pharmaceuticals
OBE101
OBEcure
obinepitide
7TM Pharma
pramlintide
Amylin Pharmaceuticals
pramlintide combination therapies
Amylin Pharmaceuticals
PYY3-36
Nastech Pharmaceutical
Qnexa
VIVUS
S-2367
Shionogi
SLV319
Solvay/BMS
taranabant
Merck & Co
tesofensine
NeuroSearch
The market for weight-loss drugs in the US, Europe and Japan totalled around US$600 million in 2005, and is expected to rise globally to approximately US$2 billion by 2010. Current long-term treatments include: Abbott's Meridia/Reductil (sibutramine), a monoamine reuptake inhibitor that is approved in the US and Europe; Roche's Xenical (orlistat), a gastric lipase inhibitor that is approved in the US and Europe; and sanofi-aventis' Acomplia (rimonabant), a cannabinoid type 1 receptor blocker that is approved only in Europe.
No single major company dominates the obesity drug market, although sanofi-aventis, GSK, Merck & Co and Pfizer all have several compounds in development. The rewards are high for those who can bring effective treatments to market, but questions remain...
What are the strengths and weaknesses for current therapy approaches?
Which research approach is likely to achieve best clinical and commercial results and when are the resulting drugs likely to reach the market?
What are the development and regulatory challenges companies must overcome?
The answers to these and many other questions can be found in this new 120+ page strategic management report Obesity Drug Discoveries: What the future holds (published August 2007). The web edition of the report includes, Obesity Tracker, an online news service for those needing to monitor this developing area. The report is also available in print and pdf formats.
The race is on among competing research strategies.
Obesity offers pharmaceutical companies a marketplace characterised by rapid and continuing growth, long-term unmet clinical need and a wide prevalence profile. The recognition of obesity as a serious global issue is relatively recent, and rising concern and interest has outpaced the industry’s ability to nurture products through the lengthy regulatory process.
Health payers will have to balance the cost of obesity treatment with the very real health benefits of reducing related conditions, such as diabetes and cardiovascular disease. With pressure to contain rising drug costs, arguments about paying for this “lifestyle” illness are bound to rage.
Furthermore, patient demand for drug-based intervention, even for those with a questionable clinical need, could significantly boost the market value.
Although 25 companies have products in clinical development, much interest lies in the research and prospects of big pharma companies such as GSK, sanofi-aventis, Merck & Co and Pfizer. However, in such a fledgling market, the opportunities for innovation to win through are better than in established and more exploited therapy areas.
UNIQUE COMPETITIVE ASSESSMENT SCORE
For each product reviewed, the report provides a critical 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; and, risks associated with drug development in the therapeutic class.
Products analysed and their developers
Product
Developer
869682
GSK
AVE1625
sanofi-aventis
cetilistat
Alizyme/Takeda
Contrave
OREXIGEN Therapeutics
CP-945,598
Pfizer
Empatic
OREXIGEN Therapeutics
KRP-204
Kyorin
liraglutide
Novo Nordisk
lorcaserin
Arena Pharmaceuticals
OBE101
OBEcure
obinepitide
7TM Pharma
pramlintide
Amylin Pharmaceuticals
pramlintide combination therapies
Amylin Pharmaceuticals
PYY3-36
Nastech Pharmaceutical
Qnexa
VIVUS
S-2367
Shionogi
SLV319
Solvay/BMS
taranabant
Merck & Co
tesofensine
NeuroSearch
FOREWORD
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
KR P-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
AVE 1625
Safety Issues
Competitors
Launch Prediction
SLV 319
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
OBE 101
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
PYY 3-36
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 076
AOD 9604
Clinical Trial Data
CP-741952
CYT 009-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
CD 36
Targeting ghrelin
Vaccines
Gene therapy
RNA interference
CONCLUSIONS
SOURCES
Espicom sources
Others
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
KR P-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
AVE 1625
Safety Issues
Competitors
Launch Prediction
SLV 319
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
OBE 101
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
PYY 3-36
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 076
AOD 9604
Clinical Trial Data
CP-741952
CYT 009-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
CD 36
Targeting ghrelin
Vaccines
Gene therapy
RNA interference
CONCLUSIONS
SOURCES
Espicom sources
Others