Obesity Drug Discoveries: what the future holds + Obesity Tracker

Date: August 22, 2007
Pages: 116
Price:
US$ 2,495.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: O848EFD41F0EN
Leaflet:

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Obesity Drug Discoveries: what the future holds + Obesity Tracker
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:
  • 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
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