Obesity Drug Discoveries: what the future holds + Obesity Tracker

Publication Date	August 2007
Publisher	Espicom
Product Type	Report
Pages	116
ISBN Number	978-1-85822-294-3
Product Code	ESP00348

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Summary

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). In addition, for those needing to monitor this developing area there is the Obesity Tracker, an online news service available for customers buying the web edition of the report.
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

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.

Content

Executive summaryWhat 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 developmentlorcaserin
  - 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
  - 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 p rogrammes
  - 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 f uture 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