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Advances in the Obesity Market

  • September 2013
  • -
  • Espicom Business Intelligence
  • -
  • 60 pages

In July 2011, the American Association of Clinical Endocrinologists (AACE) reclassified obesity as a diseased state, not a condition, in order to move it up the US healthcare agenda. In 2012, the FDA reviewed its stance on anti-obesity products and approved two new products that were previously declined.

As it stands, there are over 40 medicines currently approved or used off label to treat obesity, in addition there are more than 20 innovative products in clinical development. This new report examines the latest products and devices in development and compares them to those currently available, gathering opinions from key industry leaders to highlight the fast-moving changes that are affecting this profit potential market.


This report provides you with a detailed analysis and key opinions on the current and future obesity market...

Detailed review of the current obesity market, answering ‘Where are we now?’ for both established and emerging economies
Comprehensive insight into newly approved pharmaceuticals and medical devices, analysing how they compare to established brands
Assessment of key products and devices in development, identifying ‘Ones to Watch’ in late-stage clinical development
Reviews of products and devices that are ‘Waiting in the Wings’ in early-stage clinical development where PoC data is being gathered
Analyses of potential ‘Long Shots’ representing new and innovative products where the rationale has yet to be fully tested.
This report provides a comprehensive overview of existing anti-obesity therapies and surgical interventions. It provides a systematic appraisal of each market segment highlighting both the leading players and new entrants. The report includes thoughts from key opinion leaders across the globe to find out where the key challenges and opportunities exist for both pharma and medical device manufacturers.


Answering critical questions...

Why is obesity important to the pharmaceutical industry, why now?
What issues have been faced in the past and how can this be avoided for the future?
How does Xenical stack up against Belviq?
Have GLP-1 analogues got what it takes to treat obesity?
Will Arrowhead Research’s adipotide promote weight loss and reduce the symptoms of diabetes in the clinic?
Is gastric banding still popular among surgeons and obese patients?
What opportunities exist for the introduction of intragastric balloons in the US?
Will J&J remain the leading medical devices company for the foreseeable future?
Can BAROnova’s TransPyloric Shuttle fill the gap between pharmacotherapy and interventional surgery?


About the Author

Dr Cheryl L Barton is an independent consultant with over 16 years of research and business analysis experience. Following her research positions in academia and seven years with Merck, Dr Barton joined investment bank ABN Amro NV as a senior equity analyst to provide coverage on pan-European companies, and assess the potential impact of new drug development on European stocks. In 2002, Dr Barton founded PharmaVision to provide independent, tailor-made life science and consumer health research. For Espicom she has authored a number of business and strategy titles.


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Table Of Contents

Advances in the Obesity Market
Contents

SCOPE OF THE REPORT 1
CATALYST 2
AbOuTTHE AuTHOR 3
SECTION 1: WHY IS ObESITY IMPORTANT, WHY NOW? 4
Introduction -where are we now? 4
Obesity has infiltrated every continent in the world 4
More than 40 million children are overweight 4
Obesity rates have doubled, if not tripled during the last 25 years 6
brazil's Ministry of Health published new guidelines on the prevention and treatment of obesity 6
Childhood obesity is even more common in Russia than in the States 6
Indians at higher risk of cardio-metabolic disease at lower bMI than Caucasians 6
A fifth of China's children are overweight 7
Obesity is the greatest challenge to health this century 7
Reclassification of obesity will stimulate demand 7
Reimbursement has stifled growth but uS health insurers will have to rethink medical polices 8
Reclassification to stimulate pharma investment 8
CuRRENTPHARMACOLOgICALINTERvENTIONS 9
Anti-obesity drugs have been plagued by safety issues 10
New developments spark hope 11
Has Xenical lived up to market expectations? 11
When will generic orilstat enter the scene? 11
How does Xenical stack up against belviq? 12
How does Qsymia stack up against belviq? 12
ANTI-ObESITY - MARkETFORECASTS 14
NEW dRugSONTHE bLOCk 15
APPROACH 1: ANOREXIgENICPEPTIdEANALOguESANd MOduLATORS 16
Drug type 1: GLP-1 analogues and agonists 16
ONESTOWATCH 17
Liraglutide (Novo Nordisk) 17
WAITINg INTHEWINgS 18
Exenatide (Bristol-Myers Squibb/Eli Lilly) 18
LONg SHOTS 19
TT-401 (Eli Lilly/Transition Therapeutics) 19
ZP2929 (Zealand Pharma/Boehringer Ingelheim) 19
ZYOG1 (Zydus Cadila) 19
APPROACH 1: ANOREXIgENICPEPTIdEANALOguESANd MOduLATORS 20
Drug type II: Neuropeptide modulators 20
ONESTOWATCH 21
Empatic (Orexigen Therapeutics) 21
WAITINg INTHEWINgS 22
Velneperit (Shionogi) 22
LONg SHOTS 23
BMS-830216 (Bristol-Myers Squibb) 23
APPROACH 2: NEuROMOduLATORSANd METAbOLICMOduLATORS 24
Monoamine modulators 24
ONESTOWATCH 25
Contrave (Orexigen Therapeutics/Takeda) 25
WAITINg INTHEWINgS 26
Tesofensine (NeuroSearch) 26
APPROACH 2: NEuROMOduLATORSANd METAbOLICMOduLATORS 27
Metabolic modulators 27
ONESTOWATCH 28
Cetilistat (Takeda) 28
WAITINg INTHEWINgS 29
Beloranib (Zafgen) 29
LONg SHOTS 30
Adipotide (Arrowhead Research) 30
NEWANTI-ObESITYAgENTS - CONCLuSIONS 31
SECTION 2: MEdICAL dEvICES TARgET THE TREATMENT gAP 32
Bariatric surgery targets the morbidly obese 32
The number of weight loss procedures continues to rise on an annual basis 32
by-pass surgery provides consistent weight loss but is a more aggressive weight loss strategy 33
gastric banding is gaining popularity in the uS and Europe 34
Latin America has started to offers affordable gastric band surgery 34
New opportunities for intragastric balloons in the uS 35
Case study: ReShape duo (ReShape Medical) 35
The balloon is a tool to enhance behavioural changes to food consumption 35
bariatric surgeons are interested in Igbs for weight staging 35
ReShape duo is being positioned to fill the treatment gap in the uS 36
JandJ remains the leading medical device despite lawsuits and patent challenges 36
but why is Allergan considering moving out of the obesity intervention business? 37
NEW dEvICESONTHE bLOCk 38
APPROACH 1: NON-SuRgICALANTI-ObESITY dEvICES 39
ONESTOWATCH 40
Endobarrier (GI Dynamics) 40
gI dynamics is causing a stir with Medtronic and glaxoSmithkline 40
Endobarrier to target obese patients with type II diabetes 40
WAITINg INTHEWINgS 42
TransPyloric Shuttle (BAROnova) 42
APPROACH 2: MINIMALLYINvASIvE dEvICES 43
Neuromodulatory devices 43
ONESTOWATCH 44
Abiliti (IntraPace) 44
Pivotal data due to be releases 2H13 44
WAITINg INTHEWINgS 45
VBLOC (EnteroMedics) 45
Mixed data with vbLOC excellent safety but failed to meet primary endpoint 45
vbLOC has positive effects on diabetics and hypertensives 45
FdA approval expected 1H14 46
LONg SHOTS 47
ANTI-ObESITY dEvICES - MARkETFORECASTS 48
OuTLOOk FORObESITY 49
APPENdIX 1 50
Liraglutide trial data 50
Phase II study 50
Phase III LEAd programme 50
Phase IIIa SCALE trial 50
APPENdIX 2 51
Velneperit clinical data 51
APPENdIX 3 53
Contrave clinical studies 53
The Light Study 53
The Ignite Study 53
APPENdIX 4 54
Tesofensine clinical data 54
APPENdIX 5 55
Cetilistat clinical data 55
APPENdIX 6 56
Beloranib clinical data 56
METHOdOLOgY 57
Primary research 57
Secondary research 57
ACRONYMS 58
REFERENCES 59



List of tabLes

Table 1: Classification system for obesity 4
Table 2: Anti-obesity drugs withdrawn from the market 10
Table 3: Approved anti-obesity drugs 11
Table 4: Anti-obesity approved drugs sales forecasts, 2011-2017 14
Table 5: GLP-1 analogues and GLP agonists in clinical development 16
Table 6: Primary endpoint data for Phase IIIa SCALE trial 17
Table 7: Neuropeptides modulators in clinical development 20
Table 8: Monoamine modulators in clinical development 24
Table 9: Metabolic modulators in clinical development 27
Table 10: Clinical data for Phase I beloranib study in obese females 29
Table 11: Commonly applied bariatric techniques 33
Table 12: Anti-obesity leading devices sales forecast, 2011-2017 48



List of Charts

Figure 1: Prevalence of overweight and obesity in males 15yr and older, 2010 6
Figure 2: Prevalence of overweight and obesity in females 15yr and older, 2010 6
Figure 3: Obesity is a complex multifactorial disease 10
Figure 4: JandJ medical device division sales, 2013 37
Figure 5: Global obese patient population with type II diabetes, 2013 42

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