Will Anyone Crack the Obesity Drug Market?

Date: February 22, 2011
Pages: 102
Price:
US$ 2,615.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: W9747D65653EN
Leaflet:

Download PDF Leaflet

Will Anyone Crack the Obesity Drug Market?
EXECUTIVE SUMMARY

On 31st January 2011, the FDA issued a complete response letter regarding the NDA for Orexigen’s naltrexone sustained-release (SR) and bupropion SR combination, Contrave. The FDA noted concern about the cardiovascular safety of the drug used long-term in overweight and obese subjects and requested a new clinical trial.

The FDA’s decision was the latest in a series of setbacks for obesity product developers and a significant disappointment for Orexigen and its partner, Takeda, particularly since it followed a majority vote from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in December in favour of approval.

Other recent developments included the withdrawal of Abbott’s Meridia/Reductil (sibutramine) from the EU in January 2010 and from the US and Canada in October, following safety concerns. Also in October, there were negative responses from the FDA regarding the NDAs for Vivus’ Qnexa (phentermine+topiramate) and Arena Pharmaceuticals’ lorcaserin. In 2009, sanofi-aventis’ Acomplia (rimonabant) was withdrawn from the EU.

Contrave had been expected to be the first new pharmacological treatment for obesity for more than a decade and would have immediately doubled the choice of available therapies; currently the only prescription drug that remains approved for obesity in the US and EU is Roche’s Xenical (orlistat), a low-dose OTC version of which is marketed by GlaxoSmithKline as alli.

There is certainly no shortage of people who could potentially benefit from a wider choice of medicines in the battle to lose weight and maintain weight loss. Around one in three of the global adult population and more than 20 million children under five are overweight according to the World Health Organization. Around 10% of adults are obese. In the US, an estimated 44.2% of males and 48.3% of females have a body mass index (BMI) of 30 or more and are, therefore, classified as obese. While the proportion is not quite so high in European countries, there is a clear upward trend in overweight and obesity.

People who are overweight or obese have a substantially increased risk of developing chronic conditions and illnesses such as hypertension, dyslipidaemia, Type II diabetes, coronary artery disease, stroke, gall bladder disease, osteoarthritis, sleep apnoea, non-alcoholic steatohepatitis and respiratory problems, as well as cancers of the endometrium, breast, prostate and colon. The risk of premature mortality also increases with rising weight.

The battle against overweight and obesity may be seen as one of the biggest challenges facing departments of health in the 21st Century. For doctors and patients alike, the desire for safe and effective pharmacological interventions is likely to increase as lifestyle changes alone continue to fail for a growing number of people. While the market for pharmaceuticals in this segment has remained fairly static for some time, there is undoubtedly significant opportunity for growth.

Following the FDA’s decision on Orexigen’s Contrave, the question is: Will a successful obesity drug market ever develop?

Use this report to:
  • Understand the state of play with Orexigen’s Contrave
  • Review the prevalence and impact of obesity
  • Evaluate the therapeutic approaches being undertaken
  • Critically assess and compare the approach and potential of products in clinical research with our unique product scoring
Around one in three of the global adult population and more than 20 million children under five are overweight according to the World Health Organization. Around 10% of adults are obese. In the US, an estimated 44.2% of males and 48.3% of females have a body mass index (BMI) of 30 or more and are classified as obese.

Orexigen’s Contrave: possibly a new chapter – but when?
In December 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted positively in favour of Orexigen’s naltrexone sustained-release (SR) and bupropion SR combination, Contrave. The market was then surprised when the FDA did not approve the drug, asking instead for further clinical trials. If Contrave had been approved, it would have been the first new pharmacological treatment for obesity for more than a decade and would have immediately doubled the choice of available therapies; currently the only prescription drug that remains approved for obesity in the US and EU is Roche’s Xenical (orlistat), a low-dose OTC version of which is marketed by GlaxoSmithKline as alli.

Report contents summary
  • Executive summary
  • Current market
  • Future market
  • Background information
  • Product analysis by phase of development
FOREWORD

EXECUTIVE SUMMARY

MARKET ANALYSIS

CURRENT MARKET
  Sibutramine
  Rimonabant
  Orlistat
FUTURE MARKET
  Research and Development
    Endogenous Hormones
    Monoamine Neurotransmission Modulation
    Neuropeptide Signalling Modulators
    Peripheral Modulators of Metabolism
    Regulation of Fat Metabolism and Food Intake: a Novel Approach?
BACKGROUND INFORMATION
  What is Obesity?
  What Causes Obesity
  Obesity Health Risks
  Controlling Energy Balance
  Achieving Weight Loss
    Lifestyle Modifications
    Behaviour Therapy
    Pharmacotherapy
    Surgery
  Why are New Treatments Needed?
  The Prevalence of Obesity
    Childhood Obesity

PRODUCT ANALYSIS

ESTABLISHED PRODUCT
  Orlistat
    Mode of Action
    Current Status
      Approvals/Filings
      Development
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
    Low-dose Orlistat
    Xenical in Adolescents
    Diabetes Prevention in Obese Subjects
RECENTLY WITHDRAWN PRODUCT
  Sibutramine
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Clinical Trial Results

FILED PRODUCTS

  Bupropion+naltrexone
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
    Patents
    Patent Expiry
  Competitor Ratio Analysis
  Clinical Trial Results
    Contrave Obesity Research (COR)
Lorcaserin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
    Patents
    Patent Expiry
  Competitor Ratio Analysis
  Clinical Trial Results
    BLOSSOM
    BLOOM
    BLOOM-DM
    Abuse Potential
Phentermine+topiramate
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
    Patents
    Patent Expiry
  Competitor Ratio Analysis
  Clinical Trial Results
    Long-Term Date Show Significant and Sustained Weight Loss Over Two Years
    EQUIP (OB-302) and CONQUER (OB-303) Obesity Studies
    EQUATE Obesity Study
    Sleep Apnoea Phase II Study
PHASE III
  Cetilistat
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
    Competitor Ratio Analysis
    Clinical Trial Results
      Phase IIb
Liraglutide
  Mode of Action
  Current Status
    Approvals/Filings
    Development
  Proof of Concept/Clinical Data
    Diabetes
    Obesity
  Development Risks
  Company Expertise
  Competition within the Market-place
  Data Exclusivity
    Patent Expiry
  Competitor Ratio Analysis
  Clinical Trial Results
  Type II Diabetes
PHASE II
  Betahistine
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
      Patents
    Competitor Ratio Analysis
    Clinical Trial Results
      BET 209
      Obesity
  Pramlintide+metreleptin
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
    Competitor Ratio Analysis
    Clinical Trial Results
      Phase II
  SLx-4090
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
    Competitor Ratio Analysis
    Clinical Trial Results
      Phase II - Dyslipidaemia
      Phase I - Dyslipidaemia
      Phase I - Safety and Tolerability
  Tesofensine
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
    Competitor Ratio Analysis
    Clinical Trial Results
      TIPO-5
      TIPO-4
      TIPO-2
      TIPO-1
    Cardiovascular Safety Study
  TM30339
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
      Patents
    Clinical Trial Results
      Phase I
  Velneperit
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
    Competitor Ratio Analysis
    Clinical Trial Results
      Phase II
  Zonisamide+bupropion
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
      Patents
    Competitor Ratio Analysis
    Clinical Trial Results
      Phase IIb
      Post hoc analyses
      Phase IIb results at 48 weeks
      Phase IIb results at 24 weeks
  PHASE I/II
    BMS-830216
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
        Obinepitide
    Mode of Action
    Current Status
    Proof of Concept/Clinical Data
    Development Risks
    Company Expertise
    Competition within the Market-place
      Patents
    Clinical Trial Results
      Phase I/II

METHODOLOGY

Competitor Ratio Analysis Criteria

LIST OF TABLES

Competitor Ratio Analysis Summary
Drugs in Clinical Development for Obesity
Relative Risks of Health Problems Associated with Obesity
The Benefits of 10kg Weight Loss

LIST OF FIGURES

Global Prevalence of Obesity, 2010
Adult Male BMI kg/m2 in Selected Countries, 2010 (%)
Adult Female BMI kg/m2 in Selected Countries, 2010 (%)
Weight Loss Achieved With Orlistat
Skip to top


World Anti-Obesity Drug Market 2011-2021 US$ 2,325.00 Feb, 2011 · 209 pages
Obesity Drug Discoveries: what the future holds US$ 1,740.00 Aug, 2007 · 116 pages
Global Obesity Drug Market Analysis US$ 1,000.00 Jun, 2011 · 85 pages
Anti-Obesity Drugs: Market Research Report US$ 4,950.00 Jan, 2014 · 135 pages

Ask Your Question

Will Anyone Crack the Obesity Drug Market?
Company name*:
Contact person*:
Phone/fax*:
Email*:
Request invoice
Your enquiry:
Please click on a Check Box below to confirm you are not a robot: