Description
Introduction
The failure of obesity therapies to meet US FDA safety demands has resulted in a series of negative regulatory responses and has prevented new approvals in obesity. This has left Xenical as the only long term therapy approved in the US and Europe. As obese patient numbers rise, Datamonitor assesses the potential of late stage pipeline products to capitalize on a growing, unmet clinical need
Features And Benefits
• In depth analysis of late stage obesity pipeline products
• Assess the impact of recently withdrawn and discontinued obesity products
• Compare pipeline products by clinical attractiveness, commercial attractiveness and satisfaction of unmet need
• Track the successes and failures of currently marketed products, and consider their future performance
Highlights
Recently issued Complete Response Letters indicate that more evidence of long-term safety must be established for New Drug Applications in obesity. Orexigen reports that the Division of Metabolic and Endocrinologic Products is planning to hold a general advisory committee on cardiovascular assessment for obesity therapeutics in 2012
Lorqess and Qnexa both have challenging paths to approval that limit their commercial attractiveness. Unresolved safety issues have been the subject of Complete Response Letters which demonstrate the US Food and Drug Administration requires evidence of minimal risk before they can be approved
Novo Nordisk is now attempting to establish a presence in obesity by developing a higher dose of liraglutide and has shown weight loss in non-diabetics. Liraglutide’s GLP-1 mechanism avoids centrally acting side-effects that have been the cause of recent drug withdrawals. Pivotal Phase III trials are scheduled to begin in Q3 2011
Your Key Questions Answered
• Datamonitor’s updated, comprehensive obesity product profiles including latest clinical data and industry developments
• Understand the underlying reasons for Contrave’s suspension and the risk posed to other pipeline drugs
• Escalating regulatory demands have prevented new drug approvals. Assess where products are falling short what they will have to do gain approval
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
MARKET DEFINITION AND OVERVIEW
Market definition
Product overview
MARKETED PRODUCT PROFILES
Xenical (orlistat; Roche)
Drug profile
Development overview
SWOT analysis
Clinical and commercial attractiveness
Other marketed drugs for obesity
Alli (orlistat; GlaxoSmithKline)
Teronac (mazindol; Novartis)
RECENTLY WITHDRAWN OR DISCONTINUED PRODUCTS
Acomplia/Zimulti (rimonabant; Sanofi)
Drug withdrawal
Implications for obesity market
Reductil/Meridia (sibutramine; Abbott)
Drug withdrawal
Implications for obesity market
Contrave (bupropion and naltrexone; Orexigen)
Suspension of development
Implications for obesity market
Development overview
PIPELINE PRODUCT PROFILES
Qnexa (phentermine and topiramate; Vivus Inc.)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Lorqess (lorcaserin; Arena Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Liraglutide (Novo Nordisk)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other drugs in development for obesity
Cametor (cetilistat; Norgine/Takeda)
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
Appendix
PharmaVitae Explorer database
Contributing experts
Conferences attended
Report methodology
