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Reportlinker Adds R&D Trends: Obesity - 2006-2011: obesity's lean years

Thursday, May 26, 2011 General News J E 4
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NEW YORK, May 26, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

R&D Trends: Obesity - 2006–2011: obesity's lean years

http://www.reportlinker.com/p0511975/RD-Trends-Obesity----2006–2011-obesity's-lean-years.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

Introduction

Modest efficacy results and lingering safety concerns have meant that developers of obesity drugs have failed to convince regulators of their risk-benefit profiles. The continued escalation of safety requirements in the light of recent withdrawals might see another raft of discontinuations, as Datamonitor views the chances of the late-stage pipeline candidates expanding the obesity market as slim

Features and benefits

* Analyze the current obesity pipeline and identify trends that will shape its future

* Establish the minimum acceptable and target product profiles necessary for success in the obesity market

* Assess the challenges faced in treating obesity and the future direction for obesity therapy

* Provide insight into clinical trial design in obesity

Highlights

With no new approvals since rimonabant in 2006 and after the 2010 market withdrawal of sibutramine there is now only one prescription drug, Xenical (orlistat; Roche), approved for the long-term management of obesity in the US, France, Germany, Italy, Spain, and the UK. Of the five drugs that were in Phase III in 2009, all remain in development

Three Complete Response Letters issued by the FDA in 2010–11 requesting further safety information from developers indicate that a more solid clinical evidence base must be established to gain approval in obesity. This is likely to drive the trend of increasing patient enrollment numbers and trial duration for anti-obesity drugs

Antidiabetic drugs with a weight-negative profile are establishing a place in all phases of the obesity pipeline. Novo Nordisk and Eli Lilly both have glucagon-like peptide-1 agonists (GLP-1s) in development for obesity. The most advanced of which is liraglutide, in Phase III trials for obesity

Your Key questions answered

* Datamonitor's updated, comprehensive overview of the obesity pipeline

* Understand how recently issued Complete Response Letters are shaping the obesity pipeline

* Escalating regulatory demands have prevented new drug approvals and will continue to influence developmental strategy and trial design

Executive Summary

Strategic scoping and focus

Datamonitor key findings

Related reports

OVERVIEW

Catalyst

Summary

CLINICAL PIPELINE OVERVIEW

Obesity pipeline by phase

Mode of effect

Mechanisms of action

Cannabinoid receptor antagonists

Serotonergic drugs

Glucagon-like peptide 1 agonists

Company type

TARGET PRODUCT PROFILE

Xenical (orlistat; Roche)

Pivotal trial results

Target product profile versus current level of attainment

CLINICAL TRIAL DESIGN IN OBESITY

Key findings

Evolution of clinical trial design in obesity

Regulatory guidance on primary endpoints

Secondary endpoints

Clinical trial size and duration

Safety

Comparators

Typical Phase III trial

Future developments in clinical trial design

Elevated safety requirements

Alternative endpoints

THE FUTURE OF TREATMENT IN OBESITY

Patient segmentation

Combinations

Prevention

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX

Contributing experts

Conferences attended

Report methodology

To order this report:

Pathology Industry: R&D Trends: Obesity - 2006–2011: obesity's lean years

Pathology Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!

Nicolas BombourgReportlinkerEmail: nbo@reportlinker.comUS: (805)652-2626Intl: +1 805-652-2626

SOURCE Reportlinker

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