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  4. > A Strategic Analysis of the Global Anti-obesity Prescription Pharmaceuticals Market

Prescription drug therapy for the treatment of obesity is experiencing a revival of interest with new government incentives and the recent approval of 2 new drugs, with 2 more pending imminent approval. This research service focuses on the competitive landscape of prescription drugs for the treatment of obesity. A global product and pipeline assessment is provided for marketed and investigational products. Segmentation by drug class is provided along with additional supporting information, such as clinical-trial timelines and results, historical and projected launch timelines, regulatory guidelines for clinical trial design and approval, and global epidemiology by region.

Executive Summary

The FDA recently approved 2 new prescription obesity treatments: Arena
Pharmaceuticals’ Belviq (partnered with Eisai) launched in June 2013, and Vivus’ Qsymia,
which became available September 2012. These FDA approvals—the first for obesity in
more than a decade—add new therapeutic options to a market previously comprising a
single approved drug: Roche’s Xenical.

A third new drug, Orexigen’s Contrave, is pending FDA approval upon successful
demonstration of cardiac safety in an ongoing trial for cardiovascular outcomes and
resubmission of the new drug application (NDA) in December 2013. A decision is
expected from the FDA June 10, 2014, and in the second half of 2014 from the EMA.
o All three of these new drugs were initially rejected by the FDA, which sought additional
confirmation of an acceptable safety profile.

Approval of the obesity indication for Novo Nordisk’s Victoza (liraglutide) could come as
soon as mid-2014, closely coinciding with the potential approval of Contrave.

Market uptake of Qsymia and Belviq has been below expectations, largely due to
insurance reimbursement hurdles and possibly because of physician and patient concerns
about safety. Contrave, if approved, may have better uptake in light of its designation as
an uncontrolled substance and stronger marketing capabilities of partner Takeda,
particularly to the primary care and diabetes communities.
Global medical and regulatory communities recognize the urgent need for the
pharmacotherapeutic treatment of obesity when lifestyle interventions fail to adequately
address excess body fat.

While numerous sympathomimetic amine anorectics such as phentermine,
benzphetamine, and diethylpropion are available by prescription, association with serious
side effects limits their use, and prescribing is mainly limited to bariatric surgeons.

The global market potential for safe and effective obesity therapies is significant; however,
the discovery and development of efficacious weight-loss drugs that are safe enough for
chronic use has proved challenging for even the most capable pharmaceutical and biotech

Ongoing research efforts are beginning to shed new light on the pathology of obesity, as
recent discoveries of differential gene expression and genetic variants found in the
different fat depots advance our understanding of why abdominal fat is more strongly
associated with morbidity and mortality compared with subcutaneous adipose tissue.
Discoveries such as these could eventually lead to targeted therapies aimed at reducing
visceral adiposity.

Table Of Contents

A Strategic Analysis of the Global Anti-obesity Prescription Pharmaceuticals Market
Table of Contents

Executive Summary 5
Market Developments Since Q1 2013 6
Executive Summary 7
Drug Discovery Partnerships 9
Companies to Watch 11
Methodology and Scope 12
Introduction to the Global Anti-obesity Prescription Drugs Market 14
Obesity Indication Background 15
Historical and Projected Timeline for Anti-obesity Drugs 18
Potential Prescribing Behavior Scenario 19
Regulators' Recommendations for Designing Anti-obesity Drug Clinical Trials 20
Regional Comparison of Drug Approval Requirements 21
Global Prevalence of Obesity by Region 22
Market Overview—Segmentation 24
Competitive Landscape 25
Anti-obesity Prescription Pharmaceuticals Market—Competitive Landscape 26
Ongoing Phase 3 Trials for Obesity Drugs 27
Ongoing Post-marketing Trials for Obesity Drugs 28
Comparative Efficacy of Obesity Drugs 29
Pivotal Trial Programs of Recently Approved Anti-obesity Drugs 31
Pivotal Trial Programs of Late-stage Anti-obesity Drugs 32
Marketed Products Synopsis 34
Pipeline Synopsis 37
Product Dashboard—Qsymia (phentermine/topiramat ER) 43
Product Dashboard—Belviq (lorcaserin HCl) 44
Product Dashboard—Contrave (bupropion SR/ naltrexone SR) 45
Product Dashboard—Victoza (liraglutide) 46
Conclusions and Recommendations 47
Conclusions and Recommendations 48
Legal Disclaimer 50
Appendix 51
Decision Support Database—Global Prevalence of Obesity 52
List of References 56
The Frost and Sullivan Story 57

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