Pipeline and Commercial Insight: Obesity The $11 Billion Market That Never Was

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1 Pipeline and Commercial Insight: Obesity The $11 Billion Market That Never Was Report summary Defines the key clinical characteristics of the obesity sector that present a unique commercial challenge Understand why predictions for this market have been repeatedly over-stated Translation of critical clinical and regulatory issues into pertinent practical considerations for both incumbent players and new market entrants Clinical and commercial analysis of existing and late stage products targeting the sector, qualified by key opinion leader interview Seven major market forecasts for key products to 2018

2 About this report Introduction The obesity market is easily characterized as attractive, featuring a booming patient potential needing long term therapy, but repeated product withdrawals and failed pipeline candidates highlight the reality of increasingly cautious regulatory bodies, reluctant payers, and a clinical community that puts more stock in diet and exercise: $513.7m sales in 2008 fall far short of analyst prediction. Datamonitor forecasts the obesity sector to wane further to $300m by Datamonitor envisages new products having to fight for approval, commercial support, and existing prescriptions, rather than dramatically expanding the proportions of obese individuals treated with prescription drugs. If successful, they may help to revive the market to just under $560m by Key findings and highlights The 125 million obese adults in 2008 across the US, Japan, France, Germany, Italy, Spain and UK will grow to at least 143 million by If just 25 per cent of these adults were treated for one year with a dollar per day product, achieving 80 per cent compliance rates, market potential would rise from $8.6 billion in 2008 to $10.5 billion in There may be some advantages to exploring head-to-head trials of existing therapies, the combination use of drugs or demonstrating longer term improvements to cardiovascular risks, but in the current environment this is unlikely to expand the proportion of the obese population in which existing and late stage pipeline products will be used. GSK s Alli failed to sustain US launch sales, Sanofi-Aventis Acomplia has been withdrawn. 27 clinical pipeline products discontinued between publication of this report and its predecessor (2006) have cost at least $1.1 billion in trial costs alone. Some developers will be facing administration or liquidation rather than arranging partnering deals. Reasons to buy Understand why predictions for this market have been repeatedly over-stated Qualify market expectations against the practicalities of targeting this unyielding market Assess the qualities of marketed and pipeline products and their commercial handling to determine their realistic prospects You can treat [obesity] in a short time if you find the adequate silver bullet, but the silver bullet will not reach us just by doing exactly what everybody else has been doing for the last thirty years, they have to think of something else Key Opinion Leader

3 Sample pages Current market overview Pipeline Analysis & Forecasts Five major European markets current and future market assessment The five major European markets (5EU; France, Germany, Italy, Spain and the UK) have come to represent an increasingly important source of obesity market revenues over the period, growing from a 43% share of sales in the seven major markets (US, Japan, and the five major European markets) to 53% in However, two features of this region make it particularly interesting: its volatility, and the relative and absolute contributions of its constituent states. the drug, and results will have to compensate for the NB-302 outcomes. However, they have the potential to demonstrate Contrave s applicability to a broad range of clinical settings. Phase III trials Figure 41: Contrave Phase III trial plan overview Figure 17: Historical and forecast obesity market performance in the five major European markets by volume and value, Source: forecast = Datamonitor; 2008 sales data from MIDAS, IMS Health, April 2009, Copyright, reprinted with Source: Thomson Pharma, 2009; Datamonitor D A T A M O N I T O R permission D A T A M O N I T O R Pipeline & Commercial Insight: Obesity DMHC2505 Datamonitor (Published 07/2009) Page 73 This report is a licensed product and is not to be photocopied Pipeline & Commercial Insight: Obesity DMHC2505 Datamonitor (Published 07/2009) Page 180 This report is a licensed product and is not to be photocopied Contact our customer service team for more sample pages... Europe tel: fax: reports@datamonitor.com Americas tel: fax: reports@datamonitor.com Middle East tel: fax: reports@datamonitor.com Asia Pacific tel: fax: reports@datamonitor.com

4 Table of contents ABOUT DATAMONITOR HEALTHCARE BRAND DYNAMICS About the cardiovascular analysis team EXECUTIVE SUMMARY Strategic scoping and focus Datamonitor insight into the obesity market Related current reports Related future reports OBESITY MARKET POTENTIAL Key findings Definition Patient segmentation Epidemiology Current treatment options - Collective obesity management - Pharmacological interventions as components of personalized programs Unmet need in obesity - Safety - Efficacy - Compliance CURRENT MARKET OVERVIEW Seven major market current and future market overview - Impact of recent launches has been short-lived - Imminent slowdown cannot be blamed on generics - US remains core market, Europe sees greatest fluctuations, and Japanese revenues are negligible Environmental factors in the obesity market - Obesity products go over-the-counter - Is late-stage and post-marketing trial design due for an overhaul? - Defining acceptable risk means demonstrating acceptable gain - Increasing patient potential works against expensive interventions US current and future market assessment Japan current and future market assessment Five major European markets current and future market assessment - France - Germany - Italy - Spain - UK Overview of competitive landscape Drivers of brand choice Trends in marketing strategy: Xenical and Alli - Product - Pricing - Placement - Promotion Xenical (orlistat, Roche) Alli (orlistat, GlaxoSmithKline) Reductil/Meridia (sibutramine, Abbott) Sanorex/Teronac (mazindol, Sandoz) Acomplia/Zimulti (rimonabant, Sanofi-Aventis) R&D APPROACH Key findings Clinical trial design in obesity - Safety - Efficacy, endpoints and outcomes - Comparators - Future direction PIPELINE ANALYSIS & FORECASTS Key findings Overview - Pipeline summary - Comparative forecasts Comparator tool comparisons - Clinical factors

5 Table of contents (continued) - Commercial factors Contrave (bupropion and naltrexone, Orexigen) Qnexa (phentermine and topiramate, Vivus Inc.) Lorcaserin (Arena Pharmaceuticals) Cetilistat, Alizyme Plc Other drugs BIBLIOGRAPHY Journal papers Presentations Website information Reports Books Datamonitor reports APPENDIX A - MARKET ASSUMPTIONS APPENDIX B Contributing experts Report methodology About Datamonitor - About Datamonitor Healthcare - About the Cardiovascular Disease analysis team - Disclaimer LIST OF TABLES Table 1: World Health Organization classification of obesity Table 2: Projected and forecast adult obesity prevalence (million) in the seven major markets, Table 3: Projected and forecast adult obesity prevalence rate in the seven major markets, Table 4: Predicted UK prevalence of childhood obesity by gender, Table 5: Summary of selected guidelines for obesity interventions, 2009 Table 6: Examples of obesity-associated co-morbidities Table 7: Historical and forecast obesity market performance in the seven major markets by volume and value, Table 8: Historical and forecast obesity market performance by region in the seven major markets, Table 9: Sales and growth of drug classes and/or brands for obesity in the seven major markets, Table 10: Sales forecasts for obesity in the seven major markets ($m), Table 11: Summary of opportunities and threats for the obesity market, 2009 Table 12: Expected remaining lifetime healthcare costs - obese, healthy living and smoking adults, 2009 Table 13: Sales forecasts for obesity in the US ($m), Table 14: Sales forecasts for obesity in Japan ($m), Table 15: Historical and forecast obesity market performance in the five major European markets by country and value, Table 16: Historical and forecast obesity market share (%) in the five major European markets by value, 2004, 2008 and 2018 Table 17: Obesity prevalence versus volume and value sales across the five major European markets, 2008 Table 18: Sales forecasts ($m) for obesity in the five major European markets, Table 19: Sales forecasts for obesity in France ($m), Table 20: Sales forecasts for obesity in Germany ($m), Table 21: Sales forecasts for obesity in Italy ($m), Table 22: Sales forecasts for obesity in Spain($m), Table 23: Specific advice on obesity drug use, National Institute for Health & Clinical Evidence Quick Reference Guide for the National Health Service Table 24: Sales forecasts for obesity in the UK ($m), Table 25: Key branded drugs indicated for obesity, 2009 Table 26: Brand dynamics of key marketed drugs for the treatment of obesity in the seven major markets, Table 27: US formulary status for key brands for the treatment of obesity, 2009 Table 28: Contraindications, cautions, adverse reactions and drug interactions - orlistat, sibutramine and phentermine For a full list of tables and figures please refer to

6 Interested in this topic? Highlighting latest market trends and new commercial opportunities, Datamonitor s Cardiovascular portfolio features detailed analysis of development pipelines, current and future market dynamics, patient potential, treatment patterns, and strategic issues. Cardiovascular Risk Factors (hypertension, dyslipidemia, secondary prevention) Cardiovascular Disease (arrhythmia, heart failure) Thrombosis Diabetology Other reports in this series Stakeholder Opinions: Commercial Strategies in Cardiovascular and Metabolic Diseases Successful Market Positioning at Company and Brand Level Becomes Paramount Analysis of company and brand marketing positioning, drug development pipeline sourcing, post-launch strategies and methods of minimizing the impact of generic erosion. Published: Apr-09 Code: DMHC2500 Commercial Insight: Cardiovascular and Metabolic Market Overview Diabetes to the Fore as Generics Hit Primary Care Markets In-depth review of the cardiovascular and metabolic markets, including an analysis of key prescription trends in the main therapy areas between 2004 and 2017, commercial prospects of new agents and sales forecasts to Published: Feb-09 Code: DMHC2420 Pipeline and Commercial Insight: Nicotine Dependence Chantix Issues Overshadow Vaccine Potential This report provides full analysis of the current and future prescription nicotine dependence market, with forecasts to 2018 of current drugs and key pipeline products in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK). Published: Mar-09 Code: DMHC2482 Forecast Insight: Epilepsy Future Market Upgrade Following New Drug Launches Provides analysis of key events and their impact on the epilepsy market since Includes an event-based, indication- and country-specific 10 year forecast of key marketed, generic, and key pipeline products to 2017 in the seven major markets. Published: Dec-08 Code: DMHC2462 For more information about these products or to browse and purchase from our huge range of research please visit. Contact our customer service team today... Europe tel: fax: reports@datamonitor.com Americas tel: fax: reports@datamonitor.com Middle East tel: fax: reports@datamonitor.com Asia Pacific tel: fax: reports@datamonitor.com

7 Place your order now... 1) Confirm the licence type you require Pipeline and Commercial Insight: Obesity The $11 Billion Market That Never Was Single user licence Muli-user licence (Please refer to for up-to-date prices) 2) Complete your details 3) Complete your payment details Title Mr / Mrs / Ms (delete as appropriate) Name... Job Title... Department... Company... Address... City... State/Province... Post Code/ZIP... Country Telephone... Datamonitor products and services are supplied under Datamonitor s standard terms and conditions, copies of which are available on request. Payment must be received within 28 days of receipt of invoice. I do not want to receive future mailings from Datamonitor and its related companies. I do not wish to receive phone calls from Datamonitor. Occasionally, our client list is made available to other companies for carefully selected mailings. Please check here if you do not wish to receive such mailings. What is your preferred currency option? UK Euro US$ Yen How would you like to pay? I enclose a check payable to Datamonitor plc for... Please invoice my company for... Please debit my credit/charge card Amex Visa Mastercard Card no.... Expiry Date... /... Cardholder signiture... Cardholder address Please supply purchase order number (if required)... If you are an EU company (except UK) please supply your VAT / BTW / MOMS / MWST / IVA / FPA number... 4) Sign below to confirm you order X... Date... 5) Fax this completed form back (Europe) (Americas) (Middle East) (Asia Pacific) Alternatively you can scan and this form to reports@datamonitor.com

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