Printer Friendly Printed from http://www.researchandmarkets.com/reports/58455 Stakeholder Opinions: Community Acquired Respiratory Tract Infections - Room for Ketek? Description: Introduction Aventis' novel antibacterial Ketek is the first in a new class, the ketolides. It has already been launched in a number of European regions but is yet to achieve FDA approval in the US. However, this is anticipated early in 2004. The use of this product and its eventual success will depend heavily on physician perception of this product, with safety and its potential for pediatric use being key. Scope -Analysis based on interviews with key opinion leaders in the major markets -Community respiratory tract infection (RTI) market definition and assessment of relative importance to total antibacterial sector -Individual RTI therapies are compared, with an assessment of presentation routes and referral patterns and their impact on treatment decisions -In-depth evaluation of the potential of the new ketolide class and most notably Aventis’s Ketek Report Highlights Respiratory tract infections led to 174,000 deaths in Europe and 3.8 million worldwide, accounting for 6% of the global and 1.3% of European disease burden (World Health Report, 2003). As a result, RTIs are responsible for the most significant proportion of community-based antibacterial prescriptions in Europe (36% - IMS Health, 2003). While the majority of RTI patients initially present to their GP/PCP, there are other routes of access to medical care, such as ‘drop-in centers’, community-based experts and the emergency room. Companies will need to adopt region-specific marketing strategies and develop innovative ways of reaching a wider proportion of the prescribing population. Resistant pathogens pose a growing threat in the community management of RTIs. The perceived seriousness of this dynamic varies not only according to market, but type of prescribing physician so affecting promotional strategies and continued uptake of newer therapeutic options. Reasons to Purchase Improve promotional efficiency for community acquired RTI therapies, through greater understanding of presentation and referral patterns Gain expert insight into the advantages and disadvantages of competing therapies for the treatment of RTIs Understand fully the potential impact of the novel ketolide class and predict the success of Aventis’s Ketek Contents: TABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the community-acquired RTI market 4 Respiratory tract infections (RTIs) led to 174,000 deaths in Europe and 3.8 million worldwide, accounting for 6% of the global and 1.3% of European disease burden (World Health Report, 2003). As a result, the treatment of respiratory tract infections is responsible for the most significant proportion of community-based antibacterial prescriptions in Europe (36% – MIDAS Medical Data, IMS Health, September 2003) 5 While the majority of RTI patients initially present to their physician of record, there are alternative routes of access to medical care, such as ‘drop-in centers’, community-based experts and the emergency room. The availability and use of such alternatives varies significantly both between and within countries. As a result, companies marketing RTI therapies will need to adopt region-specific marketing strategies and develop innovative ways of reaching a wider proportion of the prescribing population 6 Resistant pathogens, such as penicillin-resistant Streptococcus pneumoniae (PRSP) and erythromycin-resistant Streptococcus pneumoniae (ERSP), pose a growing threat in the community management of RTIs. The perceived seriousness of this dynamic varies not only according to market, but type of prescribing physician so affecting promotional strategies and continued uptake of newer therapeutic options, such as Aventis’s Ketek, Aventis and J&J’s Tavanic/Levaquin 8 Summary 10 Key metrics 11 Burden of disease (in DALYs) attributable to RTIs across key world regions in 2002 11 Contribution of RTIs to community antibacterial prescriptions in the five major European markets, 2001–03 12 Indication comparison of leading RTI antibacterials 13 Ketek detailing volume vs. sales performance in Europe, 2001–03 14 CHAPTER 2 MARKET DEFINITION 21 Market overview 21 Global antibacterial sector 21 Hospital vs. community 25 Why are RTIs so significant? 28 Problematic in vulnerable patient groups 29 Changing epidemiology? 31 Different diseases, different diagnostic needs 33 Access to diagnostics 36 RTI incidence across the seven major markets 38 CHAPTER 3 PHYSICIAN/PATIENT INTERACTION 40 Physicians treating RTIs 40 Initial presentation 42 Referral and admission patterns 45 Conditions for referral/hospital admission 45 Treatment failure 46 Complicated infection or history 47 Comorbidities 48 Resistant pathogens 48 Impact of referral on prescription choice 50 CHAPTER 4 TREATMENT OVERVIEW 51 Key antibacterial classes in RTI treatment 51 Penicillins 51 Macrolides 55 Fluoroquinolones 58 Oral cephalosporins 60 Key success factors 63 Targeted spectrum for empiric therapy 63 Effective against Streptococcus pneumoniae 64 Activity against resistant pathogens 64 Once daily and short duration 65 Relative importance of product characteristics 65 Product comparison 66 Treatment of specific RTIs 69 Treatment of CAP 69 Treatment guidelines 69 Product comparison 70 UK case study 72 Treatment of acute sinusitis 73 Product comparison 73 UK case study 74 Treatment of AECB 75 Product comparison 75 UK case study 76 Treatment of tonsillitis/pharyngitis 78 Product comparison 78 Italian case study 80 Otitis media treatments 82 CHAPTER 5 KETEK – THE LAUNCH OF A NEW CLASS 83 Product profile 83 Key event screen 83 Clinical landmarks in 2003 85 ICAAC 2003 – Ketek effective in AMS and reduces hospitalizations 85 ALA-AST – effective in CAP and AECB with shorter treatment length 86 PROTEKT – effective against PRSP and ERSP 87 Performance to date 87 European markets drive growth 87 Ketek – a community drug? 90 Ketek – a future blockbuster? 92 US launch and approved indications 92 Pediatric indication 93 Promotional effectiveness 95 Analyst consensus 100 APPENDIX A 102 Supporting data 102 Countries included in global coverage 102 Contribution of RTIs to individual European countries 102 France 102 Germany 104 Italy 105 Spain 106 UK 107 Ketek promotional spend vs. sales 108 Contributing experts 112 List of tables 113 List of figures 113 Bibliography 117 Report methodology 117 APPENDIX B OPINION LEADER TRANSCRIPTS 118 US Opinion Leader Interview 118 French Opinion Leader Interview 133 German Opinion Leader Interview 144 Italian Opinion Leader Interview 155 Spanish Opinion Leader Interview 171 UK Opinion Leader Interview 183 APPENDIX C 197 About Datamonitor 197 About Datamonitor Healthcare 197 Datamonitor Healthcare’s research and analysis methodologies 198 Datamonitor Healthcare’s therapy area capabilities 198 About the infectious disease analysis team 199 Datamonitor Healthcare’s Consulting expertise 200 Datamonitor’s Therapeutic Consulting expertise 200 Key therapy team members 201 John Savopoulos, Lead analyst, Infectious Diseases 201 David Abramson, Therapeutic Lead Consultant 202 Disclaimer 203 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/58455 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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