Contents:

Chapter 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Insight into the hospital antibacterial market 5 Across the seven major markets the hospital antibacterial market is currently valued at $6.4 billion, representing approximately 30% of total antibacterial sales. Of these sales, $1.2 billion (25%) are attributable to the treatment of respiratory tract infections, a figure that will rise to $2.0 billion (28%) by 2008 (CAGR 2002-2008 6.2%); 6 Increasing drug resistance in the hospital environment creates demand for novel more effective drug classes. However, restrictions on the use of such specialist products might equate to lower overall hospital sales. Datamonitor estimates that sales of Pfizer’s Zyvox and Monarch’s Synercid across the seven major markets reached only $133m and $51m, in 2002. 7 The responsibility, care and treatment of hospital patients is increasingly being shared between varieties of health professionals. As a result, companies marketing antibacterials may need to re-evaluate promotional strategy to incorporate a selection of physicians, pharmacists and microbiologists, while also taking into account regional and sector variations. 8 Historically, portfolio success within the hospital antibacterial sector has been achieved with one or two broad-spectrum products. Current drivers may increase the incentive to develop portfolios of multiple narrow spectrum products. In particular, smaller companies with expertise in target driven research and development may benefit from the reduced costs associated with smaller clinical trials. 10 Summary 12 Key metrics 13 Chapter 2 HOSPITAL MARKET CONDITIONS 22 Introduction 22 Hospital-treated infections – patient composition 23 Hospital-acquired infections 23 Community-acquired infections treated in the hospital 27 Community-acquired/hospital onset infections 28 Hospital units 28 Emergency room 29 Specialist wards 29 Intensive-care unit (ICU) 29 Transplant, hematology and oncology wards 29 Impact on anti-infective strategy 29 Drug resistance 30 Resistance control measures 33 The MRSA challenge 33 Infection control 34 Cost containment 38 Generic competition 43 Chapter 3 DRIVERS OF PRESCRIPTION CHOICE 46 Decision makers 47 Hospital physicians 47 Will IT reduce the influence of the physician? 48 Interactions between decision makers 50 Laboratory staff 51 Pharmacists 52 Interaction in the prescribing process 53 Regulation and guidance 55 Licensed indications 56 Treatment guidelines 59 Resistance issues 61 Altered use of existing agents 62 Rotation of antibacterials 62 Use of antibacterial combinations 62 Off-label use 63 Regulatory control 66 Product characteristics 67 Targeted versus broad 68 Cost of therapy 70 Physician awareness of therapy costs 70 Generic versus brand 73 Promotional information 78 Chapter 4 MARKET ANALYSIS 81 Introduction 81 Global market overview 82 Product analyses 84 Drivers of product switching 85 Product profiles 87 Rocephin 87 Fortum 90 Cipro 92 Levaquin/Tavanic/Cravit 96 Ketek 98 Augmentin 100 Primaxin 103 Vancocin 106 Zyvox 109 Synercid 111 Chapter 5 STRATEGIC FOCUS 115 Introduction 115 Product costs and pricing 116 Cost containment and pharmacoeconomics 116 Cost of therapy 117 Unit price comparison 117 Treatment costs for CAP 119 Importance of step down therapy 125 Reimbursement & formulary inclusion 127 Antibacterial reimbursement 127 Reimbursement strategies 132 Product characteristics 134 Resistance issues 134 Restrictions on use 134 Impact of resistance on formulary decisions 135 Activity profile 136 Physicians and resistance issues 138 Product attributes 140 Dosing profile – IV/oral step down 140 Dosing frequency and the length of therapy 141 Combination therapies 141 Product positioning 142 Emergency room 142 General ward 143 ICU 143 Transplant, hematology and oncology wards 144 Product promotion and marketing 145 Effective use of promotional strategies 145 Effective targeting of hospital personnel 147 Detailing or seminar style teaching? 149 Portfolio composition 151 Broad versus narrow spectrum 151 Portfolio focus versus diversification 153 APPENDIX A 155 APPENDIX B 165 Contributing experts 165 List of tables 166 List of figures 167 Bibliography 171 Journal articles/published sources 171 Websites 174 Report methodology 175 APPENDIX C 177 Key Opinion Leader Interview - US 1 177 Key Opinion Leader Interview – US 2 189 Key Opinion Leader Interview – US 3 194 Key Opinion Leader Interview – US 4 200 Key Opinion Leader Interview – US 5 207 Key Opinion Leader Interview – Germany 1 218 Key Opinion Leader Interview – Germany 2 225 Key Opinion Leader Interview – Germany 3 230 Key Opinion Leader Interview – UK 1 235 Key Opinion Leader Interview – UK 2 240 Key Opinion Leader Interviews – Italy 1 249 Key Opinion Leader Interview – France 1 257 Key Opinion Leader Interview – France 2 265 Key Opinion Leader Interviews – France 3 273 Key Opinion Leader Interview – Spain 1 282 Key Opinion Leader Interviews – Pharmacist (UK) 1 290 Key Opinion Leader Interviews – Pharmacist (UK) 1 290 Key Opinion Leader Interviews – Pharmacist (US) 2 297 APPENDIX D 304 SECTION 1: 304 SECTION 2: 306 Section 3: 309