Contents:

CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Insight into the endometriosis market 4 CHAPTER 2 PATIENT POTENTIAL 15 Definition of endometriosis 15 Classification of endometriosis 16 Evolution of the classification system 17 Endometriosis – theories abound 18 Retrograde menstruation and implantation 19 Lymphatic/vascular dissemination 19 Developmental coelomic metaplasia 20 Genetic predisposition 20 Environmental factors 21 Immunological susceptibility 21 Dynamic progression of endometriosis 22 Symptomatology 23 Segmentation of endometriosis 24 Endometriosis and infertility 24 Recurrence in endometriosis 25 Epidemiology of endometriosis 26 Prevalence estimates 26 Prevalence of endometriosis in the general population 28 Prevalence of endometriosis in the gynecologic population 28 Limitations of epidmiology analysis 32 Unmet need in endometriosis 33 Need for more effective therapeutic options 33 Potential to address fertility outcomes 34 Long-term treatment and recurrence 35 Need for drugs with improved tolerability and fewer side effects 36 Need for greater awareness among PCPs and public 37 Perception of symptoms as 'normal' limits the presented population 37 Poor awareness among PCPs lengthens time to diagnosis 37 Need for a non-invasive diagnostic test 39 CHAPTER 3 R&D APPROACH 42 Classification of pipeline products 42 GnRH agonists 43 GnRH agonist overview 44 Lupron – the gold standard 45 GnRH antagonists 48 Danazol 49 Efficacy 49 Side effects 50 Hormonal contraceptives 52 Combined oral contraceptives 52 Progestogen therapy 54 Gestrinone 55 Clinical trial design in endometriosis 56 Study parameters, definitions and methodology 56 Placebo or active control? 56 Trial size 57 Length of study 58 Clinical trial endpoints in endometriosis 59 Symptom reduction – pain 59 Improving complications – infertility 59 QoL and patient satisfaction 60 Regression of disease 60 CHAPTER 4 ENDOMETRIOSIS PIPELINE ANALYSIS 62 Pipeline overview 62 Key companies involved in the endometriosis pipeline 63 Schering AG 63 Marketed products do not target endometriosis 63 Expanding women's health indication coverage 63 TAP Pharmaceuticals 65 Strategies for success 66 Tapping into the market – TAP's continuing investment in marketing and product line extension 66 Dedicated detailing approach 66 Continuing innovation 66 Pipeline SWOT analysis: comparative parameters and definitions 68 External factors 68 Internal factors 70 CHAPTER 5 GNRH ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS 74 Overview for GnRH antagonists 75 Pipeline summary 75 Definition of current comparator therapy 75 Lupron 75 Plenaxis (abarelix depot F) 78 Profile 78 Drug overview 81 Clinical trial data 81 Comment 83 Patient potential 84 Marketing factors 84 Satisfaction of unmet needs 86 Forecasts to 2014 87 Cetrorelix 88 Profile 88 Drug overview 90 Clinical trial data 90 Patient potential 92 Marketing factors 92 Satisfaction of unmet needs 93 Forecasts to 2014 94 Other drugs in the GnRH agonist/antagonist class 96 Avorelin 96 Sufugolix 96 Comparison of key compounds in the GnRH agonist/antagonist class 96 External factors 96 Internal factors 97 Drug profile 97 Company 98 CHAPTER 6 SELECTIVE PROGESTERONE RECEPTOR MODULATOR CLASS LATE-STAGE DRUG ANALYSIS AND FORECASTS 100 Overview 100 Pipeline summary 100 Definition of current comparator therapy 100 Lupron 100 Asoprisnil 101 Profile 101 Drug overview and clinical trial data 103 Patient potential 104 Marketing factors 104 Satisfaction of unmet needs 106 Forecasts to 2014 107 Comparison of key compounds in the SPRM class 109 External factors 109 Internal factors 110 Drug profile 110 Company 110 CHAPTER 7 HORMONALS/ANTI-HORMONALS LATE-STAGE ANALYSIS AND FORECASTS 113 Overview for hormonals 113 Pipeline summary 113 Definition of current comparator therapy 113 Lupron 113 Endometrion (dienogest) 114 Profile 114 Drug overview 117 Clinical trial data 117 Patient potential 123 Marketing factors 124 Satisfaction of unmet needs 126 Forecasts to 2014 127 Libra (deslorelin, estradiol and testosterone) 127 Profile 127 Drug overview 130 Clinical trial data 130 Patient potential 132 Marketing factors 132 Satisfaction of unmet needs 133 Forecasts to 2014 134 Comparison of key compounds in the hormonal/antihormonal class 134 External factors 134 Internal factors 135 Drug profile 135 Company 135 CHAPTER 8 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS 138 Overview for 'Other' class drugs 138 Pipeline summary 138 Definition of current comparator therapy 138 Lupron 138 FP1096 139 Profile 139 Clinical trial data 141 Patient potential 143 Marketing factors 143 Satisfaction of unmet needs 144 Forecasts to 2014 145 Comparison of key compounds in the 'other' class 146 External factors 146 Drug profile 146 Company 146 Other drugs in the 'other' class 148 Chronodyne (terbutaline) 148 CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS 150 Key Phase I and preclinical compounds in endometriosis 150 GnRH antagonists 150 Teverelix 150 NBI-42902, NBI-56418 and other candidates 151 TAK-810 153 GnRH agonists 153 Leuprolide (inhaled) 153 Eligard 153 Antiprogestins 154 Progenta 155 Endometriosis market size estimate 155 Methodology 155 Key research impacts on endometriosis 159 Will aromatase inhibitors offer the market anything new? Femara well placed to be first to market 159 APPENDIX A 161 Contributing experts 161 Report methodology 161 Japanese market data 161 Regional launch dates for new products 161 Standard units 161 Pricing forecasts 162 Bibliography 162 APPENDIX B 166 Research and analysis methodologies 167