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Pipeline Insight: Chronic and Acute Heart Failure - Diversity and DisappointmentPublished by: Datamonitor Published: Dec. 15, 2005 - 166 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the heart failure market 3 The R&D pipeline for heart failure is a Phase II-heavy, diverse range of novel agents. The majority of drugs are being developed for chronic heart failure (CHF), but a significant number of these are add-on therapies. 4 The heart failure market is relatively stable, with few drugs launched in the past five years. It is also a market with high unmet needs waiting to be addressed. 5 The most promising CHF pipeline products target niche populations, but with limited commercial potential 5 The acute heart failure (AHF) pipeline has high commercial potential but safety issues have led to disappointment for levosimendan, leaving tolvaptan as the most promising AHF product in the pipeline 6 CHAPTER 2 PIPELINE OVERVIEW & FUTURE FOCUS 21 Pipeline overview 21 Heart failure: a diverse pipeline 24 Greatest number of drugs in Phase II development 26 Market is not dominated by any one company 27 BMS and Sanofi-Aventis aim to boost future sales 28 Development by Japanese-based companies has increased 29 Greatest number of products being developed for chronic heart failure 29 CHAPTER 3 PIPELINE DYNAMICS 31 Definition of heart failure 31 Chronic heart failure 31 Acute heart failure 32 Etiology of heart failure 33 Segmentation of heart failure 34 Disease severity 34 ESC guidelines on the use of devices in chronic heart failure 37 Pacemakers 37 Implantable cardioverter defibrillators (ICD) 37 Age group 38 Systolic versus diastolic heart failure 39 Comorbidities, complications and risk factors 40 Anemia: an emerging risk factor in chronic heart failure 41 Epidemiology of heart failure 44 Prevalence of chronic heart failure 44 Incidence of acute heart failure 44 Future trends in the incidence and prevalence of heart failure 45 Unmet needs in heart failure 45 Chronic heart failure 46 Unmet need 1: increased safety profile 46 Unmet need 2: increased efficacy 47 Unmet need 3: ability to halt or reverse the progression of the disease 47 Unmet need 4: improved quality of life 47 Unmet need 6: increased compliance 48 Unmet need 7: targeting niche markets 49 Acute heart failure 49 Unmet need 1: increased mortality benefit 50 Unmet need 2: increased safety profile 50 Unmet need 3: increased efficacy 51 Unmet need 4: reduced length of hospital stay/ re-hospitalization 51 Unmet need 5: drugs with novel mechanisms of action 52 CHAPTER 4 R&D APPROACH 53 Classification of pipeline products 53 Chronic heart failure pipeline 54 Adenosine A1 receptor antagonists 54 Preclinical and clinical progress 54 AGE crosslink breakers 54 Preclinical and clinical progress 55 Angiotensin II antagonists 56 Preclinical and clinical progress (current) 56 Benzodiazepine agonists 56 Preclinical and clinical progress 56 Cell transplant therapy 57 Preclinical and clinical progress 57 Chelating agents 57 Preclinical and clinical progress 57 Chymase inhibitors 58 Preclinical and clinical progress 58 eNOS transcription enhancers 58 Preclinical and clinical progress 58 Glucagon-like peptide-1 59 Preclinical and clinical progress 59 Statins (HMG Co-A reductase inhibitors) 59 Preclinical and clinical progress 60 Immunomodulation therapy 60 Preclinical and clinical progress 61 Dual NEP and ECE inhibitors 61 Preclinical and clinical progress 61 Thyroid hormone agonists 62 Preclinical and clinical progress 62 Xanthine oxidase inhibitors 63 Preclinical and clinical progress 63 Acute heart failure pipeline 64 Atrial natriuretic peptide (ANP) agonists 64 Preclinical and clinical progress 64 Calcium sensitizers 64 Preclinical and clinical progress 65 CRF-R2 receptor agonists 65 Preclinical and clinical progress 65 Cardiac myosin activators 66 Preclinical and clinical progress 66 Na+,K+,ATPase inhibitors 66 Preclinical and clinical progress 66 ORL-1 agonists 67 Preclinical and clinical progress 67 Vasopressin antagonists 67 Preclinical and clinical progress 67 Clinical trial design in heart failure 68 Comparators: add-on vs. replacement therapy 68 Clinical trials endpoints in heart failure 68 Use of surrogate endpoints 68 Trials in chronic heart failure 69 True endpoints 69 Surrogate endpoints 70 Trials in acute heart failure 71 CHAPTER 5 CHRONIC HEART FAILURE LATE-STAGE DRUG ANALYSIS & FORECASTS 73 Overview of chronic heart failure drugs 73 Pipeline summary 73 Definition of current comparator therapies 73 Gold-standard therapy 73 Angiotensin II receptor blockers (ARBs) 75 Vas-991 (Celacade technology) 75 Drug overview 75 Clinical data 76 Extensive Phase III trial underway 76 Phase II trial results 76 Patient potential 77 Market potential 78 Vas-991: performance against benchmark criteria 79 SWOT analysis 80 Forecast to 2014 80 Datamonitor comments 81 Irbesartan (Aprovel) 82 Drug overview 82 Clinical data 82 Limited information on irbesartan in CHF 82 Patient potential 82 Market potential 83 Performance against benchmark criteria 84 SWOT analysis 85 Forecast to 2014 86 Datamonitor comments 86 Trientine (Laszarin) 87 Drug overview 87 Clinical data 87 Trientine improves LVH in patients with diabetes 87 Patient potential 88 Market potential 88 Performance against benchmark criteria 89 SWOT analysis 90 Forecast to 2014 91 Datamonitor comments 92 CHAPTER 6 COMPARATIVE ANALYSIS OF CHRONIC HEART FAILURE PIPELINE 94 Comparative forecasts 94 Comparative analysis 94 CHAPTER 7 ACUTE HEART FAILURE LATE-STAGE DRUG ANALYSIS & FORECASTS 99 Overview of acute heart failure drugs 99 Pipeline summary 99 Definition of current comparator therapies 99 Oral diuretics 99 Inotropic agents 100 Vasodilators 100 Nitrates 100 Tolvaptan 101 Drug overview 101 Clinical data 101 Large-scale Phase III trial ongoing 101 ACTIV in CHF 101 Trial comparing tolvaptan with furosemide 103 Patient potential 103 Market potential 104 Performance against benchmark criteria 105 SWOT analysis 106 Forecast to 2014 107 Datamonitor comments 107 Levosimendan (Simdax) 108 Drug overview 108 Clinical data 108 Mixed results from latest Phase III trials 108 Phase III trials 111 Patient potential 114 Market potential 115 Performance against benchmark criteria 117 SWOT analysis 118 Forecast to 2014 119 Datamonitor comments 119 Ularitide 120 Drug overview 120 Clinical data 121 SIRIUS II 121 SIRIUS I 121 Patient potential 122 Market potential 122 Performance against benchmark criteria 123 SWOT analysis 125 Forecast to 2014 126 Datamonitor comments 126 CHAPTER 8 COMPARATIVE ANALYSIS OF ACUTE HEART FAILURE PIPELINE 128 Comparative forecasts 128 Comparative analysis 128 CHAPTER 9 OTHER CHRONIC HEART FAILURE PRODUCTS 132 Adentri (BG9928) 132 Drug overview 132 Clinical data 132 Promising Phase II results 132 ALT-711 133 Drug overview 133 Clinical data 133 Toxicity data may cause set back in Phase II 133 Crestor (rosuvastatin) 134 Drug overview 134 Clinical data 135 The CORONA trial: investigating the role of Crestor in CHF patients 135 DITPA 135 Drug overview 135 Clinical data 135 Two Phase II trials underway to assess safety 135 Oxypurinol 137 Drug overview 137 Clinical data 137 OPT-CHF 137 La Plata 138 Oral levosimendan 138 Drug overview 138 Clinical data 138 r-GLP-1 (AC2592) 139 Drug overview 139 Clinical data 139 Continuous infusion trial suggests a novel approach 139 SLV-320 140 Drug overview 140 SLV-306 (daglutril) 140 Drug overview 140 Clinical data 140 CHAPTER 10 OTHER ACUTE HEART FAILURE PRODUCTS 142 Carperitide 142 Drug overview 142 Clinical data 142 Urocortin II 142 Drug overview 142 Clinical data 143 Promising preliminary results 143 ZP-120 143 Drug overview 143 Clinical data 143 CHAPTER 11 INNOVATIVE EARLY-STAGE PROJECTS - ACUTE AND CHRONIC 145 AN-260 145 Drug profile 145 AVE-9488 146 Drug profile 146 Preclinical data 146 Cell transplant therapy 147 Therapy profile 147 Clinical data 147 CK-1827452 147 Drug profile 147 APPENDIX A 149 Datamonitor drug assessment summary 149 Contributing experts 152 Bibliography 153 Epidemiology sources 153 General and clinical trial data 153 Epidemiology methodology 157 Prevalence of chronic heart failure 157 US 157 UK 158 Other markets 158 Incidence of acute heart failure 159 US 159 Japan 159 France 159 Germany 159 Italy 160 Spain 160 UK 160 Forecasting methodology 161 Report methodology 161 APPENDIX B 162 About Datamonitor 162 About Datamonitor Healthcare 162 Datamonitor Healthcare’s therapy area capabilities 163 About the cardiovascular analysis team 164 Disclaimer 165 AbstractIntroductionThere is a clear need for new treatments for heart failure, as mortality and morbidity rates, although improving, remain high. Heart failure already represents the leading cause of hospitalization for patients over the age of 65 in Western markets and the aging population in these markets will surely lead to growth in the prevalence of the disease and an increase in healthcare expenditure. Scope Assessment of the patient potential, including patient segmentation for developmental chronic and acute heart failure products Overview of the chronic and acute heart failure R&D pipeline with detailed information on the classes in development Commercial analysis, supported by the views of key opinion leaders, of key compounds in development in terms of their ability to satisfy unmet needs Sales forecasts for key late-stage developmental chronic and acute heart failure products in the seven major markets to 2014 Highlights The late-stage heart failure pipeline is weak in terms of quantity and quality, 81% of products are in Phase I and II of development. The majority of pipeline products are being developed for chronic heart failure with only 33% being developed for acute heart failure. Developmental chronic heart failure products hold little commercial promise because they are primarily being developed as add-on therapies with niche-focused launch strategies and the increased use of devices in this area form strong competition. The acute heart failure pipeline has high commercial potential but safety issues have led to disappointment for levosimendan, leaving tolvaptan as the most promising acute heart failure product in the pipeline. Reasons to Purchase Gain insight into the current and future prospects for the chronic and acute heart failure market from key opinion leaders Identify the opportunities and risks for late stage developmental products based on a structured assessment of clinical and commercial attractiveness View independent sales forecasts for drugs in late-stage development for treatment of chronic and acute heart failure Get Full Details About This Report >> |
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