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Pipeline Insight: Antihypertensives - Together We Stand, Divided We FailPublished by: Datamonitor Published: Aug. 6, 2004 - 209 Pages Table of ContentsTABLE OF CONTENTS ABOUT DATAMONITOR HEALTHCARE 2 About the Cardiovascular pharmaceutical analysis team 2 CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the hypertension market 5 It is no longer possible to identify one particular class of drugs as the current gold-standard treatment in hypertension. 6 While many physicians remain frustrated by the limited capability of individual antihypertensive agents to lower blood pressure to target levels, there is no superclass on the horizon with the ability to treat hypertension effectively using monotherapy. Instead, the solution will lie in physicians’ acceptance of the need to use effective drug combinations earlier in treatment and the wider issue of patient education and involvement in therapy decisions. 7 The need to address risk factors beyond hypertension, in particular raised lipids, has led to a demand for combination therapies that can treat more than one risk factor at a time. Antihypertensive combinations, both with and without a statin, are likely to be common in the future. 9 BMS’s vasopeptidase inhibitor Vanlev (omapatrilat) had demonstrated the greatest antihypertensive efficacy among novel compounds in recent years, giving rise to the development of several other potential members in this class. However, it appears that fear of litigation surrounding the potential for angioedema has restricted further progress of this class. 10 Despite continued research into logical hypertension targets such as endothelin and vasopressin, the potential for any of these agents to be successful in the treatment of essential hypertension appears limited. 11 The only agent likely to significantly challenge the unbridled growth of the ARBs during the forecast period will be Novartis’s oral renin inhibitor, aliskiren. While renin inhibition has long been a logical therapeutic objective, formulation difficulties had kept it an elusive goal until now. Its intervention in the familiar renin angiotensin aldosterone system (RAAS) at a point earlier than both ACE inhibitors and ARBs may mean it will offer superior blockade of the RAAS than either class without the bradycardia-related side effects of ACE inhibitors. 12 Summary 14 Key metrics 15 CHAPTER 2 PATIENT POTENTIAL 25 Definition of hypertension 25 Segmentation of hypertension 28 Diagnostic criteria 28 Markers of hypertension 33 Hypertension subtypes 37 Epidemiology of hypertension 39 Prevalence of hypertension 39 Methodology 41 Unmet needs in hypertension 45 Environmental unmet needs 45 Clinical unmet needs 50 Overall assessment criteria 53 CHAPTER 3 R&D APPROACH 56 Definition of current comparator therapy 57 Selecting a suitable comparator 58 Classification of pipeline products 59 Launched product classes 59 Developmental product classes 69 Clinical trial design in hypertension 74 Mortality endpoints 77 Adequately powered 78 Significant numbers of each sub-population 78 Use of the gold standard as comparator drug 79 Morbidity endpoints 79 Use of surrogate markers 80 Key research impacts on hypertension 80 CHAPTER 4 HYPERTENSION PIPELINE ANALYSIS 82 Pipeline overview 82 Key companies involved in the hypertension pipeline 83 Novartis 83 Speedel 85 CHAPTER 5 DRUGS ACTING ON RENIN ANGIOTENSIN SYSTEM 87 Vasopeptidase inhibitors 88 Overview of vasopeptidase inhibitors 89 Vanlev 90 AVE 7688 105 VEP inhibitors in early-stage development 107 Recently discontinued VEP inhibitors 107 Conclusions for VEP Inhibitors 113 NEP/ECE inhibitors 114 SLV306 114 SWOT analysis of class 117 Oral renin inhibitors 118 Pipeline summary 118 Aliskiren (SPP100) 119 Other oral renin inhibitors 133 Angiotensin receptor blockers (ARBs) 135 Pipeline overview 135 Pratosartan 136 ACE inhibitor/calcium channel blocker combinations 142 Pipeline overview 142 Lercanidipine/enalapril combination 142 Summary forecast of key pipeline products acting on renin angiotensin system 148 CHAPTER 6 DRUGS NOT ACTING ON RENIN ANGIOTENSIN SYSTEM 149 Calcium channel blockers 150 Pipeline overview 150 Clevelox (clevidipine) 150 S-amlodipine 156 Discontinued calcium channel blockers 161 AGE crosslink breakers 162 Pipeline overview 162 ALT-711 (alagebrium chloride) 162 Na+/K+ ATPase inhibitors 178 Pipeline overview 178 PST 2238 178 Endothelin receptor antagonists 182 Pipeline overview 182 ERAs in Phase III for indications other than hypertension 183 ERAs in Phase II development for hypertension 184 SWOT analysis 190 Other novel drugs in Phase II and above 191 Pipeline overview 191 MC-4232 (Cardoxal) 191 Summary forecasts of pipeline antihypertensives not acting via the RAAS 194 CHAPTER 7 KEY PHASE I COMPOUNDS 195 Pipeline overview 195 Angiotensin vaccine 195 PMD 3117 195 APPENDIX 200 Contributing experts 200 Bibliography 200 Epidemiology 200 Epidemiology Internet resources 201 Clinical trial data 202 Report methodology 205 About Datamonitor 206 About Datamonitor Healthcare 206 Datamonitor Healthcare’s research and analysis methodologies 207 Datamonitor Healthcare’s therapy area capabilities 207 About the Cardiovascular analysis team 208 Disclaimer 209 AbstractIntroductionHypertension is a relatively well served therapeutic field, with a range of well-tolerated drug classes. Despite this, the majority of patients are not controlled. Results of large-scale outcome studies in the last decade suggest there is no longer a gold standard therapy for hypertension. Will ARBs become the next gold standard and are there any new classes in development that may be superior? Scope Evaluation of patient potential for developmental antihypertensives over the period 2004-2012 Scrutiny of key impacts on the R&D approach and cost, evaluation of optimal clinical trial end points and identification of suitable comparators Evaluation of key players in the hypertensive market and opposing company approaches to development and commercialization Analysis of key antihypertensive drugs in development, their commercial prospects, and their ability to satisfy unmet market and therapeutic needs Highlights It is no longer possible to select a gold standard drug class in the treatment of hypertension. Ongoing large-scale clinical trials with ARBs are resulting in a shift in physician preference from ACE inhibitors to ARBs and many believe we have reached a significant turning point in the future of ACE inhibitors. Aliskiren will be the first oral renin inhibitor to be launched. Its intervention at an earlier stage in the Renin Angiotensin System means it may offer significant advantages in efficacy and tolerability over both ARBs and ACE inhibitors and is likely to become a blockbuster. Datamonitor believes that fixed dose combination therapy will grow substantially over the forecast period, exceeding the growth of single pills. Successful strategies for controlling hypertension will need to merge fixed dose combination options with patient-led therapeutic regimes. Reasons to Purchase View independent sales forecasts for products in late stage development for treatment of hypertension in both existing and novel classes Understand physicians' views on ARBs as the potential future gold standard class and the threats faced by existing and developmental products Identify early stage antihypertensive compounds with high potential being developed by companies seeking a marketing partner Get Full Details About This Report >> |
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