Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline

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IntroductionOsteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Across the seven major markets, sales for osteoporosis drugs grew with a compound annual growth rate (CAGR) of 2.0% from 2005 to $6.9 billion in 2009. Nonetheless, several promising pipeline drugs will help the market resume growth.ScopePatient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China).Review of the key clinical and environmental unmet needs supported by insight from key opinion leaders across the US, Europe and Japan.Analysis of target product profile for an osteoporosis drug. R&D pipeline analysis with detailed profiles and forecasts of key agents, including Amgen's Prolia (denosumab) and Merck's odanacatib.HighlightsOsteoporosis prevalence is expected to increase due to the general aging population. By 2020, the total male and female osteoporosis population is forecast to increase by 16.0% from 168 million in 2010 to reach 188 million patients across the seven major markets.Despite some long-term safety and cost concerns, Prolia will become the osteoporosis market leader by 2019, but will not achieve blockbuster sales. Moreover, its position will be threatened should odanacatib show a superior clinical profile.Over the forecast period, three new anabolic drugs are due to launch. These will have to compete on cost, efficacy and safety with the class leader Forteo (teriparatide, Eli Lilly). While these drugs will address some unmet needs, early clinical data suggests that more potent drugs such Amgen's antisclerostin may dominate the market in the future.Reasons to PurchaseUnderstand patient population dynamics Gain insight into shortcomings of current osteoporosis treatment and to what extent pipeline drugs will address these unmet clinical needs.Identify licensing opportunities based on company portfolio and market needs.

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Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Pipeline Insight: Osteoporosis - Bone building drugs become theheart of the pipelinePublished on July 2010 Report SummaryIntroductionOsteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate andunmet need. Across the seven major markets, sales for osteoporosis drugs grew with a compound annual growth rate (CAGR) of2.0% from 2005 to $6.9 billion in 2009. Nonetheless, several promising pipeline drugs will help the market resume growth.ScopePatient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China).Review of the keyclinical and environmental unmet needs supported by insight from key opinion leaders across the US, Europe and Japan.Analysis oftarget product profile for an osteoporosis drug. R&D pipeline analysis with detailed profiles and forecasts of key agents, includingAmgens Prolia (denosumab) and Mercks odanacatib.HighlightsOsteoporosis prevalence is expected to increase due to the general aging population. By 2020, the total male and femaleosteoporosis population is forecast to increase by 16.0% from 168 million in 2010 to reach 188 million patients across the sevenmajor markets.Despite some long-term safety and cost concerns, Prolia will become the osteoporosis market leader by 2019, but will not achieveblockbuster sales. Moreover, its position will be threatened should odanacatib show a superior clinical profile.Over the forecast period, three new anabolic drugs are due to launch. These will have to compete on cost, efficacy and safety with theclass leader Forteo (teriparatide, Eli Lilly). While these drugs will address some unmet needs, early clinical data suggests that morepotent drugs such Amgens antisclerostin may dominate the market in the future.Reasons to PurchaseUnderstand patient population dynamics Gain insight into shortcomings of current osteoporosis treatment and to what extent pipelinedrugs will address these unmet clinical needs.Identify licensing opportunities based on company portfolio and market needs. Table of ContentOverview 1Catalyst 1Summary 1About Datamonitor Healthcare 2Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 1/10
  2. 2. Find Industry reports, Company profilesReportLinker and Market StatisticsAbout the Genitourinary pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3Datamonitor insight into the disease market 3Related reports 5Upcoming related reports 5Table of Contents 61. Pipeline Overview and Dynamics 7Key findings 7Pipeline overview 8Clinical pipeline 8Comparative forecasts: Prolia to become market leader by 2019 15Datamonitor pipeline assessment summary: anabolic treatments are the most clinically attractive products 16Key companies involved in the osteoporosis pipeline 18Osteoporosis drug development not limited to Big Pharma 18Novartis remains a key market player 18Key R&D company strategies 20Pipeline developers focus on reformulations to address route of administration unmet needs 20Anabolic treatments become a priority in the market 21Indication expansions increase the market potential of osteoporosis drugs 222. Disease Overview - Market Potential 24Key findings 24Definition of osteoporosis 25Definition of osteoporosis 25Etiology 25Symptoms 26Diagnosis and treatment rates 28Under-diagnosis is a major problem in osteoporosis 29World Health Organization fracture risk assessment tool 30Treatment rates have been increasing but are still low 32Patient segmentation 33Disease severity 33Gender 35Epidemiology 37Seven major markets 37Female osteoporosis 38Male osteoporosis 49BRIC countries 58Brazil: hip fracture prevalence is higher in men than women 58Russia: over 85% of hip fractures occur in women over 60 years of age 59India: Indian women experience osteoporotic fractures 10-20 years earlier than Caucasian women 62China: over 76 million Chinese women will experience a hip fracture in 2010 63Rest of the world 64Current treatment options 65Bisphosphonates 66Selective estrogen receptor modulators 68Parathyroid hormones 68Calcitonins 69Dual acting bone agents 70Vitamin D and analogs 71Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 2/10
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsCalcium 71Current gold standard and comparator therapies 72Fosamax (alendronate; Merck & Co) 72Clinical trial data for Fosamax 73Individual class comparators 74Current market overview 75Market definition for this report 76Growth in the seven major markets slows down 78Bisphosphonates remain the largest class despite generic penetration 80Fosamax generic launch results in market decline 82Future outlook: despite growing pressure from generics, launch of pipeline drugs will offset decline up to 2019 84Unmet need in osteoporosis 86Need for improved anabolic therapies 86Efficacy at the hip 87Increased compliance 90Companies should focus on increasing awareness of the treatments available to increase compliance 92Better side-effect profile and safety 93Long-term safety of bisphosphonate use is questioned 93Efficacy for spine fractures 95Target product profile versus current level of attainment 953. R&D Approach 97Key findings 97Clinical trial design in osteoporosis 98Preclinical trials 98Two different animal species testing is required by the FDA and EMA 98Preclinical trial design should reflect the clinical indication 98Clinical trial design 99The FDA and EMA have different patient inclusion requirements for osteoporosis trials 101Clinical endpoints 102Future developments in osteoporosis clinical trials 1044. Pipeline Analysis & Forecasts: Bisphosphonates 106Key findings 106Overview for pipeline bisphosphonates 107Pipeline summary 107Comparative forecasts 109EX101 (alendronate; EffRx) 109Drug overview 109Drug profile 110SWOT analysis 111Datamonitor drug assessment score card for EX101 111Clinical attractiveness 114Satisfaction of unmet needs 114EX101 shows reduced gastric side effects compared to gold standard 114Commercial attractiveness 115EX101 can clearly differentiate itself in a competitive bisphosphonate market, but effervescent formulations can be unpopular withpatients 115Nycomeds market experience will help boost EX101s sales 115US partner still needed 115Forecasts to 2019 115Almerol (MER-103, alendronate; Merrion) 116Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 3/10
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsDrug overview 116Drug profile 117Clinical trial data 117SWOT analysis 118Datamonitor drug assessment score card for Almerol 119Clinical attractiveness 122Satisfaction of unmet needs 122Almerol 6mg weekly shows bioequivalence to Fosamax 122Commercial attractiveness 123Almerol will face strong competition upon launch 123Merrion requires a marketing partner to launch the drug 123Forecasts to 2019 1235. Pipeline Analysis & Forecasts: Selective Estrogen Receptor Modulators 125Key findings 125Overview for pipeline selective estrogen receptor modulators 126Pipeline summary 126Forecast summary 127Aprela (bazedoxifene with conjugated estrogens; Pfizer) 127Drug overview 127Drug profile 128Clinical trial data 128Ongoing clinical trials 129SWOT analysis 130Datamonitor drug assessment score card for Aprela 130Clinical attractiveness 132Satisfaction of unmet needs 132Aprela targets menopausal women differentiating it from its competition 133Efficacy data will boost Aprelas clinical potential 134Aprelas safety remains an issue 134Commercial attractiveness 135Further delays reduces overall commercial attractiveness 135Bazedoxifene approval in the EU paves the way for Aprela in this region 135Aprela will be mainly prescribed by gynecologists 135Forecasts to 2019 135Late-stage development compounds recently discontinued 137Eli Lilly terminates development of arzoxifene 1376. Pipeline Analysis & Forecasts: Parathyroid Hormones and Analogs 138Key findings 138Overview for pipeline parathyroid hormones and analog drugs 139Pipeline summary 139Comparative forecasts 140ZT-031 (hPTH1-31; Zelos Therapeutics) 141Drug overview 141Drug profile 142Clinical trial data 142SWOT analysis 143Datamonitor drug assessment score card for ZT-031 143Clinical attractiveness 146Satisfaction of unmet needs 146Faster onset of action provides differentiation from competition 146Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 4/10
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsSubcutaneous formulation is not favorable 147Commercial attractiveness 147Partnering is required to access the market 147Pricing strategy will be critical to exploit full market potential 147Forecasts to 2019 147ZP-PTH (hPTH1-34; Zosano Pharma) 149Drug overview 149Drug profile 149Clinical trial data 150SWOT analysis 151Datamonitor drug assessment score card for ZP-PTH 151Clinical attractiveness 154Satisfaction of unmet needs 154ZP-PTH is a patient-friendly drug 154Increased hip efficacy provides clinical differentiator 155Commercial attractiveness 156Big Pharma is required to reach full drug potential 156505b2 regulatory strategy can reduce developmental costs 156Forecasts to 2019 156BA058 (parathyroid hormone peptide fragment; Radius) 157Drug overview 158Drug profile 158Clinical trial data 159SWOT analysis 160Datamonitor drug assessment score card for BA058 160Clinical attractiveness 163Satisfaction of unmet needs 163Phase II studies suggest good drug efficacy 163Commercial attractiveness 164Radius will benefit from Novartis deal should option go ahead 164Forecasts to 2019 164Other drugs in parathyroid hormone and analog class 165ViaDerm-hPTH (parathyroid hormone peptide fragment; TransPharma/Eli Lilly) 165CaPTHymone (parathyroid hormone analog; Bone Medical) 1667. Pipeline Analysis & Forecasts: Calcitonins 167Key finding 167Overview for pipeline calcitonin drugs 168Pipeline summary 168Comparative forecasts 170SMC021 (salmon calcitonin; Novartis) 170Drug overview 170Drug profile 171Clinical trial data 171Ongoing clinical trials 172SWOT analysis 172Datamonitor drug assessment score card for SMC021 173Clinical attractiveness 175Satisfaction of unmet needs 175SMC021s oral formulation remains favorable 175Commercial attractiveness 176Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 5/10
  6. 6. Find Industry reports, Company profilesReportLinker and Market StatisticsSales for calcitonins have been declining 176Novartis market experience 177Forecasts to 2019 177Capsitonin (BN-002; Bone Medical) 179Drug overview 179Drug profile 179Clinical trial data 180SWOT analysis 180Datamonitor drug assessment score card for Capsitonin 181Clinical attractiveness 183Satisfaction of unmet needs 183Clinical attractiveness 183Oral formulation is an improvement over current modes of administration 183Commercial attractiveness 184Bone Medical will seek a marketing partner to launch the product 184Competition from oral calcitonins will be high at the time of launch 184Forecasts to 2019 1858. Pipeline Analysis & Forecasts: Dual Acting Bone Modulators 186Key finding 186Overview for pipeline dual acting bone agents 187Pipeline summary 187Forecast summary 188NBS101 (Strontium malonate; Osteologix) 188Drug overview 188Drug profile 189Clinical trial data 189SWOT analysis 190Datamonitor drug assessment score card for NBS101 191Clinical attractiveness 193Satisfaction of unmet needs 193Phase II data suggest better efficacy than Protelos 193NBS101 oral formulation is an improvement over Protelos 194Commercial attractiveness 194NBS101 can target patients who stop alendronate treatment 194US launch and partnering deals will boost the drug potential 194Forecasts to 2019 1959. Pipeline Analysis & Forecasts: Other Drugs 197Key findings 197Overview for other pipeline drugs 198Pipeline summary 198Comparative forecasts 199Prolia (denosumab; Amgen) 200Drug overview 200Drug profile 202Clinical trial data 202Clinical trial 1 204SWOT analysis 206Datamonitor drug assessment score card for Prolia 207Clinical attractiveness 209Satisfaction of unmet needs 209Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 6/10
  7. 7. Find Industry reports, Company profilesReportLinker and Market StatisticsProlia shows similar efficacy to alendronate 209Serious skin disorder risk limits patient potential despite robust efficacy 211Long-term safety remains a concern 211Commercial attractiveness 212Price to remain competitive without destroying the monoclonal antibody market 212FDA panel restricts Prolias patient potential 213Prolia is recommended for approval in the EU 214GlaxoSmithKline deal maximizes Prolias potential in tough European market 214Possible label extension for cancer indications boosts revenue potential 214Forecasts to 2019 215Odanacatib (MK0822; Merck & Co) 216Drug overview 216Drug profile 217Clinical trial data 217Ongoing clinical trials 219SWOT analysis 221Datamonitor drug assessment score card for odanacatib 221Clinical attractiveness 224Satisfaction of unmet needs 224Novel target provides potential superior efficacy 224Odanacatib shows continued efficacy after 3 years of treatment 226Commercial attractiveness 226Odanacatibs commercial potential will be driven by Merck & Cos market experience 226By the time odanacatib launches the osteoporosis market will be extremely competitive 226Forecasts to 2019 227Eldecalcitol (ED-71; Chugai/Taisho) 228Drug overview 228Drug profile 229Clinical trial data 229Clinical trial 1 231SWOT analysis 232Datamonitor drug assessment score card for eldecalcitol 232Clinical attractiveness 235Satisfaction of unmet needs 235Eldecalcitol met all Phase III endpoints and showed higher efficacy than Alfarol 235Commercial attractiveness 236Commercial potential limited by Japan launch only 236Forecasts to 2019 236Other drugs in other classes 238MK5442 (Merck & Co) 238Drug overview 238Ongoing clinical trials 239Sclerostin (AMG785; Amgen) 240Drug overview 240Ongoing clinical trials 2422MD/DP001 (vitamin D analog; Deltanoid Pharma) 242Drug overview 242Clinical trial data 243San134 (Glucagon-like peptide 2; Sanos Bioscience) 244ACE-011 (activin inhibitor; Acceleron Pharma) 245Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 7/10
  8. 8. Find Industry reports, Company profilesReportLinker and Market StatisticsLate-stage development compounds recently discontinued 245Ronacaleret fails to increase BMD and causes a mild primary hyperparathyroidism 24510. Innovative Early-Stage Approaches 246Key findings 246New targets for anabolic treatments 248Wnt signaling pathway therapeutic potential 249Bone morphogenetic protein in osteoporosis 250Insulin-like growth factor I 251The future of treatment in osteoporosis 251Combination therapies 251Bibliography 254Journals 254Websites 261Datamonitor reports 265Conferences 265APPENDIX 266Data definitions, limitations and assumptions 266Standard units 266Country group definitions 266Rest of European Union 266Middle East and North Africa (MENA) 266Rest of World 266Derivation of sales forecasts and pricing trends 266Indication-specific sales calculations 267Caveats to using Prescribing insight 267New product launches and expiries 267Forecast methodology 271Product forecasts 271Contributing experts 271Conferences attended 271About Datamonitor 272About Datamonitor Healthcare 272About the Disease analysis team 272Datamonitor consulting 273Disclaimer 275Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline Page 8/10
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