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(Medical-NewsWire.com, April 23, 2016 ) The APAC Asthma Therapeutics Market Report shows that Asthma treatment can be classed as either a long-term control medication, aimed at controlling persistent asthma, or a quick-relief medication, for the relief of exacerbations and acute symptoms. Long-term control medication includes Inhaled Corticosteroids (ICS), immunomodulators, leukotriene modifiers, cromolyn sodium, nedocromil and methylxanthines. In addition, Long-Acting Beta-Adrenoceptor Agonists (LABAs) can be used in combination with ICSs but not as monotherapies for moderate or severe persistent asthma. Currently, only one biologic Xolair (omalizumab) is approved as an add-on therapy for the treatment of allergic asthma in the Asia-Pacific region. Nevertheless, significant unmet need remains for the treatment of severe eosinophilic asthma.
Other Key Points in Report:
The current asthma market in the Asia-Pacific region contains novel products, including Xolair, a recombinant humanized monoclonal anti-IgE antibody; Seretide/Adoair, an ICS-LABA combination therapy; Relvar/Breo, an ICS-LABA combination therapy, and Spiriva, a LAMA.
- What are the competitive advantages of the existing novel drugs?
With over 274 active pipeline molecules, most of the late-stage investigational drug candidates are being evaluated, with improved dosing regimens and administration routes in comparison to currently marketed products.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the asthma market – specifically for severe eosinophilic asthma?
Analysis of clinical trials since 2006 has identified that the failure rates of asthma molecules were highest in Phase III (46%), with the overall attrition rate for asthma in development being 78%.
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Table of Content: An Overview
2 Introduction 9
2.1 Disease Introduction 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology and Pathophysiology 10
2.5 Diagnosis 11
2.6 Classification 12
2.7 Treatment Guidelines and Options 13
2.7.1 ICS Monotherapy for the Maintenance Treatment of Asthma 16
2.7.2 Montelukast sodium as First-Line Maintenance Therapy 19
2.7.3 ICS/LABA Combination Therapy 20
2.7.4 Add-on Therapies 25
3 Marketed Products 30
3.1 Overview 30
3.2 ICS for the Maintenance Treatment of Asthma 30
3.2.1 Arnuity (fluticasone furoate) 30
3.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 31
3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) - GlaxoSmithKline 31
3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-Promotion with Astellas Pharma 32
3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline 33
3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) - SkyePharma 34
3.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 35
3.4.1 Xolair (omalizumab) - Novartis and Genentech 35
3.4.2 Montelukast sodium 36
3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim 37
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3.5 Comparative Efficacy and Safety of Marketed Products 38
4 Pipeline Analysis 41
4.1 Overview 41
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 41
4.3 Pipeline by Molecular Target 43
4.4 Promising Pipeline Molecules 47
4.4.1 Mepolizumab - GlaxoSmithKline 47
4.4.2 Reslizumab - Teva Pharmaceutical 49
4.4.3 Lebrikizumab - Roche/Genentech 51
4.4.4 Dupilumab - Regeneron Pharmaceuticals in Collaboration with Sanofi 52
4.4.5 Tralokinumab - AstraZeneca 55
4.4.6 Benralizumab - AstraZeneca 56
4.5 Comparative Efficacy and Safety of Pipeline Products 58
5 Clinical Trial Analysis 62
5.1 Failure Rate 62
5.1.1 Overall Failure Rate 62
5.1.2 Failure Rate by Phase and Molecule Type 63
5.1.3 Failure Rate by Phase and Molecular Target 64
5.2 Clinical Trial Size 65
5.2.1 Patient Enrollment per Product by Stage of Development by Molecule Type and Molecular Target 65
5.2.2 Patient Enrollment per Trial by Stage of Development by Molecule Type and Molecular Target 67
5.3 Clinical Trial Duration 69
5.3.1 Trial Duration by Stage of Development by Molecule Type and Molecular Target 69
5.4 Summary of Clinical Trial Metrics 70
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