Safinamide (Parkinson’s Disease) - Forecast and Market Analysis to 2022

GlobalData
March 31, 2014
87 Pages - GLDATA18032
$3,495.00

Summary

Parkinson’s disease is a progressive condition that is characterized by bradykinesia, muscular rigidity, tremor, and postural instability. As the second most common neurodegenerative disorder, Parkinson’s disease may affect individuals of any age but prevalence is increased with age and it is most common in the elderly. Dopaminergic therapies have been fairly effective in treating bradykinesia, but several unmet needs remain. Some needs will be met during the forecast period from 2012-2022, while others, such as the need for disease-modifying drugs, will remain. GlobalData expects that advancements will be made in levodopa administration and that four new molecular entities will be introduced to the market by 2022, these factors along with increased patient numbers from an aging population will drive the market during the forecast period.

In 2012, Newron completed Phase III clinical trials for safinamide, a dual-mechanism a-aminoamide derivative, acting as an MAO-B and glutamate release inhibitor (EPDA, press release, May 14, 2012). In 2006, Merck Serono (a division of Merck KGaA) had acquired the exclusive worldwide rights for safinamide; however, in 2011 the deal was terminated, seeing Merck returning the compound to Newron due to concerns over the potential market size for the drug.

Scope

- Overview of Parkinson’s disease, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Safinamide including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Safinamide for the top seven countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Brazil.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Parkinson’s disease
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of Safinamide performance
- Obtain sales forecast for Safinamide from 2012-2022 in the top seven countries (the US, France, Germany, Italy, Spain, the UK and Brazil).

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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 16
3.1.3 Prognosis 18
3.1.4 Quality of Life 19
3.2 Symptoms 19
4 Disease Management 21
4.1 Overview 21
4.1.1 Diagnosis - The UK Brain Bank Criteria 21
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 22
4.2 Treatment Synopsis 25
4.2.1 Dopaminergic Therapy Classes 25
4.2.2 Treatment of Parkinson’s Disease by Stage 27
4.2.3 Other Treatment Options 30
4.3 Parkinson’s Disease Assessment Scales 30
4.3.1 Unified Parkinson’s Disease Rating Scale (UPDRS) 31
4.3.2 Hoehn and Yahr Clinical Staging 33
4.3.3 Other Clinical Assessments 34
5 Competitive Assessment 35
5.1 Overview 35
5.2 Strategic Competitor Assessment 37
6 Opportunity and Unmet Need 38
6.1 Overview 38
6.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 40
6.2.1 Unmet Need 40
6.2.2 Gap Analysis 42
6.2.3 Opportunity 45
6.3 Treatment of Non-Motor Symptoms and Dementia 45
6.3.1 Unmet Need 45
6.3.2 Gap Analysis 46
6.3.3 Opportunity 48
6.4 Neuroprotective/Disease-Modifying Agents 48
6.4.1 Unmet Need 48
6.4.2 Gap Analysis 49
6.4.3 Opportunity 52
6.5 Improved Drug Formulations 53
6.5.1 Unmet Need 53
6.5.2 Gap Analysis 53
6.5.3 Opportunity 54
6.6 Identification of Reliable Biomarkers 54
6.6.1 Unmet Need 54
6.6.2 Gap Analysis 55
6.6.3 Opportunity 56
6.7 Improved Clinical Trial Design 56
6.7.1 Unmet Need 56
6.7.2 Gap Analysis 57
6.7.3 Opportunity 57
7 Pipeline Assessment 58
7.1 Overview 58
7.2 Promising Drugs in Clinical Development 58
8 Safinamide 61
8.1 Overview 61
8.2 Efficacy 62
8.3 Safety 64
8.4 Dosing and Formulation 64
8.5 Potential Clinical Positioning 64
8.6 Potential Commercial Positioning 65
8.7 Pricing and Reimbursement 65
8.8 SWOT Analysis 66
8.9 Forecast 66
9 Appendix 68
9.1 Bibliography 68
9.2 Abbreviations 74
9.3 Methodology 78
9.4 Forecasting Methodology 78
9.4.1 Diagnosed Parkinson’s Disease Patients 78
9.4.2 Percent Drug-Treated Patients 79
9.4.3 General Pricing Assumptions 79
9.4.4 Compliance Assumptions 80
9.4.5 Individual Drug Assumptions 80
9.4.6 Generic Erosion 81
9.4.7 Pricing of Pipeline Agent 81
9.5 Physicians and Specialists Included in this Study 82
9.6 About the Authors 84
9.6.1 Author 84
9.6.2 Global Head of Healthcare 85
9.7 About GlobalData 86
9.8 Disclaimer 86

1.1 List of Tables
Table 1: Symptoms of Parkinson’s Disease 20
Table 2: UK Brain Bank Diagnostic Criteria 22
Table 3: Diagnosis and Treatment Guidelines for Parkinson’s Disease 23
Table 4: Most Prescribed Drugs for Parkinson’s Disease by Class in the Global Markets, 2014 24
Table 5: Dopaminergic Therapy in Parkinson’s Disease 27
Table 6: UPDRS Clinical Assessment of Disease Severity 32
Table 7: Parkinson’s Disease Assessment Scales Used in Clinical Trials 34
Table 8: Treatment of Motor Symptoms in Parkinson’s Disease 36
Table 9: Leading Treatments for Parkinson’s Disease, 2014 37
Table 10: Unmet Need and Opportunity in Parkinson’s Disease 39
Table 11: Dyskinesia Pipeline, 2014 44
Table 12: Dementia Pipeline, 2014 47
Table 13: Parkinson’s Disease-Modifying Therapeutics Pipeline, 2014 51
Table 14: Product Profile - Safinamide 62
Table 15: Summary of Relevant Clinical Trials for Safinamide 63
Table 16: Safinamide SWOT Analysis, 2014 66
Table 17: Global Sales Forecasts ($m) for Safinamide, 2012-2022 67

1.2 List of Figures
Figure 1: Overview - L-dopa Metabolism and Inhibitor Classes 26
Figure 2: Overview - Treatment of Motor Symptoms of Parkinson’s Disease 28
Figure 3: Pharmacokinetics of Levodopa 41
Figure 4: Parkinson’s Disease - Phase II-III Pipeline, Segmented by Indication, 2014 59
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson’s Disease, 2012-2022 60

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