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DS5565 (Neuropathic Pain) - Forecast and Market Analysis to 2022

Summary

Neuropathic pain (NP) is defined as a disorder of the sensorimotor system and is distinctly different from nociceptive pain, which is a consequence of trauma, injury, or inflammation. The main difference between neuropathic and nociceptive pain is the absence of a continuous nociceptive input in neuropathic pain. Although the term neuropathic pain is used to describe a wide range of pain syndromes with varying etiologies, this report focuses on 3 distinct forms of NP: Painful diabetic neuropathy, Postherpetic neuralgia and trigeminal neuralgia. The main classes of drugs used to treat these three neuropathic pain indications include anticonvulsants, antidepressants, opioids and topical treatments. However, despite the availability of multiple pain medications only 50% of patients respond to any given drug and there are numerous the side effects associated particularly with systemically administered drugs, that reduce their tolerability. New treatments will target some key unmet needs in terms of efficacy and tolerability, but opportunities will remain for drugs that can more reliably eradicated NP in targeted patient populations, as well as offering an improved safety profile.

DS-5565 is an oral, small-molecule analgesic being developed by Daiichi Sankyo for the treatment of PDN. It is a voltage-dependent calcium channel alpha-2-delta ligand, meaning that it has a mechanism of action similar to Lyrica and gabapentin, and reduces pain through the inhibition of calcium channel-associated currents. These compounds bind to the a-2-d subunits (a-2-d-1 and a-2-d-2) of voltage-dependent calcium channels, where the a-2-d-1 subunit is the main target for the analgesic effect of a-2-d ligands, while the a-2-d-2 subunit is thought to contribute to the CNS side effects of a-2-d ligands, although this has not been fully demonstrated (Yokoyama et al., 2013).

Scope

- Overview of Neuropathic pain, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on DS-5565 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for DS-5565 for the top seven countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan.

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 Neuropathic pain
- 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 DS-5565 performance
- Obtain sales forecast for DS-5565 from 2012-2022 in the top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan).

Table Of Contents

DS5565 (Neuropathic Pain) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
3 Disease Overview 12
3.1 Clinical Manifestations of Neuropathic Pain - Signs and Symptoms 14
3.1.1 Painful Diabetic Neuropathy 16
3.1.2 Postherpetic Neuralgia 17
3.1.3 Trigeminal Neuralgia 17
3.2 Etiology and Pathophysiology 18
3.2.1 Etiology 19
3.2.2 Pathophysiology 20
4 Disease Management 28
4.1 Diagnosis and Treatment Overview 28
4.1.1 Diagnosis 28
4.1.2 Treatment Overview and Guidelines 35
5 Competitive Assessment 45
5.1 Overview 45
6 Unmet Need and Opportunity 50
6.1 Overview 50
6.2 Physician Knowledge or Awareness 51
6.2.1 Unmet Need 51
6.2.2 Gap Analysis 52
6.2.3 Opportunity 53
6.3 Diagnostic Challenges 53
6.3.1 Unmet Need 53
6.3.2 Gap Analysis 54
6.3.3 Opportunity 54
6.4 Low Treatment Rate and Underdosing of Medications 54
6.4.1 Unmet Need 54
6.4.2 Gap Analysis 56
6.4.3 Opportunity 56
6.5 Unsatisfactory Efficacy and Safety Profiles of Pharmacological Treatments 57
6.5.1 Unmet Need 57
6.5.2 Gap Analysis 58
6.5.3 Opportunity 58
6.6 Elderly Patient Population - Drug Tolerability 59
6.6.1 Unmet Need 59
6.6.2 Gap Analysis 59
6.6.3 Opportunity 60
6.7 Rational or Personalized Therapies 60
6.7.1 Unmet Need 60
6.7.2 Gap Analysis 61
6.7.3 Opportunity 61
7 Pipeline Assessment 63
7.1 Overview 63
7.2 Promising Drugs in Clinical Development 64
8 DS-5565 67
8.1 Overview 67
8.2 Efficacy 68
8.3 Safety 69
8.4 Dosing and Formulation 69
8.5 Potential Clinical and Commercial Positioning 69
8.6 Pricing and Reimbursement 69
8.7 SWOT analysis 70
8.8 Forecast 70
9 Appendix 72
9.1 Bibliography 72
9.2 Abbreviations 76
9.3 Methodology 79
9.4 Forecasting Methodology 79
9.4.1 Diagnosed PDN, PHN, and TN Patients 80
9.4.2 Percent Drug-Treated Patients 80
9.4.3 General Pricing Assumptions 80
9.4.4 Generic Erosion 81
9.4.5 Pricing of Pipeline Agents 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: Classification of NP Syndromes Based on the Site of Somatosensory Damage 14
Table 2: Signs and Symptoms of NP 15
Table 3: Screening Tools for NP 29
Table 4: NP-Related Signs and Symptoms 31
Table 5: Treatment Guidelines for NP 36
Table 6: Recommended Drug Therapies for NP Conditions by Line of Therapy 42
Table 7: Most Prescribed Drugs for NP by Indication and Line of Therapy in the Global Markets, 2012 44
Table 8: NNT and NNH for Classes of Oral Drugs used in NP Treatment, 2013 47
Table 9: Select Products Used for NP Treatment, 2013 49
Table 10: Unmet Need and Opportunity in NP 51
Table 11: NP - Promising Drugs in Clinical Development 65
Table 12: Comparison of Drugs in Development for NP, 2014 65
Table 13: Product Profile - DS-5565 68
Table 14: DS-5565 SWOT Analysis, 2013 70
Table 15: Global Sales Forecasts ($) for DS-5565, 2012-2022 71

1.2 List of Figures

Figure 1: Nociceptive Versus Neuropathic Pain 13
Figure 2: Etiology and Pathophysiology of NP 18
Figure 3: Pain Pathway - Somatosensory System 21
Figure 4: Pathophysiological Mechanisms of NP at Different Levels of the Nervous System 25
Figure 5: Pathophysiological Targets of NP Drugs 26
Figure 6: NeuSPIG Diagnostic Certainty Algorithm for NP 32
Figure 7: General Treatment Algorithm for NP 41
Figure 8: Competitive Assessment of Mid-to-Late Stage Pipeline Agents in NP, 2012-2022 66

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