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JSB Market Research: Cebranopadol (Neuropathic
Pain) - Forecast and Market Analysis to 2022
On 9
th
July 2014

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

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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.

Cebranopadol (GRT-6005) is a small-molecule opioid analgesic that is being
developed by Grnenthal for the treatment of moderate to severe chronic pain
conditions. In December 2010, Grnenthal entered into a licensing agreement with
Forest Laboratories for the co-development and commercialization of
cebranopadol and its follow-on compound, GRT-6006. The drug is currently in
Phase IIb of clinical development for PDN, and is also in Phase III of development
for cancer pain, as well as in Phase II for chronic nociceptive pain, moderate to
severe pain due to osteoarthritis of the knee, and chronic low back pain.

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 Cebranopadol including product description, safety and
efficacy profiles as well as a SWOT analysis.
- Sales forecast for Cebranopadol for the top six countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain and the UK.

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

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- Make more informed business decisions from insightful and in-depth analysis of
Cebranopadol performance
- Obtain sales forecast for Cebranopadol from 2012-2022 in the top six countries
(the US, France, Germany, Italy, Spain and the UK).

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

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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

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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 Cebranopadol 67
8.1 Overview 67
8.2 Efficacy 68
8.3 Safety 68
8.4 Dosing and Formulation 68
8.5 Potential Clinical and Commercial Positioning 68
8.6 Pricing and Reimbursement 69

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8.7 SWOT Analysis 69
8.8 Forecast 70
9 Appendix 71
9.1 Bibliography 71
9.2 Abbreviations 75
9.3 Methodology 78
9.4 Forecasting Methodology 78
9.4.1 Diagnosed PDN, PHN, and TN Patients 78
9.4.2 Percent Drug-Treated Patients 79
9.4.3 General Pricing Assumptions 79
9.4.4 Generic Erosion 79
9.4.5 Pricing of Pipeline Agents 80
9.5 Physicians and Specialists Included in This Study 80
9.6 About the Authors 82
9.6.1 Author 82
9.6.2 Global Head of Healthcare 83
9.7 About GlobalData 84
9.8 Disclaimer 84


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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 - Cebranopadol 67
Table 14: Cebranopadol SWOT Analysis, 2013 69
Table 15: Global Sales Forecasts ($) for Cebranopadol, 2012-2022 70



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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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