Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022

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Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022
Published on February 2013

Report Summary


Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, 'Ganaxolone (Epilepsy) - Forecast and Market Analysis to
2022'. Epilepsy is a brain disorder characterized by spontaneously occurring and recurrent seizures. The market is heavily driven by
the sales of antiepileptic drugs (AEDs) targeted at seizure reduction. The AED market is currently dominated by UCB's Keppra and
GlaxoSmithKline's Lamictal. Although both drugs have experienced significant generic erosion, they form the mainstay of epilepsy
treatment in the nine markets and will continue to have significant market share during the forecast period. Other key drugs include
older generation AEDs such as Pfizer's Dilantin, Abbott's Depakote, and Novartis' Tegretol and Trileptal which still have significant
usage due to their longevity in the market. However, the AED dominance landscape will continue to shift towards newer generation
drugs particularly following the recent market entry of GlaxoSmithKline's Trobalt/Potiga and Eisai's Fycompa which both offer
first-in-class mechanisms of action.

Ganaxolone is a first-in-class synthetic neurosteroid analog of the endogenous neurosteroid allopregnanolone. It has novel GABA-A
receptor modulation and unique broad-spectrum protective efficacy, and is under development for the treatment of uncontrolled
partial-onset seizures and infantile spasms. Marinus Pharmaceuticals licensed ganaxolone from Purdue Pharma and is currently
conducting late-stage Phase II trials for ganaxolone as an adjunctive therapy in adult patients with refractory partial seizures and in
children with infantile spasms. Ganaxolone has been administered to more than 900 healthy adult volunteers and patients in Phase I
and Phase II studies, and was shown to be well tolerated and safe in adults, children, and infants (Marinus Pharmaceuticals, 2012).

Scope

- Overview of Epilepsy, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an
overview on the competitive landscape.
- Detailed information on Ganaxolone including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Ganaxolone 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 Epilepsy
- 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 Ganaxolone performance
- Obtain sales forecast for Ganaxolone from 2012-2022 in top six countries (the US, France, Germany, Italy, Spain and the UK)

Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022 (From Slideshare) Page 1/6


Table of Content

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
3 Disease Overview 12
3.1 Classification of Seizures 14
3.2 Etiology and Pathophysiology 15
3.2.1 Etiology 15
3.2.2 Pathophysiology 18
3.2.3 Prognosis 23
3.2.4 Quality of Life 24
4 Disease Management 25
4.1 Diagnosis 25
4.2 Treatment Guidelines 26
4.3 Clinical Practice 27
5 Competitive Assessment 33
5.1 Overview 33
5.2 Strategic Competitor Assessment 35
6 Opportunity and Unmet Need 38
6.1 Overview 38
6.2 Unmet Needs 39
6.2.1 Refractory Epilepsy 39
6.2.2 Safety/Side Effect Profiles 40
6.2.3 Curative/Disease-Modifying Agents 41
6.2.4 Predictive Tools and Need for More Directed Treatments 41
6.2.5 Improved Preclinical Models and Clinical Trial Paradigms 42
6.2.6 Treatment Gap 43
6.3 Unmet Needs Gap Analysis 44
6.4 Opportunities 45
6.4.1 Disease-Modifying Agents 45
6.4.2 Improved Preclinical Models and Clinical Trial Paradigms 45
6.4.3 Treatment Gap 45
7 Pipeline Assessment 46
7.1 Overview 46
7.2 Strategic Pipeline Assessment 46
7.3 Pipeline by Phases of Development 47
7.3.1 Phase III Pipeline 47
7.3.2 Phase III Pipeline ' Reformulations/New Delivery Systems 48
7.3.3 Phase IIb Pipeline 48
7.3.4 Phase II Pipeline 49



7.3.5 Phase I Pipeline 49
7.3.6 Preclinical Pipeline 50
7.3.7 Discovery Pipeline 51
7.4 Pipeline by Mechanism of Action 51
7.5 Promising Drugs in Clinical Development 53
8 Ganaxolone 54
8.1 Overview 54
8.2 Efficacy 55
8.3 Safety 55
8.4 Dosing and Formulation 56
8.5 Potential Clinical Positioning 56
8.6 Potential Commercial Positioning 56
8.7 Pricing and Reimbursement 56
8.8 SWOT Analysis 57
8.9 Forecast 57
9 Appendix 58
9.1 Bibliography 58
9.2 Abbreviations 61
9.3 Methodology 63
9.4 Forecasting Methodology 63
9.4.1 Prevalent Epilepsy Patients 63
9.4.2 Percent Drug-Treated Patients 64
9.4.3 General Pricing Assumptions 64
9.4.4 Generic Erosion 65
9.4.5 Pricing of Pipeline Agents 65
9.5 Physicians and Specialists Included in this Study 65
9.6 Primary Research - Prescriber Survey 66
9.7 About the Authors 67
9.7.1 Authors 67
9.7.2 Global Head of Healthcare 68
9.8 About GlobalData 69
9.9 Contact Us 69
9.10 Disclaimer 69

List of Tables

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification) 13
Table 2: Classification of Seizures 14
Table 3: Etiology of Epilepsy According to Age 15
Table 4: Etiology of Partial Seizures 16
Table 5: Etiology of Generalized Seizures 17
Table 6: Some of the Genes Involved in Epilepsy 22
Table 7: Summary of Diagnostic Tools for Epilepsy 25
Table 8: Treatment Guidelines for Epilepsy 26
Table 9: AED Options by Seizure Type 30
Table 10: Top Three AEDs Prescribed for Epilepsy by Market 31
Table 11: Types of Epilepsy Surgery 32



Table 12: Leading Treatments for Epilepsy, 2012 37
Table 13: Overall Unmet Needs ' Current Level of Attainment 38
Table 14: Clinical Unmet Needs ' Gap Analysis, 2012 44
Table 15: Epilepsy ' Phase III Pipeline, 2012 47
Table 16: Epilepsy ' Phase III Pipeline (Reformulations), 2012 48
Table 17: Epilepsy ' Phase IIb Pipeline, 2012 48
Table 18: Epilepsy ' Phase II Pipeline, 2012 49
Table 19: Epilepsy ' Phase I Pipeline, 2012 49
Table 20: Epilepsy ' Preclinical Pipeline, 2012 50
Table 21: Epilepsy - Discovery Pipeline, 2012 51
Table 22: Comparison of MOA of Drugs in Development for Epilepsy, 2012 52
Table 23: Epilepsy ' Promising Drugs in Clinical Development 53
Table 24: Product Profile ' Ganaxolone 54
Table 25: Ganaxolone SWOT Analysis, 2012 57
Table 26: Global Sales Forecasts ($m) for Ganaxolone, 2012'2022 57
Table 27: Physicians Surveyed, By Country 66

List of Figures

Figure 1: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 19
Figure 2: Mechanisms of Action of AEDs at the Synapse 21
Figure 3: AED Selection Based on Comorbidity 29
Figure 4: Epilepsy ' Pipeline by MOA, 2012 52
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012'2022 53


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Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022

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