Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022

Date: February 25, 2013
Pages: 69
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US$ 3,495.00
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Publisher: GlobalData
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: GFB10B43B11EN
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Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022
Ganaxolone (Epilepsy) - Forecast and Market Analysis to 2022

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)
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 INTRODUCTION

2.1 Catalyst
2.2 Related Reports

3 DISEASE OVERVIEW

3.1 Classification of Seizures
3.2 Etiology and Pathophysiology
  3.2.1 Etiology
  3.2.2 Pathophysiology
  3.2.3 Prognosis
  3.2.4 Quality of Life

4 DISEASE MANAGEMENT

4.1 Diagnosis
4.2 Treatment Guidelines
4.3 Clinical Practice

5 COMPETITIVE ASSESSMENT

5.1 Overview
5.2 Strategic Competitor Assessment

6 OPPORTUNITY AND UNMET NEED

6.1 Overview
6.2 Unmet Needs
  6.2.1 Refractory Epilepsy
  6.2.2 Safety/Side Effect Profiles
  6.2.3 Curative/Disease-Modifying Agents
  6.2.4 Predictive Tools and Need for More Directed Treatments
  6.2.5 Improved Preclinical Models and Clinical Trial Paradigms
  6.2.6 Treatment Gap
6.3 Unmet Needs Gap Analysis
6.4 Opportunities
  6.4.1 Disease-Modifying Agents
  6.4.2 Improved Preclinical Models and Clinical Trial Paradigms
  6.4.3 Treatment Gap

7 PIPELINE ASSESSMENT

7.1 Overview
7.2 Strategic Pipeline Assessment
7.3 Pipeline by Phases of Development
  7.3.1 Phase III Pipeline
  7.3.2 Phase III Pipeline – Reformulations/New Delivery Systems
  7.3.3 Phase IIb Pipeline
  7.3.4 Phase II Pipeline
  7.3.5 Phase I Pipeline
  7.3.6 Preclinical Pipeline
  7.3.7 Discovery Pipeline
7.4 Pipeline by Mechanism of Action
7.5 Promising Drugs in Clinical Development

8 GANAXOLONE

8.1 Overview
8.2 Efficacy
8.3 Safety
8.4 Dosing and Formulation
8.5 Potential Clinical Positioning
8.6 Potential Commercial Positioning
8.7 Pricing and Reimbursement
8.8 SWOT Analysis
8.9 Forecast

9 APPENDIX

9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
  9.4.1 Prevalent Epilepsy Patients
  9.4.2 Percent Drug-Treated Patients
  9.4.3 General Pricing Assumptions
  9.4.4 Generic Erosion
  9.4.5 Pricing of Pipeline Agents
9.5 Physicians and Specialists Included in this Study
9.6 Primary Research - Prescriber Survey
9.7 About the Authors
  9.7.1 Authors
  9.7.2 Global Head of Healthcare
9.8 About GlobalData
9.9 Contact Us
9.10 Disclaimer

LIST OF TABLES

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification)
Table 2: Classification of Seizures
Table 3: Etiology of Epilepsy According to Age
Table 4: Etiology of Partial Seizures
Table 5: Etiology of Generalized Seizures
Table 6: Some of the Genes Involved in Epilepsy
Table 7: Summary of Diagnostic Tools for Epilepsy
Table 8: Treatment Guidelines for Epilepsy
Table 9: AED Options by Seizure Type
Table 10: Top Three AEDs Prescribed for Epilepsy by Market
Table 11: Types of Epilepsy Surgery
Table 12: Leading Treatments for Epilepsy, 2012
Table 13: Overall Unmet Needs – Current Level of Attainment
Table 14: Clinical Unmet Needs – Gap Analysis, 2012
Table 15: Epilepsy – Phase III Pipeline, 2012
Table 16: Epilepsy – Phase III Pipeline (Reformulations), 2012
Table 17: Epilepsy – Phase IIb Pipeline, 2012
Table 18: Epilepsy – Phase II Pipeline, 2012
Table 19: Epilepsy – Phase I Pipeline, 2012
Table 20: Epilepsy – Preclinical Pipeline, 2012
Table 21: Epilepsy - Discovery Pipeline, 2012
Table 22: Comparison of MOA of Drugs in Development for Epilepsy, 2012
Table 23: Epilepsy – Promising Drugs in Clinical Development
Table 24: Product Profile – Ganaxolone
Table 25: Ganaxolone SWOT Analysis, 2012
Table 26: Global Sales Forecasts ($m) for Ganaxolone, 2012–2022
Table 27: Physicians Surveyed, By Country

LIST OF FIGURES

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

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