PharmaPoint: Epilepsy - Italy Drug Forecast and Market Analysis to 2022

GlobalData has released its new Country report, “PharmaPoint: Epilepsy - Italy Drug 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.

The main driver for growth in this market is the launch of new AEDs, the continued uptake of recent AEDs, and the lower-than-average rate of generic substitution in Italy compared with other countries, although this may change during the forecast period due to government cost-cutting strategies.

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 the key drugs in Italy including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in Italy from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting Italy Epilesy market.

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 drug performance
• Obtain sales forecast for drugs from 2012-2022 in Italy

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9

2 Introduction
2.1 Catalyst 10
2.2 Related Reports 11

3 Disease Overview
3.1 Classification of Seizures 15
3.2 Etiology and Pathophysiology 16
3.2.1 Etiology 16
3.2.2 Pathophysiology 19
3.2.3 Prognosis 24
3.2.4 Quality of Life 25

4 Disease Management
4.1 Diagnosis 26
4.2 Treatment Guidelines 27
4.3 Clinical Practice 28
4.4 Italy 34
4.4.1 Diagnosis 34
4.4.2 Clinical Practice 35

5 Competitive Assessment
5.1 Overview 37
5.2 Strategic Competitor Assessment 39
5.3 Product Profiles – Major Brands 42
5.3.1 Keppra (levetiracetam) 42
5.3.2 Lamictal (lamotrigine) 46
5.3.3 Lyrica (pregabalin) 50
5.3.4 Vimpat (lacosamide) 53
5.3.5 Zonegran (zonisamide) 56
5.3.6 Banzel/Inovelon (rufinamide) 59
5.3.7 Trobalt/Potiga (retigabine/ezogabine) 62
5.3.8 Zebinix (eslicarbazepine acetate) 65
5.3.9 Fycompa (perampanel) 68
5.3.10 Older-Generation AEDs 71

6 Opportunity and Unmet Need
6.1 Overview 72
6.2 Unmet Needs 73
6.2.1 Refractory Epilepsy 73
6.2.2 Safety/Side Effect Profiles 73
6.2.3 Curative/Disease-Modifying Agents 74
6.2.4 Predictive Tools and Need for More Directed Treatments 75
6.2.5 Improved Preclinical Models and Clinical Trial Paradigms 75
6.2.6 Treatment Gap 76
6.3 Unmet Needs Gap Analysis 77
6.4 Opportunities 78
6.4.1 Disease-Modifying Agents 78
6.4.2 Improved Preclinical Models and Clinical Trial Paradigms 78
6.4.3 Treatment Gap 78

7 Pipeline Assessment
7.1 Overview 79 
7.2 Strategic Pipeline Assessment 79
7.3 Pipeline by Phases of Development 80
7.3.1 Phase III Pipeline 80
7.3.2 Phase III Pipeline – Reformulations/New Delivery Systems 81
7.3.3 Phase IIb Pipeline 81
7.3.4 Phase II Pipeline 82
7.3.5 Phase I Pipeline 82
7.3.6 Preclinical Pipeline 83
7.3.7 Discovery Pipeline 84
7.4 Pipeline by Mechanism of Action 84
7.5 Promising Drugs in Clinical Development 86
7.5.1 Brivaracetam 87
7.5.2 Ganaxolone 90
7.5.3 VX-765 93

8 Market Outlook
8.1 Italy 96
8.1.1 Forecast 96
8.1.2 Key Events 99
8.1.3 Drivers and Barriers 99

9 Appendix
9.1 Bibliography 101
9.2 Abbreviations 107
9.3 Methodology 109
9.4 Forecasting Methodology 109
9.4.1 Prevalent Epilepsy Patients 109
9.4.2 Percent Drug-Treated Patients 110
9.4.3 Drugs Included in Each Therapeutic Class Based on MOA 110
9.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 111
9.4.5 General Pricing Assumptions 113
9.4.6 Individual Drug Assumptions 114
9.4.7 Generic Erosion 128
9.4.8 Pricing of Pipeline Agents 129
9.5 Physicians and Specialists Included in this Study 129
9.6 Primary Research - Prescriber Survey 130
9.7 About the Authors 130
9.7.1 Authors 130
9.7.2 Global Head of Healthcare 131
9.8 About GlobalData 132
9.9 Contact Us 132
9.10 Disclaimer 132

List of Tables

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification) 14
Table 2: Classification of Seizures 15
Table 3: Etiology of Epilepsy According to Age 16
Table 4: Etiology of Partial Seizures 17
Table 5: Etiology of Generalized Seizures 18
Table 6: Some of the Genes Involved in Epilepsy 23
Table 7: Summary of Diagnostic Tools for Epilepsy 26
Table 8: Treatment Guidelines for Epilepsy 27
Table 9: AED Options by Seizure Type 31
Table 10: Top Three AEDs Prescribed for Epilepsy by Market 32
Table 11: Types of Epilepsy Surgery 33
Table 12: Italy, Epilepsy Patient Referrals to Neurologist 34
Table 13: Italy, Most-Prescribed 1st-line and 2nd-line AEDs 35
Table 14: Leading Treatments for Epilepsy, 2012 41
Table 15: Product Profile – Keppra 43
Table 16: Keppra SWOT Analysis, 2012 45
Table 17: Product Profile – Lamictal 46
Table 18: Lamictal SWOT Analysis, 2012 49
Table 19: Product Profile – Lyrica 50
Table 20: Lyrica SWOT Analysis, 2012 52
Table 21: Product Profile – Vimpat 53
Table 22: Vimpat SWOT Analysis, 2012 55
Table 23: Product Profile – Zonegran 56
Table 24: Zonegran SWOT Analysis, 2012 58
Table 25: Product Profile – Banzel/Inovelon 59
Table 26: Banzel/Inovelon SWOT Analysis, 2012 61
Table 27: Product Profile – Trobalt/Potiga 62
Table 28: Trobalt/Potiga SWOT Analysis, 2012 64
Table 29: Product Profile – Zebinix 65
Table 30: Zebinix SWOT Analysis, 2012 67
Table 31: Product Profile – Fycompa 68
Table 32: Fycompa SWOT Analysis, 2012 70
Table 33: Summary of Minor Drug Classes, 2012 71
Table 34: Overall Unmet Needs – Current Level of Attainment 72
Table 35: Clinical Unmet Needs – Gap Analysis, 2012 77
Table 36: Epilepsy – Phase III Pipeline, 2012 80
Table 37: Epilepsy – Phase III Pipeline (Reformulations), 2012 81
Table 38: Epilepsy – Phase IIb Pipeline, 2012 81
Table 39: Epilepsy – Phase II Pipeline, 2012 82
Table 40: Epilepsy – Phase I Pipeline, 2012 82
Table 41: Epilepsy – Preclinical Pipeline, 2012 83
Table 42: Epilepsy - Discovery Pipeline, 2012 84
Table 43: Comparison of MOA of Drugs in Development for Epilepsy, 2012 85
Table 44: Epilepsy – Promising Drugs in Clinical Development 86
Table 45: Product Profile – Brivaracetam 87
Table 46: Brivaracetam SWOT Analysis, 2012 89
Table 47: Product Profile – Ganaxolone 90
Table 48: Ganaxolone SWOT Analysis, 2012 92
Table 49: Product Profile – VX-765 93
Table 50: VX-765 SWOT Analysis, 2012 95
Table 51: Sales Forecasts ($m) for Epilepsy in Italy, 2012–2022 97
Table 52: Key Events Impacting Sales for Epilepsy in Italy, 2012–2022 99
Table 53: Epilepsy Market in Italy – Drivers and Barriers, 2012–2022 99
Table 54: Key Launch Dates 111
Table 55: Key Patent Expiries and Market Exclusivity Expiries* 112
Table 56: Physicians Surveyed, By Country 130

List of Figures

Figure 1: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 20
Figure 2: Mechanisms of Action of AEDs at the Synapse 22
Figure 3: AED Selection Based on Comorbidity 30
Figure 4: Epilepsy – Pipeline by MOA, 2012 85
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012–2022 86
Figure 6: Sales for Epilepsy in Italy by Drug Class, 2012–2022 98