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Lemtrada (Multiple Sclerosis) - Forecast and Market Analysis to 2022

Published By :

GlobalData

Published Date : Mar 2013

Category :

Therapeutic Area

No. of Pages : 63 Pages


Lemtrada (Multiple Sclerosis) Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Lemtrada (Multiple Sclerosis) Forecast and Market Analysis to 2022”. Multiple sclerosis (MS) is a chronic, inflammatory neurological disorder characterized pathologically by demyelination, axonal transection and neurodegeneration within the central nervous system. With curative therapy still elusive, current disease management is dependent on life-long pharmacotherapy with disease-modifying therapies (DMT). The dominance of first-line injectable DMTs, including the interferon beta (IFNB) agents: Bayer’s Betaseron/Betaferon (IFNB-1b), Biogen’s Avonex (IFNB-1a) and Merck’s Rebif (IFNB-1a), and Teva’s Copaxone (glatiramer acetate), has been a salient feature of the MS therapeutics market. However, the competitive landscape is undergoing significant change with the emergence of oral therapies, several pipeline products with notable efficacies, and looming generics/biosimilars following the patent expiries of key branded products during the forecast period. In addition, the entry of new companies such as Sanofi/Genzyme and F. Hoffmann-La-Roche/Genentech will challenge the position of the established players in the MS marketplace.

Lemtrada (alemtuzumab) is an IV-administered humanized mAb being investigated as a potential therapy for RRMS. Sanofi’s and Genzyme’s Lemtrada is currently being developed in collaboration with Bayer HealthCare, which has recently announced its intention to co-promote the drug for MS. It is approved under the trade name Campath as a monotherapy for the treatment of B-cell chronic lymphocytic leukemia (CLL). However, Sanofi’s Genzyme unit recently decided to withdraw Campath from the US and EU markets in order to optimize the drug as a treatment for MS. By using a different dose and the trade name Lemtrada, the company is making a bid to stop physicians from prescribing the drug off-label for MS. Once approved, this would also allow the company to charge a significantly higher price for Lemtrada in the MS market.

Scope


  • Overview of Multiple Sclerosis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Lemtrada including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Lemtrada for the top ten countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India

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 Multiple Sclerosis
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed busineB decisions from insightful and in-depth analysis of Lemtrada performance
  • Obtain sales forecast for Lemtrada from 2012-2022 in top ten countries (the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India)
Table of Contents

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

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9

3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 12
3.1.3 Classification of Multiple Sclerosis 13
3.2 Symptoms 15
3.2.1 Prognosis 16
3.2.2 Quality of Life 17

4 Disease Management 18
4.1 Diagnosis 18
4.2 Treatment Overview 21
4.2.1 Management of Acute Relapse 22
4.2.2 Treatment with Disease-Modifying Therapies 22
4.2.3 Symptomatic Therapies 25

5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 27

6 Opportunity and Unmet Need 29
6.1 Overview 29
6.2 Unmet Needs 30
6.2.1 Currently Available MS Drugs Only Provide Partial Benefits 30
6.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 31
6.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 32
6.2.4 Effective Treatments for Progressive MS Are Still Elusive 33
6.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 34
6.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 35
6.3 Unmet Needs Gap Analysis 36
6.4 Opportunities 37
6.4.1 Treatments for Progressive MS 37
6.4.2 Targeting Patients with Clinically Isolated Syndrome 37

7 Pipeline Assessment 38
7.1 Overview 38
7.2 Promising Drugs in Clinical Development 40

8 Lemtrada (alemtuzumab) 42
8.1 Overview 42
8.2 Efficacy 44
8.3 Safety 45
8.4 Dosing and Formulation 45
8.5 Potential Clinical Positioning 45
8.6 Potential Commercial Positioning 46
8.7 Pricing and Reimbursement 46
8.8 SWOT Analysis 47
8.9 Forecast 47

9 Appendix 49
9.1 Bibliography 49
9.2 Abbreviations 54
9.3 Methodology 56
9.4 Forecasting Methodology 56
9.4.1 Diagnosed MS patients 56
9.4.2 Percent Drug-Treated Patients 57
9.4.3 General Pricing Assumptions 57
9.4.4 Generic Erosion 58
9.4.5 Pricing of Pipeline agents 58
9.5 Physicians and Specialists Included in This Report 59
9.6 Primary Research – Prescriber Survey 60
9.7 About the Authors 61
9.7.1 Analysts 61
9.7.2 Global Head of Healthcare 62
9.8 About GlobalData 63
9.9 Contact Us 63
9.10 Disclaimer 63

List of Table


Table 1: Common Presenting Symptoms of Multiple Sclerosis 15
Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis 16
Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis 19
Table 4: Treatment Guidelines for Multiple Sclerosis 21
Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market 23
Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms 25
Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 28
Table 8: Overall Unmet Needs Current Level of Attainment 29
Table 9: Clinical Unmet Needs Gap Analysis, 2012 36
Table 10: Multiple Sclerosis Phase Pipeline, 2012 40
Table 11: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 41
Table 12: Product Profile Lemtrada 43
Table 13: Lemtrada SWOT Analysis, 2012 47
Table 14: Global Sales Forecasts ($m) for Lemtrada, 20122022 48
Table 15: Physicians Surveyed, By Country 60

List of Chart


Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis 14
Figure 2: Expanded Disability Status Scale (EDSS) 20
Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies 24
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 20122022 40

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