gdhc1073cfr multiple sclerosis country cut france sample(dmt) for multiple sclerosis (ms) in france...

Multiple Sclerosis France Drug Forecast and Market Analysis to 2022

GDHC1073CFR / Published March 2013

Executive Summary

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. GDHC1073CFR / Published MAR 2013

Sales for Multiple Sclerosis in France

GlobalData estimates that disease-modifying therapies

(DMT) for multiple sclerosis (MS) in France generated

$305.3 million in 2012, and that the market will increase

to $357.5 million in 2022 at a CAGR of 1.6%.

Major drivers to the growth of the MS market over the

forecast period will include:

The anticipated launch of efficacious pipeline

products that target the progressive MS subtypes,

which will increase the treatment rates in patients

with primary-progressive MS (PPMS) and secondary-

progressive MS (SPMS).

Launch of oral therapies such as Aubagio and BG-

12, will drive up overall treatment rates, due to their

improved convenience of administration over the

current injectables.

Major barriers to the growth of the MS market will

include:

Government initiatives to increase generic uptake will

accelerate brand erosion of off-patent drugs.

Healthcare cuts will limit pricing and reimbursement

Patent expiries of market-leading branded products

throughout the forecast period, which will significantly

expose sales to generic erosion and will result in

market contraction.

The figure below illustrates the MS DMT sales by drug

class in France during the forecast period.

Sales for Multiple Sclerosis in France by Drug Class, 2012–2022

Source: GlobalData

56.6%

17.3%

5.8%

20.2%

0.1%

IFNβ agentsImmunomodulatory agentsS1P receptor modulatorsS.E.M inhibitorsAnti-CD52 agentsIL-2 receptor modulatorsAnti-CD20 agentsKinase inhibitorsMS vaccinesOther

2012Total: $305.3m

17.2%

19.5%

13.6%10.7%

9.7%

10.9%

12.3%

2.2%

3.9%0.0%

IFNβ agentsImmunomodulatory agentsS1P receptor modulatorsS.E.M inhibitorsAnti-CD52 agentsIL-2 receptor modulatorsAnti-CD20 agentsKinase inhibitorsMS vaccinesOther

2022Total: $357.5m

Executive Summary


What Do the Physicians Think?

Our experts believe that the most promising DMTs in

the Phase III pipeline are Biogen’s BG-12 and

Roche’s/Genentech’s/Biogen’s ocrelizumab.

“Higher efficacy generally comes with higher risks. The

only drug which has not followed this pattern is BG-12 –

that has a high efficacy, but there haven’t been very

many associated infections. So far, the BG-12 profile has

been quite safe, so I would expect it will come out as a

first-line drug.”

[EU] Key Opinion Leader, November 2012

“I think ocrelizumab will have a big impact. It is

essentially the same drug as rituximab, which we have a

lot of experience with, but is more humanized. Like

rituximab, it looks to be well-tolerated and doesn’t need

to be taken very often because of its long-lasting effect.”

[US] Key Opinion Leader, November 2012

The launch of oral MS DMTs is expected to

progressively diminish the role of the injectable first-

line therapies through the forecast period.

“If we just focus on the interferons and glatiramer acetate

[Copaxone], I would say the main downfall of them is that

they are injectable agents, as a lot of patients don’t like

injecting themselves. Plus, they also have to be

administered quite frequently, so people might find them

quite disruptive. Oral DMTs are highly desired by

patients, as they are much more convenient, and

fortunately, there are several in the pipeline. I expect the

role of the first-line injectable drugs will diminish over

time, as more patients will prefer the oral drugs.”


Physicians interviewed in this report have highlighted

the current challenges in diagnosing MS, which can

negatively impact the treatment of patients.

“I would say the biggest challenge in diagnosing MS is

differential diagnosis. Without a definitive test, ruling out

that your patient may have something else is difficult, and

there are a lot of conditions that share the same features

as MS, like neuromyelitis optica. So, do you wait and

delay starting your patient on treatment while you monitor

progress? Or, do you risk giving the wrong treatment to

your patient? That is the problem we currently face.”

[EU] Key Opinion Leader, November 2012

Key Opinion Leaders (KOLs) interviewed for this

report are in agreement that the proportion of

patients with SPMS will progressively decrease over

time as more efficacious DMTs become available for

patients with RRMS, as well as the earlier initiation of

treatment in patients.

“In the next few years, there will be many strong disease-

modifying drugs that will become available for patients. I

really do expect, and I think we are already starting to

see this trend, is that the overall population of secondary-

progressive patients will drop over time as therapies

become more effective in stopping patients from

progressing to this subtype,”


“As more patients are started on treatment early in MS,

we will see fewer patients with secondary-progressive

MS in the future,”

[EU] Key Opinion Leader, October 2012

Table of Contents


1 Table of Contents

1 Table of Contents ............................................................................................................... 4

1.1 List of Tables ............................................................................................................... 8

1.2 List of Figures ........................................................................................................... 10

2 Introduction ....................................................................................................................... 11

2.1 Catalyst ..................................................................................................................... 11

2.2 Related Reports ........................................................................................................ 12

2.3 Upcoming Related Reports ........................................................................................ 13

3 Disease Overview ............................................................................................................. 14

3.1 Etiology and Pathophysiology .................................................................................... 14

3.1.1 Etiology ............................................................................................................... 14

3.1.2 Pathophysiology.................................................................................................. 15

3.1.3 Classification of Multiple Sclerosis ....................................................................... 16

3.2 Symptoms ................................................................................................................. 18

3.2.1 Prognosis ............................................................................................................ 19

3.2.2 Quality of Life ...................................................................................................... 20

4 Disease Management ....................................................................................................... 21

4.1 Diagnosis .................................................................................................................. 21

4.2 Treatment Overview .................................................................................................. 24

4.2.1 Management of Acute Relapse ........................................................................... 25

4.2.2 Treatment with Disease-Modifying Therapies ...................................................... 25

4.2.3 Symptomatic Therapies....................................................................................... 28

4.3 France ...................................................................................................................... 29

4.3.1 Diagnosis ............................................................................................................ 29

4.3.2 Clinical Practice .................................................................................................. 29

5 Competitive Assessment ................................................................................................... 31

5.1 Overview ................................................................................................................... 31

5.2 Strategic Competitor Assessment .............................................................................. 32

Table of Contents


5.3 Product Profiles – Major Brands ................................................................................ 34

5.3.1 Betaseron/Betaferon (interferon beta-1b)............................................................. 34

5.3.2 Avonex (interferon beta-1a) ................................................................................. 39

5.3.3 Rebif (interferon beta-1a) .................................................................................... 44

5.3.4 Copaxone (glatiramer acetate; copolymer-1) ....................................................... 48

5.3.5 Tysabri (natalizumab) .......................................................................................... 52

5.3.6 Gilenya/Imusera (fingolimod; FTY720) ................................................................ 57

5.3.7 Aubagio (teriflunomide) ....................................................................................... 62

5.3.8 Other Disease–Modifying Therapies .................................................................... 67

6 Opportunity and Unmet Need ............................................................................................ 68

6.1 Overview ................................................................................................................... 68

6.2 Unmet Needs ............................................................................................................ 69

6.2.1 Currently Available MS Drugs Only Provide Partial Benefits ................................ 69

6.2.2 The High Cost of MS Drugs Could Continue to Price out Patients ........................ 70

6.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects ........................ 71

6.2.4 Effective Treatments for Progressive MS Are Still Elusive .................................... 72

6.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance .... 73

6.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis .................................... 74

6.3 Unmet Needs Gap Analysis ....................................................................................... 75

6.4 Opportunities ............................................................................................................. 76

6.4.1 Treatments for Progressive MS ........................................................................... 76

6.4.2 Targeting Patients with Clinically Isolated Syndrome ........................................... 76

7 Pipeline Assessment......................................................................................................... 77

7.1 Overview ................................................................................................................... 77

7.2 Promising Drugs in Clinical Development .................................................................. 79

7.2.1 BG-12 (dimethyl fumarate; BG00012).................................................................. 81

7.2.2 Lemtrada (alemtuzumab) .................................................................................... 86

7.2.3 Laquinimod (ABR-215062) .................................................................................. 92

Table of Contents


7.2.4 Daclizumab High-Yield Process (HYP) ................................................................ 97

7.2.5 Ocrelizumab (RG1594) ..................................................................................... 102

7.2.6 Siponimod (BAF-312) ........................................................................................ 107

7.2.7 NU-100 (interferon beta-1b) .............................................................................. 111

7.2.8 Masitinib (AB-1010)........................................................................................... 115

7.2.9 Tcelna (imilecleucel-T) ...................................................................................... 119

8 Market Outlook ............................................................................................................... 123

8.1 France .................................................................................................................... 123

8.1.1 Forecast............................................................................................................ 123

8.1.2 Key Events ....................................................................................................... 127

8.1.3 Drivers and Barriers .......................................................................................... 127

9 Appendix ........................................................................................................................ 130

9.1 Bibliography ............................................................................................................ 130

9.2 Abbreviations .......................................................................................................... 141

9.3 Methodology ........................................................................................................... 145

9.4 Forecasting Methodology ........................................................................................ 145

9.4.1 Diagnosed MS patients ..................................................................................... 145

9.4.2 Percent Drug-Treated Patients .......................................................................... 146

9.4.3 Drugs Included in Each Therapeutic Class ........................................................ 146

9.4.4 Launch and Patent Expiry Dates ....................................................................... 147

9.4.5 General Pricing Assumptions ............................................................................ 148

9.4.6 Individual Drug Assumptions ............................................................................. 149

9.4.7 Generic Erosion ................................................................................................ 153

9.4.8 Pricing of Pipeline agents .................................................................................. 153

9.5 Physicians and Specialists Included in This Report .................................................. 154

9.6 Primary Research – Prescriber Survey .................................................................... 155

9.7 About the Authors ................................................................................................... 156

9.7.1 Analysts ............................................................................................................ 156

Table of Contents


9.7.2 Global Head of Healthcare ................................................................................ 157

9.8 About GlobalData .................................................................................................... 158

9.9 Contact Us .............................................................................................................. 158

9.10 Disclaimer ............................................................................................................... 158

Table of Contents


1.1 List of Tables

Table 1: Common Presenting Symptoms of Multiple Sclerosis ............................................ 18

Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis ........................................ 19

Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis ................ 22

Table 4: Treatment Guidelines for Multiple Sclerosis .......................................................... 24

Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market

............................................................................................................................. 26

Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms ................................ 28

Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 ................. 33

Table 8: Product Profile – Betaseron .................................................................................. 35

Table 9: Betaseron/Betaferon SWOT Analysis, 2012 .......................................................... 38

Table 10: Product Profile – Avonex ...................................................................................... 40

Table 11: Avonex SWOT Analysis, 2012 .............................................................................. 43

Table 12: Product Profile – Rebif .......................................................................................... 45

Table 13: Rebif SWOT Analysis, 2012 .................................................................................. 47

Table 14: Product Profile – Copaxone .................................................................................. 49

Table 15: Copaxone SWOT Analysis, 2012 .......................................................................... 51

Table 16: Product Profile – Tysabri ....................................................................................... 53

Table 17: Tysabri SWOT Analysis, 2012 .............................................................................. 56

Table 18: Product Profile – Gilenya ...................................................................................... 58

Table 19: Gilenya SWOT Analysis, 2012 .............................................................................. 61

Table 20: Product Profile – Aubagio ..................................................................................... 63

Table 21: Aubagio SWOT Analysis, 2012 ............................................................................. 66

Table 22: Summary of Alternative MS DMTs, 2012............................................................... 67

Table 23: Overall Unmet Needs – Current Level of Attainment ............................................. 68

Table 24: Clinical Unmet Needs – Gap Analysis, 2012 ......................................................... 75

Table 25: Multiple Sclerosis – Phase Pipeline, 2012 ............................................................. 79

Table 26: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 .. 80

Table 27: Product Profile – BG-12 ........................................................................................ 82

Table of Contents


Table 28: BG-12 SWOT Analysis, 2012 ................................................................................ 85

Table 29: Product Profile – Lemtrada ................................................................................... 87

Table 30: Lemtrada SWOT Analysis, 2012 ........................................................................... 91

Table 31: Product Profile – Laquinimod ................................................................................ 93

Table 32: Laquinimod SWOT Analysis, 2012 ........................................................................ 96

Table 33: Product Profile – Daclizumab High-Yield Process ................................................. 98

Table 34: Daclizumab SWOT Analysis, 2012...................................................................... 101

Table 35: Product Profile – Ocrelizumab............................................................................. 103

Table 36: Ocrelizumab SWOT Analysis, 2012 .................................................................... 106

Table 37: Product Profile – Siponimod ................................................................................ 107

Table 38: Siponimod SWOT Analysis, 2012 ....................................................................... 110

Table 39: Product Profile – NU-100 .................................................................................... 112

Table 40: NU-100 SWOT Analysis, 2012 ............................................................................ 114

Table 41: Product Profile – Masitinib .................................................................................. 115

Table 42: Masitinib SWOT Analysis, 2012 .......................................................................... 118

Table 43: Product Profile – Tcelna...................................................................................... 120

Table 44: Tcelna SWOT Analysis, 2012 ............................................................................. 122

Table 45: Sales Forecasts ($m) for Multiple Sclerosis in France, 2012–2022 ...................... 125

Table 46: Key Events Impacting Sales for Multiple Sclerosis in France, 2012 ..................... 127

Table 47: Multiple Sclerosis Market in France – Drivers and Barriers, 2012 ....................... 127

Table 48: Key Launch Dates .............................................................................................. 147

Table 49: Key Patent Expiries ............................................................................................ 147

Table 50: Physicians Surveyed, By Country ....................................................................... 155

Table of Contents


1.2 List of Figures

Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis.............................. 17

Figure 2: Expanded Disability Status Scale (EDSS) ............................................................. 23

Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies ....... 27

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis,

2012–2022 ........................................................................................................... 79

Figure 5: Sales for Multiple Sclerosis in France by Drug Class, 2012–2022 ....................... 126

Introduction


2 Introduction

2.1 Catalyst

The Multiple Sclerosis (MS) therapeutics market is set to enter an exciting phase, with an upsurge

of available treatment options and several promising late-stage pipeline products offering diverse

mechanisms of action. The arrival of novel oral disease-modifying therapies (DMTs) fulfills a

significant unmet need in the treatment of MS by providing patients with a more convenient route of

administration. Novartis’s Gilenya (fingolimod), the first available oral MS drug, and the recently

approved Aubagio (teriflunomide; Sanofi/Genzyme) are threatening the stronghold of the currently

established injectable therapies, including Teva’s Copaxone (glatiramer acetate) and the interferon

beta (IFNβ) agents. However, the safety concerns of Gilenya and the modest efficacy of Aubagio

are key stumbling blocks in their attempts to make a significant impact in the rapidly growing MS

market.

The current MS pipeline is very robust, with numerous promising DMTs set to enter the market

within the forecast period. Biogen Idec’s BG-12 (dimethyl fumarate) demonstrated an impressive

efficacy and safety profile in clinical trials prior to its expected launch in 2013, and anticipation is

high that it could become the next mega-blockbuster oral treatment for MS. In addition, agents

such as Sanofi/Genzyme’s Lemtrada (alemtuzumab) will provide stiff competition for Biogen’s

Tysabri (natalizumab) and challenge its position as the escalating therapy of choice when first-line

treatment options have failed. With the market becoming increasingly competitive, the established

players are investing heavily to bolster their MS portfolios and are entering into key collaborations

with innovative biotech companies. The most recent is Merck (EMD) Serono’s agreement with

Opexa Therapeutics for the development and commercialization of Tcelna (imilecleucel-T), a novel

first-in-class MS vaccine that is making important strides through the phases of clinical

development.

There are several drivers for growth in the MS market. Initiating early DMT treatment in patients

with clinically isolated syndrome (CIS) will delay the onset of clinically-definite MS and increase the

overall treated patient population. However, the challenges of the MS industry include an

increasingly crowded marketplace, making it more difficult for drugs to distinguish themselves,

whereas a natural conservatism among neurologists will also delay the uptake of new drugs trying

to gain market entry. Furthermore, the impending patent expiry of current leading DMTs, such as

Copaxone, will pave the way for the entry of generics and biosimilars, forcing pharmaceutical

companies to derive alternative strategies to offset potential losses in sales.

Introduction


2.2 Related Reports

GlobalData (2013). Multiple Sclerosis – US Drug Forecast and Market Analysis to 2022.

GDHC1072CFR

GlobalData (2013). Multiple Sclerosis – Germany Drug Forecast and Market Analysis to 2022.

GDHC1074CFR

GlobalData (2013). Multiple Sclerosis – Italy Drug Forecast and Market Analysis to 2022.

GDHC1075CFR

GlobalData (2013). Multiple Sclerosis – Spain Drug Forecast and Market Analysis to 2022.

GDHC1076CFR

GlobalData (2013). Multiple Sclerosis – UK Drug Forecast and Market Analysis to 2022.

GDHC1077CFR

GlobalData (2013). Multiple Sclerosis – Japan Drug Forecast and Market Analysis to 2022.

GDHC1078CFR

GlobalData (2013). Multiple Sclerosis – India Drug Forecast and Market Analysis to 2022.

GDHC1079CFR

GlobalData (2013). Multiple Sclerosis – China Drug Forecast and Market Analysis to 2022.

GDHC1080CFR

GlobalData (2013). Multiple Sclerosis – Canada Drug Forecast and Market Analysis to 2022.

GDHC1081CFR

GlobalData (2013). Betaseron/Betaferon (Multiple Sclerosis) –Forecast and Market Analysis to

2022. GDHC1112DFR

GlobalData (2013). Avonex (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1113DFR

GlobalData (2013). Copaxone (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1114DFR

GlobalData (2013). Rebif (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1115DFR

GlobalData (2013). Tysabri (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1116DFR

Introduction


GlobalData (2013). Gilenya/Imusera (Multiple Sclerosis) –Forecast and Market Analysis to

2022. GDHC1117DFR

GlobalData (2013). Aubagio (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1118DFR

GlobalData (2013). BG-12 (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1119DFR

GlobalData (2013). Lemtrada (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1120DFR

GlobalData (2013). Laquinimod (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1121DFR

GlobalData (2013). Ocrelizumab (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1122DFR

GlobalData (2013). Daclizumab (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1123DFR

GlobalData (2013). Masitinib (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1124DFR

GlobalData (2013). Siponimod (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1125DFR

GlobalData (2013). NU-100 (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1126DFR

GlobalData (2013). Tcelna (Multiple Sclerosis) –Forecast and Market Analysis to 2022.

GDHC1127DFR

GlobalData (2013). Multiple Sclerosis – Current and Future Players. GDHC1009FPR

Appendix

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 158 GDHC1073CFR / Published MAR 2013

9.8 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports and

forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India, and Singapore.

9.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.

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