Reportlinker Adds Multiple Sclerosis Drug Discoveries: what the future holds

NEW YORK, Nov. 3, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Multiple Sclerosis Drug Discoveries: what the future holds

http://www.reportlinker.com/p0323695/Multiple-Sclerosis-Drug-Discoveries-what-the-future-holds.html

EXTENSIVE ANALYSIS OF THE GLOBAL

MULTIPLE SCLEROSIS MARKET AND ASSESSMENT OF ALL SIGNIFICANT CURRENT AND FUTURE PRODUCTS

The recent approval in the US of Novartis' orally administered Gilenya (fingolimod) heralds a new phase in the treatment of Multiple Sclerosis (MS).

Over the last few years, the MS market has been driven by five disease-modifying agents: Teva's Copaxone (glatiramer acetate), Biogen Idec's Avonex (interferon beta-1a) and Tysabri (natalizumab), Merck KGaA's Rebif (interferon beta-1a) and Bayer's Betaferon (interferon beta-1b). From 2009, interferon beta-1b has also been available from Novartis as Extavia; this is the same formulation as Betaferon.

In addition to these, Amgen's Novantrone (mitoxantrone) has been available to treat MS. Generic mitoxantrone is also available. Avonex, Betaferon/Extavia, Rebif and Copaxone are all used in first-line therapy for RRMS. They are generally well accepted and have accumulated comprehensive safety and clinical trial data supporting their use in modifying the course of the disease. Tysabri and mitoxantrone are generally used in second-line therapy in RRMS. Mitoxantrone is also approved to treat SPMS and PRMS. Both of these agents are associated with serious side-effects.

The arrival of oral treatments brings big clinical advantages

The development of oral therapies for MS has attracted significant investment from pharmaceutical companies and the first of these have begun to receive marketing approvals, signaling another major change in the way MS is treated. In September 2010, Novartis won the race to gain the first oral approval in the US with its sphingosine-1-phosphate (S1P) receptor agonist, Gilenya. The product was also approved in Russia in the same month. Merck's oral product, Movectro (cladribine) was approved in Russia in July 2010 and in Australia in September 2010 for the treatment of RRMS for a maximum duration of two years. However, the European Medicine Agency's CHMP issued a negative opinion for Movectro for the treatment of RRMS.

Espicom estimates the current MS market value is in the region of US$12.6 billion with strong growth going forward

Background to the disease

Multiple Sclerosis is a chronic autoimmune neurological disease affecting up to 2.5 million people worldwide, the majority of whom live in North America and Europe. It is a complex disorder that affects people in different ways. Around 85% of patients are initially diagnosed with relapsing remitting MS (RRMS). Up to half of these will go on to develop secondary-progressive MS (SPMS).

The other main types identified are primary progressive MS (PPMS), which affects around 10% of patients at onset, and progressive-relapsing MS (PRMS) which affects up to 5% of patients. There is currently no cure for MS and treatment is aimed at its symptoms and slowing disease progression. The launch of interferons during the 1990s transformed the treatment of MS but there is still a large unmet clinical need in reducing disease progression.

Shape of the industry in 2010...

At the forefront of the MS market is Biogen Idec, with a market share of 27% due to sales of Avonex and Tysabri. Following closely are Teva and sanofi-aventis who currently market Copaxone, giving them a combined share of the market by sales value of around 30%. With the third biggest seller, Rebif, Merck Serono has been attributed with a market share of 19%; Bayer Schering takes 15% of the market with Betaferon sales; while Elan's share of Tysabri sales provide the company with around 4%.

...and in 2016

By 2016, a number of new agents will be available to treat MS, and their contribution to revenues will enhance Biogen Idec's leading position. In addition, Teva's Copaxone will lose patent protection in the US in May 2014. If approved, generic versions of Copaxone would undoubtedly put pricing pressures on both the branded version and related therapies. The combined effect of an influx of new therapies and generic competition for the market leader is likely to cause a ripple through the entire MS therapy market. Consequently, the current market leaders will all have their share of the US$15.3 billion market reduced as competition increases. Over US$4 billion of the MS market will be generated by recently approved or developmental products that will be launched in the near term.

Key company, market and product questions answered such as...

What are the four main types of MS?

Research into MS vaccines has stalled. What is the current situation and are there still opportunities in this area?

How might the asthma treatment salbutamol (albuterol) help control MS?

Which countries have the highest prevalence of patients per 100,000 population?

MS is a geographically specific condition – what are the theories as to why this is so?

Despite having patent protection until 2014, generic companies are already making a play for Teva's Copaxone. Who's involved and what is the current status?

What are the expected sales in 2016 of Novartis' novel oral MS treatment Gilenya?

What are the patient safety concerns with Biogen Idec's Ampyra (dalfampridine), the first in class treatment for treating MS symptoms?

How many Phase III products are in the pipeline and when are they expected to launch?

What positive clinical trial results did sanofi-aventis report for its oral MS drug teriflunomide?

About the Author

The report has been researched and written by Espicom's Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include:

Injectable Generic Drugs: Prospects and Opportunities, Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs, Diabetes Drug Discoveries: what the future holds

The Indian Pharmaceutical Industry: New strategies in a changing world.

More Information...

Unique market share and 5-year sales forecasts for leading products, pipeline prospects and companies

A comprehensive examination of the multiple sclerosis market and disease prevalence

Critical competitive evaluation and scoring of current and future products

This report delivers real insights to MS drugs, prospects and companies…

Evaluate the current clinical understanding of multiple sclerosis

Know the disease prevalence trends in major markets

Contrast and compare the competitive landscape in 2010 and 2016

Profile product potential with original 5-year sales forecasts for current products

Compare and review up and coming Phase II/III products with 5-year forecasts from year of launch for significant late-stage candidates

Benefit from Espicom's unique product assessment and scoring

CONTENTS

FOREWORD 1

EXECUTIVE SUMMARY . 3

MARKET ANALYSIS . 5

CURRENT MARKET . 7

FUTURE MARKET 9

What's in the Pipeline? 12

MS Vaccines in Limbo? . 13

Asthma medication may benefit MS patients 13

BACKGROUND INFORMATION 14

What is MS? 14

Why are New Treatments Needed? 15

Patient Statistics 16

PRODUCT ANALYSIS 20

ESTABLISHED PRODUCTS . 20

Copaxone (glatiramer acetate) . 20

Mode of Action . 20

Current Status 20

Approvals/Filings . 20

Development . 21

Proof of Concept/Clinical Data . 21

Development Risks 22

Company Expertise . 22

Competition within the Market-place . 22

Patents and Exclusivity 22

Generic Competition 23

Competitor Ratio Analysis 24

Forecast 24

Clinical Trial Results . 25

Avonex (interferon beta-1a) . 30

Mode of Action . 30

Current Status 30

Approvals/Filings . 30

Development . 30

Proof of Concept/Clinical Data . 31

Development Risks 31

Company Expertise . 31

Competition within the Market-place . 31

Patents 31

Competitor Ratio Analysis 32

Forecast 32

Clinical Trial Results . 33

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

Mode of Action . 34

Current Status 34

Approvals/Filings . 34

Development . 35

Proof of Concept/Clinical Data . 35

Development Risks 35

Company Expertise . 35

Competition within the Market-place . 36

Patents 36

Competitor Ratio Analysis 36

Forecast 36

Clinical Trial Results . 37

Rebif (interferon beta-1a) 39

Mode of Action . 39

Current Status 39

Approvals/Filings . 39

Development . 40

Proof of Concept/Clinical Data . 40

Development Risks 41

Company Expertise . 41

Competition within the Market-place . 41

Competitor Ratio Analysis 41

Forecast 41

Clinical Trial Results . 42

Novantrone (mitoxantrone) . 44

Mode of Action . 44

Current Status 44

Approvals/Filings . 44

Proof of Concept/Clinical Data . 45

Development Risks 45

Company Expertise . 46

Competition within the Market-place . 46

Generic Competition 46

Competitor Ratio Analysis 47

Clinical Trial Results . 47

Tysabri (natalizumab) 48

Mode of Action . 48

Current Status 48

Approvals/Filings . 48

Development . 49

Proof of Concept/Clinical Data . 49

Development Risks 49

Company Expertise . 49

Competition within the Market-place . 50

Patents 50

Competitor Ratio Analysis 50

Forecast 50

Clinical Trial Results . 51

NEW APPROVALS/FILED PRODUCTS 52

Gilenya (fingolimod) 52

Mode of Action . 52

Current Status 52

Approvals/Filings . 52

Development . 53

Proof of Concept/Clinical Data . 53

Development Risks 53

Company Expertise . 54

Competition within the Market-place . 54

Competitor Ratio Analysis 54

Forecast 54

Clinical Trial Results . 55

Movectro (cladribine) 58

Mode of Action . 58

Current Status 58

Approvals/Filings . 58

Development . 58

Proof of Concept/Clinical Data . 59

Development Risks 59

Company Expertise . 59

Competition within the Market-place . 60

Competitor Ratio Analysis 60

Forecast 60

Clinical Trial Results . 61

Ampyra (dalfampridine) . 63

Mode of Action . 63

Current Status 63

Approvals/Filings . 63

Proof of Concept/Clinical Data . 63

Development Risks 64

Company Expertise . 64

Competition within the Market-place . 64

Competitor Ratio Analysis 64

Forecast 65

Clinical Trial Results . 66

PHASE III . 67

Alemtuzumab . 67

Mode of Action . 67

Current Status 67

Approvals/Filings . 67

Development . 67

Proof of Concept/Clinical Data . 68

Development Risks 68

Company Expertise . 68

Competition within the Market-place . 68

Competitor Ratio Analysis 69

Forecast 69

Clinical Trial Results . 70

MS Phase II . 70

BG-12 72

Mode of Action . 72

Current Status 72

Proof of Concept/Clinical Data . 72

Development Risks 72

Company Expertise . 73

Competition within the Market-place . 73

Competitor Ratio Analysis 73

Forecast 73

Clinical Trial Results . 74

Daclizumab 76

Mode of Action . 76

Current Status 76

Approvals/Filings . 76

Development . 76

Proof of Concept/Clinical Data . 77

Development Risks 77

Company Expertise . 77

Competition within the Market-place . 77

Competitor Ratio Analysis 77

Forecast 78

Clinical Trial Results . 79

Laquinimod . 80

Mode of Action . 80

Current Status 80

Proof of Concept/Clinical Data . 80

Development Risks 80

Company Expertise . 81

Competition within the Market-place . 81

Competitor Ratio Analysis 81

Forecast 81

Clinical Trial Results . 82

Teriflunomide . 84

Mode of Action . 84

Current Status 84

Proof of Concept/Clinical Data . 84

Development Risks 85

Company Expertise . 85

Competition within the Market-place . 85

Competitor Ratio Analysis 85

Forecast 85

Clinical Trial Results . 86

PHASE II 88

ACT-128800 . 88

Mode of Action . 88

Current Status 88

Proof of Concept/Clinical Data . 88

Development Risks 88

Company Expertise . 88

Competition within the Market-place . 89

Competitor Ratio Analysis 89

BAF312 . 90

Mode of Action . 90

Current Status 90

Proof of Concept/Clinical Data . 90

Development Risks 90

Company Expertise . 90

Competition within the Market-place . 90

Competitor Ratio Analysis 91

Firategrast 92

Mode of Action . 92

Current Status 92

Proof of Concept/Clinical Data . 92

Development Risks 92

Company Expertise . 92

Competition within the Market-place . 93

Competitor Ratio Analysis 93

Ocrelizumab 94

Mode of Action . 94

Current Status 94

Proof of Concept/Clinical Data . 94

Development Risks 94

Company Expertise . 95

Competition within the Market-place . 95

Competitor Ratio Analysis 95

Clinical Trial Results . 95

Ofatumumab . 96

Mode of Action . 96

Current Status 96

Approvals/Filings . 96

Development . 96

Proof of Concept/Clinical Data 97

Development Risks 97

Company Expertise . 97

Competition within the Market-place . 97

Competitor Ratio Analysis 97

Clinical Trial Results . 98

Perampanel 99

Mode of Action . 99

Current Status 99

Proof of Concept/Clinical Data . 99

Development Risks 99

Company Expertise . 99

Competition within the Market-place 100

Competitor Ratio Analysis . 100

METHODOLOGY . 101

Competitor Ratio Analysis Criteria . 101

Drug Sales Forecasting . 101

LIST OF TABLES

Competitor Ratio Analysis Summary 6

Global MS Drug Sales, 2009-2016 (US$ Millions) 7

Drugs in Clinical Development for MS . 12

People with MS by Country and Region, 2010-2015 . 17

Prevalence of MS per 100,000 Population by Country & Region, 2010 . 18

Data Exclusivity . 22

Patent Expiry 23

Copaxone Sales by Company (2008-2016) 24

Patent Expiry 31

Avonex Sales (2008-2016) 32

Interferon Beta-1b Sales by Company (2008-2016) 36

Rebif Sales (2008-2016) 42

Patent Expiry 46

FDA ANDA Approvals for Mitoxantrone . 47

Tysabri Sales by Company (2008-2016) . 50

Gilenya Sales (2011-2016) . 54

Movectro/Mylinax Sales (2011-2016) 60

Data Exclusivity . 64

Patent Expiry 64

Ampyra Sales (2010-2016) 65

Patent Expiry 69

Campath Sales by Indication (2008-2016) 69

BG-12 Sales (2012-2016) 73

Daclizumab Sales in MS (2012-2016) . 78

Laquinimod Sales (2012-2016) . 81

Teriflunommide Sales (2012-2016) . 85

LIST OF FIGURES

Leading MS Products by Sales Value, 2009 (%) . 8

MS Market by Company, 2009 (%) . 8

Leading MS Products by Sales Value, 2016 (%) 10

MS Market by Company, 2016 (%) 11

Total Number of People with MS, 2007 . 16

Mean Age of Onset of MS, 2007 . 17

Geographic Spread of People with MS, 2010 (%) 18

Geographic Prevalence of MS per 100,000 Population, 2010 19

Copaxone Sales by Company (2008-2016) . 25

Avonex Sales (2008-2016) . 32

Interferon Beta-1b Sales by Company (2008-2016) 37

Rebif Sales (2008-2016) 42

Tysabri Sales by Company (2008-2016) . 51

Gilenya Sales (2011-2016) . 55

Movectro/Mylinax Sales (2010-2016) . 61

Ampyra Sales (2008-2016) 65

Campath Sales by Indication (2008-2016) 70

BG-12 Sales (2012-2016) 74

Daclizumab Sales in MS (2011-2016) . 78

Laquinimod Sales (2012-2016) . 82

Teriflunomide Sales (2012-2016) . 86

To order this report:

Drug Discovery and Development Industry: Multiple Sclerosis Drug Discoveries: what the future holds

Drug Discovery and Development Business News

More  Market Research Report

Check our  Company Profile, SWOT and Revenue Analysis!


CONTACT:  

Nicolas Bombourg

Reportlinker

Email: [email protected]

US: (805)652-2626

Intl: +1 805-652-2626




SOURCE Reportlinker

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