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Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules

  • March 2013
  • -
  • Firstword Pharma
  • -
  • 183 pages

The multiple sclerosis treatment landscape has undergone dramatic changes over the past year. Biogen’s Tecfidera has revolutionised multiple sclerosis treatment in the U.S., eroding significant market share from older therapies. However, patent concerns has stalled Tecfidera’s launch in Europe. Genzyme have taken advantage of this delay with Lemtrada’s (alemtuzumab) and Aubagio’s (teriflunomide) EU approval. The arrival of these drugs is expected to transform multiple sclerosis treatment and be a catalyst for unprecedented market growth.

Over the next five years, the global multiple sclerosis (MS) market is set to grow from $14.3 billion in 2012 to $21.5 billion in 2017. Primary drivers of this growth will be the entry of new pipeline therapies, satisfying the unmet needs of convenient administration and more efficacious therapy, and continued uptake of existing therapies.

A Complete Ongoing Analysis of Current Trends, Future Forecasts and Landscape Modifiers

For instant access to an accurate, unbiased, qualitative review of the latest treatment trends along with a five-year quantitative diabetes market forecast look no further than FirstWord’s Therapy Trends: Multiple Sclerosis. This comprehensive FirstWord research is available in two comprehensive modules:

The KOL Insight: Multiple Sclerosis module provides a complete review and is enhanced with exclusive in-depth interviews with leading KOLs from the US and Europe
The Consensus Outlook: Multiple Sclerosis data analysis module provides annual historical and forecast product-level sales data from an average of leading equity analysts’ projections

KOL Insight
Therapy Trends KOL Insight: Multiple Sclerosis analyses the current and predicted key issues, current products and late-stage pipeline products. The report gives you qualitative, inside information from exclusive FirstWord interviews with 12 key opinion leaders (KOLs) through the following:

KOL Insight Report — an in-depth analytical report on diabetes treatment trends
Full report updates — issued to you after each and every significant diabetes market event
Event Bulletins — the latest KOL views in response to each event

Key Report Features and Benefits

Critical insights on products and market developments from leading US and European clinicians

Critical insights on products and market developments from leading US, European and Australian clinicians
Assessment of current leading multiple sclerosis products
Analysis of late-stage pipeline multiple sclerosis therapies
Competitive evaluation of leading players
Current thinking and trends in the treatment of multiple sclerosis
Predicted KOL treatment trends and market leaders
Ongoing FirstWord clinical and market updates

Expert Opinion for Real World Insights

The data and analysis in the report is enriched through the specific insights and opinions of leading clinicians working in multiple sclerosis in the US, Europe and Australia. Their views on specific drugs and treatment pathways provide a unique front line perspective from those working in clinical setting. The results of these detailed and extensive interviews are incorporated though out the text so they can be read in the context of the issue or product being discussed.

KOL Panel

David Hafler, Chief and Chair of Neurology at Yale-New Haven Hospital and Yale School of Medicine, New Haven, Connecticut, US
Professor Douglas Jeffery, MD, PhD, Associate Professor of Neurology, the Department of Neurology, The Multiple Sclerosis and Movement Disorders Centre at Advance Neurology at Cornerstone Health Care Winston-Salem, North Carolina, US
Professor Paul O’Connor, Professor, Division of Neurology, University of Toronto, Toronto, Canada
Professor Lawrence Steinman, Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics, Stanford University School of Medicine, California, US
Professor and Medical Neurologist, MD, and expert in multiple sclerosis at the Ottawa Hospital Research Institute, Ottawa, Canada (requested anonymous)
Professor and Medical Neurologist, MD, and expert in multiple sclerosis at the Mount Sinai School of Medicine, New York, US (requested anonymous)
Dr Mike Bogglid, Staff Specialist Neurologist, Townsville Hospital, University of Queensland, Australia
Dr Patrick Vermersch, Department of Neurology, University of Lille North of France, Hôpital Roger Salengro, Lille, France
Dr Heinz Wiendl, Department of Neurology, Neuroimmunology and Neuro-Oncology, University of Muenster, Muenster, Germany
Dr Martin Wilson. Consultant Neurologist, Walton Centre for Neurology and Neurosurgery NHS Trust, Liverpool, UK
Professor and Medical Neurologist, MD, and expert in multiple sclerosis at Centre Neurologique et de Réadaptation Fonctionnelle, Fraiture-en-Condroz, Belgium (requested anonymous)
Professor and Medical Neurologist, MD, and expert in multiple sclerosis at Heinrich-Heine University, Düsseldorf, Germany (requested anonymous)

Key Quotes from the Report

“I think alemtuzumab is an excellent drug. It's very, very efficacious, and surprisingly well tolerated, considering its potency. They do need some blood monitoring each month but it's actually pretty easy to give and to monitor and certainly very effective.” Dr Martin Wilson (Europe)

“Using Lemtrada is different from the other options we have available. It is a real investment in the patient's time. You enter into a contract over five years at least with monthly monitoring. That is something that a lot of patients cannot really foresee when they start such therapies. They need to have a certain insight into the disease and its nature. This is a difference between, let's say, a drug that you rather easily start on and get off, like Tecfidera versus Lemtrada, that is something you start and you don't get off ever.” Dr Heinz Wiendl (EU)

“I think teriflunomide is moderately effective. It seems that there are no major severe risks. I would put it in the efficacy range of the current injectables, I don't think it offers an advantage over the currently available first-line drugs, but of course, as a tablet it's more convenient and would hold the promise of increasing adherence” European Key Opinion Leader

KOL Insights -- Key Topics

Current multiple sclerosis marketplace
Current treatment landscape
Reimbursement of key multiple sclerosis brands
Unmet needs
Current therapies
Symptomatic treatment
Pipeline therapies
Future developments in multiple sclerosis

Consensus Outlook
Use this detailed report and powerful interactive Excel spreadsheet to compare and contrast companies and products now and in the future. Therapy Trends Consensus Outlook: Multiple Sclerosis includes the following comprehensive resources:

An in-depth 5-year forecast report based on analyst consensus, mapping the impact of future events to predicted product performance
A detailed forecast data analysis spreadsheet model comparing critical market parameters including market size, product sales, market shares and competitive status over the period 2007 to 2017
Timely event-driven market forecast report and data analysis updates over the next 12 months

Report features:

Historical MS sales from 2007–2012
Forecast MS sales from 2013-2017
Key competitors and drug developers
Predicted product positioning
Current and late-stage pipeline drugs
Future event mapping to forecast data points
Comparative clinical trial results

Use Consensus Outlook to:

Chart predicted market growth and product sales
Map your own market parameters
Tailor your strategic and investment focus
Assess your current and future sales resources
Set proactive launches and branding strategies

Analysts compared:

Barclays Capital
Credit Suisse
Deutsche Bank
Goldman & Sachs
International Strategy & Investment
JP Morgan
Merrill Lynch
Morgan & Stanley
Societe Generale
Stifel Nicolaus
Wells Fargo

Content Highlights and Products Covered:

Research Methodology
Multiple Sclerosis Marketplace
Key Multiple Sclerosis Developers
Multiple Sclerosis Class Dynamics
Tecfidera (dimethyl fumarate; Biogen) forecast
Aubagio (teriflunomide; Sanofi) forecast
Gilenya (fingolimod; Novartis Mitsubishi Tanabe) forecast
Tysabri (natalizumab; Biogen) forecast
Copaxone (glatiramer acetate; Teva) forecast
Avonex (interferon beta-1a; Biogen) forecast
Betaseron (interferon beta-1b; Bayer) forecast
Rebif (interferon beta-1a; Merck Serono) forecast
Extavia (interferon beta-1b; Novartis) forecast
Lemtrada (alemtuzumab; Genzyme/Sanofi) forecast
Laquinimod (Teva/Active Biotech) forecast
Daclizumab HYP (Biogen/AbbVie) forecast
Ocrelizumab (Biogen/Roche/Biogen) forecast

Ongoing Benefits
Continually Updated in Response to Market Developments
The world of pharma is ever changing and executives must always be up-to-date with the latest developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends updated offers real commercial advantage.
Consider the benefits:

Content will be fully updated in response to market developments such as new product approvals or pivotal research results for 12 months from the date of purchase
Such updates are incorporated throughout the KOL reports ensuring the change is reflected in every aspect of the report
There is no limit and all relevant events will result in an update
You’ll receive these updates directly, within days of each event’s occurrence
All updates are included in the price

Whatever happens in the market you’ll always be able to assess the impact with FirstWord Therapy Trends
Unrivalled Sources Ensure Complete Coverage
Our unique disease selection matrix pinpoints those disease sectors of the highest commercial potential, and draws information from multiple novel and expert sources, including:

Exclusive views from leading global experts
Comprehensive consensus research
Live dispatches and critical industry data
Online opinions from 535,000 vetted physicians
Data from over 125 medical conferences each year
Over 2,000 peer-reviewed medical journals
Over 450 pharmaceutical news sources

Table Of Contents

Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules
Consensus Outlook
1.Forecast Data Model (Excel)
1.1.Tabs: Market size
1.2.Product sales
1.3.Company forecast
1.4.Mechanism of action
1.5.Future Events

2.Forecast Analysis Report (PDF)
2.1. Contents: FirstWord Analysis Highlights
2.2.Research Methodology
2.3.Multiple Sclerosis Marketplace
2.4.Key Multiple Sclerosis Developers
2.5.Multiple Sclerosis Class Dynamics
2.6.Tecfidera (dimethyl fumarate; Biogen) forecast
2.7.Aubagio (teriflunomide; Sanofi) forecast
2.8.Gilenya (fingolimod; Novartis Mitsubishi Tanabe) forecast
2.9.Tysabri (natalizumab; Biogen) forecast
2.10.Copaxone (glatiramer acetate; Teva) forecast
2.11.Avonex (interferon beta-1a; Biogen) forecast
2.12.Betaseron (interferon beta-1b; Bayer) forecast
2.13.Rebif (interferon beta-1a; Merck Serono) forecast
2.14.Extavia (interferon beta-1b; Novartis) forecast
2.15.Lemtrada (alemtuzumab; Genzyme/Sanofi) forecast
2.16.Laquinimod (Teva/Active Biotech) forecast
2.17.Daclizumab HYP (Biogen/AbbVie) forecast
2.18.Ocrelizumab (Biogen/Roche/Biogen) forecast

KOL Insights
2.Executive summary
5.Current Multiple sclerosis marketplace
5.1 Current treatment landscape

5.2. Multiple Sclerosis market definition

5.3. Current market overview

5.4. Reimbursement of key multiple sclerosis brands

5.5. Multiple sclerosis unmet needs

5.6. Unmet need 1: Efficacy for progressive subtypes

5.7. Unmet need 2: Therapies offering better clinical profiles

5.8. Unmet need 3: Drugs to halt or repair neuronal damage

5.9. Unmet need 4: Improving multiple sclerosis induced cognition dysfunction

5.10. Unmet need 5: Need for improved adherence

6.Current therapies
6.1. Clinical trial results of marketed therapies
6.2. Cross trial comparisons is not an ideal assessment
6.3. Tecfidera (dimethyl fumarate; Biogen) trends
6.4. Tecfidera becomes the latest FDA approved MS therapy
6.5. Tecfidera will become a first-line therapy and a major threat to Gilenya
6.6. Favourable label with no black box warnings and limited patient monitoring required
6.7 Discontinuation rates higher than existing therapies and may potentially get higher in a real world setting
6.8. Opportunity to expand draft label to include disability improvement
6.9. Treating warehoused patients will expand market
6.10. Practical Tecfidera pricing in-line with current first-line therapies
6.11. Tecfidera patent extended to 2028
6.12. Lemtrada (alemtuzumab; Genzyme/Sanofi) trends
6.13 Sanofi's Lemtrada receives first worldwide approval
6.14. Lemtrada's broad label is best case scenario for Sanofi
6.15. Lemtrada is one of the most effective marketed therapies

6.16, Safety concerns may hamper uptake

6.17. Sanofi will price Lemtrada in line with current treatments

6.18. Aubagio (teriflunomide; Sanofi/Genzyme) trends

6.19. Aubagio is approved by the FDA - drug becomes the second oral therapy to enter the market

6.20. Despite favourable tolerability the FDA have issued a black box warning on the prescription label

6.21. Surveyed neurologists are aware of Aubagio and intend to prescribe the drug

6.22. Interviewed neurologists believe Aubagio will find use as a monotherapy and combination therapy

6.23. Pricing at $45,000 places the drug cheaper than existing first-line therapies

6.24. Gilenya (fingolimod; Novartis) trends

6.25. Gilenya has first oral to market advantage

6.26. Gilenya raises bar for pipeline therapies entering the market

6.27. Deaths mar Gilenya's side effect profile and positions drug as a second line

6.28. Vigilance program is cumbersome and likely to restrict access

6.29. Gilenya's high price will restrict use

6.30 Clinical trials in progressive multiple sclerosis ongoing

6.31. Tysabri (natalizumab; Biogen) trends

.6.32. Tysabri is the most effective approved multiple sclerosis therapy
6.33. PML fears positions drug as second or later line

6.34. JCV test will promote use and allay fears

6.35. Progressive multiple sclerosis trials ongoing for Tysabri

6.36. Copaxone (glatiramer acetate; Teva) trends

6.37. Copaxone is the leading selling multiple sclerosis therapy

6.38. Teva fights generic Copaxone applications

6.39. Interferon betas (Avonex, Betaseron, Rebif, Extavia) trends

6.40 Interferons are the mainstay of multiple sclerosis treatment

6.41. Needles have evolved to avoid injection site reactions

6.42. Biosimilar guidelines in place for interferons

6.43. Current treatment algorithm

7.Symptomatic Treatment
7.1. Multiple sclerosis symptoms

7.2. Symptomatic multiple sclerosis therapies

7.3. Ampyra/Fampyra (dalfampridine; Acorda Therapeutics/Biogen) trends

7.4. Controlled release formulation minimises risk of seizures

7.5. Ampyra only works in certain patient populations

7.6. High cost could restrict uptake

7.7. Sativex (nabiximols; GW Pharma/Almirall/Otsuka/Bayer/Novartis) trends

7.8. First cannabis -based drug enters Europe
7.9. Opinion leaders believe approval in US will follow European expansion

7.10 Partnerships will enable further market penetration

8.Pipeline therapies
8.1.Laquinimod (Teva) trends

8.2. Third laquinimod trial initiated concentrating on neuroprotective effect but doubts persist

8.3. Phase III efficacy data is disappointing and less than current therapies

8.4. Safety data and mechanism suits role as an add-on therapy

8.5. Daclizumab HYP (Biogen/Abbott) trends

8.6 Daclizumab complements Biogen's portfolio with good safety and efficacy

8.7. Daclizumab positioning will be important for Biogen franchise

8.8. Ocrelizumab (Biogen/Roche) trends

8.9. Ocrelizumab represents the most advanced B-cell therapy

8.10. Ocrelizumab is highly effective in reducing relapses

8.11. Long-term safety needs to be investigated

8.12. Future treatment algorithm

8.13. More use of induction therapy in highly relapsing patients
8.14. Current first-line therapies will have a less prominent role in future treatment

8.15. Interferons and Copaxone can find a niche as combination therapies

8.16. Oral therapies will become the leading first- and second-line therapies

8.17. JCV test will drive earlier use of Tysabri

8.19. Potent but less safe therapies will remain last line

9. Future developments in multiple sclerosis
9.1. Constrained pricing environments will reduce market access

9.2.Clinically isolated syndrome will be considered early stage multiple sclerosis in the future

9.3. Trend for earlier diagnosis and treatment will produce better outcomes

9.4. Trend to more symptomatic therapies being developed

9.5. Eventual development of biomarkers will aid treatment

9.6. Better understanding of underlying multiple sclerosis etiology

9.7. Methods to assess treatment failure could be implemented in the future

9.8. More emphasis should be placed on long-term outcome measures

10.1. KOL biographies

10.2. KOLs from North America:

10.3.KOLs from Europe

View This Report »

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