Multiple Sclerosis: KOL Insight

  • September 2013
  • -
  • Firstword Pharma
  • -
  • 148 pages

The multiple sclerosis treatment landscape has undergone dramatic changes over the past year. Biogen’s Tecfidera (dimethyl fumarate) has revolutionised multiple sclerosis treatment in the US, 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 revolutionise multiple sclerosis treatment and be a catalyst for unprecedented market growth.

Driven by in-depth interviews with the world’s leading multiple sclerosis KOLs, Therapy Trends: Multiple Sclerosis uncovers how the current treatment landscape will be impacted by significant future events, with particular focus on pipeline therapies and how these will modify the way MS is managed by neurologists in the future.

Key Benefits

Multiple Sclerosis: The oral era begins examines the most prominent insights gained from the field’s key opinion leaders. Key benefits include:

Unmet needs analysis to identify opportunities and address the challenges facing disease management
Strategic mapping of future treatment algorithms based on KOL insight
Commercial and clinical analysis of pipeline therapies
In-depth, dynamic event impact assessments to evaluate current strategies and plans against new conditions
Align investment and resource planning to future trends
Know the story driving the trends

Multiple Sclerosis: The oral era begins answers key questions including:

What are the key unmet needs? There is a high risk, high reward opportunity in the development of a therapy with efficacy for progressive subtypes.
How will therapies will be positioned against each other in the future of MS treatment? Biogen’s new oral therapy BG-12 is expected to usurp the current market leaders and become the first-line therapy of choice.
Where do neurologists position Lemtrada? Insight from 100 5EU prescribers on positioning and the likely strength of uptake at launch.
How will treatment developments play out in the near future? Biogen's activity in broadening its robust pipeline shows its resolve in maintaining its leading position in MS.
Is there potential for new players in the lucrative MS market? New entrants are set to capture significant share and erode sales of the leading drugs.
How will the launch of biosimilars affect prescribing behaviour? Pricing will be a key determinant in positioning and uptake.
How will Teficdera’s European patent concerns affect its launch?
Will the John Cunningham Virus test encourage earlier adoption of Tysabri? This offers the first example of personalised medicine; a trend that will aid uptake in future.

Reasons to Buy this Report

Multiple Sclerosis Panel of Key Opinion Leaders

The MS KOL panel assembled for this Therapy Trends research is drawn from North America, Europe and Australia

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)

Event Assessments

Stay a step ahead with Therapy Trends Event Assessments. Over the next 12 months, you will receive updated qualitative analysis every time a major market event breaks. Updates will be delivered straight into your inbox within days of each event’s occurrence.

Whether it’s a predicted product approval or an unexpected late stage failure, Therapy Trends has the resources and knowledge to keep you up to date with the latest market analysis.

Methodology

This report provides a qualitative assessment of the current and future Multiple Sclerosis market. Information was gathered from in-depth telephone interviews with twelve key opinion leaders (KOLs), from across the major Multiple Sclerosis markets, including Australia, Canada, France, Germany, the UK and the US. These regions were selected because they contain many of the largest global markets for the pharmaceutical industry, and also dictate the dynamics of Pharma markets in other countries.

In order to critically select Key Opinion Leaders (KOLs) a number of parameters were considered including their clinical experience, scientific publications, involvement with Pharma, involvement in clinical trials, and record of presenting at high profile international conferences.

Subject matter for discussion in the interviews covered future diagnostic and therapeutic strategies for Multiple Sclerosis, the future drug classes, and new drugs entering the market. These leading KOLs also gave their views on current research, the usefulness of existing drug classes, the cost of newer drugs and other concerns in the therapy area.

Table Of Contents

1.Contents
2.Executive summary
3.Introduction
4.Methodology
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.Appendix
10.1. KOL biographies
10.2. KOLs from North America:
10.3.KOLs from Europe

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