KOL Insight: Multiple Sclerosis

October 2014 | | ID: KA37FBCD6FCEN
FirstWord

Abstracts

Recent launches of oral therapies have brought clinical advantages and clear patient benefits and are set to transform the treatment of Multiple Sclerosis (MS). The question is, which products will rise to become first choice treatments in relapsing forms of the disease and which products have potential for progressive forms of the disease?

Multiple Sclerosis – Oral therapy takes centre stage is a comprehensive Therapy Trends report packed with knowledgeable opinions and insights of 12 leading US and European KOLs on current and future products, why and when they would use them and the competing clinical benefits and challenges each one has.

This report provides a complete and inclusive analysis of current and late stage MS drugs and expert insights to give essential decision support intelligence for marketers, researchers and planners.

Get Answers to Critical Questions

• Why is Biogen Idec’s Tecfidera seen as the “gold standard” by clinicians?
• Why are US KOLs less enthusiastic about Sanofi’s Aubagio than their European colleagues?
• What regulatory and “real world” experience is driving growth of Novartis’ Gilenya in Europe?
• Sanofi’s Lemtrada, still to be approved in the US, is highly effective in patients with very aggressive disease, but will its ADR profile limit its use and what clinical research results might affect its uptake?
• Will the dosing advantages of Biogen Idec’s Plegridy rejuvenate interferon therapy and cannibalise currently established therapies?
• What clinical advantages might establish Genentech/Biogen Idec’s ocrelizumab as the second-line treatment of choice in patients with aggressive Relapsing-Remitting MS (RRMS)?
• What new therapeutic approaches are in the next generation pipeline?

Key Benefits

• Advantage in knowing the detailed views and opinions of leading front line clinicians on current and future MS treatments and what they see as critical advantages/disadvantages affecting their decision to prescribe
• Fully understand the seismic changes affecting MS treatment and access informed insight to gauge the likely effect these changes will have on the future competitive landscape
• Assess, compare and contrast current treatments, late-stage pipeline products and new future approaches in research
• Evaluate the impact of oral therapies on established treatments such as Avonex, Betaseron, Copaxone and Rebif
• Learn which products might be effective in meeting the unmet clinical needs of patients with progressive forms of the disease
• Evaluate the role that biomarkers will play in the MS market

Key Takeaways

• Hone product plans and communications in response to concerns of KOLs
• Map current and future drug options to MS disease patient sub sets
• Identify areas of clinical research that are currently not well covered
• Review early stage approaches and identify opportunity areas

KOL Panel

North America

• Prof Bianca Weinstock-Guttman, MD, Professor of Neurology, State University of New York at Buffalo, Director, Baird MS Center, The Jacobs Neurological Institute
• Prof Staley A Brod, MD, Professor of Neurology, University of Texas Health Science Center, Houston School of Medicine
• Prof Aaron Miller, MD, is a preeminent MS clinician at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Co-Director, Multiple Sclerosis Care Center, Maimonides Medical Center
• Dr Robert Naismith, MD, Assistant Professor of Neurology, School of Medicine, Washington University
• Prof David Hafler, MD, Chief and Chair of Neurology, Yale-New Haven Hospital and Yale School of Medicine, New Haven, Connecticut
• Prof Lawrence Steinman, MD, Professor of Neurology and Neurological Sciences, Pediatrics, and Genetics, Stanford University School of Medicine

Europe

• Prof Celia Oreja-Guevara, Chair of Clinical Research, Multiple Sclerosis Unit, Hospital Clinico San Carlos, Madrid, Spain
• Prof Heinz Wiendl, Professor of Neurology, Department of Neurology, Neuroimmunology and Neuro-Oncology, University of Muenster, Muenster, Germany
• Prof Gilles Defer , Head of Department of Neurology, University Hospital of Caen, France
• Prof Bernd C Kieseier, Professor of Neurology, Heinrich-Heine-University
• Prof Óscar Fernández , Head, Institute of Neurosciences of Carlos Haya University Hospital
• Prof Cris Constantinescu, Head, Academic Division of Clinical Neurology, University of Nottingham

KOL Quotes

• 'There are oral drugs that have better efficacy and are much more favoured…ABCR therapy will not be used very often [in five years' time].' US Key Opinion Leader
• 'Tecfidera is the go-to drug.' US Key Opinion Leader
• 'Disability progression results with Tecfidera were ambiguous – we tend to prescribe Aubagio in patients who have rapid progression. Aubagio has had good results in disability studies.' EU Key Opinion Leader
• 'The real world experience, together with the safety profile knowledge of Gilenya, has dramatically increased, making this drug a second-line option as per the EU label. We have gained more confidence in this drug. So beyond the first dose issue there is rather less strict contraindicative concerns, except for cardiac comorbidity. We now have a rather clear risk-benefit portfolio on this drug. My opinion is that Gilenya more and more moves out of a very clear second-line option into an intermediate option, between first- and second-line.' EU Key Opinion Leader
• 'Tysabri is the best drug we have right now. The problem is that neurologists are afraid to use this drug. We have so many possibilities to stratify patients according to JCV risk these days and yet neurologists are hesitant because they fear the complications surrounding PML. This drug should be used more often.' EU Key Opinion Leader

Ongoing Benefits

• The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with regular update bulletins offers a real commercial advantage.
• Consider the benefits: Regular updates to cover significant market events such as new product approvals or pivotal research results will be covered with primary market research with preeminent KOLs
• Each Update Bulletin provides Therapy Trends clients with fresh expert insights on the likely impact of the latest market developments
• Therapy Trends clients get access to the results of primary research through Update Bulletins – brief reports that bring the impact of the latest events into sharp focus
• All updates are included in the price

Contents

1. EXECUTIVE SUMMARY

2. RESEARCH OBJECTIVES

3. RESEARCH FOCUS

4. MARKETED THERAPIES

4.1. Overview
4.2. Interferons (Avonex, Rebif, Betaseron, Extavia)
4.3. Copaxone (glatiramer acetate; Teva)
4.4. Tecfidera (dimethyl fumarate; Biogen Idec)
4.5. Aubagio (teriflunomide; Sanofi/Genzyme)
4.6. Gilenya (fingolimod; Novartis/Mitsubishi Tanabe Pharma)
4.7. Tysabri (natalizumab; Biogen Idec)
4.8. Lemtrada (alemtuzumab; Sanofi/Genzyme)

5. PIPELINE DRUGS

5.1. Overview
5.2. Plegridy (peginterferon beta-1a, BIIB017; Biogen Idec)
5.3. Relonsiv (interferon beta-1b, NU100; Nuron Biotech)
5.4. siponimod (BAF 312; Novartis)
5.5. Zinbryta (daclizumab high-yield process, DAC-HYP; Biogen Idec/AbbVie)
5.6. masitinib (AB 1010; AB Science)
5.7. ocrelizumab (Roche/Biogen Idec)
5.8. RPC 1063 (Receptos)
5.9. Nerventra (laquinimod; Active Biotech/Teva)

6. FUTURE DEVELOPMENTS IN MS

7. CURRENT AND FUTURE TREATMENT ALGORITHM

8. CONCLUSION

9. APPENDIX

9.1. KOL biographies