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Targeted Therapies in Asthma [2017]

1.Executive Summary
2.Research Objectives
3.Research Focus
4.Market Overview
5.Marketed Products
5.1 Anti-IgE monoclonal antibodies (mAbs)
5.2 Anti-IL-5 mAbs
6. Pipeline Products
6.1 Anti-IgE mAbs
6.2 Anti-IL-5 mAbs
6.3 Anti-IL-13 mAbs
6.4 Anti-IL-4/IL-13 mAbs
6.5 Other targeted therapies
6.6 Future Developments in the Treatment of Severe Asthma
7.Current and future treatment algorithm
8.Conclusion
9.Appendix
9.1 KOL biographies

Targeted Therapies in Asthma [2017]

Introduction

As new targeted asthma therapies emerge, is time running out for Xolair?

Xolair’s unique position in the targeted asthma treatment market is under threat. Teva’s Cinqair and GSK’s Nucala have emerged as significant threats to Xolair’s dominance. What can Roche and Novartis do to stop the rot? Will clinical data save the day, or will commercial tactics be the critical difference in a rapidly evolving market? Learn how key opinion leaders (KOLs) see the market evolving, and how they expect developers to differentiate their pipeline asthma antibodies in KOL Insight: Targeted Therapies in Asthma. Twelve US and European KOLs give their insight on three marketed products and 8 pipeline programmes. KOLs also provide their candid views on the potential for Xolair biosimilars, and what it would take for these products to gain traction in the targeted asthma treatment market.

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Top takeaways

Will Xolair (omalizumab) remain the treatment of choice for allergic asthma patients?Xolair may remain first-line-therapy for allergic asthma patients with elevated serum IgE levels, but for some patients other treatment options might be a better strategy. Find out what they are.

How important is Xolair’s paediatric label extension, and will it support future clinical differentiation? KOLs provide their insights on Xolair’s expanded labelling to include paediatric patients, but will it mean anything clinically? And do KOLs expect long-term Xolair therapy to have any disease-modifying activity in this patient cohort?

Do current and emerging anti-IL5 mAbs represent a clinically significant advancement in the treatment of severe asthma? Nucala (mepolizumab) represents the first mAb to receive approval for severe asthma in over a decade. Other anti-IL5 mAbs are in development (e.g. AstraZeneca’s benralizumab). But will targeting this pathway improve clinical outcomes in severe asthma? Find out what KOLs think.

What pipeline programmes are KOLs becoming particularly excited about? Are next-generation anti-IL5 mAbs set to change the course of the severe asthma treatment market, or will it be Regeneron/Sanofi’s anti-IL-4/IL-13 mAb, dupilumab? Find out what KOLs are monitoring, and what they hope late-stage clinical studies will tell them.

Biosimilar versions of omalizumab are coming, but what impact will they have on the market? Xolair biosimilars are in development and could come to certain markets by 2018. What do KOLs think about these products, and how important will clinical studies proving equivalent safety and efficacy be in driving uptake? Moreover, how can Xolair biosimilars help cut the cost of treating severe asthma, an issue which many KOLs believe is limiting patient access and negatively impacting patient care.

What’s the future of biomarkers in identifying responsive patients? With precision medicine becoming a critical enabler of product use in a number of disease areas, find out what KOLs think about the use of biomarkers in defining eligible patient populations in the severe asthma market and how this could help eliminate “trial and error” approaches to treatment decisions.

Quotes

“The concept of biosimilars is going to be a big challenge. They don’t have a lot in the peer review literature to really give us a sense of the efficacy that they’re going to provide. I think it’s hard to make a definitive statement around those.” US Key Opinion Leader

“There will be patients that are treated better with Xolair, we will have patients that are treated only with Nucala, but we will have patients that are eligible for both. We switch uncontrolled Xolair patients to Nucala, and some patients have to switch back to Xolair because Nucala, despite their eosinophilia of 300 or 400, is not as effective as Xolair, and vice versa.” European Key Opinion Leader

KOLs Interviewed

KOLs from North America

Dr Leonard B. Bacharier MD, Professor of Pediatrics and Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine at Washington University School of Medicine in St. Louis, USA

Dr Mark J. Fitzgerald MD, Director at the Centre for Heart and Lung Health at Vancouver Coastal Health Research Institute, Vancouver, Canada

Dr Gailen D. Marshall, MD, PhD, Professor of Medicine and Pediatrics, Director, Division of Clinical Immunology and Allergy, The University of Mississippi Medical Center MS, USA

Dr Reynold A. Panettieri, MD, Professor of Medicine, Perelman School of Medicine, University of Pennsylvania PA, USA

Dr Mike E. Wechsler MD, MMSc, Associate Physician, Brigham and Women's Hospital, Assistant Professor of Medicine, Harvard Medical School, Boston, MA, USA

Anonymous US KOL, internal medicine expert specialising in asthma

KOLs from Europe

Professor Arnaud Bourdin, MD, Head of General Pneumology, CHU de Montpellier, Montpellier, France

Professor Andy Wardlaw, MD, Head of Department and Professor of Respiratory Medicine, Glenfield Hospital, Leicester, UK

Professor Kian Fan Chung, MD, Professor of Respiratory Medicine, Royal Brompton Hospital, London, UK

Anonymous French KOL, Professor at leading university in France

Anonymous German KOL, Professor at a leading university in Germany

Anonymous German KOL, Professor at a leading university in Germany

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