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Chronic Obstructive Pulmonary Disorder (COPD): KOL Insight [2018]

Chronic Obstructive Pulmonary Disorder (COPD): KOL Insight [2018]

Introduction

Established brands, generics, biologics and new MOAs fight for supremacy in the COPD treatment landscape

Established treatments are coming under pressure from generics, new combinations, biologics and new MOAs as the COPD treatment landscape continues to evolve. Of the key companies currently competing in this space -- AstraZeneca, Boehringer Ingelheim, GSK and Novartis -- which companies do key opinion leaders (KOLs) think will take the spoils? More importantly, how can smaller companies which are offering new treatment options (e.g. Chiesi’s Trimbow, one of the first closed triple ICS/LABA/LAMA combination therapies approved in Europe) carve themselves out a niche?

KOLs also offer fresh insight on the continued development of biologic treatment options (e.g. anti-IL-4 and anti-IL-5 mAbs from Sanofi/Regeneron, AstraZeneca and GSK), as well as their updated views on several next-generation therapies and new mechanisms of action, including gene therapies, vaccines and others. Twelve of the world’s leading KOLs offer their candid insights on these issues and more.

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The table of contents

The key business questions answered

The key KOL quotes

See the therapies covered

Find out who the 6 EU & 6 US KOLs are

Review an extract from the report - 1 drug profile

Top takeaways

Is it all change in the COPD treatment paradigm? Three products continue to dominate the COPD treatment landscape, so how quickly will these products lose ground to the newer single and combination therapies, and generics, entering the market?

What impact have updated Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines had on treatment practice? New guidelines on COPD patient assessment, segmentation and treatment were published in 2017, so what has been the ‘real-world’ impact and which companies have benefited?B3

Are fixed-dose triple combination therapies the answer to remaining clinical unmet needs? With the approval of two ICS/LABA/LAMA combos -- Trelegy Ellipta from GSK and Trimbow from Chiesi -- how do KOLs expect these to be used in clinical practice; will they improve clinical outcomes, and are there any lingering concerns?

Seretide/Advair generics are here, but what impact will they have in the treatment of COPD? Generic versions of GSK’s Seretide/Advair are expected to penetrate the market in the near term. Will the potential for lowering the costs of therapy win the argument, or has treatment guidance changed before their impact can be felt?

Will biologics find a niche in the management of COPD? Development of anti-IL-5 mAbs from GSK (mepolizumab) and AstraZeneca (benralizumab), and an anti-IL-4 mAb from Sanofi/Regeneron (dupilumab), continues but what does the future hold? Are KOLs optimistic or will biologics fail to breathe new life into the COPD treatment landscape?

Do KOLs think any of the new MOAs in development warrant excitement? New MOAs range from vaccines, gene therapies, and novel combinations, but do any of them ignite excitement with the KOLs? If so, which ones and how could they fare?

Quotes

“I think dual bronchodilators have become the gold standard. Most of my patients are on dual bronchodilators alone or with something else. I would say that this is the centre or the baseline of the therapy, according to the guidelines, but it is only guidance.” EU Key Opinion Leader

“I’m very enthusiastic about this. We have vaccinations for some types of streptococcus pneumonia and I frequently recommend these to patients, but there are many other causes of infection in healthy people as well as COPD.” US Key Opinion Leader

Sample of therapies covered

Marketed Therapies

LAMA monotherapies


Spiriva (tiotropium; Boehringer Ingelheim)

Seebri (glycopyrronium; Novartis)

Eklira/Tudorza (aclidinium; AstraZeneca/Takeda)

Incruse (umeclidinium; GSK)

Arcapta/Onbrez (indacaterol; Novartis)

Striverdi (olodaterol; Boehringer Ingelheim)

LAMA/LABA combinations

Stiolto/Spiolto (tiotropium/olodaterol; Boehringer Ingelheim)

Ultibro/Utibron (glycopyrronium/indacaterol; Novartis)

Eklira/Tudorza (aclidinium; AstraZeneca/Takeda)

Anoro (umeclidinium/vilanterol; GSK)

Bevespi (glycopyrronium/formoterol; AstraZeneca)

ICS/LABA combinations

Seretide/Advair (fluticasone propionate/salmeterol; GSK)

Relvar Ellipta/Breo Ellipta (fluticasone furoate/vilanterol; GSK)

Symbicort (budesonide/formoterol; AstraZeneca)

ICS/LABA/LAMA triple combinations

Trelegy Ellipta (fluticasone furoate/vilanterol/umeclidinium; GSK)

Trimbow (beclometasone/formoterol/glycopyrronium; Chiesi)

Pipeline Programmes

budesonide/formoterol (PT009; AstraZeneca)

budesonide/formoterol /glycopyrrolate (PT010; AstraZeneca)

benralizumab (Fasenra; AstraZeneca)

Mepolizumab (Nucala; GSK)

Revefenacin (Theravance/Mylan)

GSK3277511A (GSK)

SB010 (Sternal Biologicals)

Batefenterol (GSK)

BCT197 (Mereo Biopharma)

Nemiralisib (GSK)

Danirixin (GSK)

RPL554 (Verona)

KOLs interviewed

KOLs from North America


Roger Abrahams. President, Morgantown Pulmonary Associates, Morgantown, WV, USA

Richard Casaburi. Professor and Chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor at the University of California at Los Angeles Medical Center, CA, USA

Donald A. Mahler. Emeritus Professor of Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH, USA

Donald Tashkin. Emeritus Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), CA, USA

Robert (Bob) Wise. Director of Research, Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medical School, Baltimore, MD, USA

Anonymous US KOL. Professor of Medicine, and former Chief, Division of Pulmonary Diseases and Critical Care Medicine, at a leading respiratory hospital in the US

KOLs from Europe

Leif Hilding Bjermer. Professor of Pulmonary Medicine, Department of Respiratory Medicine and Allergology, Lund University, Sweden

Marc Miravitlles. Chest Physician and Senior Researcher, Department of Pneumology, Hospital Universitari Vall d'Hebron, Barcelona, Spain

David Singh. Professor of Clinical Pharmacology and Respiratory Medicine, University Hospital Of South Manchester NHS Foundation Trust, Manchester, UK

Jadwiga Wedzicha. Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College, London, UK

Anonymous German KOL. Professor and leading pulmonologist focused on COPD, asthma and general pulmonary medicine at a leading German teaching hospital

Anonymous German KOL. Professor and specialist in internal medicine, pulmonology, allergology and sleep medicine at a leading German teaching hospital

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 Update Bulletins offers a real commercial advantage.

Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date.


1. Executive summary
2. Research objectives
3. Research focus
3.1 COPD treatment protocols (by disease severity)
4. Disease overview, treatment goals, unmet needs and market challenges
4.1 Current treatment paradigm
4.1.1 Key insights summary
5. LABA monotherapies
5.1 Overview
5.1.1 Key insights summary
5.2 Pipeline therapies
5.2.1 Abediterol (AstraZeneca)
6. LAMA monotherapies
6.1 Overview
6.1.1 Key insights summary
6.2 Marketed therapies
6.2.1 Seebri Neohaler/Lonhala Magnair (Sunovion)
6.3 Pipeline therapies
6.3.1 Revefenacin (Theravance/Mylan)
7. LABA/LAMA combination therapies
7.1 Overview
7.1.1 Key insights summary
7.2 Marketed therapies
7.2.1 Duaklir Genuair (AstraZeneca)
7.2.2 Bevespi Aerosphere (AstraZeneca)
8. ICS/LABA combination therapies
8.1 Overview
8.2 Pipeline therapies
8.2.1 PT009 (budesonide/formoterol MDI; AstraZeneca)
9. ICS/LABA/LAMA triple combination therapies
9.1 Overview
9.1.1 Key insights summary
9.2 Marketed therapies
9.2.1 Trelegy Ellipta (fluticasone/vilanterol/umeclidinium; GSK/Innoviva)
9.2.2 Trimbow (beclometasone/formoterol/glycopyrronium; Chiesi)
9.3 Pipeline ICS/LABA/LABA combination therapies
9.3.1 PT010 (budesonide/formoterol/glycopyrrolate; AstraZeneca)
10. Biologic therapies
10.1 Anti-IL-5 mAbs
10.1.1 Key insights summary
10.2 Anti-IL-4 mAbs
10.2.1 Key insights summary
11. Early-stage pipeline products
11.1 GSK3277511A (NTHi/Mcat-vaccine; GSK)
11.1.1 Key insights summary
11.2 GATA3 transcription factor inhibitors
11.2.1 Key insights summary
11.3 MABAs (M3 antagonist-beta2 agonists)
11.3.1 Key insights summary
11.4 P38 mitogen activated protein kinase inhibitors
11.4.1 Key insights summary
11.5 Phosphoinositide 3-kinase delta (PI3K-delta) inhibitors
11.5.1 Key insights summary
11.6 Chemokine receptor (CXCR2) inhibitors
11.6.1 Key insights summary
11.7 Mixed phosphodiesterase (PDE) 3/4 inhibitors
11.7.1 Key insights summary
12. Future treatment paradigm
12.1 Key insights summary
13. Conclusion
14. Appendix
14.1 KOL details
14.1.1 KOLs from North America
14.1.2 KOLs from the EU

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