COPD [2017]

COPD [2017]


Are closed triple combos expected to change treatment dynamics?

New treatment guidelines look set to change the way in which COPD is treated. New guidelines from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommend LABA/LAMAs as first line therapy in symptomatic patients regardless of exacerbation risk, and KOLs agree. LABA/LAMA marketing companies set to benefit include AstraZeneca, Boehringer Ingelheim, GSK and Novartis, but which company will take the spoils. Meanwhile, how will closed triple ICS/LABA/LAMA combination therapies fair when approved? Do they offer real clinical benefits, and which pipeline programmes (from GSK, Chiesi and AstraZeneca) do KOLs believe has the edge over other rivals? Experts also give their views on how anti-IL5 mAbs are likely to fair in the COPD treatment paradigm, as well as provide insights on next-generation therapies and new mechanisms of action.

6 KOLs from the US and 6 KOLs from Europe offer their candid insights on these issues and more.

  • 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
Reasons to Purchases

Top Takeaways
  • Is it all change in the COPD treatment paradigm? Three products have dominated the COPD treatment landscape over the past decade, so how quickly will these products lose ground to the newer single and combination therapies entering the market?
  • What impact will new Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have on treatment practice? New guidelines on COPD patient assessment, segmentation and treatment were published in 2017, but what will be the ‘real-world’ impact and which companies are set to benefit?
  • What does the future hold for disease modifying treatments? Do any of the pipeline programmes offer the potential for disease modification, or do KOLs believe it’s too early to say?
  • Do the new GOLD guidelines glitter for combo LABA/LAMA brands? With five LABA/LAMA combo brands all vying for a slice of the action, which treatments do KOLs prefer and how will usage evolve over the coming years?
  • Are fixed-dose triple combination therapies the answer to remaining clinical unmet needs? ICS/LABA/LAMA combos are coming, and some will be launched by 2018. Is it all about improved outcomes, or is it simply about improved patient convenience? KOLs speak out.
  • 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?

“The once daily LABA/LAMAs are pretty much similar as far as I can judge. Lung function, symptoms, prevention of exacerbations, they're all pretty similar, although no one's done a head-to-head comparison.” European Key Opinion Leader

“Patients will benefit because they will have just one device. There will be more room to add other medications without endangering the compliance. Unfortunately when you have all medications in just one device, there will be a lot of interest from many physicians and even patients, even for cases in which it's not recommended.” US Key Opinion Leader

Sample of therapies covered

Marketed Therapies
  • Long-acting muscarinic antagonists (LAMAs)
  • Spiriva (tiotropium; Boehringer Ingelheim)
  • Seebri (glycopyrronium; Novartis)
  • Eklira/Tudorza (aclidinium; AstraZeneca/Takeda)
  • LAMA/LABA combinations
  • Stiolto/Spiolto (tiotropium/olodaterol; Boehringer Ingelheim)
  • Ultibro/Utibron (glycopyrronium/indacaterol; Novartis)
  • Eklira/Tudorza (aclidinium/formoterol; AstraZeneca/Takeda)
  • ICS/LABA combinations
  • Seretide/Advair (fluticasone propionate/salmeterol; GSK)
  • Relvar Ellipta/Breo Ellipta (fluticasone furoate/vilanterol; GSK)
  • Symbicort (budesonide/formoterol; AstraZeneca)
Pipeline Therapies (Phase II/III)
  • benralizumab (AstraZeneca)
  • mepolizumab (GSK)
  • budesonide/formoterol/glycopyrrolate (PT010; AstraZeneca)
  • beclometasone/formoterol/glycopyrrolate (CHF5993; Chiesi)
Sample of KOLs interviewed

KOLs from North America
  • Professor Antonio Anzueto. Chief of the Pulmonary Disease Section, South Texas Veterans Health Care System and Medical Director of the Pulmonary Function Laboratory at the University Hospital in San Antonio.
  • Professor Richard Casaburi. Professor and Chief, Division of Respiratory and Critical Care Physiology and Medicine, University of California at Los Angeles Medical Center.
  • Dr. Carlos Martinez. Assistant Professor, Department of Internal Medicine and Medical Director, Pulmonary Rehabilitation Services, University of Michigan.
KOLs from Europe
  • Professor Fan Chung. Professor of Respiratory Medicine and Head of Experimental Studies Medicine at National Heart & Lung Institute, Imperial College London, UK.
  • Professor Peter J. Barnes. Professor of Thoracic Medicine and Head of Respiratory Medicine at the National Heart and Lung Institute and Honorary Consultant Physician at Royal Brompton Hospital, London, UK
  • Professor Nicolas Roche. Professor of Respiratory Medicine, Service de Pneumologie et Réanimation, Hôpital de l’Hôtel Dieu 1, Paris.
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1. Executive Summary
2. Research objectives
3. Research focus
4. COPD market overview
4.1 Established products remain market leaders in the treatment of COPD
4.2 Disease-modifying treatments are a key unmet need
4.3 Spirometry underutilised in the diagnosis of COPD
4.4 Updated GOLD guidelines undermine use of spirometry in primary care
4.5 Categorisation of disease severity ambiguous with new GOLD patient assessment guidelines
4.6 Late diagnosis of patients remains a persistent problem
4.7 Treatment naïve patients frequently receive LAMA monotherapy in the first instance, stepping up to LABA/LAMA
4.8 ICS monotherapy has no place in the treatment of COPD
4.9 The available range of devices complicates prescribing decisions
5. Long acting bronchodilators
5.1 LAMA therapies are considered equally efficacious
5.2 Tiotropium the go-to product for many prescribers, but umeclidinium could erode sales
5.3 Novel LAMA revefenacin comparable to existing therapies, but with a clear differentiating factor
5.4 Revefenacin could be of benefit in a niche patient population
6. LABA/LAMA combination therapies
6.1 LABA/LAMA therapies are broadly similar in terms of clinical efficacy
6.2 Delivery device an important determinant of choice of LABA/LAMA therapy
6.3 KOLs are supportive of the GOLD recommendation of LABA/LAMAs as first line therapy in symptomatic patients regardless of exacerbation risk
6.4 Results of the IMPACT head-to-head study are highly anticipated
6.5 AstraZeneca’s Bevespi approved in the US for COPD but only brings comparable efficacy to other drugs in the class, suggest KOLs
7. ICS/LABA combinations
7.1 Competitively priced ICS/LABA generics will gain a strong foothold in the market
7.2 Sales of ICS/LABA therapies will decline but not become obsolete
8. Pipeline products
8.1 ICS/LABA/LAMA triple combination therapies
8.1.1 Triple therapies offer convenience but do not address any specific unmet needs
8.1.2 KOLs ambivalent about the use of eosinophil count to differentiate patients
8.1.3 GSK’s triple combination may have a competitive edge
8.2 Anti-interleukin 5 (IL5) monoclonal antibodies (mAbs)
8.2.1 Anti-IL-5s expected to have less of an impact in COPD than asthma
8.2.2 mAb therapies may struggle to carve a clinical niche in COPD
8.2.3 Mepolizumab and benralizumab considered equally clinically effective
8.3 Other pipeline products
8.3.1 Novel anti-inflammatories promising, but side effects a potential concern
8.3.2 Danirixin’s mechanism of action, in targeting neutrophilic inflammation, makes sense as a treatment approach for COPD, argue KOLs
8.3.3 KOLs question the commercial viability of MABA therapies
9. Future developments in the treatment of COPD
9.1 Triple combination products will not expand the market
9.2 KOLs cautious concerning the potential of blood eosinophil concentration as a biomarker for response to ICS
9.3 FLAME study results support the benefits of LABA/LAMA over ICS/LABA but switching established patients unlikely
9.4 LAMA monotherapies expected to lose ground to LAMA/LABA therapies in the medium term
9.5 LABA/LAMA therapies expected to become the treatment of choice despite slow initial uptake
10. The current and future COPD treatment paradigm
11. Conclusion
12. Appendix
12.1 KOL Biographies
12.1.1 North American KOLs
12.1.2 European KOLs

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