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COPD: Update Bulletin

COPD: Update Bulletin

  • January 2018
  • ID: 5385515
  • Format: PDF
  • By Firstword Pharma

Summary

This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the chronic obstructive pulmonary disease (COPD) market, including; Theravance and Mylan announcing the submission of a New Drug Application (NDA) for the once-daily, nebulised, long-acting muscarinic antagonist (LAMA) revefenacin, to the US FDA; Novartis announcing positive results from the Phase IV study, FLASH, examining the safety and efficacy of directly switching moderate-to-severe, symptomatic COPD patients from Seretide/Advair to Ultibro/Utibron; The initiation by GlaxoSmithKline (GSK) of a Phase IIb proof-of-concept study aiming to assess if the vaccine GSK3277511A can reduce the frequency of exacerbations in COPD; Mereo BioPharma announcing positive top-line data from a Phase II clinical trial with BCT-197, a novel, orally active p38 MAP kinase inhibitor in development as a first-line therapy for patients who experience acute exacerbations of COPD.

Business Questions:
• How does revefenacin compare to other LAMAs as an active ingredient?
• Could revefenacin in a nebuliser format address any unmet needs?
• Which patient types could benefit most from revefenacin, and how big is this population?
• What steps could Theravance and Mylan take to further differentiate revefenacin and secure market access?
• To what extent will data from FLASH encourage switching in moderate-to-severe, symptomatic COPD patients?
• Will FLASH findings impact on other dual bronchodilator therapies, or just Ultibro/Utibron?
• What else needs be done to accelerate the switching process?
• What new therapies are perceived as threats to Ultibro/Utibron?
• How do experts view the rationale of respiratory infection vaccination for exacerbation reduction which lies behind the development of GSK3277511A?
• How confident are KOLs that GSK3277511A is the right candidate to progress to Phase IIb?
• In terms of efficacy goals for GSK3277511A, what do KOLs benchmark against, and how optimistic are these?
• What patient types are likely to be GSK3277511A’s target market, and how could these be theoretically broadened?

After many p38 MAP kinase inhibitor failures in COPD, how optimistic are KOLs about BCT-197?
• Could BCT-197 represent a step-change in therapy?
• In terms of market access, what will BCT-197 be benchmarked against, and what will it need to demonstrate to differentiate itself?
• Is there scope for an expanded indication for BCT-197 into long-term treatment?

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