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?
- 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?
