Physician Views: Lessons from ERS on the LABA/LAMA and triple-combination opportunities in COPD

With the opportunity for LABA/LAMA and LABA/LAMA/ICS combination therapies seen as critical in expanding the size of the COPD market, a number of presentations at this week's European Respiratory Society (ERS) congress will have been assessed with interest.

Novartis disclosed, for example, that its LABA/LAMA combination Ultibro was more effective than GlaxoSmithKline's ICS/LABA product Advair (it demonstrated similar overall efficacy to GlaxoSmithKline's own LABA/LAMA Anoro Ellipta) but, specifically, was more effective at preventing exacerbations in less exacerbation prone-COPD patients. With the steroid component in Advair expected to have more impact on exacerbations, noted Bernstein analyst Ronny Gal, the data presented by Novartis were not only somewhat surprising, but could support switching to LABA/LAMA combinations if further validated.

Boehringer Ingelheim also supported its potential position in this market with data for its own LABA/LAMA combination at ERS, which in addition showcased the company's Respimat inhaler device. Although the device has faced some regulatory scrutiny, key opinion leaders interviewed by FirstWord's Therapy Trends team have expressed very positive views on this type of inhaler.

Beyond the LABA/LAMA opportunity, leading respiratory players are also investing heavily in the development of triple-combination products – which add an ICS into the mix. Touted in some quarters as possessing a potential commercial impact on a par with GlaxoSmithKline's Advair in 2000 (sales of the drug peaked at about $8 billion), enthusiasm for triple-combination products is shared by many analysts.

One presentation at the ERS meeting this week – which demonstrated that removing the ICS component from a triple therapy had no adverse impact on the frequency of exacerbations among moderate-to-severe COPD patients – caused Bloomberg Industries analyst Sam Fazeli to speculate as to whether the triple-combination therapy will be as lucrative as industry players expect.

In addition, Celon Pharma used the ERS congress to suggest it will launch its generic version of Advair (branded as Seretide in Europe) in France at the beginning of 2015. Generic versions of the drug represent not only a threat to branded Advair/Seretide sales, but also once-daily ICS/LABA combinations (such as GlaxoSmithKline's Breo Ellipta) and possibly the switch to LABA/LAMA combinations. This threat appears to have intensified in the US given the recent shift in the respiratory market where pricing pressure has increased significantly.

In light of the issues arising at the ERS congress, we are asking EU5 and US-based pulmonologists...

Q1. Novartis reported this week that its LABA/LAMA combination Ultibro was more effective than Advair in preventing exacerbation in less exacerbation-prone COPD patients. One analyst noted this was surprising given that the steroid component in Advair should "do more to reduce exacerbations." Do you agree with the view that among patients without history of exacerbation, the combination of two bronchodilators may be more important than inclusion of a steroid, and if so, will this possibly help to shift patients from LABA/ICS combination products to LABA/LAMA combination products?

Q2. Based on your experience to date, what advantage do LABA/LAMA combinations deliver for the treatment of moderate-to-severe COPD patients?

Q3. One presentation made at this week's ERS congress demonstrated that removal of the ICS component from a 'triple therapy' (comprising ICS, LABA, LAMA components) made no difference to the frequency of exacerbations in moderate-to-severe COPD patients. Triple combinations are viewed by industry players as a potential paradigm-shifting therapy type – do you agree with this view based on your experience with ICS/LABA/LAMA products and data presented to date?

Q4. How significant an impact do you expect the availability of generic Advair to have on limiting switch rates to LABA/LAMA combinations for the treatment of COPD?

Q5. Based on your experience and suggestions that this type of design allows for better delivery of drugs to a patient's lower respiratory tract – while being less dependent on a patient's inspiratory capacity – would you like to see more devices utilise the 'soft mist' technology associated with Boehringer Ingelheim's Respimat device?

You will be able to read the results and analysis later this week.

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