Physician Views: Idiopathic pulmonary fibrosis – on the cusp of a revolution; how will forthcoming approvals shape the treatment and development landscapes?
Data presented at last week's American Thoracic Society (ATS) conference confirmed that InterMune and Boehringer Ingelheim are on the cusp of driving a revolution in the treatment of US patients suffering from idiopathic pulmonary fibrosis (IPF).
Positive Phase III data are expected to act as the springboard for FDA approvals of InterMune's Esbriet (pirfenidone) and Boehringer Ingelheim's nintedanib by late 2014/early 2015. Launch and uptake of these products will have not only a profound impact on the IPF community, but development programmes for earlier-stage IPF compounds being developed by the likes of AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Roche.
Reaction to the data presented for both products at the ATS conference indicates a consensus among analysts that InterMune's Esbriet will be positioned more favourably based on small advantages regarding its clinical profile. Some observers are already suggesting that Esbriet could easily beat consensus revenue expectations for 2015 and deliver a level of performance that would heavily entrench the compound; also indicating that nintedanib will experience healthy market share gain, potentially boosted by combination use in more severe patients.
To help assess the accuracy of this reading of the Phase III data – and its commercial implications – FirstWord is polling US-based pulmonologists to ascertain how they anticipate using Esbriet and nintedanib once they become available; and how usage of these drugs will potentially dictate the design of late-stage studies for current pipeline therapies.
Specifically, we asked US pulmonologists...
Positive Phase III data are expected to act as the springboard for FDA approvals of InterMune's Esbriet (pirfenidone) and Boehringer Ingelheim's nintedanib by late 2014/early 2015. Launch and uptake of these products will have not only a profound impact on the IPF community, but development programmes for earlier-stage IPF compounds being developed by the likes of AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline and Roche.
Reaction to the data presented for both products at the ATS conference indicates a consensus among analysts that InterMune's Esbriet will be positioned more favourably based on small advantages regarding its clinical profile. Some observers are already suggesting that Esbriet could easily beat consensus revenue expectations for 2015 and deliver a level of performance that would heavily entrench the compound; also indicating that nintedanib will experience healthy market share gain, potentially boosted by combination use in more severe patients.
To help assess the accuracy of this reading of the Phase III data – and its commercial implications – FirstWord is polling US-based pulmonologists to ascertain how they anticipate using Esbriet and nintedanib once they become available; and how usage of these drugs will potentially dictate the design of late-stage studies for current pipeline therapies.
Specifically, we asked US pulmonologists...
- To what percentage of IPF patients they would expect to treat with either product by the end of 2015 (based on an initial launch of Esbriet in late 2014/early 2015 and nintedanib in early 2015)?
- Which product – Esbriet or nintedanib – do they believe to be superior, and to what extent?
- What clinical factor would primarily drive them to prescribe one of these products in favour of the other in the majority of IPF patients?
- What peak market share they anticipate Esbriet to achieve?
- How strongly they agree with the assertion that Phase III trial design protocol for earlier-stage development compounds should incorporate background therapy with Esbriet and/or nintedanib owing to potential complimentary mechanisms of action?
