Boehringer Ingelheim's COPD treatment, Spiolto Respimat, is up against a raft of competitors--especially in the EU, where it recently won its first approvals. Now, though, it's touting new data from a quality of life study that it hopes will give it a leg up.
|University of Manchester's Dave Singh|
According to results from a pair of Phase IIIb trials, the drug provides "consistent, clinically meaningful improvements in quality of life" over placebo, Boehringer said Monday. And those improvements "could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life," according to lead investigator Dave Singh, a professor of respiratory medicine at the University of Manchester.
"This could mean that patients are able to walk up stairs without stopping, go out to socialize with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better," he said.
Boehringer will be trumpeting the findings as it squares off against Novartis' ($NVS) Ultibro Breezhaler--a LAMA/LABA product that's awaiting FDA approval in the U.S.--and GlaxoSmithKline's ($GSK) Anoro Ellipta, which already has regulatory go-aheads on both sides of the pond. Right now, BI is rolling out Spiolto in Croatia, the U.K., Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain, and last month it said it anticipates more European approvals soon.
The data could also come in handy in the U.S., where payers are increasingly looking for outcomes data and excluding drugs that don't bring something new to the table--or come with a discount. The aggressive payer tactics in the respiratory field in particular have hobbled GlaxoSmithKline's behemoth Advair, sending sales crashing, and Boehringer's own Spiriva sales tumbled 8.1% last year.
And with Spiriva's patent expiration approaching in 2018, that's a trend Boehringer wants to reverse. The German pharma is hoping Spiolto--which combines the active ingredient in Spiriva with that in fellow BI med Striverdi--can help boost the elder drug, which generated €3.2 billion in 2014 sales.
- read BI's release
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