Over the weekend some of the world's largest drug developers rolled out new data on their late-stage COPD drugs, staying upbeat despite a growing sense among some analysts that many of these new drugs will find it hard to offer much in the way of a significant improvement for patients.
Boehringer Ingelheim offered up Phase III data for olodaterol at the annual meeting of the European Respiratory Society. The pharma company reported that in one set of Phase III results at 48 weeks, olodaterol 5 and 10 µg delivered once daily with its Respimat inhaler "provided statistically significant improvements in lung function, as measured by FEV1, versus placebo plus usual care in patients with moderate to very severe COPD."
Boehringer is trying to protect the $4.7 billion franchise it has for Spiriva, which competes against GlaxoSmithKline's ($GSK) $8 billion Advair while AstraZeneca ($AZN) earns $3.2 billion from Symbicort. And as Bloomberg reports in its assessment today, Citigroup is estimating that the COPD market is likely to swell from $10 billion this year to $14 billion in 2018.
That's the kind of blockbuster market these giants--facing severe generic pressure--need to capitalize on. And while several of the new therapies in development appear destined for an approval, it won't be easy.
Boehringer's olodaterol, a LABA, represents some of the problems that developers face. When FDA regulators looked it over early this year, they couldn't find much wrong with it, nor could they discover all that much of an advantage over existing drugs. And Anoro Ellipta, the new COPD drug from GlaxoSmithKline and Theravance, is up for a panel review tomorrow after regulators also offered a mild endorsement of its efficacy late last week. A number of analysts expect it to earn more than a billion dollars a year in what promises to be a crowded market.
Perhaps one of the contenders, Novartis' ($NVS) QVA149, a LAMA/LABA combo, can shake up the market. The EMA endorsed the once-daily drug in July. But facing some challenges at the FDA, an NDA isn't expected in the U.S. until later in the year.
Novartis released an analysis of pooled data on 4,891 COPD patients in the IGNITE clinical trial program (SHINE, ILLUMINATE and SPARK studies) which "showed that investigational QVA149 provided rapid and sustained improvements in lung function, and significantly reduced shortness of breath, evaluated against comparator treatments widely used as current standards of care evaluated in the study."
How that drug fares in a market where patients are often reluctant to seek treatment, though, will be closely watched. Boehringer and Almirall, meanwhile, have their own LAMA/LABA combos that could arrive on the market in 2015.
- here's the rundown from Bloomberg
- see the press release from Boehringer
- and the release from Novartis