Yesterday’s US advisory committee recommendation for Spiriva Respimat is another vote of confidence in Boehringer Ingelheim’s turnaround strategy, though the group now has to contend with growing pressure in the healthcare space overall.
The 10-3 adcom vote is the second recent endorsement of the group’s novel Respimat delivery device on which effectively its entire Spiriva lifecycle management plan is based. Still, this week’s revelation that 15% must be trimmed off Boehringer’s cost base in Germany suggests that broader market problems will not go away overnight.
The German company’s regulatory successes have followed in quick succession since the lifting of a US warning over the Ingelheim am Rhein plant in June. The manufacturing warning had held up all US approvals, including those of Spiriva Respimat and the LABA product Striverdi, and prompted a US complete response letter for the diabetes project empagliflozin.
Striverdi Respimat finally got US approval two weeks ago – a year and a half after it got adcom backing – as did empagliflozin (Light at the end of the tunnel for Boehringer’s manufacturing woes, April 16, 2014). Yesterday’s panel vote clearly bodes well for Spiriva Respimat.
Against these operating successes, however, market pressure is an unwelcome distraction. Boehringer reported an 8% fall in first-half group sales, which it put down to growing competitive threats and having to accept significant price cuts in the US, and said full-year revenue would decline in the low single digits at constant currency exchange.
It also moved to slash operating spending by 15% in Germany via job cuts and/or a hiring freeze, while committing to capital expenditure of some €300m ($402m) this year. A spokesperson stressed that headcount in Germany had risen from 13,122 to 14,087 over the past year, and said there was no formal timeframe for implementing the 15% cut.
Focus on Respimat
If the FDA follows the adcom’s advice Boehringer’s COPD blockbuster, Spiriva, will be available in both the novel Respimat mist inhaler and the older dry-powder Handihaler device – as is already the case in Europe.
The company appears to play down the significance, saying only that thanks to this doctors will have greater choice, but the fact is that widespread adoption of Respimat forms the cornerstone of its Spiriva strategy. This includes Striverdi, the combination of tiotropium and olodaterol, and future COPD products.
Already major investment and a big marketing push have been put behind Respimat, highlighting the novel technology behind it and futuristic aspects such as a downloadable app to allow patients to practise the necessary way of inhaling.
As part of the adcom eight efficacy trials were reviewed, including the all-important 17,000-patient Tiospir study showing similar median times to COPD exacerbation and an equal impact on all-cause mortality between the Respimat and Handihaler devices. An increase in deaths due to COPD exacerbation had led to a US complete response letter for Spiriva Respimat in 2008.
If the earlier fears can be ruled out Boehringer’s lifecycle strategy should come together. The tiotropium plus olodaterol combo has already been filed in Europe, and a US submission is planned for later this year.
With Spiriva set to lose patent protection in 2018 the resolution of Boehringer’s manufacturing woes could not have come soon enough.