With US advisory panel backing for Boehringer Ingelheim’s long-acting beta agonist olodaterol, the world’s biggest private pharma company has taken another small step towards protecting its blockbuster COPD franchise.
The panel’s overwhelming 15-1 vote on safety and efficacy positions the long-acting beta-agonist (LABA), trade named Striverdi Respimat, for US approval this year, although the action date has not been disclosed. The much bigger prize for Boehringer is a combination of olodaterol with Spiriva – something that is now a real possibility given certain aspects of the panel’s recommendation.
The FDA has voiced much concern over the safety of LABAs, which has led the agency to limit exposure to only the lowest doses. As such, the biggest worry for the German group had been that the panel might baulk at olodaterol’s once-daily 5mcg dose and instead recommend 2mcg twice daily, which had shown a similar profile (Event – Boehringer plays catch-up in COPD combination race, January 18, 2013).
Given Spiriva’s once-daily dosing, such a recommendation could have seriously hampered development of the combo, but these fears did not come to pass. While they might of course arise in future – and indeed FDA scrutiny has focused on the LABA component of combination products – for now the signs are good.
There had also been doubts over olodaterol’s efficacy, the panel’s briefing notes questioning the clinical meaningfulness of a “relatively modest” bronchodilator effect against background therapy. In the event, six- and 48-week phase III studies, whose full results have yet to be released, did support approval, the panel found.
The issue now will be how Boehringer proceeds. Approval and launch of Striverdi would follow that of Novartis’s LABA indacaterol (Onbrez Breezehaler), which has been on the market for two years now and is forecast to generate sales of $425m by 2018.
The holy grail for Novartis is QVA149, a combination of indacaterol with its established long-acting muscarinic antagonist (LAMA) glycopyrrolate that analysts expect to become a blockbuster within the same timeframe. This mirrors Boehringer’s plans for a combination of olodaterol with Spiriva.
No analysts’ forecasts exist for Boehringer’s combo, which at present is running behind QVA149 as well as GlaxoSmithKline’s own LABA/LAMA combo, Anoro (umeclidinium plus vilanterol). Anoro is already awaiting US approval, and QVA149 has been filed in Europe and Japan, while the Boehringer combination is in no fewer than 11 phase III studies that should start reading out this year.
These subtle differences of timing are important given how much is at stake. Spiriva, Boehringer’s standalone LAMA, is set to come off patent in 2018 – a year in which it is expected to account for a massive $3.3bn of revenue. Combivent, Boehringer’s first-generation short-acting beta and muscarinic agonist combo, is currently a blockbuster but goes generic in two years.
With serious threats ahead and the ground shifting fast, it is vital for Boehringer to maintain its leading position in COPD against the impending threat of Novartis, Glaxo and others.
If the FDA follows the panel’s advice and nods Striverdi through, the first line of defence will be in place.