UK group Vectura saw its shares drop 10 percent after partner Munipharma reported that respiratory drug flutiform failed to hit targets in a late-stage trial involving patients with chronic obstructive pulmonary disease (COPD).
The Phase III trial missed its primary endpoint of demonstrating statistically significant superiority in the reduction of annualised rates of moderate and severe COPD exacerbations in patients taking flutiform compared to those taking mono-component long-acting beta 2 agonist (LABA) treatment alone.
Flutiform combines fluticasone propionate (fluticasone), an inhaled corticosteroid, and formoterol fumarate, an LABA, in a single aerosol inhaler incorporating Vectura's SkyeDry technology, acquired through its purchase of SkyePharma and approved for asthma. Mundipharma holds marketing rights to the drug for most of the world outside North America and Japan.
Investors will be disappointed with the news because the trial was intended to support expanding the drug's approved uses in Europe to include COPD, which is now looking unlikely.
"Whilst this result is disappointing, flutiform continues to grow strongly based on the approved asthma indication, which continues to underpin our expectations for future growth of the product," noted James Ward-Lilley, Vectura's chief executive.
"Vectura already benefits from sizeable and growing revenues from other partnered products on the market in Europe and elsewhere for the treatment of COPD, including Ultibro and Seebri," he added.