SkyePharma’s shares were given a hefty boost yesterday after the company announced that a late-stage trial of Flutiform was a success, paving the way for the drug’s filing in Europe during the first quarter of next year.
The group’s stock had already jumped more than 22% by mid-morning trading on the London Stock Exchange as investors welcomed news that development and marketing partner Mundipharma has completed the final Phase III clinical trial of the European development programme for its flagship asthma combination drug Flutiform (fluticasone and formoterol), and that the higher dose strength study hit its primary targets.
Flutiform HFA-MDI has been designed to bring together the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a long-acting beta-agonist (formoterol fumarate) in one product, delivered via “an environmentally-friendly aerosol propellant hydrofluoroalkane” and through a metered dose inhaler, with which the companies will be hoping to gain a significant share of the multi-billion-euro asthma market.
In the multi-centre study, 529 patients with severe, persistent and reversible asthma were randomised to receive either Flutiform (fluticasone 500 _g/formoterol 20 _g); a mix of (Flixotide (fluticasone 500 _g) and Foradil (formoterol 24 _g); a lower dose form of Flutiform (fluticasone 100 _g /formoterol 10 _g); or Flixotide alone.
The results showed that Flutiform was at least as effective as the Flixotide/Foradil combination in improving pre- and post-dose FEV1 (Forced Expiratory Volume in the first second) over the eight week duration of the study, and also that the drug was well tolerated in patients, enabling a European Marketing Authorisation Application to be filed in Q1 2010, confirmed SkyePharma’s chief executive Dr Ken Cunningham.
The news will be particularly welcome given the delays the drug, the success of which is crucial to the company’s future, is facing across the pond. Back in September SkyePharma’s stock was given a knock after it was announced the US regulators have requested more dosing data on the drug, requiring additional clinical work and delaying its potential approval for at least a couple of years.
