SkyePharma soars on strong Ph III Flutiform EU clinical trial program

The UK's drug delivery specialist SkyePharma saw its share price leap 22.3% to 101.5 pence, after the firm revealed that the asthma drug Flutiform (fluticasone/formoterol) had met endpoints of a final Phase III study, which will allow for regulatory filing with the European Union authorities to take place in the first quarter of 2010 as planned.

The company said that its development and marketing partner, Mundipharma International, has successfully completed the final Phase III clinical study for the European development program for Flutiform with the higher dose strength study (FLT 3503) meeting its primary endpoints. Switzerland-based Mundipharma has the rights to commercialize Flutiform outside the Americas and Japan, SkyePharma noted.

Study FLT-3503 included 529 patients, who met the requirements for the "per protocol" analysis, and were suffering from severe, persistent and reversible asthma. They were treated in an eight week double-blind, double dummy, randomized multicenter four arm parallel group study to assess the efficacy and safety of Flutiform. The four treatment arms were: Flutiform (fluticasone 500mcg/formoterol 20mcg); Flixotide (fluticasone 500mcg) and Swiss drug major Novartis' Foradil (formoterol 24mcg) administered concurrently; Flutiform (fluticasone 100mcg/formoterol 10mcg); and Flixotide (fluticasone 500mcg). Enrolled patients had to have a disease history of at least six months.

The changes in the mean pre-dose FEV 1(Forced Expiratory Volume in the first second) at baseline to the pre-dose FEV1 and the two hour post-dose FEV1 at eight weeks, were the primary endpoints measured and the top line analysis confirms that Flutiform produces similar results (statistically not inferior) when compared with the concurrent administration of Flixotide and Foradil. The results demonstrated that Flutiform was well tolerated in the study patients. The analysis of multiple secondary endpoints is ongoing.

In September, the drug delivery company, which licensed Flutiform marketing rights to Abbott in the US, said that the US Food and Drug Administration had called for more data on dosing, meaning the drugmaker now expected approval in the USA - where it is licensed to Abbott Laboratories - in late 2011.