SkyePharma partner Kyorin completes Japanese Flutiform clinical program

UK drug delivery specialist SkyePharma (LSE: SKP) saw its shares leap nearly 11% to £76.50 last week, after the company announced that its development and marketing partner Kyorin Pharmaceutical (TSE; 4569) has successfully completed the Phase III clinical studies for the Japanese development program for KRP-108 (Flutiform, a fixed dose formulation of fluticasone and formoterol), with both studies (A301 and A302) meeting their primary endpoints.

This will enable the regulatory filing with the Japanese authorities to take place in Kyorin's fiscal year ending in March 2013 as planned. Kyorin gained Japanese development and distribution rights to the product in Japan in 2008, under a deal the financial terms of which were not disclosed.

Study A301 included patients suffering from asthma. They were treated in an eight week single-blind, randomized multiple center, two arm parallel group study, to assess the efficacy and safety of KRP-108. The two treatment arms were: KRP-108; and Flutide 50 (fluticasone).