In setback, FDA demands new work on SkyePharma's Flutiform

The FDA is throwing a hurdle in the way of SkyePharma's experimental asthma therapy Flutiform. As the U.K. developer had feared, the agency is demanding new clinical work on dosing before it will approve the therapy, and that will likely delay any market launch until at least the second half of 2011. The delay will also take a big bite out of SkyePharma's expected milestones and royalties.

"Under the current license agreement," SkyePharma states, "Abbott is responsible for paying for additional clinical or other trials required by the FDA, and is entitled to recoup such costs out of up to 25 per cent of any approval or post-approval milestones and royalties." But the developer adds that the FDA's position shouldn't affect its regulatory timetable in Europe or Japan. 

The delay is bad news for SkyePharma, which had made Flutiform its lead drug prospect with annual sales anticipated at around the $500 million mark. The setback will also interfere with Abbott's game plan to introduce the drug alongside next-gen asthma treatments as well as new generic versions of big earners like Advair.

- read the SkyePharma release