SkyePharma's long-troubled attempt to gain FDA approval for the asthma drug Flutiform officially hit a brick wall today, with the agency demanding what the developer termed significant new clinical work before it could OK the therapy.
"From the discussions held at the meeting it is apparent that the FDA's requirements for approving Flutiform have changed materially during the course of the development program and meeting these requirements would involve significant additional work, including a large post-approval safety study," SkyePharma complained in a release. The company added that it is working with its advisers to review all of the options available to it "with a view to determining whether there is a viable way forward."
Analysts, though, were quick to assume that there is no viable path forward. Singer Capital Markets analyst Shawn Manning told Dow Jones that it is all but certain that SkyePharma will pull the plug on U.S. development of the drug, which was submitted for an approval in 2007. Investors weren't holding out much hope either, abandoning the company as its shares fell to a low of 27 pence.
- read SkyePharma's release
- here's the report from Dow Jones