Following the FDA's decision in June to require more clinical trials of SkyePharma's asthma drug Flutiform, partner Abbott has returned U.S. marketing rights to the British drugmaker. Under an agreement, there are no material payments due by either party on termination.
Earlier this year, the FDA said 'substantive' issues would need to be addressed before Flutiform app could be approved. And this effort would require significant clinical work, as the agency wanted additional data on dosing. The agency would also require a large post-approval safety study. Those conditions were sufficient to scare Abbott away; the company had already handed back control of the U.S. NDA to SkyePharma before today's announcement.
"Given the delay in obtaining approval for Flutiform in the United States, we are not surprised that Abbott has decided to terminate its interest in the product," notes SkyePharma CEO Ken Cunningham. "However, SkyePharma is continuing to investigate whether there is a viable way forward in the United States, and we have not given up on finding a pathway. If there is a way forward, the group would seek a new U.S. licensee with strategic interest in the product and which would finance any additional clinical work required."
The company has filed a Flutiform app in Europe and is also pursuing Japanese approval of the drug, with Phase III trials expected to begin in March 2011.
- here's the release from SkyePharma
- read the Reuters report for more