BioWorld International Correspondent
LONDON - Shares in SkyePharma plc fell by 11 percent to 19 pence early on Monday after the company disclosed that the FDA has raised "unexpected" concerns about the Phase III trial design for flutiform, a combined asthma treatment.
Frank Condella, CEO, said the additional clinical work required would cost between £3 million to £5 million (US$6.1 million to US$10.2 million) and push back the filing date from the end of this year to the second half of 2008.
The discrepancy on the trial design arose in the course of a pre-NDA discussion. "Overall this meeting went well," Condella said in a conference call. "There were no substantive issues."
Ken Cunningham, chief operating officer, declined to specify exactly what shortcoming the FDA specified with the trial design, but said it is "entirely addressable."
"We expect more clinical data will be needed, but we are in negotiations. We don't want to have that discussion in public," he said. London-based SkyePharma expects to define exactly how much more data it needs to generate by the end of September.
Condella emphasized that the meeting was pre-NDA, and the FDA reservations are not based on any review of the safety or efficacy data, as none has been submitted as yet. "It's good to get this [feedback] now, and not as an approvable letter. There is a silver lining when you get into dialogue with the FDA at this stage."
Cunningham said the extra cost is manageable within current cash projections. The U.S. marketing partner for flutiform, Abbott Laboratories Inc., of Abbott Park, Ill., will be making a "substantial contribution" that will be taken back from the first major milestone after approval.
The Phase III trial design was agreed with the FDA in February 2006, just after Condella joined SkyePharma, but the pre-NDA meeting was the first time he has been involved directly in any talks with the FDA over flutiform.
"As happens from time to time with the FDA, things change. It's always their prerogative to request other information," he said.
The European filing, due by the end of 2008, will not be affected by the FDA's stance. Cunningham does not think the overall competitive position will be harmed by the delay. "We believe we are reasonably well ahead of the competition, even moving into the second half of 2008 for a [U.S.] filing."