Shares in UK drugmaker SkyePharma have taken a bashing this morning on the news that US regulators are asking for more information on its lead development product Flutiform, for asthma, which is almost certain to delay a filing.
Following a routine pre-New Drug Application meeting with the US Food and Drug Administration, SkyePharma has noted that the agency “unexpectedly queried one particular aspect of the design of the clinical trial programme” for the combination respiratory drug Flutiform (fluticasone and formoterol). The company said that it has considered the issue carefully and has concluded that, “in order to provide further information to satisfy the FDA, it may be necessary to generate additional clinical data to supplement the ongoing Phase III programme”.
A company spokeswoman told PharmaTimes World News that discussions will be held with the FDA to agree the scope of any additional clinical work and that SkyePharma hopes to have the answer by September. If the firm’s worst fears are realised, undertaking this work could result in the filing of the Flutiform NDA being delayed to the second half of 2008 and could cost in the order of £3-£5 million.
However, SkyePharma chief executive Frank Condella was upbeat and said that “Flutiform’s potential is exciting due to its unique combination of the fastest onset long-acting beta-agonist (formoterol) and the most commonly prescribed steroid (fluticasone)” and although the potential requirement for additional clinical data would clearly hurt, “we are pleased with the progress being made with the FDA on all other aspects of the planned filing.”
He added that the firm is “encouraged by the level of commitment of Abbott Laboratories, our US partner, to the project”, a view reinforced by Eugene Sun, vice president of global pharmaceutical clinical development at the latter firm. He added that "Abbott supports undertaking the best clinical approach to producing the scientific evidence needed to secure an FDA approval for Flutiform.”
Such statements have failed to reassure investors for the moment, however, and at 9.50am, SkyePharma shares were down 9.3% at 19.5 pence.