FlutiformTreatment for Asthma
SkyePharma PLC - Flutiform Progress Update
LONDON, UK, 6 August 2007 - SkyePharma PLC today provides an update to investors on Flutiform, the Company's lead development product for the treatment of asthma. As envisaged in the AGM statement released on 29 June 2007, a routine pre-NDA (New Drug Application) meeting was held in July with the US Food and Drug Administration ('FDA') to discuss the planned regulatory filing for Flutiform. The meeting covered the clinical, non-clinical and CMC (Chemistry, Manufacture and Control) development aspects of the project.
Following the meeting with the FDA, the Company has increased confidence with the progress being made with the CMC programme. However, unexpectedly, the FDA queried one particular aspect of the design of the clinical trial programme. The Company has considered this issue carefully and it 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. Further discussions will be held over the coming weeks with the FDA to agree the scope of any additional clinical work. Undertaking this work could result in the filing of the Flutiform NDA being delayed to the second half of 2008. Our current estimate is that the additional net cash cost to the Company of any additional clinical work over the period up to approval could be in the order of £3m to £5m. The Company will make a further announcement when the FDA's requirements have been clarified.
Encouraging progress continues to be made with the current Phase III trials, with over 1,500 patients recruited to date (over 85% recruitment). The long-term safety study is now complete and the data is being collated.
Any additional clinical work required for the FDA is not expected to affect the timescales or costs of completing the development of Flutiform in Europe.
Commenting, Frank Condella, CEO of SkyePharma, said:
'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). Although the potential requirement for additional clinical data would mean that we face some delay to the filing of Flutiform, we are pleased with the progress being made with the FDA on all other aspects of the planned filing and we are encouraged by the level of commitment of Abbott Laboratories, our US partner, to the project.'
Eugene Sun, M.D., vice president of Global Pharmaceutical Clinical Development of Abbott Laboratories, added:
'Abbott supports undertaking the best clinical approach to producing the scientific evidence needed to secure an FDA approval for Flutiform.'
For further information please contact:
Frank Condella +44 20 7491 1777
Financial Dynamics (UK Enquiries)
David Yates +44 20 7831 3113
Trout Group (US Enquiries)
Christine Labaree +1 617 583 1308
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies.
For more information, visit www.skyepharma.com
Note to Analysts
There will be a conference call for financial analysts today at 9 a.m. Please call Mo Noonan for further details on 020 7269 7116 or email firstname.lastname@example.org. In addition there will be a webcast for other interested parties at www.skyepharma.com.
Certain statements in this news release are forward-looking statements. in particular in relation to the timing of regulatory filings and estimated costs. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma's Annual Report. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the timing and scope of any additional clinical work . SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.
Posted: August 2007
- SkyePharma Inc. Says FDA May Need More Flutiform Data - June 10, 2009
- Skyepharma plc: Flutiform NDA Accepted for Review - May 22, 2009