6th Aug 2007 07:01
Skyepharma PLC06 August 2007 Flutiform(TM) Progress Update LONDON, UK, 6 August 2007 - SkyePharma PLC (LSE: SKP) today provides an updateto investors on Flutiform(TM), the Company's lead development product for thetreatment of asthma. As envisaged in the AGM statement released on 29 June2007, a routine pre-NDA (New Drug Application) meeting was held in July with theUS Food and Drug Administration ("FDA") to discuss the planned regulatory filingfor Flutiform(TM). 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 withthe progress being made with the CMC programme. However, unexpectedly, the FDAqueried one particular aspect of the design of the clinical trial programme.The Company has considered this issue carefully and it has concluded that, inorder to provide further information to satisfy the FDA, it may be necessary togenerate additional clinical data to supplement the ongoing Phase III programme.Further discussions will be held over the coming weeks with the FDA to agreethe scope of any additional clinical work. Undertaking this work could resultin the filing of the Flutiform(TM) NDA being delayed to the second half of 2008.Our current estimate is that the additional net cash cost to the Company of anyadditional 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'srequirements 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). Thelong-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 thetimescales or costs of completing the development of Flutiform(TM) in Europe. Commenting, Frank Condella, CEO of SkyePharma, said: "Flutiform(TM)'s potential is exciting due to its unique combination of thefastest onset long-acting beta-agonist (formoterol) and the most commonlyprescribed steroid (fluticasone). Although the potential requirement foradditional clinical data would mean that we face some delay to the filing ofFlutiform(TM), we are pleased with the progress being made with the FDA on allother aspects of the planned filing and we are encouraged by the level ofcommitment of Abbott Laboratories, our US partner, to the project." Eugene Sun, M.D., vice president of Global Pharmaceutical Clinical Developmentof Abbott Laboratories, added: "Abbott supports undertaking the best clinical approach to producing thescientific evidence needed to secure an FDA approval for Flutiform(TM)." For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has eleven approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe 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. Pleasecall Mo Noonan for further details on 020 7269 7116 or email [email protected] addition there will be a webcast for other interested parties atwww.skyepharma.com. Certain statements in this news release are forward-looking statements. inparticular in relation to the timing of regulatory filings and estimated costs.Although SkyePharma believes that the expectations reflected in theseforward-looking statements are reasonable, it can give no assurance that theseexpectations will materialize. Because the expectations are subject to risks anduncertainties, actual results may vary significantly from those expressed orimplied by the forward-looking statements based upon a number of factors, whichare described in SkyePharma's Annual Report. Factors that could causedifferences between actual results and those implied by the forward-lookingstatements contained in this news release include, without limitation, risksrelated to the timing and scope of any additional clinical work . SkyePharmaundertakes no obligation to revise or update any such forward-looking statementto reflect events or circumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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