20th Dec 2007 07:01
Skyepharma PLC20 December 2007 SkyePharma Amends U.S. FlutiformTM Agreement LONDON, UK, 20 December 2007 - SkyePharma PLC (LSE: SKP) today announces it hasrevised the agreement with Abbott for the development and commercialization inthe United States of FlutiformTM, the Company's product under development forthe treatment of asthma. Under the terms of the amended agreement, Abbottassumes the responsibility and costs for additional clinical work required andagreed upon by the U.S. Food and Drug Administration (FDA) and submitting theNew Drug Application (NDA) for Flutiform. SkyePharma's Chief Executive, Frank Condella, said, "We are very pleased toannounce this revised agreement. Abbott has been a very supportive partnersince acquiring Kos Pharmaceuticals, which had licensed the U.S. marketing anddistribution rights for Flutiform. We welcome Abbott's increased involvement inthe required additional clinical work and NDA filing, areas where they havesubstantial expertise." SkyePharma will no longer incur the planned research and developmentexpenditures of approximately US$20 million (£9.8 million) on the additionalPhase III FDA-required studies. In return for Abbott incurring the additionalcosts on completing the development of Flutiform, SkyePharma has agreed toreduced milestone payments due on the acceptance of filing and approval. Takingthis into account, together with the effects on milestones of the delay infiling announced on 6 August 2007, SkyePharma may now receive up to US$124.5million (£61 million) in total milestones instead of the previously statedUS$165.0 million (£80.9 million). Sales-related milestones and royalty ratesremain unchanged. Abbott continues to be responsible for managing and funding any trials neededfor additional indications, as well as any required post-marketing studies. Onceapproved by the FDA, Abbott retains its exclusive rights to market Flutiform inthe United States. SkyePharma remains responsible for the existing Phase III clinical developmentprogram costs, which comprises the completed safety study and three efficacytrials that are on schedule to be completed by April 2008. Additionally,SkyePharma continues to manage the Chemistry, Manufacture and Control programand the supply chain for Flutiform. FlutiformTM HFA-MDI FlutiformTM HFA-MDI is a fixed-dose combination of formoterol and the inhaledsteroid fluticasone in a metered dose inhaler ('MDI'). The investigationalproduct incorporates a fast onset long-acting beta-agonist (formoterol) with themost commonly prescribed steroid (fluticasone) in combination with anenvironmentally friendly aerosol propellant ('HFA') and is being developed forasthma. FlutiformTM is aimed at the market for combination steroid andlong-acting beta-agonist inhalers which is forecast to be approximately US$10billion worldwide (including US$8 billion in the US) by 2010, which is when weexpect FlutiformTM to be in the market in both the US and Europe. 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, visitwww.skyepharma.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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