7th Nov 2006 07:01
Skyepharma PLC07 November 2006 For Immediate Release 7 November 2006 SkyePharma PLC ABBOTT ACQUIRES KOS PHARMACEUTICALS POSITIVE DEVELOPMENTS FOR FLUTIFORM(TM) LONDON, UK, 7 November 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) notesthat Abbott yesterday announced the acquisition of Kos Pharmaceuticals, Inc. Koshas the exclusive licence to jointly develop Flutiform(TM), SkyePharma's novelcombination product for asthma and chronic obstructive pulmonary disease ("COPD"). In their statement Abbott said: "Flutiform(TM), in-licensed from SkyePharma, is currently in late-stagedevelopment for adult and adolescent asthma and will provide an expandedpresence for Abbott in the $10 billion asthma market, in addition to Kos'currently marketed asthma product." SkyePharma Chief Executive Officer, Frank Condella, said: "We are encouraged by Abbott's statement regarding Flutiform(TM). Thistransaction is a positive development for our lead product. Abbott bringsadditional size and marketing strength in the primary care area whichcomplements the specific expertise Kos has in inhalation therapies." For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich The Trout Group + 1 617 583 1308Seth Lewis About SkyePharma PLC SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now eleven approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. About Flutiform(TM) SkyePharma's product Flutiform(TM) consists of a unique fixed-dose combination ofthe long-acting bronchodilator formoterol with the inhaled steroid fluticasonein a proprietary non-CFC metered-dose aerosol inhaler with a dose counter.Formoterol provides 12 hours of bronchodilation and has a rapid onset of action(1-3 minutes). By contrast salmeterol, the bronchodilator used inGlaxoSmithKline's Advair/Seretide, also provides 12 hours of bronchodilation butneeds up to 30 minutes after inhalation to take effect. The inhaled steroidfluticasone (a component of Advair/Seretide) has low systemic absorption and isperceived to have a better safety and efficacy profile than budesonide, thesteroid used in AstraZeneca's Symbicort, and is the physician-preferred inhaledsteroid in the US. The proprietary SkyeDry(TM) formulation technology employed inFlutiform(TM), designed to stabilise the active components and thereby ensure areproducible dose even after prolonged storage, provides patent protection to2019. The product will be available in two dose combinations with each dosedelivering 10 microgrammes of formoterol with either 100 or 250 microgrammes offluticasone. Flutiform(TM) completed its Phase II trial in asthma in 2005. The resultsconfirmed that Flutiform(TM) behaved exactly as if the two component drugs hadbeen taken separately, with rapid onset of bronchodilation that was maintainedfor 12 hours, no evidence of drug-drug interactions and no safety concerns. Following discussions with the FDA on the Phase II trial results, the Phase IIItrial of Flutiform(TM) started on schedule in February 2006. The trial programmeis on track for SkyePharma's target of regulatory submission in the second halfof 2007. SkyePharma believes that Flutiform(TM) should reach the US market in2009. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances 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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